On Monday April 15th, the FDA asked Sarepta to provide additional information on the drug, eteplirsen, to consider early approval. Eteplirsen is an antisense PMO-based therapeutic for the treatment of individuals with Duchenne Muscular Dystrophy (DMD).
As I have reiterated a few times now, I feel early approval is likely here, and sooner rather than later. The FDA just wants as much data as possible, so when the organization does grant the early approval, it will not be seen as a politically based decision. There has been a substantial advocacy push to get the drug to market as soon as possible. If the FDA simply approved it now, it might fall under criticism for caving into advocacy groups - at least in my opinion.
While there is no set date for the FDA to grant accelerated/early approval for eteplirsen, I feel it can happen within the next 3 months or less, so Sarepta is a stock investors and traders should keep on close watch.