Anavex Life Sciences Corp (AVXL)

[abew4me]

I think all of Denali's drugs will eventually fail in a P3 trial.
[BTW, they said they would address the FDA letter below, but I have yet to hear anything one year later.]

Denali Therapeutics Announces The Co. Received A Formal Clinical Hold Letter And Is Moving Forward To Address The FDA's Observations Related To The Preclinical Toxicology Assessment And To Provide The Information Requested To Initiate Clinical Studies

6:45 am ET February 14, 2022 (Benzinga) Print
As previously announced, Denali Therapeutics Inc. (“Denali”) was informed on January 12, 2022, via e-mail communication from the U.S. Food and Drug Administration (FDA) that the DNL919 Investigational New Drug (IND) application to begin clinical testing was placed on clinical hold. Denali has now received a formal clinical hold letter and is moving forward to address the FDA’s observations related to the preclinical toxicology assessment and to provide the information requested to initiate clinical studies, including proposed changes to the clinical trial protocol, the informed consent form, and the investigator brochure. Denali intends to provide an update once a clear path forward has been established.