Replies to post #409522 on Anavex Life Sciences Corp (AVXL)

[12x]

If the AD p2a/3 trial is as successful as many of the posters anticipated, the millions spent in PD ph3 is just a drop in the 20 billion market cap gain bucket. On the other hand, if the AD p2a/3 trial results are not as convincing (as the SP indicated), the PD p3 will be the only trial with outcome in the 2024 pipeline. Investors invest in drug pipeline not cash in hand.

Compared to AD, PD is such a low hanging fruit for A2-73: Only one primary endpoint (UPRS score), half of the trial duration, much younger patients (one dose at 50mg). Together,. PD trial has much higher chance to succeed. It’s a no brainer to start as soon as an SPA is obtained from FDA.

The positive PD p3 trial might also serve a purpose as the 2nd AD p3. An added bonus.

[Investor2014]

Biogen/Eisai had completed a large P3 study prior to AA.

FDA Accepts Eisai’s Filing of a Supplemental Biologics License Application and Grants Priority Review for Traditional Approval of LEQEMBI™ (lecanemab-irmb) for the Treatment of Alzheimer’s Disease

The P3 results was presented at CTAD with a complete TLR deck of data the way Anavex should have done, still haven't done and likely won't do.

Context and detail is important, not least for biotech investing!

The sBLA is based on the findings from Eisai’s recently published large, global confirmatory Phase 3 clinical trial, Clarity AD. LEQEMBI met the primary endpoint and all key secondary endpoints with highly statistically significant results. In November 2022, results of the Clarity AD study were presented at the Clinical Trials on Alzheimer's Disease (CTAD) conference and simultaneously published in the peer-reviewed medical journal, The New England Journal of Medicine.