Anavex Life Sciences Corp (AVXL)

[Doktornolittle]

https://www.sec.gov/ix?doc=/Archives/edgar/data/0001314052/000173112221001347/e3018_10-q.htm

The EMA approved Anavex's trial design back in 2021. Anavex then spent about a hundred million dollars executing the trial based on that acceptance. The EMA is obligated to approve Anavex 2-73 if it met it's endpoints. That is how all these trials work.

Under "Business Update" and "Clinical Development," the filing states: "In July 2021, the U.S. Food and Drug Administration (FDA) granted Special Protocol Assessment (SPA) for the Phase 2b/3 clinical trial of ANAVEX®2-73 in early Alzheimer's disease. Additionally, the Company received positive Scientific Advice from the European Medicines Agency (EMA) on the same protocol, confirming the acceptability of the trial design, including the primary endpoints of ADAS-Cog13 and ADCS-ADL, and the planned SIGMAR1 WT subgroup analysis for precision medicine." This filing ties the advice directly to the trial's progression and endpoints.