Nope- an actual delay due to REMS never raised by the FDA at AdCom.
FDA never said there will be a delay or might be a delay, all they said was its cutting it close on a REMS agreement due to PDUFA coming up soon.They never said they didnt think it can get done in time.
Priority review designation might' help to get FDA to expedite on this with Braeburn.
Yes its cutting it close but not out of the question that PDUFA will be on time.
Yes there is a chance for PDUFA delay and as a few here mentioned,,I doubt it would take 3 additional.months to come to an agreement...
IF there is a delay, look out for a PR 1 to 2 weeks before PDUFA.
Just a 3 month delay for REMs might be read as a positive as it would signal a likely approval after getting it sorted out. It will take Braeburn months to set up and train the sales force and set up the seminars for training the docs. I don't see the 3 month thing as some kind of huge binary event of any significance. The stock is valued quite low right now so clearly a number of shocks and disappointments are already factored in. The REMs thing is pretty much a non-issue to the share price, I think because it has been right out there in the open for neverybody to see. Good luck!