An FDA Advisory Committee voted 17-0 saying Dendreon's Provenge for prostate cancer is "reasonably safe". And it voted 13-4 saying there's "substantial evidence" that it's efficacious. At first the efficacy question was phrased by the FDA like this: "Does the submitted data establish the efficacy of (Provenge) in the intended population?" Call it semantics, but as they started going around the room it sounded like it might go down with that language. So, with a few panel members struggling to articulate a yes or no answer to that question, the FDA liaison said its standard for efficacy is actually "substantial evidence" and rephrased the question using those words.
Suddenly, the tide turned and the vote turned positive. At least a couple of the panel members cited the impact the public comment portion of today's meeting had on them. I've covered a number of these meetings and often times they can be a huge bore. Very tedious and scientifically dense with data minutiae. This one had plenty of that but it also had the most heartrending "testimony" from patients, their loved ones and advocates that I've ever heard. (FYI: my producer and I watched and listened to the webcast that you can purchase at FDAlive.com for 150 bucks.) Now the question becomes, "Will the FDA approve Provenge?" Decision day is scheduled for May 15th.
The FDA usually, but not always, follows the advice of its expert panels. And lately it seems to be handing out more "approvable" letters than "approval" letters. Approvable means the agency might approve it sometime down the road if you cross your t's and dot your i's or do another clinical trial. You can bet that now that Dendreon has cleared this hurdle that the shorts (investors who believe the stock will go down) will now subscribe to the theory that an "approvable" letter (a euphemism for "delay") is what's coming.
The other shorts will have to cover their positions if they didn't do that during Wednesday's crazy trading session (record volume and a 13% move up) because some analysts believe this stock could nearly double Friday.
I interviewed Dendreon's CEO, Dr. Mitchell Gold - check it out: