Anavex Life Sciences Corp (AVXL)

[Doc328]

Why did they change the endpoint for Rett?

Anavex updated the endpoints on clinicaltrials.gov website January 18, 2022 - well after analysis was underway and probably after the primary endpoint results were known to some (The 'TLD' data PR was 2 weeks later). Missling later said they had decided to change the endpoints earlier but the CRO took a while to update clinicaltrials.gov (though tasks can be delegated to the CRO, the sponsor (Anavex) has ultimate responsibility). The stated reason for the change was it was made based on the US Rett data. Changing endpoints would have been less of a deal if it occurred months earlier. Even with the late update, FUD could have been muted (though not eliminated) if Anavex also released the original primary endpoint result. The absence of that release leaves room for analysts and others to assume the worse - that the new endpoint was significant but the old endpoint was not. Months later, the old endpoint still has not been released. If the new endpoint was met and the old was not, the most likely statistical explanation would be that 4 week data looked good but 7 week data did not separate from placebo with significance.

Here's a link to when the endpoints were updated on clinicaltrials.gov