Cassava Sciences Inc. has submitted an investigational new drug $(IND)$ application to the U.S. Food and Drug Administration (FDA) for a proposed proof-of-concept clinical trial of simufilam in tuberous sclerosis complex (TSC)-related epilepsy. The FDA has requested additional information from the company to assess potential risks and support the initiation of the study. Cassava Sciences expects to receive a formal letter from the FDA detailing the required steps to address these issues and plans to work collaboratively with the agency, aiming to begin the trial in the first half of 2026.
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