109-38: Sarepta Numerology Headed Toward May 26 Deadline On Eteplirsen
This article was originally published in RPM Report
Executive Summary
It sounds like a lopsided high-school basketball score; but 109-38 is the ratio of members of Congress urging approval to Duchenne Muscular Dystrophy patients who have completed efficacy trials with eteplirsen. It is the kind of score that creates a tough challenge for an FDA decision.