That’s a good question. I personally don’t think that the adult trial is anywhere close to large enough to persuade the FDA. Perhaps if there were no other treatments available but with Daybue on the market, even with its side effects, I think the FDA will want more robust data for Blarcamesine to be considered for approval.
It’s clear that Anavex hasn’t given up on Rett but the focus now is getting the Alzheimer’s data ready for the EMA. Finding enough Rett patients, especially if limited to Australia for the next trial, will take time — time that Anavex has decided is better spent focusing on its bread and butter. Rett seemed to be the placeholder while Dr Missling waited to see where the bar would be set with the -mab family of Alzheimer’s drugs. Fortunately for us, that bar was not set very high.
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