tremendous pressure towards early Approval is upon the FDA. There is no more reason for them to deny the approval which after two more years of testing have been proven to be effective and safe for the treatment of prostate cancer!
Hate too throw water on your parade BUT, no early approval coming.
As said before, FDA is nothing more than a political machine. Two sides too the politics for DNDN. Ours and CHemo/Oncl lobbies who have more money too loose than we have to gain.
I know for a fact that they are working very hard to impact the final outcome for Provenge.
Out of "respect" for those folks NO early release of approval will happen. More important for the FDA to look like they are responsive too the lobby than too dieing patience.
Now here is the inside track of this: Huessein and others have been busy at work trying to confince the FDA that while Provenge may in fact have some theaputic benefit the newness of this radical approach will put many more patience at risk of dying because they will start to use this and forgo CHemo and loose lives. They are trying to get the FDA to approval Provenge on a marketing letter with strings that would open the current blind study so all can get Provenge but still "study" the drug during this limited marketing approval.
This approach will delay Provenge for another 12 to 18 months. All they want to do now is create more delays. Think about the impact on DNDN if, after they have made the construction committments they only have limited marketing to only patients currently in the trial and "certain other" eligible patience.
Anyone who really wants this approved by the end of April had better start ginning up the political pressure now. It has been pretty quiet for some time. If those who want this approved just sit back believing it is only the data that matters watch out.
I am very long this stock but am not overconfident, things can and do happen./