I have never seen anything here or elsewhere that makes it demonstrably legit replacing a confirmatory RCT in a neurology indication like AD with an OLE - that KOL idea still stands as nonsense until perhaps proven otherwise.
Especially in cancer, there are many examples of accelerated approvals given benefits outweighing risks for younger patients otherwise fully functioning but terminal without treatment. A benefit risk equation very different to AD.
At present it seems far from certain that Anavex can achieve a CMA. More likely that the confirmatory trial that should have been initiated in 2023 now will need to be under the FDA with sites in the U.S.
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