Replies to post #285199 on Anavex Life Sciences Corp (AVXL)

[Investor2014]

Hint: What does "% patients in top interval" actually mean?

As I have maintained for some time now, the genetic biomarkers are useful to show an influence based on the target MoA of A2-73. However, the response differences demonstrated so far between Wt. and Variants does not seem to display significant difference to clinically meaningful outcomes.

Actually that is a good thing since concentration is by far most influential for response to A2-73. Consequently, if A2-73 is approved most patients that can tolerate a dose bringing concentration to >= 4 Ng/mL should benefit.

[blu_1]

8% more of the wt only subjects were in the top interval after 14 weeks of 2-73 than the wt's + variants on 2-73 were at 14 weeks. 8% difference can make or break a trial and is significant. Not too shabby results for the group receiving 2-73 considering pdd is degenerative, as demonstrated by the placebo group.

[RipperMagoo1]

frrol,

Hoping you can clarify my calculations and layman assumptions re slide 17 https://www.anavex.com/wp-content/uploads/2020/11/CTAD-Anavex-PDD-001-Topline-data-Presentation-2020.pdf

Not 8% "higher" (though at least you know it's not "48% improvement".) And the difference is in contrast to what group(s)?

- Actual % improvement over placebo at week 14 isolating WT carriers is 12.12% compared to the entire n=132 (74%-66%)/66%
- Isolating the 50mg could/should/might yield better results, however it was not broken out from 30mg cohort which could be bringing down the overall improvement %.
- Improvement % when up from week 8 to week 14. Therefore, % improvement could/should/might be even better at week 22 or any future OLE date.
- 16-20% of the population DO NOT have the WT gene. Is it safe to assume that the MAX improvement could be ~20% identifying this biomarker? i.e. 20% improvement would be a perfect score and 100% identify the WT biomarker?
- Paraphrasing - you & Doc mentioned this % improvement was "weak". What % improvement at week 14 would have been considered "good" or "great" to you?
- IMO (at this point) with more time and isolating 50mg data, we would be very close to this 16-20% improvement validating the biomarker (if my prior assumptions are valid) and would find out when this plateaus in OLE.

Feel free to rip those apart. Just a 6 month biotech newbie here.

TIA