Anavex Life Sciences Corp (AVXL)

[RedShoulder]

I'm highly optimistic that FDA and TGA will approve A2-73 Blarcamesine for PDD on this data alone shown below. There are no other drugs on the market that can "improve" PDD like Anavex can on the high dose. The bar is so low it is in the grass. Anavex has the FDA and TGA approval IMO after the pivotal trial coming up soon.

PDD and PD is a huge revenue market, this disease is the largest population in the CNS market after Alzheimer.

I'm looking for that peer review of the PDD/PD top line results before Missling speaks a word about the details and specifics.

However a great clue to it's efficacy is slide 26 in the recent Corporate Presentation:

https://www.anavex.com/wp-content/uploads/2021/02/Anavex-Presentation-February-2021.pdf

"Significant Improvements in Episodic Memory with Increased Dose"

1) Those on the Placebo continued to decline in the disease.

2) Those on Low dose did not decline but maintained as when started.

3) Those on High dose improved.
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Plus this positive data from the PDD/PD trial PR:

Proof of Concept Controlled Phase 2 Clinical Trial Data Evaluating ANAVEX®2-73 (blarcamesine) in Parkinson’s Disease Dementia Presented at CTAD 2020 Conference:

Statistically significant improvements in CDR system Cognitive Domain of Attention assessed by Choice Reaction Time (p = 0.039) and Digital Vigilance (p = 0.008)

Statistically significant dose-dependent improvements in Episodic Memory (p = 0.003)

ANAVEX®2-73 (blarcamesine) prevented the on-going cognitive decline in treated patients compared to placebo.

Broad and statistically significant improvements in CDR system Cognitive Domain of Attention assessed by Choice Reaction Time (p = 0.039) and Digital Vigilance (p = 0.008) and CDR system Episodic Memory (p = 0.047), representing complex cognitive tasks with impact on quality of life such as making a choice between similar objects and remembering daily personal experiences, which are mostly impaired in both PD and AD.3

Statistically significant dose-dependent (p = 0.003) improvement of Episodic Memory, which has been shown to be highly correlated (70%) with the Alzheimer’s Disease Assessment Scale–Cognitive score (ADAS-Cog; r = 0.7).

ANAVEX®2-73 (blarcamesine) does not impair sleep and has a positive effect on REM sleep behavior disorder.

ANAVEX®2-73 (blarcamesine) was generally safe, well tolerated, and improved safety profile compared to dementia drugs associated with typical adverse effects.

PR link:
https://finance.yahoo.com/news/proof-concept-controlled-phase-2-154500899.html
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The above data alone is more than enough for FDA and TGA approval for PDD. We await the full top line data release to see how the secondary PD data figures into the approvals.

I believe we will see PDD/PD receive FDA and TGA approval before Alheimer because the PDD/PD pivotal trial will be much shorter.

PDD/PD is the second largest WW market in CNS, just behind Alzheimer. The revenues will be huge, and Missling so far has indicated Anavex will not partner, so the revenues will not be shared.