"at a clinically meaningful improvement of ADCS-ADL score change of +3.5 points or better, Odds Ratio = 2.67 (p=0.0255). This reflects a robust improved and clinically meaningful outcome in cognition and function from baseline."
What other AD drug offers p=0.0255 in ADCS-ADL? Does missing it by p=0.005, disqualify Blarcamesine? That is reason for a failed trial? Why does AVXL say it is a clinically meaningful outcome(functional) from baseline? Close but no cigar? Is this what you are potentially banking an FDA thumbs down on?
Sorry, we can't offer all these improvements to the suffering because .0255 is NOT .025 and statistically significant.
Significant slowing in the rate of pathological brain atrophy, more REM sleep, and significant reduction in pathological amyloid beta levels, doesn't come into play here? And lets again mention other current drugs have AE's like further acceleration of brain atrophy beyond typical AD brain volume reduction, brain bleeding & forced monitoring through PET scans and periodical spinal taps...... I'd say that 0255 is a hard reach for a failure.
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