Replies to post #404122 on Anavex Life Sciences Corp (AVXL)

[boi568]

The FDA can approve an NDA based on "one adequate and well-controlled clinical investigation plus confirmatory evidence." FDAMA 1997.

In December 2019 the FDA in draft guidance clarified this as "one adequate and well-controlled large multicenter trial that can provide substantial evidence of effectiveness."

That's the standard.

[Pjay65]

For approval, you need “substantial evidence” of efficacy — which is defined as “two well-controlled and one very compelling clinical trial” demonstrating statistically significant efficacy of clinical endpoint. Of course, the safety should be “tolerable”.

Are getting brain bleeds and/or getting swollen brains "tolerable" in a safety profile. According to your statement for approval, they are 'tolerable'.

[bas2020]

Such a laughable conclusion...

but AVXL is hiding many aspects of them, so they are likely insufficient.

[Rubyred77]

Sure glad I can laugh at amateur conclusions.

Reminds me of that line from Tommy Boy