RE:The 88/12 rulerunning, re. 88% rule and my perspective (which i've provided before):
a) it is a reflection of the way it should be, most companies who get to AdCom typically have sufficiently supportive substantial data, etc. to support a yes vote; i offer AMGeN (???) recent T-Vec AdCom...they had a ton of clinical data generally but weakly supportive of effecicacy that didn't actually extend life, but it was safe and AdCom had no doubts as to what they were voting yes to.
b) BRMN from yesterday got rejected by Adcom (although sneakily FDA didn't actually ask for a "indication/label benefit vs. risks" vote (as Q 6 was with MCNA, but i do believe and have to check that they did ask for formal votes on all Q's which is don't think MCNA did)..their data IMO was rejectable and rejection was appropriate
c) TST data package was "slim and weak" quite frankly and no one should deny this... safety was great but efficicacy support required certain beliefs from members ( i had a personal prediction of like 16 yes and 6 no) as data was not unequivacal in this matter (imo most damaging was that durability of response was questioned as to whether it was MCNA or BCG effect)
..and IMO TST execs knew of teh "slim and weak" data they had and should've known where they would likely be attacked and IMO simply failed to message and communicate properly
ps IMO the 88% rule is silly and shouldn't be part of investment decision, there are very few AdCom's per year and each AdCom is very unique..but in general most companies come to AdCom with strong enough safet and efficacy data and message sufficiently well to gain AdCom support...