Replies to post #423592 on Anavex Life Sciences Corp (AVXL)

[Joseph_K]

That's the spirit! :) (No sarcasm intended. I mean it.)

We have a winner and I appreciate the opportunities that you and doc and investor give me to underscore this for other investors who read this board. Thanks.

[Investor2014]

I don't know about 12x, but my argument is not about tolerability of sugar pills versus A2-73. It is about the impact on clear separation the dose arms in the AD P2b/3 trial, where 20-34% patients didn’t reach their 30/50mg target .

This is the reason that I doubt we will see mean to EOS data per dose arm and why ORs were published instead awaiting full subgroup analysis. The titration has meant there are no distinct 30mg and 50mg dose arms, but several doses (see quote below ref. my interpretation). So we will see subgroups by dose, but how many dose level I don't know and nor is it clear if concentration will be a more important distinction.

We need to expect some of the dynamics not quite reflecting what was concluded from the very small P2a trial. E.g. such as the bold highlight in the below quote from the Q1 2023 cc.

Soumit Roy : Hi, everyone. Congratulations on the progress. Could you give us a little color on what kind of details on the Alzheimer data we are going to expect? Are we going to see some MRI data? Or time course of how the reduction in the cognitive decline has occurred or something like that?

Christopher Missling : Yes. So several items will be in the paper, in the publication. Of course, we made sure that the study has a lot of biomarkers in additional measures of end points. So among them is MRI, which is a very important marker of pathology, which is the most accurate picture of the brain, and it’s very well described that brain atrophy moves in this pathology aggressively. So that will be part of the analysis as well as additional biomarkers of pathology like a better intel as well as the biomarker, which are specific to Anavex, which is the sigma-1 variant analysis, which was clearly prespecified which you remember, we noted that patients with a wild type sigma-1 receptor did much better compared to those who had a variant.

But because the variant carriers were in the minority, often that signal overall was not affecting the significance of all patients, but it was notable that there was a better outcome in patients with wild type sigma-1 carrier status in previous studies. So we are looking forward to seeing how this plays out in this study as well. But then also, we will see the response to the endpoints of the study depending on doses as well as over the period of time because we measure every three months the time points of the — within the study. And then you will see additional endpoints, which have been included in the study, like quality of life, sleep quality and other behavioral measures, which are related to the Alzheimer pathology.