Change Of Language On ClinicalTrials.Gov Page For Blarcamesine Phase 2b/3 Alzheimer’s Trial. $AVXL

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You can devine the future from coffee grinds as well as from the language change…

But only if you don’t know much about the implications of language in phase 2b/3 for Blarcamesine for Alzheimer’s.

Mr. Brodkin has published this tweet. Link: https://twitter.com/jesse_brodkin/status/1550477966123171840?s=20&t=MdTQ5Aes7PJyFbCFHRQQAQ

One of the points he makes is that Anavex has changed the wording refering to the primary endpoints which accordingly to him is a harbinger of coming sure failure of the the trial. illustration, please!

FDA was not Kind to Anavex….

as the agency did not allow to limit the patients to only those with the wild type SIGMAR1 and COMT genes as we, the investors, thought should be the case. Phase 2b/3 is testing Blarcamesine on so called general public, that is anybody with the conditions written on the Clinicaltrials.gov page.

On the basis of statistical data about the icidence of both SIGMAR1 genes and APOEe4 incidence and the distribution of decline in Phase2a I have arived at hypotetical distribution of scores in phase 2b/3.

I guess this is the minimum Blarcamesine can do for humanity. 55% of patients after 1 year of dosing should not experience any decline, or rather shall improve, which we can set at about +4 points on MMSE scale, only 4 points, because of ceiling effect. 12% of patients should decline less than 2 MMSE points. And finally, 33% patients should should decline 6 points on MMSE scale. Illustration of phase 2a results.

If we put that together.

.55*4+.12*(-2)+.33*(-6)=2.2-.24-1.98=-.02

Which means that overall scores can be expected to declined even if the drug can rescue about 55% patients. Because of this I have always stressed that the most important data for the clinical success of Blarcamesine is the long trend in scores experienced by those who enrolled in the Open Label Extensions trials.

This is just the worst outcome scenario for the phase 2b/3 High Dose 50 milligrams/kg cohort. I want to stress here, it is also based on genetic distribution of the genes and the APOEe4 alle.

In the real phase2b/3, we have 3 cohorts: Placebo, 30 milligrams and 50 milligrams per kilogram body weight. The aforementioned wording change might have been caused by increased effort to communicate the results from combined dosed cohorts, and not alone the 50 milligram per kg cohort, on which all the hope and attention is focused.

I can command Mr. Brodkin’s for keen attention to the change in langauge, yet in order to investigate a progress of a company or a drug a more thorough analysis is needed, as they always say the devil is in the detail.

I am starting a new effort and make short videos about comming energy crisis. My channel on Youtube is called Energy Shock Tips. I am going to list links to them here two videos.

links: https://youtu.be/dVWqd99IsNc https://youtu.be/sowV1rNfil4

Thanks for watching them.

Next post is going to be on my missgiving on $SAVA ‘s data. Sorry for all those spelling mistakes.