Replies to post #285235 on Anavex Life Sciences Corp (AVXL)

[georgejjl]

Statistically significant dose-dependent (p = 0.003) improvement of CDR system 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)

https://www.anavex.com/wp-content/uploads/2020/11/CTAD-Anavex-PDD-001-Topline-data-Presentation-2020.pdf

HAPPY THANKSGIVING DAY

GOD bless,

[tradeherpete]

Thanks Doc,

I knew I could count on you.

Happy Thanksgiving.

[Talon38]

Doc...good review of P2 clinical meetings with the FDA. We can be assured that Anavex is fully aware of these progress meetings as Tayo Fadiran was involved/conducting the meetings within the FDA while working in CDER. Also, the Rare Pediatric Disease status also involves increased liaison between the "Sponsor' and the FDA. Anavex officers are also familiar with the process thru their extensive clinical trial experience which now extends to TGA and EMA requirements..

"A major focus of Dr. Kaufmann’s research has been Rett syndrome, a field where he has published extensively on neurobiology and clinical aspects. He served as founder and leader of RettSearch, the international consortium of Rett syndrome clinical researchers. As such, he co-authored the current diagnostic guidelines for the disorder. He also edited the first clinical textbook on Rett syndrome, published in late 2017. Dr. Kaufmann has also served as Co-Principal Investigator of the NIH-funded Natural History Study of Rett syndrome (RDCRN program). Currently, he leads the Rett Syndrome Molecular Biomarkers Working Group for the Rettsyndrome.org foundation and the Rett Syndrome Behaviour Questionnaire Working Group. Dr. Kaufmann has played different roles, including site investigator, Principal Investigator, and DSMB member/chair, in almost 20 drug trials for neurodevelopmental disorders. In this context, he has been involved in virtually all neurobiologically-based drug trials for Rett syndrome."

[tradeherpete]

Despite not specifically stating the endpoints were met in the PDD trial I think Anavex can specify endpoints the FDA could approve 2-73 for with what they did present.

Barring a significant scientific development that requires otherwise, studies conducted in accordance with the agreement shall be presumed to be sufficient in objective and design for the purpose of obtaining marketing approval for the drug.

“From my understanding based on conversations in the past with an SVP Research, the most important thing to pin down with the FDA is the primary endpoint so that the sponsor and FDA are on the same page as to what constitutes a successful phase 3. Realized and potential Adverse events must also be completely discussed for the safety of participants (not a huge issue for Anavex273 compared say to immunosuppressant for MS).

The FDA does not design the study... the sponsor does. But they need to listen carefully to what the FDA says to help design features of the study. The company's statisticians will help decide population size once the primary endpoint is agreed upon. IMO, ADAS-Cog will be the primary endpoint for PDD because of precedence -- it was with Rivastigmine (success on primary and secondary endpoints) and donepezil (failed primary endpoint despite hitting almost all secondary endpoints)”