May. 7 at 1:15 AM
$CING I looked at 4 different companies that had 90 day extensions to pdufa . Unfortunately no consistency, 2 were notified about 6 weeks before pdufa and 2 of them about 2 days before pdufa . All of them were considered major amendments to the filing . Which was not the case for cing . šSo basically itās going to come down to the big day itself . Iām still leaning on the approval side. No efficacy issues , mfg issues basically as we understood which bio bend is not knew to this game . They prob pulled the A team out and knew from experience and exactly how quickly they needed to respond to fda issues , I think itās mar 16 when they got the 483 which should have been enough time to respond and still leave fda time to overview again imo
