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April 22, 2014
09:07 EDTSRPTSarepta must enhance dataset for acceptable NDA filing, says Janney Capital
Janney Capital noted that the FDA said Sarepta's current dataset is not strong enough alone to file an adequate NDA for eteplirsen for Duchenne Muscular Dystrophy. The FDA suggested a fourth muscle biopsy in Study 202 patients, but Janney believes the company may be challenged to convince patients to undergo such surgeries. The firm maintains its Sell rating and $10 fair value estimate on shares of Sarepta.
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