The Peripheral and Central Nervous System Drugs Advisory Committee ([PCNS]) on 7th September 2022, Wednesday, will reconvene to review a new drug application (NDA) 216660, for oral formulation (suspension powder) of sodium phenylbutyrate/taurursodiol (AMX0035) for the treatment of Amyotrophic lateral sclerosis (ALS). The advisory committee is reconvening to debate over additional analyses of data from Amylyx’s clinical studies that were determined by the FDA to constitute a major amendment to the NDA.