RE:RE:RE:FDA Letter w/online petition.....
IMO the COO (most likely) should've had the leader role in the Adcom meeting, it was IMO too much to expect the VP to lead and then also be a "technical expert" to handle the specific trial discussions...she was failed by TST leadership IMO..the COO as lead would've helped greatly (assuming his is competent in this kind of environment) in coordinating, adding valued colour and additional info, etc...it was too much to have the VP "onguard" to answer technical questions well and by herself and then coordinate, etc.
..now having said that IMO i doubt it would've changed the outcome by much for instance IMO TST was handed a lobball question on race (it was reasonable to ask) and they answered it very well, but i suspect the member asking the question didn't care what the answer would be (no placating) and was voting no because there were no black people in the trial...nothing TST could do about it.
IMO when Bartlett (??? i believe) eviserated them on efficacy (somewhat easy to do really) and got down to 3 of 93 showing unequivacal benefit (that was a killer statement) TST seemed dumbfounded by the statement...that was the critical failure of not having the COO there, he could've softdanced whilst TST collected there thoughts to answer, that IMO was the most critical failure of the day and exec leadership was needed but not there...and FYI i suspect that attack was not thought of in preparation for the day