FDA wants just a little more data because they want to approve
The FDa, imo is telling SRPT to give them some more data so when they file for AA, this will get approved. The fda is basically looking AA as a formality to approval. They don't want them to apply right now only to ask for this info. Give the FDA what they want and this is approved.
i believe some of it was analysis of the drisparen and its functionality. not a big deal. they are not asking for new trials. they want to make sure all info and analysis is given. kind of flush out the data a little more. very positive imo. i know people are complaining but many felt trial was too small and srpt had no chance of AA. this is not the case from todays news. fda willing to approve. things look good.