Sarepta’s Latest Bid In Race For DMD Indication: Submit NDA With Phase IIB Data
This article was originally published in The Pink Sheet Daily
Executive Summary
The sponsor plans to submit an application for eteplirsen for Duchenne Muscular Dystrophy in the first half of 2014; company executives say they took encouragement from an end-of-Phase II meeting when FDA said it is open to considering an NDA filing based on existing data, although the agency did not make any guarantees about accepting the NDA.