I was motivated by today's GSK announcement to contact my Senator to find out why the FDA is dragging its feet with regard to SRPT yet fast-tracks GSK's drug which is less effective and less safe. I doubt it will help, but I am following the right processes to try to apply the appropriate equalizing pressure.
SRPT has had Fast Track Status from the FDA for Eteplirsen for more than two years. FDA will have given Accelerated Approval indications to SRPT by the time your Senator gets back from vacation.
Sentiment: Strong Buy
how do you know this is what's going on???? relax already!!! gsk applied for btd, srpt did not. why? because at this time, srpt does not need to waste time and money on getting btd because AA is much more important. only if the fda tells srpt not to file for AA would they then probably apply for btd. nothing bad has happened today other than it appears the fda has validated the desperate need for this treatment which is great for SRPT given that their drug is superior. btd does not mean approval. AA, imo, means a much more likelihood of approval. i don't know why so many of you are hysterical right now.
Nobody is "hysterical", I'm not sure why you felt compelled to make that up.
The annoyance is that the FDA appears to favor GSK and cater to them while not being sufficiently responsive to SRPT.
Good reply and I agree that today's news is good news for Sarepta. Everyone gets a little alarmed with deep pocket competitors with a big name. Fact is their product is inferior, so I expect an announcement soon from Srpt. A positive one too.