Replies to post #438662 on Anavex Life Sciences Corp (AVXL)

[Investor2014]

I am not back to the position that all endpoint were not met, I have consistently maintained that I don't believe they were.

You are back to your position that Missling lied in announcing all endpoints met in the 2b/3 trial. I won't say good luck with that, but believe what you want.

When a biotech company has to resort to declare trial succes with one failed co-primary endpoint and the other together with a secondary endpoint, then all endpoints were 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.

What I fail to understand is how a hardcore bunch of WGT 'biotech investor' doggedly refuse to accept as fact that ADCS-ADL failed.

The saving grace will be having an NDA accepted for Accelerated Approval based upon above and one or more acceptable surrogate biomarkers. If that doesn't happen and the EXCELLENCE readout does not meaningfully drive the up price of $AVXL, it is pretty much guaranteed that class action law firms will be investigating and looking for a lead plaintiff with losses to show based on their reliance on all endpoints met. As I said, if that then leads to the filing of complaint and then to a case is unknown at this point, but it won't be a zero chance.