Clene announces it will meet in-person with FDA to discuss CNM-Au8

Clene announced that it will meet in-person with the U.S. Food and Drug Administration, FDA, before the end of November 2024 to discuss CNM-Au8 development for ALS. The meeting will include the FDA’s Director of the Office on New Drugs, the Director of the Office of Neuroscience, and the Division of Neurology 1 review team, as well as recognized key opinion leaders in ALS, biostatistics, and biomarkers. Clene is appreciative of the FDA’s use of process and regulatory flexibility to obtain the best outcome for people living with ALS.