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Please, read the latest news from $AVXL (3-16-2021), first. There is a link here: https://www.anavex.com/anavex-life-sciences-reports-anavex2-73-blarcamesine-featured-as-a-disease-modifying-small-molecule-in-phase-3-clinical-trials-in-a-new-publication-in-medical-journal-titled-future-av/
My take on this is that we are being given early insight into the result of the phase2b/3 (Alzheimer’s). The company has never kept the same group of patients to present the data or rather it kept changing many metrics as the knowledge of the benefits of the drugs has been deepening or became broader. From the wording of the newspiece my conclusion is that it references to the Super Responders as the ones who are SIGMAR1 wild type and are above 20 MMSE baseline, therefore respond readily to Blarcamesine.
There has been a change in Dr. Missling’s tight lip policy, before we had to deal with just the bland official information from the company communiques. But now Dr Missling gives to this data a lot of color with statements like this (paraphrase here) “If we give Blarcamesine, even to those who do not readily respond, for long enough time we can also rescue them” (acctually combining of mine of two statements into one). And another green shoot of hope: “We can rescue those who are above 20 MMSE points”.
Where the first statemet comes from? Maybe from this plot:
Please, read this old post link: https://piotrpeterblog.com/2018/08/18/something-about-dropout-rate-avxl/ But think about it the extension still keeps everybody on their initial dosing so it includes those on 10mg and 30 mg. Yet, I have heard voices that the dose was adjusted in the extension so the avove paraphrased sentenses from Dr. Missling might hitting the nail on the head.
And the second statement from this slide from CTAD 2017 presentation:
The comunique states that the initial average score was 22.3 for those patients (71.1 ADCS-ADL) and that they improved @57 weeks +2 MMSE and +3 MMSE @ 70 weeks. I have long ago determined that standar deviation for that group of patients was +/-2.6 and assumed that it was +/-1.2 for placebo or Donezepil. Combining these into the formula for Cohen’s d Effect Size we get 2.2 @ 57 weeks and 3.4 @70 weeks.
Just as a remainder:
It seems that with ever additional month the Cohen’s d for Blarcamesine is going to increase. The name of the game becomes to hold your patients at least steady as the placebo cohort deteriorates, which means that these people ultimately need be taken care of or institutionalized. The added bonus is that in reality Blarcamesine can raise the MMSE scores of those above 20 MMSE baseline. From all the information released I teased out the picture of a drug which can rrescue the majority with only minority still declining in slow motion respective to placebo.
Right now, the cost of Alzheimer’s drugs is higher than cancer drugs, and the later is about $65,000 per death (USA). There is 600,000 deaths due to cancer and only 120,000 deaths due to Alzheimer’s, but one fact explains this disparity best. Only 1/3 of all those afflicted by dementia, mostly Alzheimer’s, die due to its severity. 2/3 dies of other comorbidites. Maybe in next post I tackle this.
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