Dendreon Corporation (DNDN) class-action?

Seriously, is anyone thinking about taking legal action, class-action wise? What would our chances be? This is the 2nd time I got skinned alive, and don't want to go down without a fight this time around. If anybody starts one, count me (and thousands of others) in. It's time the retail persons spoke up....!!!!!




Stocks in the News May 9, 2007, 2:55PM EST text size: TT
A Dreadful Day for Dendreon

Shares plunged Wednesday after the FDA requested more data on the biotech's prostate cancer drug, dashing hopes of a quick approval

Talk about a roller coaster ride. Just over a month after its stock soared on word that a U.S. Food and Drug Administration advisory panel had vouched for the safety and efficacy of its lead drug candidate, shares of Dendreon (DNDN) cratered May 9 after the agency requested more clinical data. The latest decision derails market hopes that the company's Prvoenge compound for treatment of prostate cancer would be approved quickly.

The Seattle-based biotech announced on May 9 that it received an "approvable" letter the preceding day from the FDA regarding its Biologics License Application (BLA) for Provenge, which was accepted for filing by the agency in January, 2007. The FDA has requested additional clinical data in support of the efficacy claim contained in the BLA. The company said in a May 9 press release that it is seeking a clarification from the FDA as to the nature of the requested data.

"Given our strong belief in the survival benefit and safety profile of Provenge, coupled with the positive outcome of the Advisory Committee meeting, we are disappointed that this decision will cause a delay in the availability of Provenge", said Dendreon CEO's, Dr. Mitchell H. Gold. "We are committed to working closely with the FDA to resolve these questions in a timely and efficient manner to bring Provenge to patients with advanced prostate cancer who currently have few appealing treatment options."

After the news hit, the selling started. The shares were down 61% to $6.88 on the Nasdaq May 9 with shares trading hands at nearly four times average daily trading volume. The stock is still above their 52-week low of $3.57 reached on Mar. 21.

The news is a textbook example of the volatility inherent in shares of smaller biotech outfits, where investor hopes live and die based on FDA pronouncements and requests. Dendreon's stock price surged nearly 150% on Mar. 30 after news that an FDA advisory committee of outside experts voted 17 to 0 in favor of Provenge's safety and 13 to 4 on its efficacy.

Provenge is designed to stimulate a patient's immune system against prostate cancer. A midstage trial of the vaccine in 127 patients with late-stage prostate cancer failed to reach its stated goal of slowing the disease's spread, usually a death knell for a new drug facing the FDA (see BusinessWeek, 4/30/07, "Teaching The Body To Fix Itself"). But when Dendreon dug into the data it discovered patients on Provenge lived an average of 4 1/2 months longer than those receiving the standard chemotherapy, Taxotere.

But since the trial wasn't meant to prove survival, it was possible something else could be prolonging these patients' lives. The trial wasn't well-designed, "so it leaves plenty of ambiguities," according to Dr. Howard I. Scher, an expert in prostate cancer at Memorial Sloan-Kettering Cancer Center in New York. "It doesn't mean the drug isn't working, but it needs more study."

The company will pin its hopes on the outcome of a Phase III trial for the drug now underway. Needham & Co,. analyst Mark Monane expects the company to report top-line data from the trial in the second half of 2008 or the first half of 2009, according to a report on Standard & Poor's MarketScope. While he continues to be enthusiastic about Provenge's market potential for this disease setting, given uncertainty of development path, expected lack of significant news flow in the next 12 to 18 months, Monane downgraded his opinion on the shares to hold from buy.

"Outside of full rejection, this is almost a worst-case scenario," analyst Paul Latta of securities firm McAdams Wright Ragen said in a May 9 note. "Unfortunately there is no timeline, which is causing a lot of uncertainty." Latta kept his hold rating on the shares. (McAdams Wright expects to receive and intends to seek compensation for investment banking services from Dendreon in the next three months.)

Use lawsuits to retrieve all losses... the panel was a sham and should be exposed as such since it cause many to buy from 12 to 25 when the stock has really no value at all now with zip sales...explain this to your lawyer and get all $$$ back from the pump and dump...

Class action lawsuits against hedge funds... Hedge funds are the cancer of the stock market. They need to get irradicated.

Terrible CC --This was just a terrible call,the CEO just had no answers and no plan at all.Although he did keep the door open to raising cash in the future which means "dilution".DNDN is done stick a fork in it,the leader is CEGE,they already have the time advantage plus a pipeline of more than 1 drugs.
The shorts had Gold pegged all along whether any longs wanted to hear it or not.Bottom line he is now a millionaire,he sold out cause he knew his chances were slim.Move on this stock will be dead for years....
Very sad so many people had their hope up for this,but after listening to the call this company has terrible management,especially from a shareholder perspective.
RIP DNDN 2007'S ENRON!!!!

DNDN=EAG, ISON, MCOM, WCOM, ERON. Get used to it. The market is full of rubble, garbage and bagholders. BwAhahahAHAHAhhahahAHAHAh!!!!

SEC AND DNDN? Have VERY small amount of DNDN stock. Got fooled by *59% drop the first day of News.

/Found it quite interesting that first day of news stock volume exceeded apparent shares outstanding (as listed by Scottrade...was their data up-to-date?). Whatever...it just looks quite odd to this investor.

Now, the SEC rather automatically scans for high volume in certain types of stocks during the market (lets stay, smaller companies stocks especially)?

Head of Co. has to be very careful what he or she says, under any circumstances (as SEC compares verbage to volume price actions).

Let us see how SEC enters this picture IF FDA (and Co.) have to lay-out the facts, herein. Insider trading could be possible in 'foreign markets', where certain types of what might be defined as shadow trades----are conducted?

It seems apparent that the more the stock is shorted, the more the one eye of govt. is called into play, to 'analysis' "trails"? One way this type of situation gets "smoothing oils" is to announce dramatic news as a method of boosting stock price dramatically and quickly. The shorts give and the beat goes on. Or, does something diffferent transpire possibly... e.g. "Hi...we have your place of business surronded and we are just now entering with legality issues of warrant'. Your telephone lines are as of now...".

This could well be a rationale that will imping on the direction and volume of stock price in coming days?

I, of course, am not an expert at the law. And, so it seems, not an expert at stocks. DisClaimer

The SEC went to the FDA and Dendreon and told them that there was a huge problem ready to unfold if Provenge was approved.
The naked short position was too huge to unwind and the losses would have brought on a crack in the banking system too large to support. In exchange for relief it was proposed that the FDA and Dendreon announce a muddied letter (today's news)and let the shorts out...(hence the volume 132 million shares??)and the SEC promised meaningful changes to the structure of short selling. You will see these announcements in the coming months possibly sooner.

The company and the FDA did them a favor and now a conference call tomorrow after the close. Coincidence?

It will be revealed that the letter is not an "approvable letter" just a request for more data that they can readily provide within 30 days. When does the FDA send out a letter that needs further explanation? Wasnt the press release just a tad strange? What couldnt be explained to the company in the letter in plain english? They are medical professionals. Why did it need clarification? With so many eyes watching why wasnt the FDA explicit in its requirements?

The stock will explode on Friday a.m. and the worst case scenario for the banking system will have been avoided. Most of the short position was unwound today. They knew.

Unfortunately, the individual investor who trusted the system got hosed today but the company and Provenge will prevail and the SEC will reign in the lunacy they have allowed. Buy as much as you can tomorrow because Friday this will be a moon shot. I guarantee it.

Class action lawsuits against hedge funds!!!! Hedge funds are the cancer of the stock market. They need to get irradicated.

100% yes that is best thing we can do for America. Let us organize.

heavy organized crime in short selling. the s.e.c. hasnt caught on to the extent of it yet. if the agency is corrupted then we all have a license to steal..