The FDA has no need to rush because Sarepta needs time to manufacture the amount of drug needed for commercialization. I think the step by step process will be followed for the sake of precedent, but it will be timed in stages that keep up with the progress of bringing on the large scale manufacturing of the drug for sale to the DMD population that will want it. Step by step but the clock will be set by the pace of manufacturing. No parent could argue with that, and it allows the FDA to maintain their "rules of engagement" for the future. They don't want to set a bad precedent wherein any fly-by-night drug company can mobilize a sentimental army of advocates and walk all over the FDA. Upshot: the FDA will go as fast - and deliberately - as the pace of getting manufacturing of the drug up to speed allows them to do it. A win win for maintaining FDA traditions for scupulousness and for Sarepta's coming of age birth pangs. Approval will happen faster than ever before probably, but it will seem to slow for some, (but necessary for Sarepta) and it will look like a compromise...but it will actually be the fastest way forward in practical terms for those who see clearly what needs to be done to arrive at the finish line successfully for all concerned....FDA, Sarepta, 2,000 DMD kids.
Doubt it (unfortunately):
AA Acceptance and guidance by FDA: middle Feb 2013
72 Week Data Release: Any day now.. :))
Phase III Trial Design with a larger cross section 48 weeks: 1st QTR 2014
Commercial launch: 2nd QTR 2014.
Price Prediction: $140+/share
Long & strong...
no offense friend but you are wrong. If Accelerated Approved, they will be able to use the drug, that is what accelerated approval means. They will continue to do trials but it will be commercial right away. Do the DD. Common Sense tells you kids are dieing that's why it's accelerated approval to go commercial but they will continue the trials.
and, I think EVERYONE should descend upon the FDA with pitch forks
and fire brands to burn them out, if they don't get off their #$%$, right now..
Another year, and 10,000 kids more down the drain while we wait for "process"
doesn't make any sense. Note: Most government agencies operator under the
premise that "process" is more important than the end "product".