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.
kvncmcdd (beachinv ) read the not stupid thread (Sarepta Therapeutics Announces Eteplirsen needs big Phase3 trial for DMD) which should have been a topic relevant to Insmed today. Arikace for CF was not "compelling" and all the hype here and all the grandiose revenue projections have been cut by 2/3rds, since Insmed is not entering the US market. NTM filing in 2014 is another very risky proposition that needs "encouraging results(Lewis's words),so we dont know where the FDA will draw the line on NTM results to allow a P2b to file.
The FDA decision today to demand a large Phase3 trial (Sarepta Therapeutics) who thought they would be able to file after a 2B may be a harbinger for Insmed and NTM. A big run up after a trial and before the FDA acceptance of a filing would be a smart time to let go of shares. Will be interesting to see how it plays out.