Earliest AA filing Mid-14- Approval with 8 months revie: Q1 2015 the earliest- Need to start confirmatory study
"In the event (the Agency) agrees to file the Subpart H NDA submission, additional safety data to support approval could come from the first few months of the... pivotal confirmatory study."
Not even close. If that were the case, then the FDA would not have asked for written summaries supporting the use of dystrophin as a surrogate endpoint for approval, as well as a discussion of clinical outcomes from the phase II study. The reason the FDA is asking for this data is because they are preparing for approval and need all the supporting data to make it an approval in accordance with their rules and regulations.