Anavex Life Sciences Corp (AVXL)

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I guess the word: BINARY will only work for iHub posters who want an opinion one way or the other

View from the 30,000 foot level. AVXL has reported from it 2b/III trial and OLE data that Blarcamesine has potential disease modifying effect in the 70% ABCLEAR2 population amounting to a 19.5 month life extension. Over the 48 week trial, Blarcamesine slowed atrophy by 37.6% in key regions of the brain. These results were much higher in the ABCLEAR1 (SIGMAR wild-type subgroup). Over four years of treatment, there have been zero deaths and no adverse events affecting liver enzymes, vital signs, ECGs, or other physiological/neurological findings, Critically, there have been no brain swelling, hemorrhage, or ARIA.

If the above data has held up as verifiable during the extensive review by the CHMP, it would be unconscionable for Blarcamesine, a new AD standard of care. to be rejected and not made immediately available to AD patients. Denying this drug to patients for another three years until the completion of a confirmatory trial, would represent the height of medical negligence and human immorality. I am highly confident of CHMP approval before year end 2025. If that approval is conditional without onerous requirements, that will be of little negative consequence over the longer term.