Anavex Life Sciences Corp (AVXL)

[runncoach]

Interesting that you point out the top line (less than 10%) results from April 2017 instead of the totality of the overall results presented at AAIC and CTAD more recently. Investors must learn the difference if they want to understand the likelihood of future trial success IMO. The original 2B trial was pre-specified to see how the drug reacted with concomitant Meds and also divided into arms of 20 ug doses and 40 ug. It has been known for over 15 years (from the very beginning of cognitive research on the drug) that there is a point of down regulation (over dosing if you will like they intentionally did to cancer patients 20 years ago) to which animals actually receive no benefit. Their most recent patent application spelled this out to a "T" and I can certainly provide the Chicago U study details in the marine snails where this was first proven to be the case.

Every single patient in the non memantine cohort is charted in their peer reviewed journal article last December. Every single patient, and was pointed out as well that of the 15 of 16 patients that did improve scores on the SIB test, they did so from 5 weeks throughout at multiple data points and the scores continued to improve over time throughout the end of the trial. It's not 2.6 pts they are targeting. Hell we got that with over dosing and memantine blocking the drug due to the fact the drug works SO WELL in the proper dosing conditions. That cohort had over a 6 point increase vs non memantine placebo and over 8 against the overall placebo group.

Anything over 4 points will not only be "clinically meaningful", it will also be stat significant. In other words the company doesn't need a delta of 6 or even 8 that they saw last time, they only need 4+ OR they don't need the 94% patient improvement they got last time, more like 65%+ should do it. Lots of room to play with. Those that follow and understand the science are wise to understand what type of delta is needed and what variables can impact that IMO. AAIC poster clearly said delta of 4 while giving the viewers previous delta numbers from several vantage points to compare. Also interesting on the Aricept study that the actually improvement never even reached 5 and peaked at week 12 before decreasing along the same slope as placebo. that's not exactly the trajectory you see with bryostatin.
https://i.imgur.com/579PX0L.jpg

Some still might fail to understand what an exploratory trial is when someone else is doing it to find proper doses and comparing deltas to similar cohorts vs then confirming that hypothesis in larger trials (https://en.wikipedia.org/wiki/Confirmatory_trial). No amount of "manipulation" from any company can change the fact that 94% of bryostatin patients improved test scores on average of more than 6 pts over placebo and that the effect was still climbing at 15 weeks. Will it be confirmed in a 100 patient trial? I do not know but I do hope so. We'll see soon and if so we'll move on to a pivotal P3 trial likely 12 weeks longer. JMHO and GLTA

Here's the journal link.
https://neurotrope.com/wp-content/uploads/2018/12/JAD180759.pdf