Replies to post #448725 on Anavex Life Sciences Corp (AVXL)

[Investor2014]

The ACADIA Lavender trial ran right through the COVID-19 period from 2019-11-06 to actual completion 2021-10-28

Study of Trofinetide for the Treatment of Girls and Women With Rett Syndrome (LAVENDER™)

The Lavender trial enrolled 187 patiens and there were no issues reporting on the RSBQ and CGI-I endpoint outcome measures. The trial was succesful achieving FDA approval March 10, 2023

The Anavex not so much EXCELLENCE trial initially tried to get away with just n = 60, and even then with 2:1 drug/placebo arms, before expanding to half the size (n = 92) of the Lavender trial.

We now know the wisdom of that 'design' decision, but the Missling apologists are always ready to defend anything Anavex does and says.

Although data analysis is ongoing, the early conclusion is that the placebo rate could have been higher in the study due to a slight imbalance in disease severity at baseline, across the treatment arms, and the 2 to 1 drug to placebo randomization ratio.

Those two issues could have been addressed by not skimping on the trial size and using a 1:1 drug/placebo design.

[frrol]

Folks should understand that the Excellence trial was not "underpowered" when it was designed. It simply appears underpowered now; "statistical power" is a concept. "From the observed endpoint SD's, the trial now appears underpowered" is an accurate statement.