FDA snow day delays review of Sarepta's Duchenne drug

The FDA is taking a snow day this Friday, abandoning scheduled plans to submit Sarepta's Duchenne muscular dystrophy drug to a review by outside experts. The delay may well also force a postponement of a February 26 PDUFA deadline, though there's no official word on that. Sarepta ($SRPT) suffered a drubbing at the hands of investors at the end of last week after the FDA's internal review rejected the biotech's case on efficacy. The efficacy data just wasn't there, the agency insiders concluded. And while they didn't come right out and recommend against an approval, the review scuttled many analysts' hopes that eteplirsen would be approved on the basis of a tiny study. A pivotal study is currently underway. The FDA formally rejected BioMarin's ($BMRN) application for drisapersen just days ago. Release

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