Any news on when Sarepta is going to start a confirmatory phase III. All of this waiting around on the FDA to give them their blessing is really dragging me down! Why not do the confirmatory trial any way if there is such confidence. My son could surely benefit and I'm sure there are lots of others as well. So frustrating!!!
Sarepta may make a statement at next Earnings Conference Call 02/27/14 at 8:00 a.m. ET
The CEO said on Monday that they will meet with FDA again this month. We can hope...
We urge the Food and Drug Administration (FDA) to use the Accelerated Approval pathway for approval and access to safe, effective therapies for Duchenne Muscular Dystrophy - the leading genetic killer of children that impacts 1 out of every 3,500 boys born in the United States. It's time for the FDA to Say Yes and make this the first generation of Duchenne survivors.