I haven’t read the full Endpoints article (Jun-2022), but the first part is interesting as they noted Peter Marks stated that the use of randomized controlled trials “borders on the absurd.” for ultra-rare conditions where there might be just 20 patients worldwide, which is why an RCT may not be a good fit.
https://endpts.com/fdas-peter-marks-lays-out-plans-to-support-gene-therapies-for-ultra-rare-diseases/
Perhaps similar discussions have already been had between the FDA and MSB.
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