Replies to post #509359 on Anavex Life Sciences Corp (AVXL)

[Investor2014]

A new message board concept that can be called “ChatGPT wars” is developing with striking similarities to the school yard “my dad is stronger that your dad” arguments.

Another form of post regulatory negative outcome message board entertainment experience.

[Liliy]

hard to say how many genes were analyzed, no reason to think Chatgpt is correct, moreover the number of subgroups possible is interesing for statitics correction, three genes out of 300 are more than 4 million possible subgroups.,

https://www.medrxiv.org/content/10.1101/2025.09.27.25336656v1

therein „Unbiased GWAS analysis identified a second, additionally significant genetic marker of positive
blarcamesine response emanating from this study. Detailed methodology and results of this
GWAS are described in a companion manuscript; see our GWAS for enhanced response to
blarcamesine manuscript for more detailed results and pathobiological context of the COL24A1
gene variant which we discovered.“

Companion manuscript?

[12x]

The core issue within the MAA framework is whether Anavex can successfully argue that the 48-week RCT fits Scenario 2, even though the more defensible interpretation is that CHMP sees it as Scenario 3. The real distinction is between statistical success and regulatory acceptability: under the SAP, success required a co-primary plus the key secondary to pass the gatekeeping chain. Because ADL (a co-primary endpoint) failed in the primary ITT population, the hierarchy broke. Once that happens, ADAS and CDR can still be viewed as supportive, but they cannot be treated as confirmatory evidence for approval, even if the company can claim nominal statistical success. That’s what structurally pulls the trial toward Scenario 3.

If CHMP is indeed operating in Scenario 3, the odds on re-exam are very long because there’s no FDA/EMA precedent for approving a trial with a broken co-primary/multiplicity chain. The company will likely continue presenting this as Scenario 2 on the CC, which is exactly why I’m hoping that call sheds light on how CHMP actually views the evidence.