I think the company miscalculated, or the agency misled them, regarding the close TTP miss. I do agree that the company should have fought for the 0.052 p value at the panel meeting. However, the basis of the BLA was survival, and the company wanted to focus on that endpoint. I, along with several others, believed that the company's presentation at the panel meeting could have been a lot better. OTOH, I think in the end it wouldn't have made any difference if they had been able to persuade the committee members that the TTP p value should have been 0.052. Scher, Fleming, Hussain, and Pazdur still would have been opposed to approval.
I think Fleming would have still insisted that the 9901 TTP was a miss. Pazdur, Hussain, and Scher would have directed their argument more toward 9902A and the relatively small number of patients in the two trials...Scher's motivation being different than the others, because he is on NOVC's scientific advisory board as lead investigator of the Asentar Phase III in HRPC. It's still amazing to me that he was able to get the conflict of interest waiver.
