InvestorsHub Logo
icon url

jessellivermore

08/13/19 5:37 PM

#208574 RE: ziploc_1 #208464

zip...I sent you a Private message...

":>) JL
icon url

sts66

08/14/19 12:50 PM

#208780 RE: ziploc_1 #208464

It makes zero sense - when FDA approves an sNDA it means they have approved a label change - so what's the point of having an AC afterward to discuss what should be on the label? If FDA intends to hold an AC they WILL delay the PDUFA, they have no choice - just because they haven't publicly said it will be delayed doesn't mean they won't do it - hell, they still haven't admitted there's going to be an AC.