i didnt get a chance to listen to the mnta webcast yesterday - did i read on this board correctly that CW confirmed they are still on track for 505j and no efficacy studies
Correct. CW also said he was aware of the chatter regarding the trial but that MNTA was still in fact on the 505j track. After listening again and reading the board yesterday, I would say it seems likely it will be a bioequivalence study.