In this article, Molly Fellin Spence, writer and editor for Thomson Reuters, explains that the US Food and Drug Administration (FDA) has twice delayed a final decision. The question is whether it will approve new drug application (NDA) 206488 for eteplirsen injection for intravenous infusion, sponsored by Sarepta Therapeutics, Inc. (Sarepta). The agency has requested additional clinical data from the sponsor multiple times in the last year for the product, proposed as a treatment for Duchenne muscular dystrophy (DMD), a rare, degenerative neuromuscular disorder that primarily affects young boys.