Anavex Life Sciences Corp (AVXL)

[bas2020]

I believe Missling stated it based on discussions with, either, the FDA or Dr. Jin... who certainly would know if it's acceptable. It would certainly provide the longitudinal confirmatory data as any other trial would... and will complete next July.

We'll soon receive all the data, including subgroup analysis, and all of this combined will likely be quite compelling to the FDA:

• Odds Ratio of ADAS-Cog meaningful improvement in cognition at threshold of -0.5 points or less (90% CI) 1.839 (1.17, 2.94) P = 0.015

• Odds Ratio of ADCS-ADL meaningful improvement in function at threshold of +3.5 points or higher (90% CI) 2.67 (1.17, 6.13) P = 0.0255

• ANAVEX®2-73 treatment slowed cognitive decline by 45% compared to placebo at 48 weeks
• Mean difference in ADAS-Cog score change of -1.85 points

• Compared to placebo, ANAVEX®2-73 (blarcamesine) reduced clinical decline of cognition and function by 27% with mean score difference of -0.42 points (p=0.040) as measured by CDR-SB

• ADCS-Cog and CDR-SB (p < .025) proving further significance of stat. sig. improvements and trial success.

• Identification of two key biomarkers (Aß42/40 ratio and brain volume stabilization) for AA pathway option.