FDA today.First yes on Phase2B then say No Do big Phase3
Willy got you all preped for NTM filing cept FDA in mood in big trials.Dont be surprised by the FDA saying Do not pass go to file,go directly to Phase3
Sarepta Therapeutics Announces Eteplirsen needs big Phase3 trial for DMD
What if the FDA indicated that a formal PIII (and its costs) could be unnecessary if certain PII milestones were met? After all, it is not like Arikace is a new drug. Could be a quick pathway to an unmet critical need.