I may not be able to read SRPT/Chris mind, but I surely know the FDA's mind set/process.....AA is absolutely ruled out, certainly not with 12 patient exploratory data and certainly not given that GSK has set the precedence of completing a prospectively designed, FDA blessed phase III trial with lack of evidence that this drug class is efficacious in DMD!!!
Ultimately SRPT has to come out with truth with regards to required and success of phase III trial for approval!
What a dope you are! The FDA suggested that SRPT file an NDA with only P2 data BECAUSE they have NO PROBLEMS with the size of the trial, or the design. Misleading people about this is , well, dishonest. Of course, you know that, and are counting on your dishonesty having an impact. I doubt your misleading words have much of an impact sadly. Oh, and by the way, Max can now walk farther than he did at the start. BIlly can stand up in 1/3 the time, and the kid with the broken leg.............you know..............the type of break that NEVER heals in Dmd boys? Well, darn if he didn't heal. WHy.
E T E P L I #$%$ N..................................... It works. The FDA knows it. YOU know it, but you're still a dope!