@BiotechAutist Im long at 2.2 diluted cost. Added some more the day before Adcom. FDA made a lot of mistakes on this one. The review team is too junior to interpret the data.
@RxRegA Why changing the format? So fda have more time to cover their technical weaknesses? Why the review teams can’t do a better job? I have a proposal for the fda: make the Adcom mandatory for the sake of transparency