RE:RE:Adcom transcript and the art of being outside his confort zoI little bit of the three maybe. I mostly disappointed that the FDA didn't clearly ask, at the end of the Adcom day, for a official (extra) vote on what they see as the most favorable benefit-risk ratio for the use of MCNA...that is from their briefing document again : "in patients with CIS-containing disease refractory to BCG therapy".
But giving the fact that they had 10 or 11 yes by just adding the "can't or won't undergo cystectomy", I'm sure they would have had a majority of yes with the above benefit-risk ratio...as it is clearly favorable when considering the global picture.
M80