What about CTAD 2020? ANAVEX2-73 Blarcamesine $AVXL

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For number of years I have been speculating, fantasizing and making dumb-ass data analysis on ANAVEX2-73 Blarcamesine. My conviction that there, is there there was unwavering. We are coming into harvest season, though.

Phase 2b/3 for Alzheimer’s was posted since January 2nd 2019, so we are 22 months into the 48 weeks (11 months) dosing period and we are still recruting. Many a times, FDA allowes sponsor to to cut the trial short when the statistical significance had been reached with clear therapeutic outcome. AD Phase2a was conducted without the help of precision medicine (being pioneered by $AVXL by eliminating, ~20% of general Population, patients potentially unresponsive ) and with ridiculous High Concentration cohort of just 9 people. I was looking at all those factors connected with the decline in Alzheimer’s but one aspect of this study is the riduculous low number of subjects, had it represent any semblence of real population distribution of these factors like SIGMAR1, APOEe4 gene or any other known or unknown it would have squarely pointed out to drug approval. So I created this plot of possible outcomes in time for an average general population patient based on High Dose Cohort from AD Phase 2a.

Now, please compare the above graph to the natural course of the disease.

A drug test makes hypotesis that only 5% of outcomes in the dosed cohort could possibly be claimed to be due to dispertion in the placebo cohort or in other words natural outcome of the disease. The larger number of particpants in the trial the better defined are these cohorts. They revert to their mean or average values. With degenerative diseases like AD one factor can be the time over which the study is spread so that these two cohorts have two separate outcomes models with time. Phase 2a Open Lable Extension has just done that for me. The Phase 2b/3 is currently having about 150 subjects to each cohort and looking at 48 weeks time to detect theurapeutic effecacy. If the effect is so strong that even at 40 or let’s say 70 patients for the 48 weeks converges on p<= .05 that is statistically significant grade given for a pass in this test then could FDA declare achieving the criteria for approval?

It is possible that Phase2b/3 might be cut short due to results already hitting 95% probability of dosed patients showing therepeutic efficacy.

It is possible that similar pattern of efficacy has shown up on 14 week Phase 2 PDD trial boding for approval for PDD.

Now, cool down, it does not have happen this way, $AVXL has more enemies than friends, and I hope you count in the number of friends.

I am starting to collect for my subscription bills, do you want to defray my cost?

Thanks to Richard RR and Joseph F for donations respectively $10.00 and $5.00.