Anavex Life Sciences Corp (AVXL)

[Doc328]

Two sided is standard for placebo controlled or comparator studies and one-sided is standard for non-inferiority trials.

Eisai/Biogen used two sided for both aducanumab and lecanemab.

If one-sided is used, the standard is 0.025 not 0.05.

P values aren't everything but as a standalone trial, A273 needed to knock it out of the park and they did not. I still believe that regulatory agencies will need one additional large study (>800 patients; at least 48 maybe 78 weeks; 2 cohorts: placebo and 50 mg allowing for adjustments in dose with slow titration taken at night time ).