The BLA is based on stats sig OS in 01, with other supporting data (mainly OS in 02B and TTP in 01
i know the question of 9901's TTP "near miss" has already been hashed out quite a bit, including the lowering from .06 to "virtual" significance of .052 on final publication of the results (i don't recall the exact numbers offhand), despite the increased amount of time the immune system needs to ramp up after the vaccine, and the apparent detrimental method in how TTP was measured per 9901 (due to differences in when the clock started to measure ttp, if i understand correctly.)
best i can understand, TTP was largely discredited as a valid endpoint for PC, as concluded at an NCI or FDA sponsored PC workshop a year or two ago, IIRC. Consequently, it has been postulated (imo correctly) that Dendreon won't be relying on their near miss in TTP in 9901 to make any of their case in front of the panel.
as a layperson, i wonder whether DNDN's near TTP miss in 9901 may cause the usefulness of this endpoint for PC to be revisited? while DNDN may not use 9901 TTP results to support the case for Provenge approval, wouldn't the panel members aware of the problems of coming up with meaningful surrogate endpoints for PC survival look at the 9901 TTP result in a positive way, perhaps even supportive of approval?
just thinking out loud & on paper...
AI
