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Jul 29, 2013
 |  BC Week In Review  |  Clinical News  |  Regulatory

Eteplirsen regulatory update

Sarepta said FDA "would not commit to declaring dystrophin an acceptable surrogate endpoint" for accelerated approval of eteplirsen to treat Duchenne muscular dystrophy (DMD) prior to an NDA filing. The company plans to submit an NDA for the compound in 1H14 based on Phase IIb data. On a conference call to discuss the news, Sarepta's president and...

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