others have listened to call and have said the same thing. I think it's a done deal and you can tell that when CEO says " partnership. It's just a matter of getting the paperwork.
partners... wonder if Chris knows he let the cat out of the bag..thanks Chris. Call never said anything about meeting.. people assuming. Look for announcement at Healthcare Meeting May 39th.
I listened to call and your right it did not say anything about a meeting, the document is just a way that FDA can say approved which they are because it 100% sounds like a done deal.
he said he didnt know what form the response would be in, meeting, phone call etc nor how long. I would think FDA would take 2-4 to read/review respond at a minimum. I'm still hopeful of resolution by end of june. then they calendar the CMC for early August and file NDA before year end, with decision before June 2014.
Don't think they'd drag it out needlessly like that, actually.....Only way they would is because there's no point in doing it faster - but if there is a reason to do it faster than I believe they will choose "faster".
At least the question of IF Sarepta decides to submit will be decided once FDA responds to the white papers. And that could come shortly after they recieve them. Maybe they'll get them today. No later than May 31st....
Because as Chris said before the last (inconclusive) meeting, he'll decide IF to submit immediately after that meeting and announce it. And so that announcement is now due after the FDA responds to the new papers.
The question of WHEN to submit he said would be decided after the Maunfacturing meeting (now happening in July). But the question of IF will be answered sometime after the FDA gets the papers. And that could be next week, week after etc.