The FDA has no control on if SRPT files. They made their recommendation but it's still SRPT's decision. Since there isn't anything before them the FDA can't be accused of stalling. We know for a fact the FDA discourage filing. I wouldn't trust Ian Estepan or any of the "Welcome Back Kotter" cast members.
RU, i know it;s hard for you to be objective, especially when you want to see this drug fail which is outrageous imo. However, you don't think it's a little disingenuous for Hamburg to say there is no NDA to rule on because one was not submitted when it was the FDA themselves that told the company not to file? Come on. Hamburg looked ridiculous when she answered that question.
That could have been Hamburg creating a way out (under Federal pressure to acquiesce.) Today she says, "Well they never filed!" Chris files. It's accepted. End of Crisis. Kids get their medicine. Stock rocks. She saves face. As long as no one brings up FDA's November discouraging of SRPT from doing the same NDA app submission. (Even so, FDA could rationalize citing the Pulmonary and 120-week data.) It's always darkest right before dawn.