Thanks @Uboy,
The current approach by Sarepta to target surrogate endpoints reminded me of the definition of insanity. Its a case of fool me once shame on you but fool me twice shame on me. The FDA could well be thinking that the time has come to stop messing with surrogate endpoints and begin demonstrating patient benefit. Maybe insanity in this case could better be categorised as inanity.
So is there another approach? As you said, adding an ATL1102 combo arm to their SRP-9001 Endeavour program might just help both Sarepta and the FDA with their respective goals.
One point of interest is that dosing has commenced in the ATL1102 toxicology monkey study. This was a pre-requisite of the FDA for ANP to run a clinical trial for longer than 6 months. Could we pass Go and simply run a combination study?
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