I Think the FDA is Right..........................
Clearly, GSK has greater resources to manufacture and bring the drug to market. Also, the manufacturing of their backbone is much easier to manufacture than our morpholino. If, which I believe we are granted AA, isn't it a good thing if the boys are on GSK's drug, with all the side effects, while we are getting ready to launch, rather than progressively losing function. There is no doubt, when we are ready, their drug will be taken off the market since a new standard of care will be established. Their side effects will cause this to happen without a doubt.
If SRPT is granted AA, eteplirsen will be available by the middle of 2014. Do you really believe GSK's drug would be available much sooner than that? Your comment about the "FDA is Right" sounds like you think the granting of BTD makes it a shoe-in for approval - nothing could be further from the truth.
Tredleon, Agree with your take. "Breakthrough" designation is a fancy version of "Fast Track" designation by the FDA. Both drugs have Orphan Drug status so I really don't know what this does for Glaxo's Drisa. Most investors don't know exactly what "Breakthrough" does for a drug and/or company that receives it. I'm well versed in all things FDA and besides "Fast Track" which is covered under Orphan designation I still don't know how this moves the ball forward for Glaxo's toxic, kidney killing, sulfa cocktail AO.
In this case, I believe that first to market is less important than best to market. Just on the manufacturing side, GSK has speed on it's side. Also, breakthrough status can be revoked at any time, especially when a new drug appears that accomplishes the same thing without horrible side effects. When we get AA, the time difference will be short between us and them. JMHO
This is why FDA is the most corrupt organization in the world. They twist the codes for all these big pharma companies all the time. Majority of the FDA advisory panel is also made of these big pharma guys. so go figure. that is why big pharma can bring #$%$ drugs to market regardless of their side effect profile.