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Dendreon Perfect Storm
But prominent researchers wrote the FDA that the preliminary data did not yet meet minimum requirements for approval, the FDA made an announcement for more study in May 2007 after DNDN fell to 4.95 in four weeks. In March 2008 DNDN asked the FDA for and got a Special Protocol Assessment to shorten the additional trial by a year.
Then on 6 October 2008, 4 days before the first panic market bottom, DNDN put out a press release that sent DNDN shares up from 4.25 to 10 that day.
What was the press release? It was news that Provenge appeared to cut prostate cancer death rates 20% compared to placebo. DNDN also said it expected good results for the April 2009 release of final study results.
Members of the professional community were aghast. Publicizing the results of an unfinished study appeared to violate section 6.3 of Food and Drug Administration guidance issued in March 2006.
DNDN said they had FDA clearance, while the FDA said it was legally forbidden from commenting on experimental drugs.
Further, the DNDN CEO told analysts at a JP Morgan investor conference in January We’re clearly within shooting range…Sometimes I use a football analogy where we are on the 10-yard line and we are in the red zone, and we need to punch it in the end zone right now.
Institutional investors did not appeared moved as DNDN sold off with the market to $2.55 on 9 March 2009.
Since then the Mexican swine flu refocused investor attention on drugstore and pharmaceutical companies. The fear is a 1918 pandemic may be around the corner.
Anyone who thoroughly researches biopharmaceuticals knows the two flu-relief medicines on the market are not 100% effective. They also know it may be months before a Mexican Swine flu vaccine may be ready.
So people with a lot of drug risk cash were looking for a place to put their money for return, preferably quick.
Onto the stage came DNDN. The stock began to move up with the market, and then doubled as a Hot Stock ahead of the market and ahead of the release of the annual report and news that the results of the trial would be released at the American Urological Association Annual meeting Tuesday 28 April 2009.
