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ANAVEX MEETS ENDPOINTS PHASE2 RETT, page-131

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    Anavex still has the CGI-I listed as a secondary rather than a primary outcome on the US Clinical Trials website, despite 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.

    At the end of the day, it didn’t matter. Neither the RSBQ nor CGI-I endpoints were met.

    Anavex didn’t either bother to reveal details of the CGI-I outcome. Reading between the lines, it wasn’t even a near miss. Not to worry, said Anavex, it was a "less granular" endpoint anyway.

    In addition, brief comments about “trending favourably” suggest that the trial’s secondary endpoints weren’t met either.

    Considering the clean sweep of misses, I find the headline used by Anavex to announce its failed results in this potentially pivotal trial to be quite astonishing

    Anavex Life Sciences Provides an Update on Rett Syndrome Program
    Anavex Announces Topline Results from Phase 2/3 EXCELLENCE Clinical Study in Pediatric Rett Syndrome Validation from Real World Evidence (RWE) of Rett Syndrome Patients under Compassionate Use Authorization


    After skipping the pesky bit that none of the study endpoints were actually met, Anavex then states that the high enrolment rates in the extension study and the high level of requests for the Compassionate Use Program provide solid numerical evidence for the reported positive Real World Evidence (RWE) from patients with Rett syndrome under Compassionate Use Authorization.

    Once more, Anavex says it will talk to the regulatory authorities about the “next steps”. I think what they’re implying is that the high rates of demand for participation in the extension study and following compassionate use program should in itself be sufficient “solid numerical evidence” for the FDA and EMA to approve Anavex 2-73 in Rett syndrome.

    Unfortunately for the patients and families who found benefit from Anavex 2-73, I don’t think that the FDA and EMA will see it that way.
 
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