Anavex Life Sciences Corp (AVXL)

[Investor2014]

Anavex would not have published below were all endpoints met to protocol.

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.

For some reason there are several folks here that do not appreciate that fact or have some agenda that goes against accepting that as fact.

The EMA can recommend filing a MAA with less that clear pivotal P3 met all endpoints to protocol trial results, other agencies may do the same. We just won't know what the final outcome will be somewhere between rejection, approving with conditions (label for subgroups, confirmatory trial etc.) or possibly but less likely even award full approval.