Anavex Life Sciences Corp (AVXL)

[Investor2014]

I have never seen the ADL co-primary endpoint met as per the public clinical trial protocol.

As to lying, that charge presumes unlawful conduct without evidence. The burden is on the accuser, and I have never seen it met.

You and others seem to claim that the ADL co-primary endpoint have been met, but you lack proof of that while also referencing below (and some they Odds Ratios that do not help either).

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.

The text in read quoted above in fact makes it plain that one of the co-primary endpoints were not met, which is this one:

Reduction in decline of the ability to perform daily activities assessed from baseline over 48 weeks with ANAVEX2-73 compared to placebo using the Activities of Daily Living Scale (ADCS-ADL)

An alternative is then given for trial success with only one of the co-primary endpoints combined with one secondary outcome measure.

We haven't seen any notices from class action law firms investigating Anavex in relation to the P2b/3 AD trial readout, mainly because of the benefit of doubt given no public disclosure has been made to directly establish that all endpoints were not met. Such a disclosure may never come and certainly not if the EMA MAA is successful based upon the alternative potentially viable trial success when one co-primary endpoint is not met.

However if approval from the P2b/3 trial is not gained and if the Anavex shareholders at the time of that disclosure are damaged, then it will have been clearly disclosed that the trial did in fact not meet its endpoints as already communicated by the quote above.

I hope and obviously prefer that EMA (and / or other regulators) does approve A2-73 in AD (subgroups or otherwise) using the alternative trial success criteria based on the efficacy signals, safety profile and unmet need. I am merely stating as fact borne out by the lack to date of the ADL baseline to EOT mean results and the quote above establishing that the P2b/3 AD trial DID NOT meet all its endpoints as unfortunately stated by Anavex also in SEC filings.

I feel sure Anavex regret that statement but can't really back out of it and is now hoping to absolved by approval based on the alternative trial succes criteria supported by biomarkers and OLE data. Let's hope approval does come and also hope that Anavex have learned and with Dr. Kun et al will not repeat this kind of readouts. The first test of that is coming up (probably Feb'ish).