FDA has cited Denali Therapeutics’ preclinical toxicology assessment and has requested changes to the company’s clinical trial protocol, informed consent form, and investigator brochure, according to the company’s account of a formal clinical hold notification from the agency on its DNL919 IND, an Alzheimer’s candidate. Last month, the agency sent an email about the hold and said a subsequent letter would be sent within 30 days. Acknowledging its receipt of the second letter, (Denali says it will address FDA’s observations related to the preclinical toxicology assessment and will provide the requested clinical studies information. It says it intends to provide another update “once a clear path forward has been established.”
FDA has cited Denali Therapeutics’ preclinical toxicology assessment and has requested changes to the company’s clinical trial protocol, informed consent form, and investigator brochure, according to the company’s account of a formal clinical hold notification from the agency on its DNL919 IND, an Alzheimer’s candidate. Last month, the agency sent an email about the hold and said a subsequent letter would be sent within 30 days. Acknowledging its receipt of the second letter, (Denali says it will address FDA’s observations related to the preclinical toxicology assessment and will provide the requested clinical studies information. It says it intends to provide another update “once a clear path forward has been established.”
