Just to confirm

A narrow panel vote on data from a surrogate endpoint for eteplirsen from Sarepta Therapeutics Inc. has left the door open for accelerated approval for Duchenne muscular dystrophy caused by mutations amenable to exon 51 skipping.

Trying to guess whether FDA will let eteplirsen through that door is a fool's errand. But one of the big questions the agency will have to answer is whether the company would be able to conduct a robust confirmatory trial...