Post by
DryBones on Nov 21, 2015 10:13pm
The flip side of the coin isquye
There is no way they should be going into the FDA meeting in February with unanswered questions. They should have it all answered. As for Champagne I still don't know if she is the right person for the job. She should have laughed off some of those questions as dubious. Seriously, the idea that MCNA delays bladder removal is patently stupid.
Comment by
txbioinv on Nov 21, 2015 10:25pm
Dry, there is no scheduled meeting in February. Maybe an Adcom followup meeting, asap, as many as tst can squeeze in, most like one or two. Usually, the PDUFA /BLA decision is literally faxed or sent next day mail. Tx
Comment by
DamnYankees on Nov 21, 2015 10:36pm
TXB, i disagree. They need to figure out WTF the game plan is before re engage. F&$k the SP near term. This is big boy time and they better have the best consultants 25 mil options can buy. pitch 1 was a C f$&k and a strike. It ain't going to 3 pitches so take your f$;:$ng time and get it right. That is my take