Replies to post #445932 on Anavex Life Sciences Corp (AVXL)

[georgejjl]

The CGI-I was NOT full on failure with a p value of just 0.063. Just barely over the threshold of 0.05 for statistical significance. When the FDA looks at the total package, they will approve Anavex’s blarcamesine as a treatment for Rett syndrome.

Good luck and GOD bless,

[crescentmotor]

You [bas2020] might also want to mention that the other endpoint was a full on fail according to the PR.

The EXCELLENCE trial was an outright failure in terms of both primary endpoints and a key secondary endpoint after 12 weeks of treatment. The key co-primary endpoint (RSBQ) was described as "showed improvement". The other co-primary endpoint (CGI-I) was described as "not met". The key secondary endpoint (ADAMS) was described as "improved" and "trended favorably".

AVXL PR did an excellent job of describing the topline Rett EXCELLENCE results as a soft fail, even providing theoretical explanations for the fail such as a high placebo effect that "may" have masked the therapeutic effect of the drug. AVXL went even further putting emphasis on improvements seen after subsequent ad-hoc analysis (that doesn't count) including improvements seen after four weeks of treatment that were not sustained through the completion of the trial.

A fail is a fail is a fail. Folks like bas2020, georgejjl, and others, are rabidly engaged in misinformation casting the trial as a near miss and predicting regulatory approval later in 2024. That is disgraceful and misleading behavior.

Investors and AVXL need to put aside Retts Syndrome and focus on AD. AD is the only straw left standing.