Anavex Life Sciences Corp (AVXL)

[sokol]

It’s High Time Anavex Moved From Operation Tortoise to Operation Warp Speed.

Anavex announced completion of the Excellence Phase 2/3 Rett clinical trial (92 pediatric patients with Rett syndrome ages ≥ 5 years to 17) on June 6, 2023. This week FDA's Peter Marks was interviewed by Endpoints wherein he called for the industry to embrace the accelerated approval pathway as the agency adapts an "Operation Warp Speed" line of attack in swiftly moving investigational rare disease drugs to market. Anavex has received Fast Track designation for Blarcamesine for the treatment of Rett. It seems to me that all of this puts the ball completely in Anavex's court. The FDA is waiving a flag encouraging Anavex to seek accelerated approval from the FDA for Blarcamesine to treat Rett, and Anavex has previously received Fast Track designation for Blarcamesine to treat Rett syndrome. The FDA has adapted an "Operation Warp Speed" mentality in moving investigational rare disease drugs to market. What more can Anavex ask for from the FDA? Nothing! Let's see if Anavex is up to meeting the challenge of matching the FDA's "Operation Warp Speed" line of attack in moving Blarcamesine to market to treat Rett.

# Completion of ANAVEX®2-73 (blarcamesine) EXCELLENCE Phase 2/3 Rett Syndrome Clinical Trial

## **NEW YORK -- June 6, 2023**

Anavex Life Sciences Corp. ("Anavex" or the "Company") (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer's disease, Parkinson's disease, Rett syndrome and other central nervous system (CNS) disorders, today announced the completion of dosing of all participants of the placebo-controlled EXCELLENCE Phase 2/3 study ANAVEX®2-73-RS-003 in pediatric patients with Rett syndrome. The Company expects to announce topline results from this study in the second half of this year.
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The completion of the randomized, placebo-controlled EXCELLENCE Phase 2/3 study ANAVEX®2-73-RS-003 for the treatment of 92 pediatric patients with Rett syndrome ages ≥ 5 years to 17 (inclusive) was preceded by the successful completion of both placebo-controlled Phase 2 U.S. (ANAVEX®2-73-RS-001) [2], and Phase 3 AVATAR (ANAVEX®2-73-RS-002)[3] studies in adult patients with Rett syndrome.
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ANAVEX®2-73 (blarcamesine) has Fast Track designation, Rare Pediatric Disease designation and Orphan Drug designation from the FDA for the treatment of Rett syndrome.

https://www.anavex.com/post/anavex-life-sciences-announces-completion-of-anavex-2-73-blarcamesine-excellence


### **FDA's Peter Marks on accelerated approvals**

This week, we (Endpoints) also spoke with **Peter Marks**, FDA biologics center director, who called for the industry to embrace the [accelerated approval pathway](https://e.endpointsnews.com/t/t-l-zkdzly-jdiihkkydu-p/) as the agency adapts an "Operation Warp Speed" line of attack in swiftly but thoughtfully moving investigational rare disease drugs to market.

In closing, let's remember that it has been well over a year since the Anavex AD 2b/3 trial was completed - past the one year mark (absent an extension) requirement for reporting clinical trial results. Peter Marks remarks indicate that the FDA is especially interested in accelerated approvals for promising treatments for CNS diseases. Anavex now has three former FDA employees. It is high time that Anavex change from what seems an "Operation Tortoise" mode to "Operation Warp Speed" to match the mentality of the FDA in moving Blarcamesine to market, if it can.