Anavex Life Sciences Corp (AVXL)

[bas2020]

from another board...

SOL failed twice. They keep changing the endpoints and keep making the patients earlier in the disease hoping for some improvement. In the latest P3 trial, there was no difference between SOL and placebo in Activities of Daily Living functional scale, basic items of the ADCS-ADL, and Clinical Dementia Rating. The two Phase III trials were EXPEDITION 1 and EXPEDITION 2. EXPEDITION 1 didn't meet the predefined assessments. Lilly changed the predefined study goal in EXPEDITION 2, but EXPEDITION 2 didn't meet that goal either.
An ex-FDA official told the Financial Times that solanezumab "does not have a snowball’s chance in a very hot place" of getting conditional approval. To the FDA, missing the primary endpoint in a Phase III trial is "fatal" (from Financial Times)