SRPT should file the NDA with or without the FDA's blessing
Call Hamburg's bluff. She claimed that no one has filed an application yet so don't blame us (the fda). Well, Chris, file the darn application. Call her bluff. Put the ball in the FDA's court. At this point, eteplirsen is the best, most safe drug to treat DMD and they have the incredible backing of these parents who are going to such incredible lengths to get it approved. Let the FDA be the ones that have to come out and deny the filing. They can then answer to these parents, reporters and legislatures and explain why they denied. They can explain that even after the results, the desperate pleas on the parents and the testimony of leading experts in DMD research who believed this drug needs to be approved asap why they rejected. Come on CG, file it!!!!!!!!!