What is the current status of Avxl's FDA approval process?

Anavex Life Sciences' current status of FDA approval process is as follows:

1. **Schizophrenia Program**: The FDA has cleared a placebo-controlled Phase 2 clinical study of ANAVEX®3-71 for the treatment of schizophrenia, which has been screened ahead of schedule. The first cohort of schizophrenia patients in the ongoing Phase 2 trial has been fully enrolled. This trial is expected to begin in Q2 2024 and will study positive, negative, and cognitive domains of schizophrenia based on ANAVEX®3-71’s ability to synergistically activate both SIGMAR1 and M1 muscarinic receptors.
2. **Rett Syndrome Program**: The FDA previously granted ANAVEX®2-73 orphan drug designation for the treatment of Rett syndrome. The company has completed genomic sequencing analysis from ANAVEX®2-73-treated patients, which will be used to update the IND filing for Rett syndrome during the current quarter. While the drug has not yet been approved for Rett syndrome, this program represents a significant step in the treatment of this rare disorder.
3. **Alzheimer's Disease Programs**: Anavex has initiated the process of submitting a Marketing Authorisation application to the European Medicines Agency (EMA) for blarcamesine related to the treatment of Alzheimer’s disease. The full data from the blarcamesine Phase 2b/3 randomized clinical trial will be published in an upcoming peer-reviewed journal. This application is a significant milestone in the company's efforts to bring a treatment to the market for Alzheimer's disease, which currently has no cure or effective treatment.

In summary, Anavex Life Sciences is making progress in its FDA approval process for schizophrenia, Rett syndrome, and Alzheimer's disease. The company's focus on orphan drug designations and precision medicine reflects its commitment to addressing rare and unmet medical needs.