Until Dendreon gets a fax from the FDA, what happens next is anybody's guess.
If the agency wants to ask Dendreon for more data, it certainly has some outs.
The real question is whether the ad generates enough patients to really ring the Dendreon register.
FORBES: Is The Dendreon TV Campaign For Provenge 'Too Little, Too Late?'
Sipuleucel-T, as the vaccine in question is known, is made by Dendreon, an American firm.
Those who were not paid have recourse through Medicare resubmissions, appeals, and Dendreon itself.
In fact, Dendreon missed their earnings call by about that much, 14% 49.6 vs. 57.7 million.
Even if Dendreon has a great day on Thursday, the company won't be home free.
Dendreon needs to convince the Street that Provenge is on the road to blockbuster status.
FORBES: Good News For Dendreon As Manufacturing Site Approved
Dendreon may face years of work to get the prostate cancer treatment to the market.
So far Cell Genesys and Dendreon are in the lead, with final-stage trials under way.
Analysts had said that a vote of three or greater would be a win for Dendreon.
Dendreon's application to the FDA contains two late-stage studies with a combined total of 225 patients.
The good news for Dendreon investors is that Provenge should come through this ordeal relatively unscathed.
Last month Forbes.com warned investors to avoid the stock (see "The Danger In Dendreon").
Does Medicare dare turn Dendreon down and risk the ire of thousands of seniors with prostate cancer?
Acorda is down 6%, Auxilium is down 35%, Dendreon is down 27%, and Momenta is down 30%.
But prominent cancer researchers have said the clinical trials Dendreon conducted failed to prove Provenge helps patients.
Dendreon's clinical trials were small, containing only 225 patients, and had failed to meet their primary goals.
The panel voted 13 to 4 that Provenge should be approved, causing Dendreon shares to quadruple.
Dendreon's (nasdaq: DNDN - news - people ) Provenge is a so-called cancer vaccine.
Dendreon ( DNDN - news - people ) that recently had good trial results.
Several Arena shareholders said they had also invested in Dendreon, whose stock soared after the FDA approval.
Abiraterone is dramatically different in several ways from another high-profile prostate cancer drug, Provenge, from Dendreon of Seattle.
If it does, it could eventually be promoted by the same sales force Dendreon is building for Provenge.
Given the number of prostate cancer patients who are covered by Medicare, this could be disastrous for Dendreon.
FORBES: Dendreon Data Are Merely Moderate, But Stock Surges Anyway
One against prostate cancer, from Dendreon, is already approved, but attempts to develop such a treatment remain risky.
Gold, a urologist, became chief executive of Dendreon in January 2003 when he was in his early 30s.
In cancer, we did better: Avastin, from Roche, and Provenge, from Dendreon, were among our picks.
Right now Dendreon does not have enough manufacturing capacity to meet expected demand.
The majority of analysts think investors should stand pat on Dendreon, with 12 of 18 analysts rating it hold.
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