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boi568

01/30/23 1:03 PM

#400609 RE: bb8675309 #400595

That Seeking Alpha post is the most positive article I have seen, more positive in terms of timing than anything I have seen on this thread. You can't put much weight on it, but it helps to demonstrate a change in the narrative about blarcamesine.

bas2020

01/30/23 1:17 PM

#400616 RE: bb8675309 #400595

Credible experts believe the trial data, as well as expected approval this year...

Blarcamesine reduced cognitive decline by 45% as measured by the ADAS-Cog, performing 40% better than Leqembi, and it did so in 11 months instead of 18 months.

New news: on a January 12 presentation at the J.P. Morgan Healthcare Conference, Anavex CEO Christopher Missling doubled down on the fact that Anavex's Blarcamesine is more effective and safer than Biogen's Leqembi.

This time, CEO Missling focused entirely on the reduction in cognitive and functional decline as measured by the CDR-SB. Both Blarcamesine and Leqembi succeeded in slowing decline by 27%, but Blarcamesine did so in 48 weeks and Leqembi took 78 weeks.

If Anavex asks for emergency approval for Blarcamesine, that approval could come very quickly. Biogen/Eisai presented its Phase 3 Leqembi trial data in November; the FDA granted emergency approval in January based solely on the Phase 2 data.

Anavex will likely present and publish in a peer-reviewed journal the Phase 2b/3 data in Q1 2023. Emergency approval by the FDA could come in Q2 2023. I am thinking as early as May.


I expect approval to first come from AU and/or EU.