Stockwatch: A painful walking through approval probability
This article was originally published in Scrip
Executive Summary
After sinking over $100 million into the company, investors now want to know whether the US FDA will allow Sarepta Therapeutics to file for the fast-track approval of a drug for Duchenne muscular dystrophy (DMD) on a dataset covering just eight patients. The important information, however, is not about filing but about the chances of approval, and its timing. Sarepta has said little about its trial data, but what it has said shows that the data is probably fragile, at best.