BOSTON ( TheStreet) -- The Biotech Stock Mailbag is open for business.
I haven't written about Sarepta Therapeutics (SRPT - Get Report) lately mainly because there hasn't been much change to the story. I'm as bullish as I've ever been about the efficacy and safety of eteplirsen and the FDA agreeing to an early approval filing. I still believe the FDA's affirmative decision to allow Sarepta to file based on data from the current, small phase II study (when it happens) is tantamount to an approval. The eteplirsen data have strengthened over time. Parents and advocates working on behalf of the Duchenne muscular dystrophy kids have been very effective at lobbying FDA and Congress, pushing for early approval of eteplirsen.
FDA, in turn, has been incredibly responsive, even solicitous, to the DMD community. The agency's top officials -- Margaret Hamburg, Janet Woodcock and Bob Temple -- are all personally involved in the eteplirsen review.
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