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12/13/22 12:41 PM

#392124 RE: kund #392113

Yes and evidently the FDA guidance on approval pathway for Rett was to wait until the Excellence readout. Some may recall that my guidance was the same after the AVATAR readout endpoints mess.

Based on the results in this Phase 3 study (ANAVEX®2-73-RS-002)[3] and the prior successful U.S. Phase 2 (ANAVEX®2-73-RS-001)[4] study in adult patients with Rett syndrome, Anavex is planning to meet with FDA to discuss the approval pathway.


So that appears consistent!

However, I still want to hear about:

Anavex Life Sciences (AVXL) Q1 2022 Earnings Call Transcript

he clinical data driven evidence of efficacy and safety of our broad SIGMAR1 platform portfolio, which allows us to plan and to expand further into the rare disease phase, including implementing expanded access for adult patients with Rett syndrome, and underserved population


hristopher Missling -- President and Chief Executive Officer

Thank you, Sandra. Again, we look forward into 2022. We are very excited about the company's potential as we build on the successful completion of two important studies that allow us to confidently expand further into the rare disease phase, and plan expanded access for adult patients with Rett syndrome. While we're looking forward to further pivotal clinical trial readouts in pediatric Rett syndrome and Alzheimer's disease, and pipeline updates this year.


Charles Duncan -- Cantor Fitzgerald -- Analyst

OK. Super. Thanks, Clint. Hi, Christopher and team.

Thanks for hosting the call. Had a couple of questions on the recent AVATAR readout. One on EXCELLENCE and then I wanted to ask Sandra a little bit about the cash runway. So regarding AVATAR , we were quite intrigued with recent results, but I guess I'm wondering if you had assessed just simply the change from baseline in RSBQ and CGI and if you intend to present that data here in the near term.

And then, regarding the expanded access, is that part of an open label extension study? Or open label extension to the AVATAR study?

Christopher Missling -- President and Chief Executive Officer

Right. So get me first on the last question. The idea is expanded access is to provide not only for those patients which have been participating in the trials to give the drug for free so they can continue to enjoy the treatment effect, but also those patients, which are not part of the trial. So that is the definition of the expanded access.