Anavex Life Sciences Corp (AVXL)

[Investor2014]

Anavex have already, if not directly said, clearly implied that the ADCS-ADL co-primary endpoint was not met.

The trial is successful in meeting the co-primary endpoints if the significance of each endpoint is P < 0.05, or if the significance of only one co-primary endpoint is P < 0.025. If only one primary endpoint is significant at an a level of 0.025, then the secondary endpoint will be evaluated at the same level of 0.025. The trial was successful, since the differences in the least-squares mean (LSM) change from baseline to 48 weeks between the blarcamesine and placebo groups were -1.783 [95% CI, -3.314 to -0.251]; (P = 0.0226) for ADAS-Cog13, and -0.456 [95% CI, -0.831 to -0.080]; (P = 0.0175) for CDR-SB in patients with early Alzheimer’s disease.

Missling also stressed this point in his JPM 2024 presentation.

This is the reason $AVXL is now a $6 rather than at an all time high - the P2b/3 trail did NOT met all its per protocol endpoints, but there is a chance the totally of data will gain some kind of approval. If it does there is no basis for a case.