Anavex Life Sciences Corp (AVXL)

[kund]

I posted this last year (23) in August: Misleading tried his best to flip-flop on Excellence endpoints, but finally, he gave up. Not sure what prompted him to stick with the original endpoint as per the clinical trial site, which he keeps claiming is not the official line.

May 10/22 CC:

Christopher Missling -- President and Chief Executive Officer
Thank you for the call. Indeed, so the last communication is that, we are planning to meet the FDA to discuss the Rett program and its procedure to move forward with filing an NDA for approval. And since we finished and completed the AVATAR study in adults, a small study despite the fact that it's a successful study, a phase 2 study, which was also small in the ongoing EXCELLENCE study, which is in heterodox study, which is the largest study. So we are waiting for this meeting to take place.

It has not yet taken place, but it will take place soon. And then we will learn how to move forward. And indeed, the Rett -- EXCELLENCE study with pediatric patients is still ongoing and rolling, and we might have a press release when the enrollment is completed.
Yun Zhong -- BTIG -- Analyst
So the-well, with regard to the primary endpoint is still going to be RSBQ AUC instead of -- RSBQ?
Christopher Missling -- President and Chief Executive Officer
-- Right. That's right. So when we presented AVATAR study, we learned from the first Phase 2 study that the RSBQ AUC that includes the CGI-I linked responder analysis. So the RSBQ AUC includes the CGI-I respond analysis linked to response analysis.
That is the endpoint, which we will also propose for the EXCELLENCE study. That is correct. It's consistent with the AVATAR study.

Nov 28/22 CC

Charles Duncan : Okay. And then moving on to the EXCELLENCE study. In terms of the endpoint, can you help us understand what is the endpoint that you’re most focused on? Is it RSBQ AUC in Rett? Or is it the Clinical Global Impression of Improvement?

Dr. Christopher Missling : It’s really both. So the RSBQ is the assessment of the parents and the CGI-I is the assessment by the physician. So both are relevant and they should actually match or correlate with each other. And so we believe both endpoints are critical.

Feb7/23 CC
Yun Zhong : Okay. And then switching to the Rett syndrome study. I believe though press release announcing over enrollment had the language that with the FDA’s input, you are using the primary endpoint. So I wanted to confirm that the primary endpoint is RSBQ and you see similar to — or the same to the one used in the EBITDAR study? And so has the FDA agreed that the AUC, the modified RSBQ scale can be an appropriate endpoint for Rett syndrome study?

Christopher Missling : Yeah. We have it described in clinicaltrial.gov, and it was also never change in clinicaltrial.gov for the EXCELLENCE study. It is the RSBQ primary endpoint, and the CGI is key secondary endpoint over the course of the trial.

Yun Zhong : Is that the same endpoint that was used in the AVATAR study?

Christopher Missling : Slightly different. So it’s actually the measurement over time from beginning to end of trial. AUC.

Yun Zhong : Not AUC?

Christopher Missling : Not AUC.

Yun Zhong : Not AUC?

Christopher Missling : Exactly, yes. Because the study is large enough that it can carry the signal by itself without AUC.

June06 PR

Excellence Completion PR

In communication with the FDA, the Company received the Agency’s input on the study endpoints, which were utilized in this clinical study. The Rett Syndrome Behavior Questionnaire (RBSQ) total score and Clinical Global Impression Improvement Scale (CGI-I) score are co-primary endpoints in the statistical analysis plan with specified linear mixed-effects models for repeated measures (MMRM) as the primary analysis methods.