to me, if the numbers were too small to be approvable to begin with and if the OS data was hypothesis generating only because they missed the primary endpoint end of story, then why bother with the AC meeting or even allow DNDN to file to begin with???...either the data is good enough to be approved or it isnt...if the data is sufficient to be evaluated for approval, then the data should have led to approval.
I didnt listen to the AC meeting but I did read alot of it...I agree that DNDN imho did a horrendous job arguing on their behalf...I seriously think many on this board could have done a much better job.
And I still dont buy that Dr Small's flight was cancelled and thats why he couldnt make it...just cant buy that one at all...also, Dr Small is never quoted regarding Provenge anymore...his past views on Provenge seem very timid to me...now when you hear the principal investigators talk about Satraplatin, they will go beyond over-zealous on the TTP, DFS and time to pain data...we need a spokesperson(oncologist) who will go to bat for Provenge...find it odd that the most outspoken person in favor of Provenge is Dr Penson, who showed up to the AC on his "own dime".