wannabe,
It certainly was NOT a vote on "approval" vs. "approvable." It was a vote on "substantial" proof of efficacy vs. "established proof of efficacy." That is a totally different question. In fact, I would argue, given the confustion caused by Goodman's running up to the panel with the "real" language--whether Goodman meant to do this to provide a shot across ODAC/Pazdur's bow or whether it was just an innocent attempt to provide clarity or maybe just to give the Provenge approval a little boost--that what the panel really voted on was "non-approval" vs. "approvable." (But, as I've stated previously, I don't think the panel knew exactly what the hell they were voting on--given the rushed nature of the vote and then the confusion caused by Goodman invoking the black-and white language of the regulations--except perhaps for the four who voted "no."
Believe me, I'm 100% sure that Pazdur/Scher grasp the significance of what Goodman did by invoking the literal language AND the literal interpretation of the regulations. Some people here might not grasp the significance, but Pazdur/Scher have got it right. Scher's letter is unequivocal on this point, although, admittedly, he doesn't do the kind of "close reading" of Goodman's language change that I have done.
(My guess is that the FDA is now experiencing some of the fiercest in-fighting between divisions, CDER vs. CBER, that it has ever experienced. The fact that Scher has taken this whole mess public is testimony to that. The whole process is rather fascinating, if you're into this sort of stuff--lol)
Bladerunner
AI
