Many are looking at this as if the FDA issued a CRL. This is not a CRL. What the FDA and SRPt are doing is somewhat unprecedented. The FDA is trying to get all data prior to issuing the approval. Yes, it looks like a CRL but it's not. Once SRPT provides the remaining pieces of information, i believe the FDA will approve. They do not want to recommend applying for AA only to deny.
Agreed. This is just the FDA telling SRPT what is still needed to do the AA.
It isn't a rejection, or anything else, it is actually a good thing, because the opposite could have been "Go do another full round of clinical trials and then come back - and no you can't have AA".
This is much better because it is dotting the "I"s and crossing the "T"s for AA.