pharmaguy and other experts..Q for you.. FDA ADcom BD's..so i gotta ask having seen a few FDA BD's and Questions they ask (which IMO are sign posts to their thinking).. a couple of questions:
a) as best i can decihper FDA Adcom BD's for MCNA was actually somewhat positive and for FDA BD's that by itself is positive as i have seen these BD's be mercilessly negative...and market reaction to the FDA'S BD's tend to be real tells (stocks tank on really negative BD's)
b) the other question is FDA ask whatever Questions they want...for recent BMRN they didn't even ask an up or down approvability Q (like they did for MCNA).but FDA BD was very negative and they got a CRL...so does the asking or not of an aprpovability Q indicate any potential (or not) for approval..
regards