Share Price, page-8005

As mentioned here this morning, Anavex is releasing its FY23 end of year results this week. Tonight, to be exact.

As well as financial results, the company says it will be providing “an update on the execution of the Company’s growth strategy.” The web conference will happen at 12.30 am AEDT, a bit too late for me!

The company hasn’t said that Rett results will be released or even discussed. But it’s now over 5 months since trial completion was announced (on June 6), results were said to be due in H2 2023, which is fast running out and Anavex has previously announced trial results along with financial results.

As previously mentioned here, Anavex stated (in an understated way) on June 6 this year that the RBSQ total score and Clinical Global Impression Improvement Scale (CGI-I) score had been agreed with the FDA as the co-primary endpoints for this study.

But on the US Clinical Trial website, the company says that the RSBQ and CGI-I were originally nominated in March 2020 as the co-primary endpoints but that the co-primary endpoints were then changed in September 2021 to RSBQ along with incidents of adverse events, while the CGI-I was changed to a secondary endpoint. RSBQ and safety remain as the co-primary endpoints on the website, despite the company saying on June 6 this year that it had agreed with the FDA that the RSBQ and CGI-I would be used as co-primaries. The trial website was updated in August this year but the co-primary endpoints given in September 2021 remained unchanged.

Look, the trial results, if announced, might be great – I have no idea. But the very long time to announce these results, for a trial half the size of Acadia’s, and the lack of clarity around something as basic as what the primary endpoints are, does create some doubt.