gearle0521

Why Dendreon's Provenge Must Be Approved

I think the following are important and conflicting arguments:
* the FDA is pursuing their OWN prostate cancer vaccine. This means they are serious in believing this is a direction to be heading.
* I think the oncologists are starting to believe that cancer must be killed this way...by the body. even if a magical chemical could kill cells, unless you kill the mechanism creating NEW cellls, the cancer will come back. therefore we must teach the body to kill and continue to kill the cells.
* An approvable letter is like a disapproval to a patient because it won't be marketed. It may seem like a middle ground but it's not. Approval, doctors can prescribe it. Disapproval or approvable letter, doctors can't prescribe it.
* I don't think the FDA gives a crap about the stock. They can't. They 'kill' biotech stocks all the time; they're used to their decisions making and breaking stocks.
* People argue that they have to issue the approvable letter just to be safe. No. They could approve it, watch it and then PULL it if they think they made a mistake. They would be watching this like no other cancer drug in a long while.
* There is a chance they approve it with a label limitation concerning different ethnic groups since there was a strange divergence of issues/problems between different groups. But this would still be an approval. Maybe it only doubles then ;-)
* I can't say whether I'm bullish or bearish, I haven't made up my mind yet. So I guess I'm currently an agnostic trader.
* I am writing this as well to convince myself one way or another ;-)

Update on Dendreon's Briefing Docs: Provenge Missed All Endpoints

Hmmm... NO posts today????

Update on Dendreon's Briefing Docs: Provenge Missed All Endpoints

I guess you're going to be hot water Friday.