Replies to post #451134 on Anavex Life Sciences Corp (AVXL)

[Steady_T]

Actually the words he used were backup plan.

Remains to be seen what the FDA has to say about it.

[georgejjl]

Jav:

The following is another one of your outright lies:

Rett Excellence was not pivotal and also a failure.

The truth is that Rett Excellence was not a failure and was quite probably a pivotal trial upon further review in consultation with the FDA.

GOD bless,

[XenaLives]

Key Pipeline Updates:

--Alzheimer’s disease: Full data from the blarcamesine in Alzheimer’s disease Phase 2b/3 randomized clinical trial will be published in an upcoming peer-reviewed journal. The Company has initiated the process for submitting a Marketing Authorisation application to the European Medicines Agency (EMA) under the Centralised Procedure. The Marketing Authorisation would allow direct market access throughout the European Union for oral blarcamesine for the treatment of Alzheimer’s disease. There are an estimated 7 million people in Europe with Alzheimer’s disease, a number expected to double by 2030, according to the European Brain Council.[1]

--Alzheimer’s disease: Ongoing ATTENTION-AD open-label extension 96-week trial.

--Rett syndrome: Topline data from ANAVEX®2-73-RS-003 Phase 2/3 EXCELLENCE pediatric clinical trial was announced last month. We intend to further assess the results and discuss with the regulatory authorities next steps.

--Schizophrenia: Initiation of FDA cleared placebo-controlled ANAVEX®3-71 Phase 2 clinical trial expected to begin in Q2 2024.

--Parkinson’s disease: Initiation of ANAVEX®2-73 imaging-focused trial and Phase 2b/3 6 months trial.

--Fragile X: New disease-specific, translatable, and objective biomarker data generated with ANAVEX®2-73, support the initiation of the potentially pivotal ANAVEX®2-73 Phase 2/3 clinical trial.

--New Rare disease: Initiation of potentially pivotal ANAVEX®2-73 Phase 2/3 clinical trial.

--Publications: Continued clinical publications involving ANAVEX®2-73 and ANAVEX®3-71.

https://www.anavex.com/post/anavex-life-sciences-reports-fiscal-2024-first-quarter-financial-results-and-provides-business-updat