Sarepta claws back losses, FDA letter offers sliver of hope on early review


Sarepta (SRPT -6.1%) shares are taking back some of the day's losses (15.1% at the trough after a negative view issued by Citi) on news that an FDA official has sent a letter to people who have written the agency regarding the early approval of eteplirsen, noting in part, the "FDA has reached no conclusions about the possibility of using accelerated approval for any new drug for the treatment of Duchenne muscular dystrophy, and for eteplirsen in particular."

Adam Feuerstein opines that the consensus view on Sarepta is that the muscular dystrophy drug has virtually no chance to receive early FDA review, but that the agency "would... might... possibly... be willing to review eteplirsen based on the existing phase II data," and that "Sarepta's door isn't shut entirely." 

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