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The Ugliest Part of Wall Street: Jim Cramer and his cronies: Adam Feuerstein, Martin Shkreli                                      

By Réza Ganjavi

 

Jim Cramer

Jim Cramer is the guru of deception and lies. He boasts about deception and dishonesty: "But what's important when you're in that hedge fund mode is to not do a thing remotely truthful, because the truth is so against your view that it's important to create a new truth to develop a fiction." Jim Cramer. https://www.youtube.com/watch?v=GOS8QgAQO-k – longer version: https://www.youtube.com/watch?v=gMShFx5rThI

Jim Cramer admits to illegal activity, manipulation, deceptive practices. This is as bad and ugly as Wall Street gets.

The convicted crook, Martin Shkreli, and Adam Feuerstein both worked for Cramer – he was

their mentor and boss.

Adam Feuerstein

Adam Feuerstein has been considered by me and some others as the most hated journalist on Wall Street. What does journalism have to do with Wall Street? See the Cramer video above! 

He’s engaged in relentless bashing of some stocks that are heavily manipulated and shorted. 

Steven Pearlstein: “Adam Feuerstein, a biotech reporter whose relentlessly negative blog posts for thestreet.com this year have not only been filled with exaggeration, mischaracterization and half-truths, but curiously have also coincided with the spikes in short trading.” 

Adam Feuerstein and his friend Martin Shkreli are both from Cramer school. Shkreli was short big on Avanir. See notes in Avanir section below on Feuerstein’s bashing. Also Seeking Alpha was supporting Shkreli. I know this first hand. Shkreli is in prison.

Feuerstein is not a securities analyst. He has no academic credentials in finance, medicine, biology, or any other health-science. He studied Political Science!

This list of issues with Adam is long. Here’s a snapshot.

Citizens for responsibility and ethics in Washington (CREW) alleges that Adam Feuerstein is involved in stock manipulation scheme.

“CREW requested the Securities and Exchange Commission (SEC) investigate possible illegal manipulation of stock prices in Northwest Biotherapeutics, a biotechnology company developing cancer treatment drugs.  Strategically released blog posts by well-known biotech stock analyst and senior columnist for TheStreet.com Adam Feuerstein seem designed to cause the price of the company’s stock to fall at times when short sellers were financially overexposed.  CREW has asked the SEC and the U.S. Attorney for the Southern District of New York to conduct a full investigation of the timing of Mr. Feuerstein’s posts and their relationship to short seller financial interests.” – That completely fits the Cramer school of thought (see video above).

“It also has implied that Adam Feuerstein, a reporter for TheStreet.com, may be in cahoots with the shorts.” https://www.latimes.com/business/hiltzik/la-fi-mh-a-washington-post-columnist-takes-aim-at-shortsellers-but-misfires-20140929-column.html

Open Letter to FTC Alleges Unlawful Intent, Advertising Fraud, Deception

“This flagrant inaction to rectify obvious and possibly slanderous errors possibly establishes willful action on the part of CEO Ms. Elisabeth H. DeMarse, Adam Feuerstein, James J. Cramer & The Street, Inc. a publicly traded corporation possibly demonstrates ongoing unlawful intent in perpetrating a systematic, active and recurring Advertising Fraud and Deception within all States in the U.S. by utilizing the internet as a dissemination vehicle for possibly systematically publishing”

http://x54389.weebly.com/617-open-letter-to-ftc-re-the-street-inc-possible-nationwide-advertising-fraud-and-deception.html#page_4

Spectrum Pharmaceuticals Battles the Shorts and Adam Feuerstein

“Adam's Feuerstein's Intentionally Misleading Headlines and Distorted Articles.” https://web.archive.org/web/20170309174028/http://www.exposeadam.com/

Adam Feuerstein’s inaccurate reports are becoming patient safety issue claims biomedical company CEO

https://www.biomedreports.com/articles/most-popular/1683-reporters-inaccurate-articles-are-becoming-patient-safety-issue-claims-biomedical-company-ceo.html

Not long after the announcement, TheStreet.Com’s biomedical columnist Adam Feuerstein leveled an accusation that Oculus “appeared to be skirting U.S. drug laws by claiming that its wound-cleansing product containing common diluted bleach has drug-like therapeutic properties.” “This is becoming a patient safety issue and putting public safety at risk,” Alimi told BioMedReports in an exclusive recorded interview. “It’s no longer [about] attacking a company and the market potential and market cap. You’re damaging public safety.” Ocolus CEO felt that the publication had fallen short of reporting the truth and science behind the technology accurately. “When you haven’t done your due diligence and you don’t understand the basic chemistry of our product [and] you make recommendations like that you are putting patients’ safety at risk,” insists Alimi. “There has to be a level of integrity in the research written and I think that’s really lacking in their case.

The Truth about Adam Feuerstein

This article has a lot to say about Adam. I don’t know how much of it is true. Reader can decide for themselves: http://bioinvestor204.blogspot.com/2014/02/the-adam-feuerstein-lie-with-his.html

Collection of Adam Feuerstein Bashing Stocks

https://www.investorvillage.com/smbd.asp?mb=971&mn=336133&pt=msg&mid=8823648

Washington Post Calls For An Investigation Into Hedge Fund Trading And Adam Feuerstein's Blogging

The article was written by Steven Pearlstein, a 2008 Pulitzer prize winner. The Post suggests that there may be a wide spread criminal conspiracy that has victimized many small biotechnology companies and their investors. The Post also focuses on the prominent role of Adam Feuerstein in this situation. https://seekingalpha.com/instablog/649685-smith-on-stocks/3312775-washington-post-calls-for-an-investigation-into-hedge-fund-trading-and-adam-feuersteins-blogging

Mr. Pearlstein highlighted the role of Adam Feuerstein, a biotech columnist for TheStreet.com. Mr. Feuerstein’s “relentlessly negative blog posts”… have curiously “coincided with the spikes in short trading” of the company’s stock. https://www.citizensforethics.org/why-did-comments-critical-of-thestreet-and-adam-feuerstein-disappear/

Short & Distort

Adam clearly doesn’t have the qualifications, credentials, education, background, medical knowledge to duel with doctors and scientists who call out his lies. So where does he get his info from? Is he merely parroting lines that he’s told? By whom? I don’t have the answer to these questions explicitely, but I do know that many hedge funds who engage in “short and distort” have medical doctors and PhD’s on their payroll who help them stir up fictions and lies. Shkreli’s company claimed to to have MD’s and PhD’s on staff.

“Short & Distory” is an age old strategy on Wall Street (see Cramer’s video above). Hedge fund lobby fiercely defended the practice at a SEC’s roundtable. Is Adam part of that scheme? Many think that he’s been. I also believe that Adam is not talking only for his own opinions. 

Martin Shkreli

“Pharma bro” is known as the most hated man on Wall Street. In my book, he only comes after his guru, Jim Cramer, and Adam Feuerstein, as the worst of Wall Street. He’s serving a 7 year prison sentence.

__________________________________________________________

HEDGE FUND MANAGER MARTIN SHKRELI tried to dissuade the FDA against ARNA(Arena) (but failed -- I told him he'd fail). Before that he shorted AVNR (Avanir) in a manner which many felt uneasy about since his arguments seemed problematic to say the least. There he said he'll donate 50% of his gain to charity and agreed to be held accountable. I held him accountable as a member of public but to date he's failed to show his charity contribution.

Later on he covered his short position at a nice profit.

I wrote to him and called and exchanged emails. Here's one. The previous correspondences were to his old company MSMB CAPITAL (msmbcapital.com) doesn't seem to exist any more.

Martin Shkreli
Retrophin, Inc.
777 Third Avenue, 22nd Floor
New York, NY 10017
Telephone: (646) 837-5863
Email: info@retrophin.com

Subject:       For Martin Please    

From:           Reza Ganjavi

To:     martin@retrophin.com   (also sent later  to marc@retrophin.com, pschwartz@rxir.com since I have no idea if Martin got the mail or not despite having sent it from different accounts and requesting feedback).

Tue, 19 Mar 2013

Hi Martin

On March 21 2012 when ARNA was around $1.95 you wrote that Arena is "wildly overvalued". And your attempts to influence the FDA obviously didn't work despite the MD's and PhD's you bragged about having on your staff.

I'm writing to follow up on the pledge you made about AVNR, your assistant confirmed on February 21, 2012 that you have "committed to donating a large sum to an organization" and that you were planning a joint announcement in the near future.

It's been over a year and I haven't heard of any such announcements.

Given the fact that you made the pledge in an AVNR article (in which you misrepresented Avanir's patents before the price drops significantly), I suspect such announcement would be made to Avanir investors who were your audience at the time and were misled by your false argument on the patents.

As a reminder, you wrote an article on May 31, 2011 in which you said: "I promise to donate 50% of my personal AVNR-related profits to charity. I agree to be held accountable to this."

Since you offered, I'm holding you accountable. What charity was it donated to? When was the announcement made? What was donated?

Would appreciate an update on that.
Kind Regards

Reza Ganjavi

~~~~~~~~~~~~~~~

I never held back.

Him or his assitant had told me the gift giving was a big deal and it would take time as they'd need to get lawyers and media etc. involved. As far as I know it never happened and a promise went unfulfilled. Talk is cheap I guess. I am ready to stand corrected but I've done my diligence to see if Mr. Shkreli will acknowledge his promise or not and so far have not seen any proof of it.

~~~~~~~~~~~~~~~
CASE CLOSED.

 

 

 

__________________________________________________________ .

 

Problem of Naked Shorting; Corruption in US Financial System (as of Oct 2008); and what Dr. Patrick Byrne / DeepCapture is doing to fight it. [and related sites]

October 2008
by Reza Ganjavi

Dr. Patrick Byrne: “It’s not a little corruption at the edge of the system, it’s the system!”

Related sites : http://www.thesanitycheck.com
http://investigatethesec.com
http://www.thefaulkingtruth.com/
http://www.rgm.com/shortselling.html

If you don't know what shorting and naked shorting in the context of the stock market is, please Google the subjects.

The SEC’s charter is to protect the investors against abusive behavior but it has done very little so far. It has not brought a single case against illegal naked shorting.

Chairman Cox has said: “Illegal naked short selling is specially a threat to smaller public companies whose relatively thin market capitalization can be more easily manipulated.”

Chairman Cox: “The extreme abuses that are reflected in securities being chronically listed on Reg Sho’s threshold security list for months and years at a time is ample evidence that there is also fraud in the market that needs to be arrested.”

A couple of months ago when the financial turmoil heated up, the SEC temporarily banned naked short selling for 19 financial companies. Not all companies but just 19.

Richard Baker, a former representative and member of House Financial Services Committee who is now the CEO of “Managed Funds Association” which is the main US trade association for the hedge fund industry complained about this ban in an interview with Bloomberg with some arguments such as: “we don’t know what the SEC is trying to fix”. Really? Nothing is broken right?

And Mr. Bush’s SEC, as it stands today, has failed to properly police Wall Street. Want a good examople? Take a look at the naked short list.

Deepcapture.com does a great job of exposing naked shorts. Take a look at: “Deutsche Bank Sold Massive Amounts of Phantom Stock” story on that website.
There are so many examples. There is so much corruption on Wall Street and such a cleanup job to do. Hopefully in the administration will clean up this mess.
When a hedge fund pays over $100M per year in commissions it has clout. When SEC doesn't act, things get worse. SEC is supposed to be policing Wall Street. Wall Street has not and will not police itself.  

Secretary Hank Paulson: “Naked short selling is wrong anywhere. Any investor, before they sell short, should line up the stock, and that goes without saying.”


=====================

Allegation: SEC officials provided confidential information to former colleagues working on Wall Street.

Interestingly enough the Washington Post reported today that :

"Senate investigators are looking into allegations that the head of SEC’s enforcement division, Linda Thomsen, gave information about investigations into Bear Stearns to the general counsel of J.P. Morgan Chase."

Senator Charles Grassly wrote a letter to the SEC requesting feedback on this allegation and wrote:

"Such conduct would reinforce the appearance that Enforcement decisions, and disclosures of information about them, are sometimes based not on the merits, but rather on access to senior officials by influential representatives of power brokers on Wall Street."

There we go.

Speaking of Linda Thomsen, I wrote a hot letter to her last night and copied the SEC commissioners and some members of the congress. I was and am completely fed up with the fact that SEC enforcement division has not brought a case against any naked shorting abuses.

Here's the letter: <>

 

 

 

__________________________________________________________ .

 


TO: SEC Division of Enforcement, SEC Commissioners

7 August 2011, by Reza Ganjavi

Report to the Securities & Exchange Commission (SEC) to investigate trading and short-selling of Avanir (AVNR).

BACKGROUND

I am a proponent of Freedom of Speech. However, no form of freedom is absolute, and may not be abused. In the classic “short and distort” setting which the SEC is well aware of (reference: 5 May 2009 “Roundtable to Examine Short Sale Price Test and Circuit Breaker Restrictions” in which, I believe, it was Commissioner Walter who referred to the concept), this freedom is abused. The short who distorts often abuses freedom of speech. In certain cases companies who are victimized take action against such abuse, but in most cases, they don’t bother.

The purpose of this letter is to bring your attention to at least one such recent case, and also to bring to light other actions, which I believe, might  be abusive.

As in the case of the gun-shop owner in Texas who recently called the police because of a suspicious soldier, who turned out to be a terrorist, I believe, reporting suspicious activity to the SEC is prudent.

This complaint alleges that Avanir Pharmaceuticals may have been a victim of unethical and abusive short selling. Avanir (Nasdaq: AVNR) is a biopharmaceutical company focused on acquiring, developing, and commercializing novel therapeutic products for the treatment of central nervous system disorders. Within the past year it received approval for the first and only FDA-approved treatment for PBA, a debilitating condition which may occur in patients with ALS, MS, Parkinson's, Stroke, TBI, and other neurologic conditions.

AVANIR, A SMALL COMPANY AMONG NASDAQ’S TOP SHORT INTEREST POSITION

As of 26 July 2011, according to Bloomberg, Avanir was the 14th largest short interest position on Nasdaq – just behind Sirius Intel Dell Yahoo Cisco Microsoft etc., with 10’s of millions of shares of volume while Avanir’s volume was 1.2 million and the market caps are not comparable. 

The short thesis has been that PBA is not a real disease, and Avanir is going after a fictitious market. Science says otherwise. Credible surveys show there are hundreds of thousands of PBA patients in the US.

CONSEQUENCE OF SEC’S HANDS-OFF APPROACH TOWARDS SHORT-SELLERS ON THE ECONOMY

The SEC, specially, its Republican Commissioners, in the roundtable stated above, have demonstrated to be pro-short selling, supposedly as a tool to help liquidity, but while Wall Street enjoys its freedom to abuse short selling, Main Street is faced with the ugly, unethical, and almost criminal side of this practice on a day to day basis – something which our policeman, the SEC, doesn’t seem to care a bit about.

I believe you will go on for years seeking public comment and holding round tables but never acting, never mandating that large short sellers publicly report their position in a timely manner. The “frontrunner” excuse is just an excuse not to act. It just lets abusive short selling, together with its abuse of freedom of speech, to rape investors and small companies. This includes using journalists, and trolls who disparage Avanir around the clock on public forums attempting to persuade investors to sell their shares by causing fear uncertainty and doubt.

I also believe you will never put a stop to this lack of pre-borrow requirement which according to every criminal justice system, except the SEC’s, is just that: criminal. It is very simple: if I sell your car without even asking you if I could borrow it, it is criminal. This criminal abise happens in the US stock market every single day: people are selling things that they don’t own and not even bothered borrowing.

The consequence of the SEC not caring about these unethical acts of “short and distort” and “lack of timely disclosure of large short positions” and “lack of pre-borrow requirement” is that innovation is killed, which in turn hurts the US and the global economy.

In the case of Avanir, the company spent years and hundreds of millions of dollars in developing its medication to help hundreds of thousands of patients in the US and many more abroad, with a debilitating condition for which no other treatment had been approved. And a bunch of unethical cunning short sellers are doing everything they can to hurt the company. Avanir has enough cash to not depend on its stock in the short term but there are many other victims of short attacks which are destroyed because they can’t raise funds at attractive prices because short sellers have killed the stock.

“CHANNEL CHECKS”

In a recent Tweet, Martin Shkreli (see below) wrote: “DNDN simply breathtaking-Some hedge fund careers will end tomorrow -and I'm sure a few new superstars will be born. so much 4 channel checks”. I assume what is meant by “channel checks” is insider information. What else could it mean in this context? That if “channel checks” were effective we would have known Dendreon had poor earnings. That information is not public until it’s made public. Is it that in the world of these hedge funds, receiving public information before it’s public is not unusual? Isn’t that criminal?

CONGRESSIONAL HEARING

In 9 trading days the price of Avanir soared from $3.25 to $4.80. This translates to about $50,000,000 of losses for the short interest. Reaching $5 would have meant new funds would be eligible to buy, potentially sending the losses for short sellers into hundreds of millions of dollars as a whopping 31.6% of the float is short.

On May 23, Senator Herb Kohl, Congressman Henry Waxman, Congressman Frank Pallone, Congresswoman Diana DeGette wrote the following letter to Avanir: http://aging.senate.gov/hearing_detail.cfm?id=332993&

There are so many pharmas and so many have drugs which are much more expensive than Avanir’s. Avanir is just a new kid of the block and is just learning how to kick the ball, and just as its stock is about to reflect the true prospects for the company these congress people decide to pick on Avanir to investigate the pricing. We do not know the facts, but a lot of people, including respectable industry analysts were appalled not just by this investigation, but by its timing or considered it a non event. Influenced by shorts or not, it did set off a momentum to push the stock down.

Recently, the Senate Commission on Aging came to the conclusion that Avanir is off the hook (http://aging.senate.gov/events/hr236rpt.pdf), citing Avanir had spent $239 Million in developing the drug, etc., and outcome everybody could predict, nevertheless, the company wasted precious resources and tax payers wasted precious resources. Was this inquiry influenced by short sellers? Many believe it did. I do not know. But I collected some of the comments which can be found here: http://home.datacomm.ch/rezamusic/avanir_congress.html

MARTIN SHKRELI

Martin “Marty” Shkreli of MSMB Capital Management (212-983-1310 330 Madison Avenue, 6th Floor New York, NY 10017) is a hedge fund manager and short seller of AVNR.

Some info about his background can be found on https://sites.google.com/site/vatsire/Searching-for-Martin-Shkreli

Noteable in his background:

- Four years at Jim Cramer’s company, “Cramer Berkowitz”. I’d like to remind you of Jim Cramer’s famous statement which perfectly portrays the corrupt values of some powerful elements of Wall Street:

"But what’s important when you’re in that hedge fund mode is to not do a thing remotely truthful, because the truth is so against your view that it’s important to create a new truth to develop a fiction."

- Mr. Shkreli was sued by Lehman Brothers and a $2,300,600.00 judgment was levied against Mr. Shkreli, et al. by the Supreme Court of the State of New York.

On May 31, 2011, Mr. Shkreli published an article in which he disparaged Avanir and its patents. According to an Avanir spokesman, Shkreli’s arguments were flawed, inaccurate, and misleading. Details of his flawed arguments have been argued extensively on public forums but fact is, he is short and he uses an inaccurate argument to disparage the stock. What else is “short and distort” if not this?

The timing of this article was also suspect. It was released a few days after the Congress inquiry while the market was ignoring the congress inquiry as insignificant and the stock was beginning to rally again. The day he released the letter the stock was $4.74. Avanir was a victim of further short attacks again, the short interest rose, and the price went as low as $3 in the following weeks.

Mr. Shkreli continues to disparage Avanir in his Tweets and discourage investors from buying Avanir stock.

GOOD NEWS: MARTIN SHKRELI WAS ARRESTED TODAY, 17 DEC 2015 ON CHARGES OF FRAUD, RUNNING A PONZI SCHEME, ETC.

 

ADAM FEUERSTEIN 

Mr. Feuerstein is a senior columnist for TheStreet.com, again, associated with Jim Cramer, and reportedly in contact with Martin Shkreli (according to his Tweets). He has touted and celebrated when Avanir showed a weak week sales data in the earlier stages of the launch but remained awfully quiet on many weeks when the sales data were very good. He just tweeted a statement which some interpret as making fun of PBA: “For those who haven't laughed or cried uncontrollably enough over the past 2 days, we have $AVNR earnings on Monday.”

Neither Shkreli nor Feuerstein have any academic degrees we know about which qualifies them to judge biotech companies. Here’s one website dedicated to exposing Feuerstein: http://www.exposeadam.com. “Adam Feuerstein wouldn’t know good science if it bit him in the ass" - Dr. William A. Carter

 

THOMAS WEI - JEFFERIES & COMPANY 

Around November 2010 Jefferies had a $10 and then $15 price target for Avanir. They underwrote a public offering for the company at a price of around $4.40. Their analyst Andrew Fein was very bullish about the stock: "To add icing to the cake, there is no black box warning on Nuedexta's label, which gives Nuedexta no restrictions in its target patient population".

Things have only gotten better since then for Avanir. Weekly script numbers have been rising. Yet short interest grew to over 33 Million shares. But Jefferies’ analyst Thomas Wei “initiated” coverage of Avanir and gave it a price target to $3.50 despite citing a $4B market potential.

Three other analysts who follow the stock all have much higher price targets (e.g. Wedbush: $13, covered by the notable analyst with excellent credentials and track record, Dr. Gregory Wade). Thomas Wei has consistently done a hatchet job on Avanir including his latest so called report which we have indication to believe it makes the short interest happy. I suspect Jefferies might have clients who hold large short interests in Avanir.

In his latest hatchet job, Thomas Wei took a stab at European estimates which he’s entitled to, but whether they’re fair or accurate, and whether they’re a part of a short-and-distort scheme or not is another question. It happened on the day the company released a good news article about Europe, and the stock had enjoyed a 7 day rally. 

I tried to contact the firm, both Mr. Wei and their CEO, Mr. Handler, for comments but either they were not reachable (Mr. Handler) or rude and refused to talk to me after giving me the run around (Mr. Wei’s organization). Other analysts who stand behind what they say are not afraid of talking with investors and journalists. Whose side is Mr. Handler on? Truth, fairness, or short sellers?

Public opinion about Jefferies’ hatchet jobs have not been kind. Jefferies has been accused of “representing the interests of those who are short”, and of being a "short propagandist”. I do not know if these charges are true or not but am only including these as a citizen journalist.

If the SEC has any interest in investigating the trades in Avanir, this tiny company’s shares, which is among the top shorted stocks on Nasdaq, you may get surprised at what you find.

The least Main Street is asking the SEC for is:

 

-        Enforcement of rules that require fair analyst reports which includes disclosure of number of clients who have a large short position

-        Timely public disclosure of short interest by large short sellers

-        A pre-borrow requirement

-        Criminal prosecution of “short-and-distort” incidents and not leaving it up to victimized companies to litigate civil cases against cash rich hedge fund perpetrators

 

I hope I have provided some tips and hints in this letter. Please investigate the trading in Avanir (AVNR) shares.

Thanks & Regards

  1. Ganjavi

<contact info>

 

UPDATES

Dec  2011 -- Hedge Funds & Congress in Bed !


This is incredible but is true.

"Congressmen aren’t the only ones trading on their inside info. A lucrative practice has sprung up in Washington, in which hedge funds and other investors pay handsomely for private meetings with top lawmakers or their aides, who give them an early scoop on market-moving news, the Wall Street Journal reports."

http://www.newser.com/story/135792/lawmakers-give-inside-info-to-big-investors-legally.html

http://online.wsj.com/article/SB10001424052970204844504577100260349084878.html

http://moneymorning.com/2011/12/23/congress-handing-out-stock-tips-to-hedge-fund-managers/

http://www.marketoracle.co.uk/Article32292.html


20 DEC 2011 - Jefferies & Hedge Funds

Excerpt from CNN report:

http://money.cnn.com/2011/11/03/markets/jefferies_hedgefunds/index.htm

"Dozens of Jefferies (JEF) hedge fund clients are scrambling to find another investment bank where they can warehouse client's money and execute trades, according to sources in the prime brokerage divisions at three competing banks. These sources said they spent all day Thursday fielding calls from hedge funds who could be potential clients....Jefferies has roughly 400 hedge fund clients that use its prime brokerage services to execute trades. It typically takes months, if not years, to win new hedge fund clients.... two sources said they inked deals with several Jefferies customers Thursday and were in constant conversations all day about signing on other clients. Lehman's demise killed several hedge funds and made operations difficult for others. "

400 Hedge Fund clients !!
Are any of them part of the gang which is short 29 Million share of Avanir?  If so, is Jefferies trying to cater to these hedge funds by writing their poor quality reports about Avanir ?

20 DEC 2011 - Jefferies Journalist Distortion

Last week an article hit the wire that totally misrepresented Avanir. It stated a big big flat out lie about Avanir -- very harmful to Avanir's image. Reminded me of SEC's notion of "Short and Distort" but who's to provide proof and who's to investigate it. Nobody. So I tried.

Unlike other analysts who are civilized polite courteous respectful, if you try to call Jefferies' analysts they are rude and don't talk to you. If you're not a client, for example, one of those hedge funds, you have no chance to get a straight answer. I tried but no chance. So I went straight to the CEO and demanded an answer to what appeared to be a latest hatchet job. The call found its way to assistant of their chief council and eventually I got an email back from him saying Thomas Wei's report was distorted by some journalist. Was I a bit surprised? 400 hedge funds, analyst who regularly has a negative tone, and now how surprising that a so called research report has turned into another hatchet job. I called the journalist. They corrected the article on their website. Didn't correct the "pushed" version b/c that would be reissue of a hatchet job. Meanwhile I found a couple of high powered NY securities lawyers and a friend's friend who's a high powered tort litigation lawyer and we had good discussions. If in fact this "error" was Jefferies, they'd end up paying handsomely but for now they're off the hook.  Needless to say given the level of disgust and intensity, the journalist was very cooperative. I asked him to publish another analyst's fresh report that has a price upgrade on Avanir. He agreed. I got the report and sent it to him and provided info so next time they get this analyst's report too.

The saga continues...

15 OCT 2011 - Letter about Jefferies

A friend wrote:

"it's highly unethical that Jefferies was the LEAD underwriting on Avanir's secondary offering at $4.40 and reiterates a Buy with a $15 price target! Months later some new analyst Wei says we INITIATE coverage (like you didn't already have coverage), with a $3.50 price target WHEN the stock was heading to $5.00 at the time of Wei's statement! Hopefully the SEC is looking into this potential conflict of interest!"

I agree with him. If this stock was so bad why did they think it would go up over 300% and then say they're "initiating" and attack just as it was about to go over $5 which would have been devastating for shorts. One thing for sure is Jefferies is no friend of Avanir.

13 OCT 2011 - Letter to Jefferies

I sent a letter to Jefferies after hearing that they may be fronting for shorts. I don't know if this information is true or not but I have read their analyst Thomas Wei's reports and would not be shocked if this information is true.

I sent the letter to the following (not sure if the email addresses are correct but none of them bounced but their email server is not set up for catch all so false emails do bounce back).

MBrinkman@Jefferies.com : Michael Brinkman (who was involved in the raise that Jefferies did for Avanir last year)
bfriedman@jefferies.com : Brian P. Friedman CPA, 55 Director, Chairman of Exec. Committee and Pres of Jefferies Capital Partners
twei@jefferies.com : Thomas Wei, Biotech analyst
rhandler@jefferies.com : Richard B. Handler, CEO, President, Jefferies Group Inc. 520 Madison Avenue - 10th Floor New York, NY 10022 United States 212-284-2300

The information that I referred to was the following which was stated by a person whom I think is credible based on his history (but I do not know if the following statement is true or not).

"As a favour I asked my friend to check with the fund's traders to see what the "inside look" is on AVNR.

He came back with two things. Jefferies is a big buyer lower with blocks of 400,000 shs to buy at $3.14 and 200,000 shs to buy at $3.08 and 200,000 shs to buy at $3.11.

The second thing is that Goldman Sachs - the prime broker for this hedge fund says there are NO SHARES OF AVNR AVAILABLE TO SHORT.

The third thing is that there is very little stock for sale. Currently the sellers include Raymond James and Stifel.

So my friends it is true.

The shorts are trapped and will have to cover higher.

And imo it appears Jefferies is fronting for the shorts.
"

Source: http://messages.finance.yahoo.com/Business_%26_Finance/Investments/Stocks_(A_to_Z)/Stocks_A/threadview?bn=27718&tid=287063&mid=287063

I gave it to Jefferies. That if it is true that they're fronting for the shorts they should reconsider it, and shared my opinion that shorts should bite the bullet and cover. I also reminded them of the ethical issues and consequences of being on the side of the shorts, if it's true, and if not, I apologized.

24 DEC 2011 Response to Jefferies' email:

Dear Sir:

The "error" sees to be on the part of the journalist. I talked to the media source that terribly distorted Jefferies news about Avanir and made it look like gaining patients was losing patients -- very bad stuff and highly damaging to Avanir -- they admitted it was their error -- what's behind the scenes no-one knows. You know given all the corruption and collusion on Wall Street I can't make head and tail of it. I am not accusing you and the press to be in bed but it does happen on Wall Street. Big influential hedge fund have analysts and journalists and brokers in their pockets. This is not a mystery.

As for ethics you must have heard Jim Cramer's famous remarks about how truth is against the short sellers' agenda. So in my opinion, there's something inherently corrupt about short selling, and despite the new rules market makers can naked short without much worry.

I have no idea what Jefferies is up to with regards to Avanir. I know you have some 400 hedge fund clients. I also know Avanir has over 29 Million shares shorted. How many shares your clients have shorted if any is unknown. SEC knows who the big shorts are but they're protecting their names so shorts have a ball in this day and age.

I just read http://money.cnn.com/2011/11/03/markets/jefferies_hedgefunds/index.htm which didn't surprise me.

The sentiments against Jefferies and Mr. Wei's hatchet jobs have been strong -- it kind of comes intuitively to some people reading Wei's reports that he's trying to bat for the shorts. But we have no way of proving this.

I read recently a person writing the following sentiment about Jefferies.

"I am happy to watch Socialisms crony capitalist enablers like Corzine and now Jeffries finally pay the price and have the real results of their plans exposed for all to see. Hopefully Jeffries downfall will eliminate their ability to control AVNR's stock price. One crack in their control, at a time when AVNR is in a position to declare ramping sales, could be all we need to burn these shorts. 30,000,000 shares @ 10.00 is 300,000,000. Traders that suffer that kind of hickey will be history. Lets hope Jeffries and their hedge fund lackeys burn in hell. LONG AND STRONG AND ANGRY AS HELL. Paul"

In closing, I remind you that if you guys are involved in protecting and helping these people who are large shorts in Avanir I tell you you're batting on the side of evil. Avanir is trying to help people improve their lives and these short sellers are out to destroy Avanir in order to make a dollar in a very unethical way. Very bad Karma. I and many other people have a guess that Jefferies might be a part of this action but that is just a guess, not an accusation because we have no proof of it but only hints. If that is true, I invite you to clean up your act and run a respectable ethical business.

Regards
R.Ganjavi
By the way check out www.avnr.info   (Except you Mr. Wei. There are facts there I think you prefer to ignore).

24 Dec 2011 Another Letter to SEC

Gentlemen:

Congratulations on your recent winnings against illegal short sellers. I hope you build up on that momentum. Maybe you can have a look at the shorting of AVNR.

Jefferies has some 400 hedge fund client.

Avanir (Nasdaq: AVNR) has been under regular attacks by Jefferies' analyst Thomas Wei.

This month an article was published which totally falsified Avanir -- JEF says the journalist twisted it -- but there's so much corruption that it's hard to believe anybody. I reported this before knowing it's the journalist's fault and then reported back saying it wasn't JEF's fault but we just don't know what occurs behind the scenes. As you know pwerful hedge funds have brokers analysts and journalists in their pockets.

AVNR has been manipulated (in my and many people's opinions) by a short interest  of over 29,000,000 shares (1/4 of the float).  Shorts made the wrong bets from pre-FDA approval all the way through launch. Sales rose 100%  Q-over-Q. Over 70% of shares are owned by institutions.

A discussion on JEF and a past letter to SEC is on  http://home.datacomm.ch/rezamusic/SEC_Avanir.html

Unfortunately I don't have much evidence for you. But the wild card is in the hands of the SEC because you know who the large shorts in AVNR are.

Many people believe JEF has takes the negative attitudes it takes to possibly help shorts but we do not know if this is true by way of evidence.

Also as you know market makers are allowed to naked short a stock (almost to death) and get away with it.

It's up to you what you do but I thought I'd share this with you.

Merry Christmas and Happy New year.
Kind Regards
A beat up "Main Street" investor (vs. Wall Street's crooks).

 

__________________________________________________________ .

 

MANIPULATION OF AVANIR

 

Note: Avanir was manipulated by Martin Shkreli and others down to the $2 range. These scum hedgies were all wrong. Avanir was later acquired for $17 a share!! But the manipulation was orchestrated wide and deep. Here’s a file of letters and notes I produced on it at the time. Features the usual suspects including Adam Feuerstein.

 

 

GOOD NEWS: MARTIN SHKRELI WAS ARRESTED TODAY, 17 DEC 2015 ON CHARGES OF FRAUD, RUNNING A PONZI SCHEME, ETC.

 

Letters/postings about investigation of Avanir by 4 members of congress which many believe is ridiculous.

 

Note: as I had no way of verifying authors of these letters, if you authored one and do not want it reprinted here please let me know ((info {at} rezamusic {dot} com)). I am merely hosting this content and am not responsible for what others have written. The reason I decided to reprint this is because I share some of the sentiments expressed below and believe this inquiry might have been influenced by those who have a large short position in the stock. The timing of the inquiry as one analyst put it, is "very interesting". It occurred just as the stock was on a strong rally after a long period of being depressed, and under attack of short sellers who've kept increasing their position. Just recently the stock started to move up and boom, we have an investigation the content of which is funny !! (read below).

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http://messages.finance.yahoo.com/Stocks_(A_to_Z)/Stocks_A/threadview?m=tm&bn=27718&tid=231257&mid=231306&tof=22&rt=1&frt=2&off=1

My letter to House Committee on Ethics

“I am writing to you in your capacity as a member of the House Committee on Ethics.

As an investor in Avanir Pharmaceuticals I became aware that Representative Henry Waxman along with 3 colleagues ( Representative Frank Pallone, Representative Diana DeGette and Senator Herb Kohl ) decided that Avanir Pharmaceuticals was in need of an investigation of the pricing of a very recently approved FDA compound for the treatment of a neurological disorder. Given that the drug has barely been on the market for any length of time this is unusual. Even more interesting is the fact that Avanir Pharmaceuticals is one of the most heavily shorted stocks on the stock market. Basically the shorts placed bad bets that the FDA would not approve their neurological compound known as Neudexta. But the FDA did approve the drug and consequently the short selling hedge funds are facing the possibility of a successful drug resulting in a financially ruinous situation for themselves. This brings us to an interesting coincidence when we consider this sudden decision by Representative Waxman to investigate Avanir and their pricing structure as regards Nuedexta. Keep in mind that Nuedexta is so new a product that its prescription count is low and is just starting to become known within the neurological medical community. Even more interesting is the connection that Representative Waxman has to a political contributor of his, a legal firm Akin Gump Strauss Hauer & Feld that happens to represent Short Selling Strategy Funds. On June 14, 2011 Akin Gump Strauss Hauer & Feld's Civic Action Committee will hold a fundraiser for none other than Representative Henry Waxman.

And so the circle closes. Avanir Pharmaceuticals spend many years and $200,000,000 to get Nuedexta approved under the FDA's safety and efficacy guidelines. Wall Street's Short Selling Hedge Funds place a ruinous financial bet against Avanir's success and here Congressman Henry Waxman and 3 like minded colleagues decide that Avanir needs to be investigated for trying to recoup its and its investor's costs ? This isn't right. When companies such as Avanir Pharmaceuticals are punished for innovation and following the rules no matter how costly the endeavour and then are denied an opportunity to recoup their costs and demonized beacuse they may actually at some future date turn a profit then one can soon see the day where no one can afford to take chances and succeed. That is what America is about after all - taking chances and succeeding !

I request that you and your colleagues on the House Committee on Ethics look into this matter.

Thank You”
========================================================
Extract from Summer Street’s Conference Call on May 27, 2011

“We hosted a conference call with a manufacturing consultant to discuss the differences between GMP manufactured medicines and compounded drugs. Compounded drugs are requested on a named patient basis and are prepared that way. When done in hospital pharmacies,
there are inherently a lack of controls for sterility, stability, and potency. This situation may be more dangerous for injectable biologics than small molecules. Nevertheless, we are confident that there is inherit danger
for patients to compound generic versions of dextromethorphan and quinidine to match Nuedexta for PBA. We believe the congressmen who submitted an inquiry letter to Avanir about Nuedexta are uninformed
and have gone after the wrong product and company.

• Our consultant commented that the letter sent to AVNR was unreasonable and could be sent to every drug manufacturer. The two-page letter asks for confidential company information and correspondence that spans at least 10 years. This is nearly impossible to compile within a few weeks and is unreasonable, in our consultant’s view.

• Sterility is a key issue when deciding to compound.

• Other key issues include stability and potency. “

[And the list goes on]

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http://messages.finance.yahoo.com/Stocks_(A_to_Z)/Stocks_A/threadview?m=tm&bn=27718&tid=230727&mid=230727&tof=10&rt=1&frt=2&off=1

You can write her too at healthblog@wsj.com

For Katherine Hobson

Katherine,

I'm a financial journalist in.......and read with interest your piece on the congressional investigation into the pricing of Avanir's Nuedexta.

Leaving aside the questions about whether AVNR has indeed priced the drug irresponsibly, I think another part of the story is why this investigation now and why this company?

AVNR is a small under the radar biotech which just happens to be one of the most heavily shorted stocks on NASDAQ. The stock is highly manipulated and very volatile.
Right before the story broke about the looming investigation, AVNR's stock price had raced higher on heavy volume and was close to breaking through a critical resistance area to the upside. Very good news about market acceptance of Nuedexta and prescription growth precipitated the upside move.

Then, boom, news of the letter from Waxman, et al hit the wire. As one covering analyst from Wedbush put it: The timing is "interesting".

I think it would be worth looking into how little known AVNR got on the radar of congress and whether some behind the scenes influence from the shorts was/is at play here. The shorts stand to lose a huge amount of money if the price of AVNR stock continues to move up (as it did today).

Thanks,
========================================================
The Honorable Jo Bonner
Chairman, House Ethics Committee
1015 Longworth House Office Building
Washington, DC 20515

Dear Chairman Bonner:

Yesterday, three of your congress members, along with Senator Kohl, were signatories on a letter to Avanir Pharmaceuticals. In this letter your colleagues made misleading or false allegations that could have caused irreparable harm to this company. A Congressional investigation is not a small matter and your colleagues must evidence a clear understanding of its potential devastation to the reputation of individuals and companies.

I am an investor in Avanir and have been for over 30 years so I know the history of this company very well. They have worked diligently to develop a drug called Nuedexta which controls PBA (uncontrolled laughing or crying), a debilitating and isolating condition that can ruin a person’s life. After many years of work and millions of dollars of investment, the drug was finally approved by the FDA in November. Now, just as the company is beginning to reap some very small rewards, your colleagues have decided they know more about pricing the product than the management team that developed it.

These congress people and this senator are trying to cast this drug as too easy so it is therefore overpriced. If it was so simple why didn’t someone develop it many years ago? If it was so obvious why didn’t someone else spend millions on research and development costs before Avanir did? And those costs were incurred at the risk of never seeing a dime of return. How can these people function as protectors of the American way of life when they don’t even understand how it works?

Chairman Bonner, this event deserves some serious inquiry on the part of your committee. Congressman Waxman is keen to haul individuals and companies before his committees; it is high time he had to answer for his own transgressions. He, and your other involved members, should have to answer the questions: Who authored this letter? Who stood to gain from the doubt this letter would cast on Avanir? Are you aware of a single pharmacist who ever compounded the product developed by Avanir for $20? If you don’t, where did that number come from? If none of you wrote the letter why would you sign it without verifying its accuracy? Why was this company singled out?

These Congress people and this Senator are likely to have acted as unwitting pawns for investment interests as yet undiscovered. Your committee should have the gumption, the curiosity, the honorable intent to find out who was actually behind the letter’s origin. It was NOT a grandma in Detroit.

In the end, these members should be severely chastised for so blatantly disregarding their responsibility to act without prejudice in conducting the people’s business. We deserve much better than we received in this instance.

Thank you for considering this suggestion and the best of luck in all of your endeavors. You have a very difficult job, Chairman Bonner. If this is any example of what you have to police I’m guessing you don’t lack for something to do.

My very best,
========================================================
In research report, Wedbush writes, "On Tuesday after market close, the US Special Committee on Aging issued a press release detailing a hearing to be held regarding NUEDEXTA pricing. Response from AVNR has been requested by June 10, 2011; additional details about the inquiry are at http://aging.senate.gov/hearing_detail.cfm?id=332984&

We see no material impact on NUEDEXTA sales given this inquiry and view this as potentially a positive opportunity that will result in greater visibility of the product.

Any weakness in AVNR shares caused by this event would be a buying opportunity, in our opinion. The timing of this inquiry is “interesting”, in our opinion, considering the recent run up in the stock and high short interest in the name."
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http://messages.finance.yahoo.com/Stocks_(A_to_Z)/Stocks_A/threadview?m=tm&bn=27718&tid=231046&mid=231046&tof=13&rt=1&frt=2&off=1

Waxman-hedge fund link? Judge for yourself...

Check out he bottom of page. Note the fund raiser on 6/14/11 and the Host - Akin Gump Strauss Hauer & Feld

http://www.opencongress.org/people/money/400425_Henry_Waxman

What is Akin Gump Strauss Hauer & Feld?

http://www.akingump.com/investment-funds-litigation-practices/

Read the "Our Clients" section. It includes "short selling strategy funds".

I find this interesting, to say the least.

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http://messages.finance.yahoo.com/Stocks_(A_to_Z)/Stocks_A/threadview?m=tm&bn=27718&tid=231591&mid=231591&tof=4&frt=2

Since when does a steak cost thousands of dollars?????

Who is calling the kettle black? I can't even afford a cup of ice at these prices:

When: June 14, 2011
What: Dinner
Where: Charlie Palmer Steak
Host(s): Akin Gump Strauss Hauer & Feld Civic Action Committee, AT&T Inc Federal PAC
Beneficiaries: Henry Waxman
Contributions: $2,000 PAC; $1,000 Personal
Make Checks Payable To: Congressman Waxman Campaign Committee
When: September 30, 2010
What: Cocktail Reception
Where: Johnny's Half Shell
Beneficiaries: Henry Waxman
Contributions: $5,000 Co-Host; $2,500 PAC; $1,000 Individual
When: October 27, 2009
What: Cocktail Reception
Where: Charlie Palmer Steak
Beneficiaries: Henry Waxman
Contributions: $5,000 Co-Chair; $2,500 PAC; $1,000 Individual
Make Checks Payable To: Congressman Waxman Campaign Committee
When: June 23, 2009
What: Breakfast
Where: Charlie Palmer Steak
Host(s): Akin Gump Strauss Hauer & Feld Civic Action Committee
Beneficiaries: Henry Waxman
Contributions: $2,000 Sponsor; $1,000 Guest
Make Checks Payable To: Congressman Waxman Campaign Committee
When: September 18, 2008
What: Cocktail Reception
Where: Charlie Palmer Steak
Beneficiaries: Henry Waxman
Contributions: $5000 co-chair, $1000 guest
Make Checks Payable To: Congressman Waxman Campaign Committee
When: September 20, 2006
Where: Johnny's Half Shell
Beneficiaries: Henry Waxman
Contributions: $5,000 Co-Chair; $1,000 Guest
Make Checks Payable To: Congressman Waxman Campaign Committee


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http://messages.finance.yahoo.com/Stocks_(A_to_Z)/Stocks_A/threadview?m=tm&bn=27718&tid=229633&mid=229633&tof=19&rt=1&frt=2&off=1

Folks, I talked to an analyst. He said he's not worried about this at all and doesn't think they company is worried about it either. It's flat out a stupid step.

The analyst said it's all about script numbers and once the stock marches past $5 shorts have to think hard if they want to maintain their position or cover (covering is smarter as big funds qualify after $5).

I am convinced it's the short lobby that's behind the investigation.

Here are their fax numbers. Don't rely on email. Fax them your letters.

Representative Waxman
Fax (202) 225-4099
Fax (323) 655-0502

Senator Kohl
Fax: (202) 224-9787
Fax: (414) 297-4455

Here's my letter:

"Concerning your investigation of Avanir, I am afraid you may have fallen for the lobbying of big hedge funds who have shorted over 30 million shares of Avanir. The timing of the announcement perfectly coincides with a rally which would have caused these shorts 100's of millions of dollars in losses but instead they got a much needed relief. The allegation is utterly bogus and frivolous. Knowing what good men you are, I suspect the short sellers have tricked you into this.

I can assure you, this company has been working very hard, in the most difficult condition and with huge expenses, to bring their drug to market to help people who have no other treatment.

The only parties benefiting from your investigation are hedge funds who have short sold a quarter of the stock's float. Please be on the side of Main Street not Wall Street and drop your absolutely ridiculous investigation of Avanir.

Thank you"
...
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http://messages.finance.yahoo.com/Stocks_(A_to_Z)/Stocks_A/threadview?m=tm&bn=27718&tid=229647&mid=229647&tof=32&rt=1&frt=2&off=1

The following article and responses to it are are from:

http://seekingalpha.com/instablog/657461-bert-wilkison/181373-has-avanir-been-unjustly-targeted-for-a-congressional-pricing-inquiry

Has Avanir Been Unjustly Targeted for a Congressional Pricing Inquiry? 7 comments
May 25, 2011 3:06 PM | about stocks: AVNR
By Bert Wilkison


Shares of Avanir Pharmaceuticals (AVNR) had recently risen by more than 20% over a two week span due to improving and increasingly impressive weekly prescription data for its flagship product, Nuedexta. Nuedexta is a drug used for the treatment of pseudobulbar affect, a disease which is characterized by involuntary, sudden, and frequent episodes of laughing and/or crying. It can dramatically alter its sufferers' qualtiy of life.

No sooner did Avanir begin to silence some of its critics (and some "journalists") by demonstrating success in the market than it received a most peculiar letter from the US Congress, specifically the Senate Special Committee on Aging. It was signed by Herb Kohl, Henry Waxman, Frank Pallone and Diana DeGette. In the letter, Avanir seems to be accused of charging too much for its recently FDA approved product.

From the May 23, 2011 letter:

“Doctors and patients were understandably upset at the news that this drug, once available for about $20, was now going to be $600. In order to address these concerns, we request that Avanir Pharmaceuticals submit written documentation in response to the following questions and requests for information. The Attachment of this letter will specify in full detail what materials are to be included in response to this request.”

If it's congress' desire to include Avanir in a pharmaceutical-industry-price-gouging-witch-hunt, it would serve them better to get all of the facts straight:

“In October 2010, Avanir obtained FDA approval for this combination and received a three year term of exclusive marketing.”

Incorrect, as Avanir has patent protection that extends well beyond three years.

“Doctors and patients were understandably upset at the news that this drug, once available for about $20, was now going to be $600.”

Not true. Nuedexta has never been available for $20 or anywhere near that amount.

“Some analysts project revenue from Nuedexta to be approximately $4,365/patient after stocking fees and discounts are subtracted from Nuedexta's stated annual wholesale cost of $5,868.”

Most unusual and inaccurate. The author seems to have used the $4,365/patient figure from a 2-part Avanir article that I co-authored in March, which takes into consideration estimated royalties Avanir must pay on gross sales of Nuedexta that will be subtracted by the company as COGS and, as such, shouldn't be part of GAAP revenues.

Avanir's stock traded down as much as 8.89% on Wednesday in reaction to the letter, even though it was pointed out by multiple analysts covering the company that the congressional inquiry should have little or no impact on Nuedexta's sales which are, as previously stated, currently on the increase.

Who brought Avanir/Nuedexta to the attention of a US government special committee?

Jack Mitchell, chief of oversight and investigations at the U.S. Senate Special Committee on Aging, who is listed as the primary contact on the above referenced letter, refused to comment as to how or why Avanir was targeted and has yet to return a follow up call.

Is someone intentionally trying to throw a stick into Avanir's spokes just as the growing company is beginning to gain some market momentum? I'll leave that for you to ponder. I will say, however, that the timing of the release brings back the memory of the stock's highly suspect flash-crash of 10/29/10 (the day Nuedexta was approved by the FDA).

For now, I see no need to go into any detail as to why I feel the committee's inquiry is a blatant attack on capitalism and a slap in the face to a company that has spent several years and millions of dollars in effort to bring a safe and effective drug to market. Regardless of how or why the US Senate came to be involved in Avanir's affairs, I believe the sell-off which was sparked by the news of it should be viewed as a buying opportunity.

I am long AVNR.
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Good post Burt. I called the chair on behalf of the elderly myself at the number listed (202) 224-5364 and left a complaint. They are opening themselves up to investigation and lawsuits into why and how they specifically targeted AVNR.

This Congressional complaint is nothing more than a pat on the back to the hedgefunds and a slap in the face to the investors that have been following and tracking AVNR for years. If you count all the cash AVNR has burned on this pipeline pill, from start to finish, it is easily 100's of millions of dollars of RND. Then count advertising, salesmen/women, doctors, employees, lawyers, congressional complaint responses.

This is nothing more than a joke. I take a medication that costs roughly $1000 per monthly supply. Cost to me is about $80 a month, because i have insurance. If we are going to start counting pennies, lets ask apple how much it costs to make an IPOD or IPHONE that is manufactured in China? I can tell you that the medication i take, does not cost nearly the price that they are charging, it is all based off RND and patents. This senate subcommittee apparently thinks we live in China and are communists.

Final thoughts -- Lawsuits are going to start flying against hedge funds, shorts, the street and these jokers for being swayed by some squeaky wheels that are losing money based on manipulation of the stock market.
-Teddie
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It seems rather than investigating the price of Neudexta for whatever reasons the congress came up with. Our tax payers money would be better off spent investigating the people behind who created this supposed scandal. I have been following Avanir for more than 10 years and I am sure that ths $275million number has been exceeded with all the red tape that they have had to deal with... And just when you think ok finally they have survived the worst of FDA rejections, procedural review sessions, mal-intentioned management, stock manipulation, going from $18 to.50 in a matter of months in 2006, this letter comes out...
I think there's something scandalous going on and its not with the pricing of Neudexta.

WAKE UP look into all prescriptions and their costs and see that percentagewise the pricing for this drug is probably similar to other pharmaceutical companies. Our tax dollars need to be used in more worthy causes. And to know Adam F is behind this tells me something fishy going on in DC...smells rotten almost evil.
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Nice article Bert, I agree with your points.

Its because of AVNR that we know to combine DM and Q (ok, they purchased that IP but same thing), that physicians are becoming aware of the true impact and prevalence of PBA, and that there is a new and seemingly more effective treatment for PBA.

What did they do to bring that out?...well, they spent the greater part of the last decade running trials, teetering on the edge of bankruptcy/delisting, selling their only FDA approved product to finance continued development after the initial approvable letter, selling their only other promising pipeline product (now entering late stage trials by another company) to finance continued development after the initial approvable letter, and spending >$200 mil in total.

Can Congress say they didn't innovate? Spend huge resources? Take a huge risk of losing it all? After all that its simply noxious to even be grouped with URL and KV.A .

This will all blow over due to the factors you list and those above. But the error-filled letter sent out (they even misspelled both the drug name and one of its components) reflects poorly on those we've elected to "protect the peoples' interests".
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I encourage anyone concerned about this to send an email to mailbox@aging.senate.gov, as I did this morning. Here's what I sent:

I’m writing concerning a letter recently sent to Avanir Pharmaceuticals questioning the pricing of its recently approved drug, Nuedexta.

The premise stated in this letter is, “Doctors and patients were understandably upset at the news that this drug, once available for about $20, was now going to be $600." This is a complete fabrication.

The letter suggests that the ingredients in Nuedexta were widely prescribed in the past and available for $20. That is not true. Quinidine, one of the two ingredients, is not available generically in the dosage used in Nuedexta, and the services of a compounding pharmacist would have been required to create the formulation in Nuedexta. I really doubt that any complaints were actually received from patients or doctors who were using compounding pharmacists in the past to create this formulation.

Avanir is doing pioneering work to develop an understanding of Pseudobulbar Affect (PBA), the indication approved for Nuedexta, and is working hard to develop awareness of this debilitating and under-diagnosed condition. In addition, the company spent years and hundreds of millions of dollars to prove the safety and efficacy of Nuedexta for treating PBA and to obtain FDA approval. Other potential uses for the drug, including several for which there is no effective current treatment, such as central neuropathic pain resulting from multiple sclerosis, will require additional expensive clinical trials and regulatory hurdles. The company deserves to make a profit for doing this work. And it sets pricing based on market conditions, as is its right in our capitalist democracy.

In addition, Avanir has obtained strong patent protection for Nuedexta and is not simply depending on marketing exclusivity conferred by the FDA. Although the ingredients are generic, their combination to address certain neurological conditions is novel and was recognized as such by the patent office.

I can understand the committee’s concern that an unscrupulous drug company might swoop in and gain marketing protection for selling a previously available generic drug, unfairly boosting the price to consumers without adding any value. But that is not what occurred in the case of Avanir and Nuedexta.
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My letter to the crooked Congressman and those scums at The Street (Yes you Adam Feuerstein)

I am a shareholder of Avanir Pharmaceuticals and I have held and accumulated their shares over the past 3 years.
I am nothing but a retail investor using my retirement money to invest in something that hopefully will make me some money since I know you will never do anything to fix the Social Security system to allow me to receive one penny of that even though I have paid into that system for 25 years now and will pay into it for another 30 years so basically this is all I got to count on for my future.

I believe Avanir was doing something very valuable to help those with MS Pain, Diabetic Nueropathic Pain and of course their approval for Nuedexta to help treat PBA which is crucial for quality of living for patients with ALS, MS, Tramatic Brain Injury, etc.

Avanir did not ask for a government bailout to get the drug through the lengthy FDA approval process, they did not cause oil to go to $100 a barrel, they did not create the housing crisis, they did not cause gold to go to $1500 an ounce, and they did not cause food prices to go up because of $7 per bushel corn prices. Avanir invested their own money and the money of shareholders to get them to the point where they could market and sell the drug and now you want to come out and attempt to keep them from recouping their investment and making enough money to pay their employees and continue to invest in future research and drug approval to improve the quality of life for these patients.

Now that the drug is finally paying off for investors, our government, the same one that made Avanir wait an additional 4 years and spend millions on additional research to market this drug, is now saying they’re making too much money. Avanir isn't even making enough money from Nuedexta to pay for their yearly expenses. There is no way they will make enough to ever recoup the last 10 years of investment in getting to this stage of marketing and drug launch.

This inquiry is a waste of time and taxpayer money and I'm 100% positive there is something better you could be doing. I seriously wonder about its motivation since there are dozens of other pharmaceutical companies and large corporations who are gouging customers everyday but yet you choose a small company that has just now started to begin to work its way to just possible breaking even within maybe 18 months from now. Do you also question how much it costs Microsoft to make a DVD copy of Windows 7 but yet they charge alot more than that $1 dollar DVD.

I would love to know who brought this to your attention because that is who you should be investigating is their motive and the affect that had on the stock price.

I have worked at government facilities during my time in the military and my time as an electrical engineer doing work on military programs and if you are worried about waste start focusing on that because that is nothing more than middle class welfare. When I look around and people are sleeping and reading magazines during work hours and I'm the only one working it makes me wonder when the last time someone walked through these military depots and questioned these government workers and why they get paid $50,000 to $100,000 to do absolutely nothing. Of course you don't care about wasting taxpayers money you only care about creating an environment where small companies can't make a profit to recoup their investment and make money to do further research and bring new drugs to market.

Thank you for contributing to further market manipulation by hedge funds and those who have shorted this stock. You and your colleagues are exactly what is wrong with this country.

My new goal is to make sure you and your colleagues are not re-elected because there is no way this is what I want my government getting involved in when there are so many more pressing issues in the world and especially in the United States.

Note: I was a democrat until I saw this when I woke up this morning. I will never vote democrat again if this is what they want to pull against a company just trying to get back to even!
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I strongly believe that some big hedge fund guys or investors who are big time short on this stock have bribed some congressional people a few million dollars to target Avanir and are trying their best to derail this company's growth.

Ricky
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Something about this whole scenario just seems foul, doesn't it, Bert? Your article is well written, stating what some have thought, but would rather not say. Well done.

Sarge
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http://messages.finance.yahoo.com/Stocks_(A_to_Z)/Stocks_A/threadview?m=tm&bn=27718&tid=228808&mid=228808&tof=8&frt=2

Nothing more than the obvious...tactic to allow short friends to cover. Wonder how many Wall Street "friends" the old boys in Washington are saving with this dog and pony stunt. They all have to go...
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http://messages.finance.yahoo.com/Stocks_(A_to_Z)/Stocks_A/threadview?m=tm&bn=27718&tid=228614&mid=228640&tof=12&frt=2

The difference from KVA is huge. KVA took huge amounts of government money to test a treatment already on the market then jacked the price an obscene amount.

AVNR developed this on their while skirting the edge of bankruptcy for years to bring an entirely new treatment to market regardless of the fact that the components are older. Congress is picking the wrong fight here.
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http://messages.finance.yahoo.com/Stocks_(A_to_Z)/Stocks_A/threadview?m=tm&bn=27718&tid=229177&mid=229211&tof=17&frt=2

Several months ago I did some research on the cost of the ingredients in Nuedexta and posted here that the cost was about $20. Compounding services would add to that.

But how prevalent was compounding? The letter suggests that Nuedexta was widely available for $20 and that many patients were affected by the new price. This is absurd. Avanir is spending big bucks to try to build a market that didn't exist before.
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http://messages.finance.yahoo.com/Stocks_(A_to_Z)/Stocks_A/threadview?m=tm&bn=27718&tid=231396&mid=231397&tof=3&rt=1&frt=2&off=1

One angle I haven't seen expressed yet is the availability of N for our veterans with TBI-related PBA. There would be no good treatment for them if not for AVNR. Even one good case example put forward by AVNR would do wonders to get these jokers to back off.
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http://messages.finance.yahoo.com/Stocks_(A_to_Z)/Stocks_A/threadview?m=tm&bn=27718&tid=229177&mid=229177&tof=11&frt=2
This was the premise in the letter to Avanir:
"Doctors and patients were understandably upset at the news that this drug, once available for about $20, was now going to be $600."

This is so misleading and false (as others have mentioned). They make it sound as if a lot of doctors were happily prescribing D/Q to treat PBA and the patients were paying $20 for the drug, until big bad Avanir came a long and forced the patients to start paying $600. That is a complete fabrication.

How many doctors/patients are upset that their old $20 drug now costs $600? My guess is zero.
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http://messages.finance.yahoo.com/Stocks_(A_to_Z)/Stocks_A/threadview?m=tm&bn=27718&tid=229166&mid=229166&tof=22&frt=2

The shorts must be somewhat surprised
A suspiciosuly timed and very rapidly publicized (uhmm) letter to Avanir from Congress, and they just get a 10% drop (from the top yesterday). Notice the volume has dried up... their big down day didn't happen... no chance to cover in the 3s as they expected. Not sure they have many bullets left.

Don't forget we are massively owned by institutions. They have a few phone numbers in their rolodex too.

A lot going on behind the scenes here folks...

Even AF includes in his article:

"The timing of this inquiry is 'interesting', in our opinion, considering the recent run up in the stock and the high short interest in the name," Wade added.
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Letter is now offline

Interesting... The letter has been taken down. Here is the link that was working about an hour ago:

http://aging.senate.gov/hearing_detail.c...

I wonder if they are making corrections - or just embarrassed by the staggering amount of incorrect information it contained.

http://aging.senate.gov/hearing_detail.cfm?id=332984&
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http://messages.finance.yahoo.com/Business_%26_Finance/Investments/Stocks_(A_to_Z)/Stocks_A/threadview?bn=27718&tid=230555&mid=230555

that's what I suspect. They can hide better that way and still get the negative results they expect. Some insurance guy with the help of his buddy crooks probably put the letter together and the simple minded congress persons jumped all over it without looking. That's the kind of people who seem to always get elected...and who elects them??...you got it.
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I faxed yesterday’s letter to Waxman and Kohl. Today I called the offices of the other two representatives, DeGette and Pallone and gave it to them. I am faxing this to all four of them plus Jo Bonner today plus The Senate Special Committee on Aging, to rub it in:
--------
What an embarrassment! The congress getting played like a fiddle by hedge funds. The congress members should be fighting for Main Street not Wall Street. This “Avanir” baby has been learning to crawl for 10 years and is just getting ready to stand up and walk and Congress punches it in the face to support some hedge fund boss who is out to lose 100’s of millions of dollars and is obviously using his connections to pull strings in the Congress to investigate Avanir just so the stock price drops so these crooks can cover their short position at a more favorable price. Wake and smell the roses Congress. We’ve had enough of Wall Street’s manipulation. Fight for Main Street for a chance for God’s sake.

Out of all these pharmas big and small, isn’t it fishy that congress picks on a small company which has one of the highest short ratios in this sector. Wake up Congress. Instead of investigating Avanir investigate the hedge fund manager(s) who gave your this frivolous case and prompted you to do this bogus investigation. What a waste of tax payer money.
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First letter:

By fax:

Concerning your investigation of Avanir, I am afraid you may have fallen for the lobbying of big hedge funds who have shorted over 30 million shares of Avanir. The timing of the announcement perfectly coincides with a rally which would have caused these shorts 100's of millions of dollars in losses but instead they got a much needed relief. The allegation is utterly bogus and frivolous. Knowing what good men you are, I suspect the short sellers have tricked you into this.

I can assure you, this company has been working very hard, in the most difficult condition and with huge expenses, to bring their drug to market to help people who have no other treatment.

The only parties benefiting from your investigation are hedge funds who have short sold a quarter of the stock's float. Please be on the side of Main Street not Wall Street and drop your absolutely ridiculous investigation of Avanir.

Thank you

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http://messages.finance.yahoo.com/Stocks_(A_to_Z)/Stocks_A/threadview?m=tm&bn=27718&tid=229151&mid=229286&tof=37&rt=1&frt=2&off=1

Yes It is amazing... How powerful the shorts must be, to make a senate committee enquire about a small bio tech company.. CROOKS RULE!!
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http://messages.finance.yahoo.com/Stocks_(A_to_Z)/Stocks_A/threadview?m=tm&bn=27718&tid=229252&mid=229285&tof=31&frt=2

This is the e-mail I sent:

Dear Mr. Waxman,

I am a shareholder of Avanir Pharmaceuticals. I have held and accumulated their shares over the past 10 years.

You see, my stock in Avanir was originally going to be the cornerstone for my college account for my children. In 2002 I learned of what was to become Nuedexta. It was a combination of two older drugs. Avanir had combined 30 mg of Dextromethorphan with 30 mg of Quinidine. The drug was very effective at controlling emotional lability, where people cannot control whether they laughed or cried. The condition is suffered by MS, ALS, stroke and traumatic brain injury patients, among others. The efficacy of the combination was off the charts.

The company made a new drug application with the FDA. On Halloween, 2006, the FDA made its decision: the drug was “approvable”, but not approved. The FDA said there was a potential risk to heart patients because of the Quinidine component-specifically, it made the QTc interval too high. So the FDA told Avanir to go back to the drawing board. So Avanir did. They did a whole new Phase III trial of the drug, under two formulations: 30 mg Dex and 10 mg Q, and 20/10. Four long years later (during which I got to accumulate shares at 45 cents apiece), the drug was approved. Now, after all this time, it’s on the market. Patients with these terrible diseases are getting relief from this distressing condition. Sales are ramping up. Finally, I am making money on my investment. Of course one of my daughters is now out of college, but that’s the way it goes in the investment world sometimes.

Now, your office in its wisdom decides this drug is frankly, a ripoff. It’s a combination of two generic drugs! How hard can that be? How expensive can that be?

Many great ideas look simple in hindsight. This new medicine was the product of YEARS of trials. Now that the drug is finally paying off for investors, our government, the same one that made Avanir wait an additional 4 years and spend millions on additional research to market this drug, is now saying they’re making too much money.

This inquiry you’ve initiated is a waste of time and taxpayer money. I seriously wonder about its motivation. If you want to call me about this, I’ve got my number listed below.


Sarge

Sentiment : Buy
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http://messages.finance.yahoo.com/Stocks_(A_to_Z)/Stocks_A/threadview?m=tm&bn=27718&tid=229589&mid=229589&tof=27&frt=2

It was right at the point of breakout (see volume by price - and some powerful people with deep pockets were about to lose big.

So they called their friendly crook in congress and HURRIEDLY scrapped together this abortion of a letter, adding the other pharma to it as a smokescreen.

It can't have taken more than 2 hours to scrape together the crappy 'research', from S.A. etc. and to make a couple of meaningless bullet point questions - to which the answers are ALREADY mainly in the public domain anyhow.

What a crooked political environment you guys have over there.

And all they could do was precipitate a mere 7% retrace after a run up from 3.60. On anemic volume./

What a crock.
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http://messages.finance.yahoo.com/Stocks_(A_to_Z)/Stocks_A/threadview?m=tm&bn=27718&tid=229612&mid=229612&tof=4&frt=2

The inquiry you’ve initiated as stated in your letter made public is based on erroneous information.

There is adequate public information to answer the questions you raised. The pointed focus on a small company, among one of the most highly shorted, that has played by the rules over many years and that is in a hard earned roll out phase of a large investment and meaningful accomplishment should be explained to the SEC or an investigative reporter willing to look at the facts and motivations. Hopefully an inquiry will illuminate your interest or ignorance in participating in attempting to sabotage an innovative company. If you waste the public trust on this you’ll prove no wrongdoing other than your own.

Focusing on this company with incorrect statements made public is unethical and appears intended to manipulate the stock price.
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http://messages.finance.yahoo.com/Stocks_(A_to_Z)/Stocks_A/threadview?m=tm&bn=27718&tid=229627&mid=229627&tof=31&frt=2

I sent the following letter to my congressman, for what it's worth.

Colin
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I am writing in regard to Avanir Pharmaceuticals' new drug, Neudexta.

First, my disclosure: I am a shareholder of Avanir. My stake is not large, but I have been through the ups and downs, including the FDA rejection, and thought that with the recent approval and the commencement of marketing I was finally seeing the light at the end of the tunnel.

Now Senator Kohl and Representatives Waxman, Pallone, and DeGette have requested information from Avanir Pharmaceuticals about the pricing of their newly approved drug, Neudexta, implying that their price is exorbitant. I find this extremely inappropriate.

Pharmaceutical companies spend billions of dollars developing drugs, navigating an arduous (and often ludicrous) FDA approval system, and marketing the drugs. This will not happen if they can't make a profit from their labors. Is congress willing to subsidize all pharmaceutical research? If not, they need to stay out of the pricing game.

Yes, the ingredients are cheap. The process to get them to those who need them is not. Avanir must recoup years of enormous losses and generate sufficient income to develop future drugs, including all of those attempts that will fail. Is there a serious effort underway to price drugs at the cost of their ingredients?

I understand and share the concern over high health costs, but it simply doesn't make sense to destroy the funding that produces new medicines. These companies get money in essentially two ways: selling stock and selling medicine. The former requires that the company be profitable, and the latter requires that companies price their products appropriately. That is, investors will not fund these companies if the companies can't make a profit, and the market will dictate an appropriate price without help from Congress. Forcing a low price hurts the company in both ways.

Finally, I note in passing that there are many more significant pharmaceutical companies with more expensive drugs that have been making huge profits for years. It makes me wonder why Avanir is the one under scrutiny. (I don’t believe those other companies should have their prices regulated by Congress, either.)

Please register my discontent with the committee. I recognize that I appear to have a bias (and probably do) since I invested in the company, but I believe in these principles regardless of my position with respect to the stock. That just happens to be how I came to know of the issue.

Thank you,
XXX
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http://messages.finance.yahoo.com/Stocks_(A_to_Z)/Stocks_A/threadview?m=tm&bn=27718&tid=229647&mid=229669&tof=29&frt=2

And how about the money that will be expended by Avanir for future trials for pain and other uses? Where is that money going to come from? Congress? What a crew of idiots.
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http://messages.finance.yahoo.com/Stocks_(A_to_Z)/Stocks_A/threadview?m=tm&bn=27718&tid=229845&mid=229845&tof=20&frt=2

Today Senator Kohl, Congresspersons Waxman, Pallone and DeGette were signatories on a letter addressed to Avanir Pharmaceuticals. In the letter, much of which was easily proven false, these individuals in essence proposed that they were better qualified to price Avanir's new FDA approved drug than the management team who developed it.

The most obvious question for a news agency would be....and I sincerely hope you press them until you get a real answer....WHO wrote/created this letter? Since a great deal of it is false no one is going to want to take credit. But if they won't take credit then why would they allow they're signature under a document that is both false and anathema to both the spirit and function of the free enterprise system?

Is this the proof we've been waiting for that the Democratic Party does not believe in Capitalism? If they propose to go after one small company that has worked tirelessly for many years, spent millions of dollars in development costs, created many new jobs to market the product, then who is next. Will they go after Borden for excessive milk prices? How about General Mills for cereal prices? Are they going to suggest wage controls next?

Beyond the issue of being dumb enough to sign a document they didn't understand, a larger question would be, who had enough influence with these members of congress to get them to use power and influence to harm a fledgling company with a superior product? Could it be a hedge fund that has taken a short position in this stock? The same hedge funds that marched the US economy into near oblivion? Is that who these congressmen and women are in bed with? And if they didn't have a personal interest in the stock manipulation that was obviously going on, how could they be dumb enough to be used in this manner.

This could be a tremendous story to develop. Roast those people because they are either incredibly gullible or complicit in a clear case of stock manipulation. You might also note that the stock took a late day tumble yesterday so it wouldn't be too difficult to surmise someone was aware that letter would be issued. It's the most obvious case of crooked or stupid politicians you could ever ask to investigate.

The last thing the American public wants is Congress trying to set prices. And they will be incensed by the stock manipulation value of this story. Also, when they try to weasle out of the corner by saying the drug is a combination of two common components you might be ready with examples of any number of patented items made up of common components. It's the vision and insight to combine them into something new and valuable that makes them patentable.

Thanks for listening. And when your station gets the Pulitzer Prize for Journalism I hope you remember me.
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http://messages.finance.yahoo.com/Stocks_(A_to_Z)/Stocks_A/threadview?m=tm&bn=27718&tid=230813&mid=230813&tof=20&frt=2

Sen. Herb Kohl and Reps. Henry Waxman, Frank Pallone and Diana DeGette, all Democrats, want Avanir to explain why, if those drug components were so inexpensive (they say, about $20 a month), the price of Nuedexta is $600. Adam Feuerstein at TheStreet.com actually says the price is more like $4,800 to $5,800 a year, depending on discounts, or between $400 and $483 a month.

I for one am appalled that Avanir’s Nuedexta product is being targeted by some of our members of congress. Not only is the letter poorly written, some of the information in it is completely false. Notably this sentence – “Doctors and patients were understandably upset at the news that this drug, once available for about $20, was now going to be $600. ” This drug was NEVER AVAILABLE FOR 20$.

What entity is behind this near slander? What is the motivation here for targeting a newly approved FDA drug that has enormous potential for improve quality of life?

Millions of dollars have been put into the clinical development and safety trials for this drug. This drug has so much to offer for patients with PBA, diabetes, ALS, Alzheimers, etc. Later this year Avanir plans to initiate phase two trials for a MS pain indication and more indications will surely come. The price of development and research costs money and Avanir has the right to correctly price their new drug according to what the market will pay.
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WAS FDA REVIEW OR PROVENGE A CORRUPTED PROCESS BY CONFLICT OF INTEREST?


In 2007, an 17 member FDA advisory panel of experts voted overwhelmingly to approve Provenge, Dendreon's prostate cancer immunotherapy biologic agent. The panel voted that Provenge is safe and effective. Subsequently two of the doctors on the panel who unbelievably had received wavers from FDA of their conflict of interest -- and there is debate whether they disclosed all their conflicts of interests, rallied against Provenge's approval. And Provenge did not get approved. And meanwhile in the US alone some 30,000 advanced stage prostate cancer men die every year, and about 1/2 of them do not consider chemotherapy to be a viable option because of its terrible side effects. Provenge has virtually no side effects. Let's face it. The chemo people and the hedge funds that bet hugely against Provenge won!

A lawsuit has been filed by Caretolive against the FDA and details can be found here: http://caretolive.com/LawsuitLinks.html

Kerry M. Donahue, the trial attorney for defendants, representing some prostate cancer patients, etc. is an angel.

The following story is the best account of this horrible misery that the a bunch of suckers orchestrated against life, against goodness, against ethics, and all that stands for decency, in favor of money. It is a sad account of how money has become the new God in the minds of some people.

 

__________________________________________________________ .

 

13 DEC 2007

Congressmen Mike Michaud, Dan Burton, Tim Ryan called on the House Energy and Commerce Committee to conduct a hearing to examine the conflict of interests governing the Food and Drug Administration (FDA) and its recent decision on failing to approve licensure of Provenge.

“Many ethical questions remain about the two panelists who voted no on approving this drug,” Michaud said.  “I believe that the FDA should not be appointing scientists leading the testing of a rival drug for another firm onto an advisory committee evaluating Provenge. Congress needs to get to the bottom of this.  I believe a full disclosure is necessary in order to restore confidence in the FDA.”

“We need to ensure that the FDA gets life-saving drugs to the market as quickly and as safely as possible,” Michaud stated.  “Our priority is to ensure the prompt and efficient approval of therapies such as Provenge that could potentially benefit millions of Americans with cancer.”



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interesting post on an alleged panic meeting to help shoot down the approval of a safe effective agent for dying men :

http://www.investorvillage.com/smbd.asp?mb=971&mn=170174&pt=msg&mid=3682238


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Jonathan Aschoff of Brean Murray is a class act. He is a security analyst who impersonated doctor in order to get confidential information. I came across this web page which is quite funny (and sad). He was fined by the NASD.

http://aschoff.blogspot.com/2007/04/jonathan-aschoff-from-brean-murray-hes.html



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Very  interesting discussion about Drs. Maha Hussain and Howard Scher, conflict of interest, chemotherapy vs. immunotherapy, etc.:

http://caretolive.com/CTLfinalvsPazScher.pdf

Here is the html version: CTLfinalversion17mocontradismiss.html


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This is one heck of a post. I do not know if all the allegations are true but IF they are true, they unfold a core of evil at the FDA and shows how power play can mean lost lives.

Pazdurs fun house.....or Pazdurs house of horrors for the patients - Pazdurs playhouse.....or Pazdurs house of horrors for patients

http://www.investorvillage.com/smbd.asp?mb=971&mn=163536&pt=msg&mid=3426907



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This is an extremely interesting reading:

PLAINTIFF’S SUPPLEMENTAL MEMORANDUM IN SUPPORT OF MEMORANDUM IN OPPOSITION DEFENDANT’S MOTION TO DISMISS AND AS SUPPLEMENT TO MOTION FOR INJUNCTIVE RELIEF

9nov_provenge.pdf


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October 9, 2007 at 02:33:16

FDA Industry Insiders Derail Approval of New Cancer Treatments

by Evelyn Pringle 

http://www.opednews.com


FDA Industry Insiders Derail Approval of New Cancer Treatments

George W Bush's FDA, stacked with insiders from the industry that literally carried him to Washington, has stooped to a new low to protect the obscene profits of the multi-billion dollar cancer industry by blocking the approval of a new class of immunotherapies that can extend the lives of dying cancer patients with minimal side effects.
 
In the May 14, 2007, Wall Street Journal, a former medical officer in the FDA Office of Oncology Products, Dr Mark Thornton, denounced the FDA's decisions, and stated, "May 9, 2007, should be cited in the annals of cancer immunotherapy as Black Wednesday."

"Within an eight-hour period that day," he wrote, "the FDA succeeded in killing not one but two safe, promising therapies designed and developed to act by stimulating a patient's immune system against cancer."

Experts say, the new immunotherapies hold promise for many forms of cancer. "FDA's hubris will affect the lives and possibly the life spans of cancer patients from nearly every demographic, from elderly men with prostate cancer to young children with the rarest of bone cancers," according to Dr Thornton.

With the approval of the new therapies, the profits, along with the horrendous side effects of the only treatments now available, could become a thing of the past. "One day current treatment approaches such as surgery, radiation and chemotherapy, which often kill most but not all of a cancer, could be made obsolete by a potent immune response that eradicates the cancer cells and provides subsequent protection against return and relapse," Dr Thornton wrote.

As such, the new therapies pose a grave threat to the cancer industry as a whole, and the lost profits would not be limited to the sale of products. The pharmaceutical giants have spent a small fortune to gain control of every segment of the industry, from researchers to government regulators, and every year, billions of dollars flow through a nationwide network of research institutions and treatment providers under the guise of finding a cure for cancer.

However, the profits up for grabs have become so enormous that critics say the goal of industry-controlled research is no longer focused on finding a cure for cancer to save lives. Instead, the focus is on thwarting the development and approval of new therapies in order to protect the profits of the treatments already on the market.

The FDA's refusal to approve Provenge, a new immunotherapy vaccine manufactured by the Dendreon Corporation, has caused major outrage in the cancer community. Provenge supporters have sent thousands upon thousands of letters and other correspondence to the FDA, members of Congress, the Department of Justice and others.

In addition, the Ohio-based non-profit corporation, CareToLive, has filed a lawsuit on behalf of terminal cancer patients seeking a declaratory judgment that the FDA acted "arbitrarily" and "capriciously" by denying patients access to Provenge, in violation of their constitutional right to live.

Dendreon sought approval to treat late-stage androgen-independent prostate cancer (AIPC) patients who have no other options. A study presented to an FDA Advisory Committee at a March 29, 2007, meeting showed that, after 36 months, 34% of the men who received Provenge in a clinical trial were still alive, compared to only 11% of those who received a placebo.

Provenge is designed to stimulate the patient's own immune system to specifically attack only cancer cells, unlike chemo drugs that attack any fast-growing line of cells.
Patients who qualify for Provenge have already had their prostates removed or have undergone radiation and hormone therapy. Eligible patients receive a one-time round of treatment consisting of 3 visits to a urologist's or oncologist's office to give blood, and 3 visits for the blood enhanced with Provenge to be infused back into the body.

On September 10, 2007, CareToLive filed a motion asking the court to issue an order enjoining the FDA from denying the marketing and distribution of Provenge. The plaintiffs charge that within six months, another 15,000 patients will have died waiting for justice.

The memorandum filed with the motion points out that the only available treatment approved for terminal AIPC in the last 42 years is a chemo drug, Taxotere. "The effectiveness of Taxotere," it states, "is so superficial, and the side effects so severe, that most men decline the treatment, as the risks far outweigh the benefits."

According to the filing, between 300 and 600 patients per year die from the Taxotere treatment itself. "This is truly amazing," the memo states, "considering the cost of the treatment and the cost of hospitalization and that the average benefit is an increase in survival of only 2 ½ months."

In contrast, the Provenge safety profile is so good that nobody has died from it and less than one in four patients experience side effects consisting of mild flu-like symptoms lasting one or two days, the memo notes.

The defendants named in the lawsuit include Mike Leavitt, Secretary of the US Department of Health and Human Services; FDA Commissioner Andrew von Eschenbach; Dr Richard Pazdur, head of the FDA's Office of Oncologic Drug Division, and Dr Howard Scher, chosen by Dr Pazdur to serve on the advisory panel set up to review the approval of Provenge.

CareToLive is represented pro bono by Attorney Kerry Donahue, of the Dublin, Ohio law firm Bellinger & Donahue, while the FDA officials are represented by a legal team of 11 government attorneys, at last count, funded by tax dollars.
 
The plaintiffs allege that the defendants engaged in a conspiracy to prevent the approval of Provenge and that Dr Pazdur, "purposely located two conflicted oncologists who he was sure for a variety of reasons would be anti-Provenge and he instructed them to try to derail the approval of Provenge."

The plaintiffs charge that, by choosing Dr Scher, and also Dr Maha Hussain, to serve on the advisory panel, Dr Pazdur "likely found two of the most conflicted oncologists in the country to sit in judgment of Provenge, and who would both assuredly continue his plot to lobby others at the FDA to vote for non-approval."

At the behest of Dr Pazdur, and for their own future political and monetary gain, the plaintiffs claim, "these two oncologists did everything they could think of to obstruct and impede the approval of Provenge."

The waiver of conflicts of interest granted by the FDA to Dr Hussain, which allowed her sit on the panel, reveals that she is the lead investigator on a research contract awarded by a company that competes with Dendreon, and her husband owns stock in three competing companies valued at between $15,000 and $300,000.

The lawsuit alleges that, as part of the conspiracy, on May 9, 2007, the FDA denied terminally-ill patients access to Provenge, even though the FDA Advisory Committee recommended approval, found the vaccine safe by a 17-0 vote and found there was "substantial evidence" of efficacy with Provenge by a 13-4 vote.
In an attempt to derail an approval recommendation by the panel, the plaintiffs claim that, prior to the vote on efficacy, Dr Pazdur and "his co-conspirators changed the statutory question regarding efficacy from 'substantial evidence' to 'absolute certainty' of efficacy, in an effort to obtain a 'no' vote on Provenge."

However, during the voting, this manipulation was discovered and promptly corrected by the FDA's Dr Celia Witten and Dr Jesse Goodman, and by an overwhelming majority, the panel voted "yes" to the revised efficacy question.

"It is unprecedented for the FDA to overturn the Advisory Committee on such a positive vote when men are out of options, delaying approval and asking for more trials," according to CareToLive spokesman Mike Kearny in an August 2, 2007, press release.

"Men are dying now," he states. "They do not have years to wait."

In the case of Provenge's approval, the profits at stake could not be higher. Prostate cancer is the most common non-skin cancer in the US and the third most common cancer worldwide. More than one million men in the US have prostate cancer, with an estimated 232,000 new cases diagnosed each year and more than 30,000 men face death from the disease each year.

As an initial treatment, when diagnosed with prostate cancer, most men have their prostate removed, or undergo radiation, which can lead to various degrees of incontinence and impotence. After the initial treatments fails, hormone therapy is given to block the production of androgens such as testosterone, needed for cancer cells to grow, and some men undergo testicle removal in an attempt to stop the androgens from spreading the cancer.

With AIPC patients, prostate cancer has usually gone into remission and then returned, spreading to other parts of the body including the bones, lymph nodes, bladder, rectum, liver and lungs. All men who do not die of other causes progress to the final stage where the cells no longer respond to hormone therapy. Provenge is intended for use by patients who have already failed other types of therapy.

Because Taxotere is the only approved drug, Sanofi would have suffered the greatest immediate loss had Provenge been approved. According to firm's 2006 Annual Report, Taxotere was the company's 4th best-selling product in 2006, and the US is listed as the number one country contributing to sales.

As far as profits per dose, in the February 7, 2007, article, "What Does It Cost to Have Cancer?", a patient who received the chemo drug for breast cancer in 2006 reported that "each infusion of Taxotere cost over $16,000."

She also stated: "That's just for the drug, not administration or anything."

According to the lawsuit, defendant Dr Scher, Chief Genitourinary Oncology Service, Memorial Sloan-Kettering Cancer Center, is a scientific advisor and lead trial investigator for a competitor of Dendreon called Novacea. Under faculty disclosures at the University of Michigan, Dr Hussain is listed as an advisory board member of Novacea, and she receives research funding from Sanofi.

Dr Scher also has an interest in ProQuest Investments, which stood to reap windfall profits if Provenge was not approved. ProQuest is a venture capital fund established in 1998, in large part by Michael Milken, who was given the nickname "Junk Bond King," after being indicted on nearly 100 counts of insider trading and sentenced to 10 years in prison, in addition to being barred from the securities industry for life.

The ProQuest fund was established with a specific focus on prostate cancer, and SEC filings show that ProQuest and its principals are major shareholders of Novacea.

Citing documents from ProQuest, the plaintiffs allege that Dr Scher is a "ProQuest Executive" and "member of the Board of Directors", ProQuest reaps millions of dollars investing in prostate cancer companies based on advice from doctors such as Dr Scher, and ProQuest own stock in direct competitors including Novacea.

Dr Scher receives compensation from ProQuest as a scientific advisor recommending investments and for conducting clinical trials that result from the investments. He also holds an ownership interest in ProQuest.

The lawsuit also alleges that Dr Scher receives research support from the Prostate Cancer Foundation, as well as financial benefits, as one of a consortium of members who reviews new research on cancer drugs to determine which grants should be awarded by the Foundation.

The PCF, also founded by Mr Milken, is one of the largest sources of funding for the National Cancer Institute and government research programs. A following of the tangled web involved in the PCF reveals that Dr Jonathan Simons, President of the Foundation, Dr Stuart Holden, Medical Director, and Dr Howard Soule, an Executive Vice President of the Foundation, are all scientific advisors to ProQuest.

Another research arm found to be infested with several of the same insiders is the Prostrate Cancer Research Program, within the Department of Defense, which since 1997 has been appropriated a total of $730 million by Congress. According to a PCRP report, "Today, the PCRP is the second leading source of extramural prostate cancer research funding in the United States."

The PCRP funds a Clinical Consortium Award to support the creation of a major multi-institutional clinical trial resource, "to speed development of novel therapeutics that will ultimately decrease the impact of the disease."

Here, too, Dr Scher is listed as the leader of the consortium, and the list of participating clinical sites and lead investigators includes none other than Dr Hussain. Dr Simons is listed as developing new clinical therapeutics for late-stage prostate cancer, but a review of upcoming research listed in the report shows immunotherapies are not in the cards.

These consortium members are invaluable to the industry and investors due to their unique access to insider information about clinical trials and influence over the FDA approval process. Evidence of this claim came on May 30, 2007, less than 3 weeks after approval for Provenge was denied, when Novacea announced an agreement with Schering-Plough worth over $450 million, in which Schering agreed to jointly fund and develop Asentar, a competing prostate cancer drug, for which Dr Scher happens to be the lead investigator.

"The partnership leverages Novacea's existing capabilities with Schering-Plough's experienced development, regulatory and commercial teams and will provide Novacea with an opportunity to support the commercialization of Asentar in the United States," John Walker, company chairman and interim CEO, stated in a May 30, 2007 press release.

A May 2000 ProQuest document provides insight about the investment firm's interest in Asentar's success and states: "ProQuest Investments is a $100 million oncology-focused investment fund, partnered by Jeremy Goldberg and Jay Moorin."

Mr Moorin owned 1,910,988 shares of Novacea stock at the time of a May 15, 2006, SEC filing, and the ProQuest document mentions an investment from Domain Associates, "whose general partner, Jim Blair, has also worked with the fund to plot its strategy."

As it turns out, Mr Blair and Mr Moorin were both members of Novacea's board of directors when the Schering deal was set up. However, apparently their services are no longer needed, because on August 30, 2007, Novacea announced the resignation of James Blair and Jay Moorin, effective September 4, 2007, and September 19, 2007, respectively.

All that said, it does not take a financial genius to figure out that this whole deal could have gone up in smoke had Provenge been approved, because there would have been a drastic drop in the enrollment of late-stage cancer patients in clinical trials as soon as they learned that there was a new vaccine that could not only increase their survival rate but allow them to live out their final days without the agonizing side effects of chemotherapy.

Provenge's approval also would have caused many patients currently participating in trials to drop out. Novacea's 2006 Annual Report filed on April 2, 2007, less than 2 months before the Shering announcement, warned that the "clinical development and regulatory approval processes inherently contain significant risks and uncertainties."

The report shows Novacea was going broke trying to keep the Asentar trials running, with research and development expenses associated with the drug of $12.9 million for the year ended December 31, 2006, up from $7.3 million for the year ended December 31, 2005.

The $5.6 million increase was due primarily to the Phase 3 Asentar trial, and the filing warns that Novacea could experience many delays in getting its product to market due to problems in trials including, "patient enrollment may be slower than expected at trial sites due to factors including the limited number of, and substantial competition for, suitable patients with the particular types of cancer required for enrollment in our clinical trials".

It also notes that there "is a limited number of, and substantial competition for, suitable sites to conduct our clinical trials; clinical trial sites may terminate our clinical trials"; "patients and medical investigators may be unwilling or unable to follow our clinical trial protocols;" and "patients may fail to complete our clinical trials once enrolled."

In addition, another ongoing trial is evaluating Asentar as part of a combination therapy for AIPC patients with Sanofi's Taxotere. If safety or efficacy issues arise with Taxotere, the annual report warns, Novacea could experience significant regulatory delays, and the clinical trial may need to be terminated or redesigned.

Even if Asentar were to receive FDA approval, Novacea would continue to be subject to the risks that could arise with Taxotere or that Taxotere may be replaced as the standard of care for AIPC. "This could result in Asentar ™ being removed from the market or being less commercially successful," the report states.

Ironically, in one of 3 derogatory letters sent to the FDA urging the non-approval of Provenge leaked to the media following the failed efforts to rig the advisory panel vote, Dr Scher discussed the same fatal effects that the approval could have on the research industry. "An approval recommendation has far reaching implications beyond making the product available that the data simply do not support or justify," he wrote.

Approval would provide the Agency's endorsement of Provenge as a "standard of care" for men with AICP, he said, and by extension, elevate Provenge "to a position of being the new 'control' arm for future randomized phase 3 trials that are being designed for the regulatory approval of any new experimental agent or approach."

In other words, all the billions of dollars invested in the clinical trials now underway, or set to begin, conducted in hopes of gaining FDA approval for a new ACIP treatment, could go right down the drain if Provenge is approved as the first-line treatment for this patient population.

Dr Scher is probably more aware of this fact than anybody. On February 26, 2007, MedPage Today reported that in a satellite symposium titled, "Improving Upon Current Standards: The Integration of Novel Therapies in the Treatment of Androgen-Independent Prostate Cancer," sponsored by Novacea, Dr Scher said Taxotere-based combination therapy is being investigated in a dozen clinical trials for ACIP patients, and he reported receiving grants and research support from both Novacea and Sanofi.



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 http://www.investorvillage.com/smbd.asp?mb=971&mn=161294&pt=msg&mid=3305795

CTL Lawsuit Reflections

After reading the better part of Kerry's unbelievable legal work I am left with the following basic questions that I hope the Judge will carefully consider prior to making his decision in the CTL case.

How often is the head of CDER present at a CBER AC meeting?
How often is the Substantial Efficacy question miss-worded at AC Meetings?
How often are such conflicted AC panelists permitted to attend AC's & vote?
How often are letters leaked post AC to influence an FDA decision?
How often has the FDA overruled a positive AC vote for a late stage disease?
How often does the SI in a stock increase markedly after considering the above?
How often has the media been so negative after considering the above?

Obviously, there are many other questions that can be added to the list (i.e. Von E's speeches for one). My point and opinion is that the more oddities/irregularities that are introduced to the list the more clear it becomes how unbelievably jaded and corrupt the Provenge travesty was. Of course none of this information is new to anyone here; I just pray that the Judge lets his eyes be opened as wide as ours have.

One very big thank you to Kerry and all the other incredibly selfless people here that have given so much! IMHO you will all take up a bigger chapter in history than is readily apparent today.

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A great letter to Hon. Senator Charles (Chuck) Grassley regarding Howard Scher's letter:

http://www.investorvillage.com/smbd.asp?mb=971&mn=161222&pt=msg&mid=3300906


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On Michael Milken:

http://www1.investorvillage.com/smbd.asp?mb=971&mn=172822&pt=msg&mid=3765225

Michael Milken and the Prostate Cancer Foundation’s Foul Balls:

http://caretolive.com/2007-11-18/michael-milken-and-the-prostate-cancer-foundations-foul-balls/

Picture of Michael Milken and Andy Von Eschenbach and Picture of Mike Milken & Howard Scher:

http://www.prostatecancerfoundation.org/site/c.itIWK2OSG/b.734793/k.3E28/Photos_from_the_2005_Home_Run_Challenge_to_support_the_Prostate_Cancer_Foundation.htm

 

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Good article in Nature about the crooked elements working to delay a life extending safe agent from reaching terminal patients:
http://www.nature.com/nbt/journal/v26/n1/full/nbt0108-1.html

Quoting from the article:
"At least one of the Office of Cellular, Tissue and Gene Therapies Advisory Committee members who voted against Provenge and then wrote to FDA to criticize the approval recommendation—Howard Scher of Memorial Sloan-Kettering Cancer Center—failed to disclose important competing financial interests. Scher is a scientific advisory board member of venture capital firm ProQuest, which owns an 8.3% stake in Novacea, a company that was developing a competing prostate cancer drug, Asentar. Scher also happens to be the lead investigator in Asentar trials."

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Here's an interesting post about Howard Scher, Maha Hussain, etc.

http://www.investorvillage.com/smbd.asp?mb=971&mn=177793&pt=msg&mid=3961558

http://www.investorvillage.com/smbd.asp?mb=971&mn=181520&pt=msg&mid=4103477
5 reasons the E&C should conduct the investigation




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A post by KDDublin (reprinted with permission): http://www.investorvillage.com/smbd.asp?mb=971&mn=199222&pt=msg&mid=4876203 Hey, hey FDA, ain’t no way were ever going to go away.

Trust me when I tell you, that not only does the FDA monitor this site, but so does their counsel.

Here is an open letter:

Listen up FDA. We are never, ever, going to go away!!!

Tomorrow is merely one day. ONE DAY!! It is merely the first day in the rest of your lives!!

While I am confident that Andy’s days are numbered for his complete incompetence in running the FDA, you other career bureaucrats, Pazdur, Woodcock and Goodman, need to know that we will be here for you every step of the rest of your pathetic careers. You get to look forward to our presence for many years to come!

This grass roots movement has just begun. We are just now starting the fight. We grow stronger by the week. The CareToLive web site has thousands of new and unique visitors to its site every week. The word is spreading fast now and you can’t stop it anymore. Once the world knows of your misdeeds you will no longer be able to hide amongst your fellow corrupt brethren.

While you and your big pharma buddies laugh and giggle and plot against little biotech companies like Dendreon, so you can maintain your big bucks status quo, and seek to climb you career ladders and grab what power you think you can, those who are trying hard to make Cancer a treatable condition rather than a deadly disease, will expose those Andy bullshit “bridge not a barrier” speeches that he makes in the name of politics for the benefits of Congress, and the real advocates fighting on the front lines of the war on cancer will continue to fight the number one barrier to winning that war,…...THE CORRUPT FDA!!!!!!!!!

Tomorrow it is Coast to Coast demonstrations and that will be a nice start. But you need to understand it is merely A START! Next we are coming to MLB ballparks throughout the country, and then to back to Rockville, and this time there won’t be two hundred people in Rockville, there will be two thousand!

Men are dying while Woodcock, Pazdur and the FDA are wined and dined by big pharma. Men are dying while Scher lines his pockets at the expense of the patients he is sworn to protect. Men are dying while your friends profit. NO MORE!!!!!

Stand up 2 cancer. You bet we will. Those at CareToLive know where the front lines are and we will keep reinforcing those lines until we defeat cancer and the enemy that stands in the way of the patient’s ability to win that war, which those with knowledge know to be YOU!!!!!

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Words of Howard Scher at the panel meeting. Makes you really wonder if this jackass is in the pocket of Big Pharma and/or hedge funds who had a lot to lose on Provenge's approval? Only ones who lost were dying cancer patients who were denied a life extending safe biologic agent.

---

Does anyone remember Dr. Scher's answer to the 2nd question? Here is is...
I wonder what he meant? About what was he concerned? Hmmmmmmmm...what could possibly be on his mind?  Asentar?  Naw!

DR. MULÉ: Dr. Scher?

2 DR. SCHER: I think we are really

3 poised at the beginning of what will be

4 hopefully an outstanding era of

5 immunotherapy. I think there is sufficient

6 evidence demonstrated which justifies the

7 definitive study, and obviously there are

8 investors in that who concurred, but I think

9 it does not meet the -- as the question was

10 phrased, to establish the efficacy. I think

11 this is still an open question.

12 DR. MULÉ: So I take it you're

13 saying yes with these provisos?

14 DR. SCHER: We have two

15 questions. I would say yes to one, no to

16 the second. The first question as posed, as

17 established, I say no.

18 DR. MULÉ: No, it's substantial

19 evidence.

20 DR. SCHER: I will say no.

 

Original Content at http://www.opednews.com/articles/genera_evelyn_p_080108_bush_s_fda___perpetu.htm

Reprinted with permission

January 8, 2008

Bush's FDA - Perpetual Leaker of Insider Information

By Evelyn Pringle


Bush's FDA - Perpetual Leaker of Insider Information

The steady leaking of insider information about products under review by the FDA has caused enormous losses for average American investors since the Bush Administration took control of the agency six years ago.

There are several ways that investors can profit from this type of insider information. The first is obvious, buy the stock because approval of a product will almost certainly raise a company's stock value. Investors who know about the decision ahead of time can bet the farm based on that information.

But investors who are tipped off that a product will not be approved can do the opposite. They can bet that company's stock value will fall by selling the stock short knowing full-well that the minute the news of non-approval becomes public, the stock's value will drop like a rock.

When the leaking of this type of information occurs, the losers are always the investors who play by the rules and make bets based on the best public information available. Unfortunately, in many instances, these are the very people who can least afford the loss.

One high-ranking member of the Bush Administration's FDA, Dr Richard Pazdur, has been one of the leakers in two cases involving cancer drugs that caused investors to lose vast amounts of money.

The first case devastated investors when a company's stock value dropped more than $1.5 billion in less than 3 weeks after Dr Pazdur tipped off the Cancer Leadership Council's legal counsel Samuel Turner that the FDA planned to reject the application for approval of a cancer drug the week before the decision was scheduled to be sent to the main sponsor, ImClone, on December 28, 2001.

At that time, Mr Turner also was a registered lobbyist for a number of pharmaceutical companies, including Bristol-Myers Squibb, which just happens to be the largest manufacturer of chemotherapeutic drugs.

Bristol-Meyer tipped off ImClone owners Harlan and Sam Waxal, and family members immediately started selling their stock. An investigation by the SEC later determined that the Waksals sold more than $10 million worth of stock in the 48 hours before the FDA's rejection of the application for drug was made public.

According to a June 16, 2002 report on Newsbytes News Network, short sellers also made millions by placing bets that ImClone's stock value would fall in the weeks before the FDA publicly rejected the application.

The House Committee on Energy and Commerce investigated the insider trading in this case, and a subcommittee held a hearing on June 13, 2002. At the start, the chairman noted that there were two stories here.

One, he said, "will be more fully told by the SEC and the Justice Department as it examines how the FDA process and what appears to be some rather amoristic players conspired in a way that allowed insider trading to potentially occur and an awful lot of investors to lose a lot of money while insiders were trading on information that was available only to them."

"The other story," he noted, "is about the process at FDA and how the FDA process allowed this to happen."

A transcript of the hearings shows that when members of Congress asked directly who within the FDA leaked the information to Bristol-Myers, Dr Pazdur and the rest of the Bush Administration officials talked in circles and never answered.

But in the end, somebody pulled some strings because Dr Pazdur got off Scott free, which probably accounts for his lack of fear when engaging in similar, behind-the-scenes activities in 2007.

In the more recent case, the continued short selling in Dendreon's stock following the Provenge Advisory Committee meeting of March 29, 2006, despite the fact that the Committee recommended approval of the drug, surely indicates that information leaked to Wall Street from inside the FDA guaranteed that the drug would not be approved.

On May 9, 2007, when Dendreon announced to the public that the FDA had issued the company a Complete Response Letter instead of an approval letter, the market value of Dendreon dropped more than 60% in one day.

The known people behind the "leaks" in this case are Dr Pazdur, along 2 members of the Advisory Committee who were chosen to participate on the panel by Dr Pazdur. When persons serve on these committees, they become "special government employees," and are subject to the same rules and regulations as all government employees.

When the Provenge Committee recommended approval, there were two votes taken. The first was on safety and the vote was 17-0 that the drug was safe. The second was on efficacy and the vote was 13-4 that the drug demonstrated "substantial evidence" of efficacy, the federally mandated standard.

The approval of this new cancer vaccine represented a grave threat to the multi-billion dollar chemotherapy industry. Dendreon is the first company to seek approval of a drug in a promising new class of immunotherapies that direct the body's own immune system to attack only cancer cells, unlike chemotherapy which destroys cancer cells but damages healthy cells and the immune system as well.

Provenge sought approval to treat men in the final stage of prostate cancer whose only option is months of chemotherapy with the drug Taxotere, which causes debilitating side effects and extends life on average 2.5 months.

In applying for approval, Dendreon submitted a study that showed 3 injections of Provenge extended life by nearly double that chemotherapy and the side effects, if any, consisted of flu-like symptoms for one or 2 days.

If the new immunotherapies turn out to be as effective as some experts claim, chemotherapy and radiation treatments could become obsolete in the not to distant future. Dr Pazdur knew this all too well. In fact, his fear was that if Provenge were to be approved, it would establish a new standard of care for late stage prostate cancer patients and from then on testing of new therapies would be up against Provenge.

He was also ticked off about the fact that the FDA had chosen the Center for Biologics Evaluation and Research to control the Provenge Advisory Committee instead of the Center for Drug Evaluation and Research, which he controlled.

So as a back-door means of regaining control, he recruited his two partners in crime, Dr Howard Scher, from the Memorial Sloan-Kettering Cancer Center, and Dr Maha Hussain, from Michigan University, to serve on the Advisory Committee to assist him in thwarting Dendreon's bid for the approval of Provenge.

Both of these doctors have made a fortune from their involvement in the cancer treatment and research racket over the past 2 decades. And they also stood to lose a fortune if the chemo-cartel was dismantled.

Investors had every reason to believe that Provenge would be approved once the Advisory Committee voted for approval. The FDA had never refused to follow a recommendation by its own experts to approve a drug for dying cancer patients who had no other options.

While testifying at the hearing, Dr David Penson, Associate Professor of Urology and Preventative Medicine at the University of Southern California, told the panel: "If you turn this drug down, it will likely set back the innovative field of active cellular immunotherapy in cancer many, many years."

He warned that the Committee's decision "will not only affect prostate cancer patients, but it may have an effect on the larger population of oncology patients in general."

Dr Hussain and Dr Scher were positioned on the panel to do everything in their power to make sure the vaccine was not approved. But their best efforts failed and within two weeks after the panel voted to approve the Provenge, Dendreon stock had nearly tripled in value and analysts were predicting that the vaccine could bring in $1 billion annually.

However, it was soon obvious that something was up, because the short sellers were still betting millions that the stock value would fall. On April 29, 2007, Bloomberg reported that shares were being sold short "at a record pace" as investors "bet the company's experimental prostate-cancer drug will fail to win approval from U.S. regulators."

All totalled, 33.9 million shares were sold short by the end of April. In hindsight, figuring out why people would engage in such risky betting was a no-brainer. The only people who could have known that Dendreon stock was headed for a nose-dive on May 9, 2007, because the FDA was going to overrule it's own panel by denying the approval of a cancer drug for dying patients for the first time in history, were the people who made it happen.

As late as May 7, 2007, Prohost Biotechnology, a firm that evaluates companies and publishes a monthly newsletter for investors, was calling Dendreon a good investment on its web site, stating: We Have A New Pick "DENDERON AGAIN."

The web site went on to explain why the firm was predicting that the short sellers were wrong in betting against the company, by stating in part:

This time, positive investors/analysts are determined to neutralize the shorters' efforts. Why not, if the verdict is expected in 10 days only and the committee, which was appointed by the FDA itself has already voted 17-0 in favor of safety and 13-4 in favor of efficacy?

We are with the approval, Prohost said. "As a matter of fact, we expect it on May 15, based on many facts, the most important is the result of the FDA committee's voting."

The firm noted that the experts on the panel would not have been chosen by the FDA if they were not highly regarded researchers, medical doctors, and academicians, and stated:

"If the results of voting would have been 50-50, we would have understood the need for the FDA to take a stand. But with a landslide voting in favor of approval, we do not see why the FDA should hesitate to follow the committee's recommendation of approval.

"Besides, the vaccine is safe. It acts synergistically with the available treatments and it helped desperate patients survive advanced prostate cancer."

But as it turns out, another plot was put in action immediately after the news came out that the panel recommended approval, in which government officials at the FDA and the National Cancer Institute worked with Dr Scher, and probably Dr Hussain, to compose letters with bogus reasons why the FDA should not follow the recommendation.

Once the rough drafts were edited, the letters were sent to the FDA by email and hardcopy, and leaked for publication on the internet by "The Cancer Letter," which just happens to be the same rag used to leak insider information in the ImClone case.

The overly dramatic Dr Scher, even went so far as to tell Thomas Fleming, another doctor who just happened to send a letter to the FDA, disparaging Provenge, which was also put out on the internet by "The Cancer Letter," that he could not sleep because he was so concerned over the possibility of patients being harmed if Provenge was approved and that's why he wrote the letter. Dr Fleming then noted that he could not sleep either.

This is an utterly ridiculous remark coming from Dr Scher, considering that he and Dr Hussain voted with the majority 17-0 that Provenge was safe at the hearing.

The pharmaceutical companies that stood to benefit the most from the non-approval of Provenge were Novacea, Schering-Plough and Sanofi-Aventis because they have billions of dollars invested in research, drug trials, and cancer treatments involving therapies that would compete directly with Provenge for the same late stage prostate cancer patients.

Dr Scher and Dr Hussain, as well as her husband, are involved in dozens of studies conducted by the same companies. Both Dr Scher and Dr Hussain are consultants and members of the scientific advisory board for Novacea, which produces Asentar together with Schering-Plough.

Asentar would directly compete with Provenge and at the time of the Advisory Committee hearing, Dr Scher was the co-lead investigator on trials of Asentar

According to www.portfolio.com, Dr Scher is also an officer, member of the Board of Directors, and a member of the Scientific Advisory Board of ProQuest Investments, which was had mega-bucks invested in Novacea during 2007. However, for some odd reason, ProQuest's web site no longer lists the names for the Scientific Advisory Board.

Dr Scher and Dr Hussain have also both received research funding from Sanofi-Aventis the maker of Taxotere.

A review of Dr Hussain's most current resume in fact, shows that she's been on one long global junket funded by the cancer treatment and research racket for close to 2 decades. She apparently began her journey in Bagdad, Iraq, in1980, and 2 years later she was in the UK and a year after that she ended up in Detroit, Michigan.

It looks like her home base has been Ann Arbor, Michigan since late 2002, that is in between her 6 trips to Canada, 3 to Hawaii, 3 to Puerto Rico, 2 to St Thomas, 2 to Barcelona, and at least 1 trip to Japan, China, Jordon, Lisbon, Monte Carlo, Bermuda, and Austria, in addition to her 17 trips to California, 9 to Chicago, 4 to New Orleans, 5 to New York, 9 to Florida, and at least 38 trips to other states.

The list of excursions certainly demonstrates that the good doctor enjoyed quite a lot of travel on someone else's dime. In fact, her hotel fees alone would put a bonifide hooker to shame.

Its impossible to determine the amount of "research" funding funneled her way because the amount is redacted for half of the grants listed. But at a bare minimum, she had at least 28 million "current" reasons to sabotage the approval of Provenge.

Under "Current Grant Support," she lists 11 grants, although 5 have no amounts. But the total for the other 6 comes to over $28 million, and she will be receiving income from a few of these grants for several more years.

Dr Hussain also lists another 2 grants as submitted, with all information redacted. She lists 5 under "Active Research," all involving treatments for late stage prostate cancer, but not one includes the amount. No dates are listed for these 5 grants either, which makes it impossible to estimate how long she intends to profit from this research.

The doctor also lists 30 funding sources under "Past", but only 6 have amounts. The total for those 6 comes to more than $20 million, so it would probably be safe to say that if all amounts were to be listed, Dr Hussain had at least 100 million good reasons to derail the approval of Provenge.

All the plotting by persons benefiting from the non-approval of Provenge might have gone undetected if not for the non-profit advocacy group, Care-To-Live. The group filed a lawsuit in Federal court against officials in charge of the FDA, including Dr Pazdur and Dr Scher, seeking an injunction to overturn the FDA's decision and to make Provenge available immediately to extend the lives of dying prostate cancer patients.

By filing the lawsuit, the group was able to gain access to a lot of information and after reading much of it, one thing's for sure, the government officials involved in this sick plot will never be accused of wasting time on the clock worrying about dying cancer victims.

Another case of leaking occurred on March 1, 2006, when the FDA sent a letter to the Canadian investment firm, Infinium Capital, that said the agency would allow testing for a generic version of Vancocin, marketed by ViroPharma, to be conducted in a test tube.

Two weeks later, after allowing plenty of time for persons with the inside information to position themselves to make a killing in the stock market, Infinium issued a report on ViroPharma stating, "Generics . . . sooner than you think".

According to an SEC filing by ViroPharma, Infinium's report was the first public disclosure of the new testing standard and:

"ViroPharma itself had not previously heard that OGD had lowered its BE standard for Vancocin. Nor it would seem, except those to whom OGD had privately communicated, had anyone else."

ViroPharma's filing went on to note that Infinium's report stated:

"Our recent communications with the FDA regarding the approval process for a potential generic competitor to Vancocin lead us to believe a generic could enter the market 1-2 years sooner than current expectations."

What "recent communications with FDA" might mean, the filing states, beyond the March 1, 2006 letter to Infinium, is unclear to ViroPharma. On March 16, 2006, Medindia.com dropped a bombshell when it informed the public of the news by quoting analysts at Infinium as saying it could mean a generic version would be available by early 2008.

"Previously, generic manufacturers may not have been interested in developing this therapeutic due to its low revenue potential; however, with the recent sales growth of 133 percent in 2005, Vancocin is now on the radar screen," an Infinium analyst told Medindia.

Infinium's announcement caused shares of ViroPharma "to dip by about 33 percent," according to Medindia. But in fact, Infinium's report triggered a multi-day stock sell-off that cut the company's market capitalization by 40%, or roughly $500,000,000.

The approval process prior to the FDA's unexpected announcement required trials to be conducted on humans. ViroPharma has filed a Petition to stop the approval of generic versions with allegations that the FDA violated the Freedom of Information Act, the Data Quality Act, the Administrative Procedure Act, and its own Standards of Conduct.

Vancocin is used to treat hospital-acquired bacterial infections in the lower gastrointestinal tract caused by the bacterium Clostridium difficile. In order to be effective, the drug must be released in one specific section of the intestines, making its release mechanism far more difficult to replicate than other drugs.

The release of an ineffective version of Vancocin at this point in time would be especially dangerous because recent studies have shown that cases of Clostridium difficile-associated disease (CDAD) are increasing world-world. The disease causes 400,000 cases of diarrhea and colitis each year in the US, according to the US Department of Veterans Affairs.

In addition, a paper by Michel Warney, et al., entitled, "Toxin Production by an Emerging Strain of Clostridium difficile Associated with Outbreaks of Severe Disease in North America and Europe," in the September 2005 Lancet medical journal, reported a new strain of C difficile that produces up to 23 times more toxins than previous strains; this strain has been implicated as the cause of a more severe form of the disease

A May 11, 2007, report by the Pennsylvania Health Care Cost Containment Council said that in 2005, patients with CDAD were hospitalized 2-and-a-half times longer, charged over twice as much, and were 4 times as likely to die as patients without the disease.

On average, the report notes, patients with CDAD remain in the hospital almost 7 days longer at a cost of $73,576, verses the average charge of $30,833 for patients without the disease. A November 2007 report entitled, "The Emerging Infectious Challenge of Clostridium difficile-Associated Disease in Massachusetts Hospitals: Clinical and Economic Consequences," cites a "conservative estimate" of the annual cost for CDAD management in the US as $3.2 billion.

People treated with antibiotics are at the highest risk because antibiotics disrupt the balance of bacteria in the GI tract, which allows C difficile bacteria to multiply. CDAD is highly infectious and can spread by contact with patients or touching surfaces contaminated with C difficile spores. The severity of the disease ranges from mild cases of diarrhea to painful colitis, bloodstream infections or death.

Years ago, CDAD was almost exclusively limited to patients in hospital or long-term care settings where infectious diseases spread easily. But there are now widespread reports of patients developing CDAD outside hospital settings, referred to as "community-acquired" CDAD, and with no antibiotic exposure.

Recent studies indicate that many cases may be caused by proton pump inhibitor drugs which inhibit the production of gastric acid in the stomach that acts as a defense against bacteria and spores, widely used by persons with ulcers and other GI illnesses.

The December 21, 2005, Journal of American Medical Association published a report by Canadian researchers based on studies that determined that gastric acid-suppressant drugs were associated with the rising cases of community-acquired CDAD.

The researchers used the United Kingdom General Practice Research Database and identified all 1,672 cases of CDAD recorded between 1994 and 2004 and found that 1,233, or 74%, of the patients had not been hospitalized in the year prior to the diagnosis and were considered community-acquired.

The study showed the increase in community-acquired cases rose from less than 1 per 100,000 in 1994 to 22 per 100,000 in 2004 and during this same period, prescriptions for antibiotics had decreased while prescriptions for proton pump inhibitors had increased.

The first course of treatment for CDAD caused by antibiotics is to stop the antibiotics. But if diarrhea continues and becomes severe, Vancocin is a treatment of last resort for very sick patients which means there is no room for error.

The FDA claims that dissolution testing for the generic version can be done by creating a test tube solution that replicates the environment in the lower intestine. But experts say it would be next to impossible to replicate the GI tracts of very ill and elderly patients to determine whether the generic version will work the same in the targeted area.

Experts also point out that drug interactions, such as those in patients on proton pump inhibitors would make it hard to develop a solution that would replicate the GI tract.

The approval of an ineffective generic version of Vancocin, will subject millions of people to potentially fatal risks because the patients who end up being treated with this medication will have no second chances if it fails.

The FDA is currently under attack for doing the exact same thing by not requiring adequate testing for the generic version of the antidepressant Wellbutrin. The FDA approved the generic in 2006 and after a steady stream of patients reported that they were experiencing serious side effects, testing by ConsumerLabs, revealed that the time release rate of the active ingredient was much faster than the release rate in the original drug.

The consumer-product testing group, ConsumerLab began investigating the drug after Joe and Terry Graedon, authors of The People's Pharmacy column, came to the group with complaints received from readers of their column. While the Graedons had received complaints about generic drugs before, "we had never received this volume of response," Joe Graedon, a pharmacologist, told MSNBC on October 12, 2007.

"In almost all cases people were saying their depression returned," he said. Users also complained about severe headaches, digestive problems, insomnia, anxiety, and tremors.

ConsumerLab performed dissolution testing on 6 samples of each medication and found that even though both contained the same amount of the active ingredient, the generic released nearly 50% of the ingredient in the first 4 hours verses 25% by Wellbutrin.

"It's been an eye-opener for everyone," ConsumerLab President, Dr Tod Cooperman, told MSNBC. "It makes you question whether generics are always going to be equivalent to the original product."

"If these things are releasing at such different rates," he advised, "it's hard to believe they'd be acting the same way in your body."

"It would seem very difficult to imagine that the results we saw would be acceptable results," Dr Cooperman told MSNBC.

He pointed out that the release of the active ingredient more quickly could mean there is less medication available to the patient later, and may explain why patients experienced a return of their depression.

He said a time-release problem might also explain why patients experienced more side effects, such as headache, irritability and nausea, if they received a high dose of the medicine upfront. "Too much Wellbutrin can cause side effects, even the potential for seizure," he told MSNBC.

The Canadian firm Biovial filed a petition with the FDA in 2005, asking the agency to require generic makers to conduct more rigorous testing of generic versions of Wellbutrin prior to their approval but apparently the agency ignored the request.

An agency spokesperson told MSNBC that the FDA does not require generic makers to do clinical trials on hundreds or thousands of people as required for name brand drugs. It only requires lab data and "bioequivalence" testing in about 24 to 36 healthy volunteers showing that the drug enters the bloodstream in a similar manner to the original product.

Since the generic version was approved, millions of consumers have switched to the drug to save money which means a high number of patients may be experiencing serious side effects without knowledge of the cause. Experts say this whole problem could have been avoided had testing on humans been conducted to check the release mechanism before millions of scripts were written.

"Sustained release mechanisms are not that easy to develop, and they tend to be proprietary in nature," Michael Katz, clinical associate professor of pharmacy practice and science at the University of Arizona College of Pharmacy told MSNBC.

"It would be difficult for a generic manufacturer to reproduce the same release characteristics as the brand-name product," he stated.

"Such differences clearly could have an impact on patients," he said, "and my view is that sustained-release products are among the relatively short list of products that should not be switched."

Experts say the time release characteristics would be even more difficult to replicate in a generic version of Vancocin, where the concern is not just about how much of the drug is released into the blood stream but rather in one specific section of the GI tract.

The leaking of information in the Vancocin case is reminiscent of a major scandal that erupted during the first Bush Administration in 1989, when FDA officials were charged with taking bribes from generic makers and sharing insider information.

On August 28, 1989, Time magazine reported that an investigation by the Justice Department had uncovered evidence that "some makers of generic pharmaceuticals falsified laboratory test results and paid off FDA chemists to gain quick Government approval for their products."

In that case, Charles Chang the head of the FDA's generic division and two co-workers pleaded guilty to accepting a total of $24,300 in illegal gifts in exchange for preferential treatment for certain generic makers in July 1989, according to the Time report.

In the end, the generic scandal during the first Bush Administration landed Mr Chang in federal prison and caused 42 others and 10 companies to be convicted on charges of fraud and corruption and the FDA Commissioner Frank Young resigned in November 1989.

The crooks in the current Bush Administration's FDA deserve the same fate.

Evelyn Pringle
evelyn-pringle@sbcglobal.net

(Evelyn Pringle is a columnist for OpEd News and an investigative reporter focused on exposing corruption in government and corporate America)



Authors Bio: Evelyn Pringle is a columnist for OpEd News and investigative journalist focused on exposing corruption in government and corporate America.


 

__________________________________________________________ .

 

SHKRELI PRISON

 

It Is especially important to give Martin a very harsh sentence. He has set himself up as Some sort of an  Icon among the youth because he owns the only copy of a rap album.  If you let him off the hook easily, he will  wiggle his nose at you ??????????  and negatively influence people  that his kind of behavior is acceptable,  and that’ll further contribute to the decadence. It’ll also embolden other such miscreant on Wall Street who will think they can weasels their way out of Breaking the law

No jail means fraud is acceptable

 

 

__________________________________________________________ .

 

  1. On or about February 1, 2011, the defendant MARTIN SHKRELI took a

large short sale position in Orexigen Therapeutics, Inc. ("OREX") in MSMB Capital's brokerage

account at Merrill, Lynch, Pierce, Fenner & Smith, Incorporated ("Merrill Lynch"). Specifically,

SHKRELI sold short over 32 million shares of OREX. Contrary to SHKRELI' s representations

to Merrill Lynch, MSMB Capital had failed to locate OREX shares to borrow in order to settle

MSMB Capital's short sales. As a result, MSMB Capital failed to settle a short position of over

11 million shares of OREX, which Merrill Lynch ultimately closed at a loss of over $7 million.

In addition to the losses in the Merrill Lynch account, MSMB Capital suffered over $1 million in

other trading losses in approximately February 2011. Based on these trading losses, the value of

assets in MSMB Capital's bank and brokerage accounts, not including the OREX losses at

Merrill Lynch, declined from more than $1.12 million on or about January 31, 2011 to $58,500

at the end of February 2011.

_____________________________________________________________________________________

 

Why the hell is ML just trusting a hedge fund manager saying, yes we’ve located !!

 

 

 

__________________________________________________________ .

 

On September 9, 2010, Mr. Shkreli sent an email to an FDA official requesting to be

included in an upcoming advisory committee panel on the weight-loss drug Lorcaserin produced

by Arena Pharmaceuticals.51 After his request was rejected, he sent a follow-up email to which

he attached a PowerPoint presentation attempting to refute the drug’s efficacy.52

 

[lorcaserin turned out to have very good safety, but years later was pulled off the market for safety issues]

 

 

 

__________________________________________________________ .

After four years as an associate at Cramer Berkowitz, Shkreli worked as an analyst with Intrepid Capital Management and UBS Wealth Management, and an associate for Cramer Berkowitz.[12][when?] before starting his first hedge fund, Elea Capital Management, in approximately 2006.[13]

In September 2009, Shkreli launched MSMB Capital Management,[6][14] which takes its name after the initials of the two founding Portfolio Managers, Shkreli and Marek Biestek.[10][11]

EVIL

In 2011, Shkreli filed requests with the U.S. Food and Drug Administration (FDA) to reject a new cancer diagnostic device from Navidea Biopharmaceuticals and an inhalable insulin therapy from MannKind Corporation while publicly short-selling both companies' stocks, the values of which dropped after Shkreli's interventions; the companies had difficulty launching the products as a result, although the FDA ultimately approved both therapies.[11][15]

The scum did the same things to Avanir, hurting us shareholders a lot, and lied about his contribution to charity from profit of short sale.

 

EVIL

Around 2008, Shkreli started a second hedge fund, MSMB, a name made from his initials and those of his business partner and childhood friend, Marek Biestek. They developed a reputation for shorting biotech companies and then using stock chat rooms and other aggressive tactics to savage them, to cause the stock to go down.

 

 

 

__________________________________________________________ .

 

15 January 2016

 

Subject:

USA v. Shkreli et al., CRIMINAL CASE # 1:15-cr-00637-KAM-1 (Filed 12/14/2015)

 

To (via Fedex): 

Honorable Kiyo A. Matsumoto, United States District Judge, Eastern District of New York, United States Courthouse, 225 Cadman Plaza East, Brooklyn, NY 11201, Secretary:(718) 613-2180

Cc:

Honorable Robert M. Levy, United States Magistrate Judge, Eastern District of New York, United States Courthouse, 225 Cadman Plaza East, Brooklyn, NY 11201, Secretary: (718) 613-2340, Law Clerk: (718) 613-2340

 

United States Department of Justice

Eastern District of New York (EDNY), 271 Cadman Plaza East, Brooklyn, NY 11201

 

Mr. Robert L. Capers – United States Attorney

718-254-6023, Fax: 718-254-7499, robert.capers@usdoj.gov

 

Mr. Winston M. Paes – Chief, Business and Securities Fraud Section

718-254-6023, Fax: 718-254-7499, winston.paes@usdoj.gov (alternate: Mr. James Loonam, AUSA 718-254-7520)

 

Ms. Alixandra Eleis Smith – Assistant US Attorney

718-254-6370, Fax: 718-254-6076, alixandra.smith@usdoj.gov (alternate: Ms. Veronica Di Mattia 718-254-6043, Ms. Patricia Di Meglio 718-254-6226)

 

Federal Bureau of Investigation

935 Pennsylvania Avenue, NW., Washington, D.C. 20535-0001. (202) 324-3000.

 

Mr. James B. Comey – Director, FBI

Mr. Diego Rodriguez – Assistant Director in Charge, FBI

Mr. Michael Harpster – Special Agents in Charge, FBI

Ms. Lilian Perez – Supervisory Special Agent, FBI

Mr. Christopher Delzotto, Mr. Michael Braconi – FBI agents

 

U.S. Securities and Exchange Commission, 100 F Street, NE, Washington, DC 20549

Ms. Mary Jo White, Chair, SEC, (202) 551-2100, chairmancorres@sec.gov, fax: 202-772-9200

Mr. Andrew J. Ceresney, Director, Division of Enforcement, SEC (CeresneyA@sec.gov)

Mr. Andrew M. Calamari, Director, New York Regional Office, SEC (calamaria@sec.gov)

Mr. Sanjay Wadhwa, Supervisor, SEC (WadhwaS@sec.gov)

Mr. Gerald Gross, Mr. Eric Schmidt, Ms. Melissa Coppola, Mr. Paul Gizzi – SEC

 

Mr. Richard G. Ketchum, Chairman & Chief Executive Officer, FINRA

1735 K Street, Washington DC, 20006, (301) 590-6500 richard.ketchum@finra.org

 

 

Dear Honorable Kiyo A. Matsumoto:

 

SUMMARY

 

Congratulations to the DOJ, SEC, FINRA, FBI, and others involved in bringing Martin Shkreli to justice. He’s a terrible person who deserves to get maximum sentence and no leniency.

 

CASES

 

There are two cases before you against Martin Shkreli, a civil and a criminal one. The criminal case was filed on 12/14/2015 for:

 

  • CONSPIRACY TO COMMIT FRAUD- MSMB CAPITAL SCHEME
  • CONSPIRACY TO COMMIT WIRE FRAUD- MSMB CAPITAL SCHEME
  • SECURITIES FRAUD- MSMB CAPITAL SCHEME
  • CONSPIRACY TO COMMIT SECURITIES FRAUD- MSMB HEALTHCARE SCHEME
  • CONSPIRACY TO COMMIT WIRE FRAUD- MSMB HEALTHCARE SCHEME
  • SECURITIES FRAUD- MSMB HEALTHCARE SCHEME
  • CONSPIRACY TO COMMIT WIRE FRAUD- RETROPHIN SCHEME

 

The Civil case was brought by the SEC which charged Shkreli with violating:

 

  • Sections 17(a)(1) and 17(a)(2) of the Securities Act of 1933
  • Section 10(b) of the Securities Exchange Act of 1934
  • Rules 10b-5 and 10b-21
  • Sections 206(1), 206(2), and 206(4) of the Investment Advisers Act of 1940
  • Rule 206(4)-8

 

DISCUSSION

 

I am writing to humbly ask you to not have mercy on defendant Shkreli and impose the toughest conditions, restrictions, and penalties on him. I unfortunately came across Shkreli long before he became famous for his allegedly immoral act of pumping the price of a life-saving drug by more than 5000%, and for buying the only copy of a Rap album.

 

I was a victim in a short&distort scheme which Shkreli conducted, and he claims to have made a lot of money from it. The allegations in the cases at bar mention his naked-shorting shares of another company and lying to the broker about it. This tells you how corrupt the system is: any hedge fund manager can lie to a broker and have the broker sell property which he does not own and has not borrowed.

 

I speak on behalf of Main Street investors who are regularly defrauded by Wall Street’s rigged games. The aforementioned cases represent everything that is wrong on Wall Street: arrogance, greed, dishonesty, lies, fraud, and the attitude of being above the law.

 

I beg you to not have mercy on Martin Shkreli. For Wall Street miscreants paying a fine is the equivalent of a parking ticket – it’s business as usual afterwards. It was disappointing to hear that the SEC made a deal with Stevie Cohen, the billionaire hedge fund manager running SAC Capital. The only thing that sends the right signal is prison time.

 

Shkreli represents a huge crisis in morality. He was “schooled” at Jim Cramer’s hedge fund. Cramer is on record for saying “truth is your enemy” and that “you should not do anything remotely truthful when in hedge fund mode”. Main Street is regularly the victim of these lies – people who invest their hard-earned money do not have the same access to information, insider tips, clout, journalists and analysts who bat for big money, and bank accounts to compete with the miscreants who abuse those things.

 

We The People need the Judiciary to teach a lesson to these miscreants.

 

There are many many Shkrelis running wild on Wall Street. He just happened to get caught. By punishing him to the full extent of law you send a signal to the others, and diffuse his attempts to portray his actions as ok, cool, acceptable, normal.

 

On the other hand, if convicted, if you let him off the hook easy (lack of prison time) this will send a strong signal that his conduct is acceptable – that one can “get away with murder” on Wall Street and buy one’s way out.

 

Shkreli is an arrogant and unrepentant person who’s acted as though he’s above the law. Since being arrested and released on bail, he’s been trying to drum up public support by appealing to the younger section of society who are electronically well connected. DOJ needs to send the signal to the society that there’s nothing “cool” about being a miscreants, a criminal, a fraudster, if he’s convicted.

 

Thank you very much for your consideration to this message.

All the very best

 

Reza Ganjavi

<adr>

__________________________________________________________ .

 

14 December 2017

 

Subject:

USA v. Shkreli et al., CRIMINAL CASE # 1:15-cr-00637-KAM-1 (Filed 12/14/2015)

 

To: Honorable Kiyo A. Matsumoto, United States District Judge, Eastern District of New York, United States Courthouse, 225 Cadman Plaza East, Brooklyn, NY 11201, Secretary:(718) 613-2180

 

Cc: Ms. Alixandra Eleis Smith – US Attorney

718-254-6370, Fax: 718-254-6076, alixandra.smith@usdoj.gov

 

 

Dear Honorable Matsumoto:

 

As I have brought to your attention before, I am one of Shkreli’s victims. I know others too in the same shoes as me where that crook engaged in deceptive and highly immoral activities to enrich himself at the cost of us little people.

 

That crook has no respect for truth whatsoever. We are so happy you put him behind bars, and we encourage you to please give him the MAXIMUM sentence allowed by law. Otherwise, being the evil man he is, he will influence the society that crime pays off.

 

Thanks for being as harsh on him as possible. It will also send a very important and badly needed sign to other criminal entities including some on Wall Street that justice will catch up with you.

 

 

Many Thanks & Best regards

 

 

__________________________________________________________ .

 

 

Subject:

USA v. Shkreli et al., CRIMINAL CASE # 1:15-cr-00637-KAM-1 (Filed 12/14/2015)

  

Honorable Kiyo A. Matsumoto, United States District Judge, Eastern District of New York, United States Courthouse, 225 Cadman Plaza East, Brooklyn, NY 11201, Secretary:(718) 613-2180 Fax: (718) 613-2185.

 

Dear Honorable Matsumoto:

 
I am still having nightmares from the pain that Martin Shkreli put us through by his fraud. Please give him a very harsh sentence. He should rot in prison. 20 years will set a great example in society that malicious, intentional fraud doesn't pay.

Many thanks. Looking forward to hearing your tough sentencing of that crook.

Kind Regards

Reza Ganjavi

 

 

__________________________________________________________ .

 

Subject:

USA v. Shkreli et al., CRIMINAL CASE # 1:15-cr-00637-KAM-1 (Filed 12/14/2015)

 

 

08 September 2017

 

To: Honorable Kiyo A. Matsumoto, United States District Judge, Eastern District of New York, United States Courthouse, 225 Cadman Plaza East, Brooklyn, NY 11201, Secretary:(718) 613-2180 Fax: (718) 613-2185.

 

Cc: Ms. Alixandra Eleis Smith – US Attorney

718-254-6370, Fax: 718-254-6076, alixandra.smith@usdoj.gov

 

 

Dear Honorable Matsumoto:

 

Please refer to my letter of 15 Jan 2016, reprinted for you convenience below.


Martin Shkreli is an evil person who has intentionally harmed many people. I was one of his many victims and I know other victims who are too afraid to speak out.  I lost a lot of money because of that crook.  He lied through his teeth after he shorted a stock I owned and used his media connections such as Seeking Alpha to propagate his lies and misinformation.  I can provide you any details necessary. He made a lot of money on this trade, as he boasted about in a subsequent article after he covered his short position. During that time, which spanned over a year, many investors suffered due to his hurting the company and its stock by his malicious actions.

 

He further promised to donate a large portion of his gain to charity, which he never did. I had correspondence with him about he subject.

 

Lastly, he is corrupting minds of young people on social media. It’s important that he is imprisoned for the maximum sentence of 20 years, to send a signal to  a) the investment community  b) young people  that such criminal, evil, dishonest, arrogant behavior has no place in our great society which is founded on values which Shkreli opposes.

 

Many thanks for your consideration and sentencing that criminal to the maximum sentence, and immediately revoking his bail as the prosecutor has demanded.

 

Best regards

 

 

__________________________________________________________ .

 

GREAT NEWS. Martin Shkreli got a 7 year prison sentence. Can't tell you how good this feels after what that scum did to biotech investors which his deception, lies, and fraud.  I had a number of direct interactions with the crook, and called him out on his lies.

  • I had an email exchange with him about Arena. He said lorcaserin won't be approved. I said it will, and it did.
  • I also discussed Avanir with him. The scum shorted Avanir in the 4's and engaged in the most ridiculous "short & distort" by publishing impressive sounding but wrong bearish arguments on May 31, 2011. One of my analyst friends told me his arguments were lies (around IP value), and she was right. But at the time, the scum promised to give a big portion of his gains to charity and that he could be held accountable. He made a ton of money on that trade when he covered in the 2's and I called him out on the charity donation he promised. Zilch. He said he has to call reporters and have a big media blitz and blah blah and that was something that never happened.
  • Among his other achievements which are not officially reflected in the prosecutor's case is his short & distort on MNKD.
  • I was so happy to hear he got his ass kicked with OREX. And with ARNA I think he was too chicken to bet against lorc's approval.
  • Later on he went cyber and engaged in promoting his persona which had nothing to offer to the world than a big ego. Keep in mind he was trained by Kramer who is on record for saying truth is your enemy when you're in hedge fund mode. That truth zapped Shkreli in the back and put the sucker behind bars. Sigh of relief.

 

 

__________________________________________________________ .

 

December 17, 2015 ·

FINALLY, WALL STREET SCUM ARRESTED FOR FRAUD & RUNNING A PONZI SCHEME

FBI, SEC & DOJ finally caught up with a very evil hedge fund manager who'd hurt many investors, and allegedly defrauded many.

Martin Shkreli shorted and distorted biotech stocks and has recently been in news as the most hated man in America. He was finally arrested today on securities fraud charges. Hallelujah!

I came across him when he shorted AVNR and distorted the strength of their intellectual property by misinformation -- typical "short & distort". He made a ton of money off that immoral act and promised to give a big chunk to charity and last time I checked he still hadn't done it.

Of course he was proven dead wrong. The company's patents were rock solid as a couple of analysts I respect thought... Shkreli shorted the stock at around 4 and covered at around 2 -- later the company was bought for around 17/share.

Shkreli is so self-obsessed that he's uploading videos of himself sleeping all night, on youtube. Who in their right mind would spend hours watching someone sleep?! LOL...

Recently he became famous for increasing the price of a life saving medicine from $13.50 to $700. Scum!

Here are some letters that I wrote to regulators that mention him.

Finally he's caught. His arrogance and disrespect for law has made him tweet the way after his arrest that the charges are bogus. Well, these are easy cases because the trade confirmations and fund transfers all leave records. Plus, it seems like some insiders are cooperating with law enforcement.

It's part of Wall Street's corruption to deny charges, whilst, pleading guilty will get him a much lower sentence but I doubt he's humble and wise enough to go that route. On the other hand, I don't think he's stupid enough to want to go to trial because given his track record I wouldn't be surprised at getting maximum sentence.

He embodies everything that's wrong on Wall Street: greed, corruption, lies, arrogance, and thinking you're above the law.

 

__________________________________________________________ .

 

It's gotten better. SAC Capital doesn't exist any more and a few years ago nobody thought that empire of Stevie Cohen would ever vanish. I've spoken with SEC and FINRA and helped them investigate some miscreants. There are too many of them out there and so they try to go after the biggest ones and hope that slapping them would teach the smaller fish to behave. Here's the results of one investigation. This one made reverse conversions stop!!

 

Just in: SEC is suing him for fraud as well (civil suite). So the scum is now under investigation by both Department of Justice and Securities & Exchange Commission. SEC is after him for the past 5 years, lying to investors, etc.

 

One of my letters about that scum had a visit from The Associated Press, New York today.

 

A reporter who met him said he looks pale and looks like a vampire. One can't be too healthy when living a life of lies, deceit, cheating other people, fraud, and thinking one is above the law. He embodies everything that is wrong on Wall Street with the worship of money, as the new god.

 

Talk about Karma, the scumbag had a $7M loss on OREX. That's more than double the his undeserved gain in AVNR which he made through misinformation and damaging many investors. I wouldn't touch OREX with a 10 foot pole because Contrave has very heavy side effects.

 

Basically the FEDs have got an evil punk by his private parts and I hope, given how bad this person is, they send him behind bars.

 

The scum posted a video of him hanging up when FBI special agent. His ex-boss Jim Cramer, who should also be behind bars, tore up a SEC subpoena, on TV! Cramer is on record for saying truth is the enemy! https://www.youtube.com/watch?v=VMuEis3byY4 What lowlives these guys are. Add to the list Adam Feuerstein who works for Cramer's organization, TheStreet.com -- he's on record for publishing falsehoods as facts -- these scums have no reservation putting convenience ahead of truth!

 

 

 

__________________________________________________________ .

 

3 March 2018

 

Subject:

USA v. Shkreli et al., CRIMINAL CASE # 1:15-cr-00637-KAM-1 (Filed 12/14/2015)

 

To:

Honorable Kiyo A. Matsumoto, United States District Judge, Eastern District of New York, United States Courthouse, 225 Cadman Plaza East, Brooklyn, NY 11201, Secretary:(718) 613-2180, Fax: (718) 613-2185

Cc:

Ms. Alixandra Eleis Smith – Assistant US Attorney

718-254-6370, Fax: 718-254-6076, alixandra.smith@usdoj.gov

 

Dear Honorable Kiyo A. Matsumoto:

 

Please do not believe Martin Shkreli. He would say anything to get a lower sentence. Reading the lines he wrote to you, and knowing him from the past, and what a crooked liar he is, I humbly recommend that you do not believe him. It takes a lot more than a few months in jail to change this bad person who’s consistently acted as he’s above the law. He needs a humiliating long sentence to truly teach him a lesson. 

 

The “I should have known better” in his letter probably refers to “getting caught” and not “acting morally”. The roots of immoral behavior, having no respect for truth, having no care about hurting other humans, is so deep rooted in this evil person’s mind, that a short prison sentence is not enough to correct that.

 

Also, please consider the kind of message a short sentence would sent to other crooks and people he inspires: that you can get defraud people, cheat, lie, steal, do everything illegal and immoral, and away with a 2 year prison sentence.

 

Please give this bad person maximum sentence allowed by law. He’s hurt many people you’ve never seen in the court, people like me, and others I know whom he damaged by his immoral behaviors.

 

Many thanks and kind regards

 

Reza Ganjavi

 



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