What part of avoiding the delay entailed by a Phase III Trial is lost on you? Accelerated Approval does NOT excuse the FDA from due diligence, in fact it requires that the FDA be extremely cautious in reviewing information that supports any application for AA.
Beyond that, until facilities are ready, inspected and approved it would be completely impossible for Sarepta to even begin to meet the anticipated demand for this treatment - even at full capacity they are going to have to have some method of prioritizing which boys will be first in line. A late Q3/early Q4 launch was always a best case scenario and nothing that has happened to date has (or can) change that.
None of what was discussed in yesterday's presentation indicates that the FDA is being anything but supportive and prudent in their actions. There simply are no "no brainers" in this arena, nor should there be.
I think the market will get a huge surprise from FDA this time around. The white paper SRPT submitted contains no new information, it's a collection of all the latest research. I can assure you FDA already reviewed all those research before SRPT's submission. It's merely a formality. What's new to FDA is the 74-week data and SRPT's interpretation. Considering FDA already has all previous data including 36- and 48-week, I don't think it will take FDA more than a few weeks to come to the conclusion that the treatment effect is durable and safe, in particular.
IMHO, FDA will come out by end of June to tell SRPT they can go ahead file for AA and the meeting in Q3 will go over in detail what expectation they have on manufacturing and P3 design. Traders who sold their June and July calls will regret big time when this happens.
As I understand it, accelerated approval would mean the FDA is using dystrophin production to demonstrate efficacy. What does the white paper say is the cut-off for determining success and failure. How was the cut-off number determined?