ADCOM reviewer question
Just to be sure, am i correct that there is no reviewer assigned to the BLA, so there will be no briefing docs from the reviewer as input for the ADCOM ?
Trying to figure out if there are any potential negative publications before Adcom.
Below a link to a Adcom rollercoaster (FYI role reviewer and Phase 3 design).
first time :neg review -> 7-4 adcom -> FDA CRL
second time : neg review -> 16-1 Adcom -> FDA approval -> stock sold out way to cheap.
https://www.streetinsider.com/Analyst+Comments/Chelsea+Therapeutics+%28CHTP%29+Remains+Outperform+at+Wedbush+Despite+Negative+FDA+Briefing+Docs/9044661.html