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BakedLangostino

11/10/25 8:42 PM

#506777 RE: bdinic #506773

People are overly sensitive right now. Understandably so, as the expectation of a quick and relatively smooth agenda to decision process experienced a bit of a hiccup today.

It is what it is. Anavex gets an opportunity to try to convince the EMA that conditional approval is worth getting Blarcamesine onto the market two years earlier than it would take to run a confirmatory P3 trial that would probably last around 96 weeks. Does the current evidence, taken as a whole, paint a picture of something that could confer benefit?

I believe it'll ultimately come down to whether the rapporteur believes in Blarcamesine -- they present the case for or against first, then Anavex enters the meeting, and has a chance to present and answer questions. I'd imagine that they already know what those questions will be and have prepared answers in advance.

Worst case, two years from now we'll have P3 data that should also be excellent. Best case, we find out within weeks whether the EMA approves either conditionally or fully.

Either way I believe Blarcamesine will be available in the future and that makes owning the stock a worthwhile gamble.