Dendreon Corp fka DNDNQ

[fordwill1953]

Sam...

In a way your post is perhaps the best answer as to why the FDA is requiring another set of data from DNDN regarding Provenge. You hit the ambivalence square in the head with your question.

We are all hoping for another 9901 set of survival data for 9902B. But remember, Sam, early on in 9902a, the curves actually inverted. Remember, there were more deaths in the Provenge arm early on and it caused all of us to scratch our heads to figure out how that could be until they figured out the problem with the level of illness in the Provenge arm and used the Cox Regression to adjust the data. The Board was collectively stunned for a few weeks over that phenomena.

Now that the Cox is offered as a legitimate tool on a prescribed basis, in the adjusted SPA, hopefully we don't get another set of wierd data. But, this has been the problem all along for DNDN. The trial sizes kept us all holding our breaths for the actual data thinking that only a few "bad" survival experiences could sink the ship.

I'm still not convinced that we are out of the woods on the interim look with 9902B even with the Cox helping us. I'm trying to remain optimistic with the data but I for one will exhale a very deep sigh when the 9902B interim is behind us and it supports the 9901 story and not 9902a.

I wish I could be my normal optimistic self, but when it comes to the data and Provenge, the story has been a mixed case.

But before everyone grabs the nearest rock and tosses it at me, yes, I acknowledge that even 9902a supported the survival stat, eventually. But please, everyone, the curves in 9902a didn't get supportive until the 29th/30th month or very late in the trial.

So, please be more circumspeck and careful about projecting the outcome. Everyone is saying this is a slam dunk. I hope so but I'm not in that camp just yet.