Replies to post #508178 on Anavex Life Sciences Corp (AVXL)

[Homeless Economist]

You may be right. I'm going to re-read more throughly the re-examination opinion this weekend to confirm, since I likely misremembered.

A quick read produced the following interesting quotes:

Leqembi

The provided post-hoc analyses are in support of a better safety and at least comparable efficacy
profile in this restricted population compared to the originally proposed population including APOE4 homozygous carriers.

Kisunla

The applicant provided a post-hoc analysis for ARIA as the key unfavourable effect separated by APOE4 carrier status (homozygotes, heterozygotes, and noncarriers of APOE4) as well as APOE4 noncarriers and heterozygotes combined, for which the applicant seeks approval.

These suggest that new analyses based on the previously provided trial data are acceptable, so the ADNI analysis and even the ABCLEAR2 and ABCLEAR3 subgroup analyses are likely acceptable for the re-examination. Based on the press release (and the safety of Blarcamesine), it's likely that the committee did not find sufficient evidence for the benefits (since Anavex explicitly said that they're going to provide more biomarker data, which suggests that the committee did not find the efficacy evidence convincing). Thus, I'm hopeful that the ABCLEAR2 and ABCLEAR3 subgroups are statistically robust and clinically meaningful enough to warrant approval upon a re-examination. If the committee's primary concern is something more structural such as small sample size then I'm afraid nothing will change.

For anyone else interested, here are the opinions.
https://www.ema.europa.eu/en/documents/assessment-report/leqembi-epar-public-assessment-report_en.pdf
https://www.ema.europa.eu/en/documents/assessment-report/kisunla-epar-public-assessment-report_en.pdf