RE:RE:how good was TST's preparation and AdCom Strategy???bigs,
i have a different opinion, "slaughtered" is pretty inflamatory but 18 no vs. 6 yes is a substantial and very negative outcome..and i save harmless the entire team that was there to present including the VP..
..IMO and based on listening to the webcast and the commentary was this: it was a small single arm PIII trial that failed to meet its primary endpoint objective...that is a real problem and hole to dig out from..and EOD the vote comments on the negative side focussed in on this issue by "failed to prove" that was the most constant theme and in my handicapping of likely voting that was the obstacle to overcome and IMO they simply failed that front but..
..where they failed in some areas and FYI the FDA acknowledged something about not just the trial but the entire context was relevant to them but:
a) really really drive home AUA/FDA guidelines and that 301 met that standard
b) it was only to be given to "surgery unfit and surgery unwilling" 2nd liners
c) there was no "harm" to patients if they have to go back to surgery option
d) the failure of Valstar to be used, the approval of Valstar
..now as evidence of their failures when some bladder doc stated about not agreeing with TST on no 2nd line therapy for bladder and then went on to extoll chemo as 2nd line (gem, paci,etc) and then id'ed TST own expert (ODonnell who i believe holds patents on BCG yet supports MCNA but has written about use of chemo as 2nd line) TST had no effective response
..i could go on but suffice to say IMO because they were ill prepared and lacked having the
CEO/CSO or COO on the "team" they were "failing to communicate" at critical times...IMO a majority of the panel was convincable TST just failed to do it
..which BTW i suspect is rare.