Anavex Life Sciences Corp (AVXL)

[abew4me]

Although I love the price action, I'm nervous as to why it's taking so long for the Rett P3 trial results. One of our competitors (BIVI) had their SP drop almost 80% after reporting problems collecting data from all of their sites. (See below)

BioVie Data for Alzheimer's Treatment Endpoint Misses Statistical Significance
November 29, 2023

BioVie said Wednesday that its Alzheimer phase-3 trial wasn't able reach statistical significance due to too many exclusions to its study.

BioVie said Wednesday that the third trial phase for its drug NE3107, an Alzheimer's disease treatment, showed positive results, but missed its primary efficacy endpoint after excluding much of its data due to protocol violation during the pandemic.

Originally, the trials began with 439 patients across 39 sites during the Covid-19 pandemic, and BioVie later found that it was in violation at 15 sites of protocol and good clinical practice, leading it to exclude all patients from those sites.

The positive data it did collect was from a 57 per-protocol patient pool. While that data found the treatment is biologically active and might have impact on cognitive, functional, and biomarker endpoints, "the data missed statistically significance due to site exclusions."

Shares halted trading at 07:58 ET before releasing the update. The stock was up 3% in premarket trading at $5.12 before being halted. [Now trading at $1.36/share]

By Adriano Marchese