Replies to post #508287 on Anavex Life Sciences Corp (AVXL)

[jlucer53]

Hope this post from grok helps provide some value. Thank you for your insightful post. Very objective

"Precedents on Negative Trend Votes and Re-Examinations
Negative trend votes in AD: 4 cases (aducanumab 2021, lecanemab initial 2023, donanemab 2025, gantenerumab 2022)—all led to initial negatives, with 0 flips to positive in December meetings; 1/4 (leqembi) approved post-re-exam on subsets (restricted label, additional data).
Re-exam outcomes: ~50% success overall (7–8 of 15 negatives reversed 2016–2025); 0% in AD (no reversals). Appeals focus on subsets or new analyses, but require addressing major objections (e.g., stats, biomarkers).
Single vs. Two Trials: EMA approved lecanemab/donanemab on one pivotal + confirmatory, but required strong data; novel drugs like blarcamesine (mixed endpoints, no tau effects) often need second trial per guideline (Article 8(3))."

[Boopka]

Steady, what are your thoughts regarding the FDA?
Anavex can present all their recent data to support an approval. I would hope Anavex has been able to communicate these new findings to the FDA to read the tea leaves.