On March 24, 2025, Tonix Pharmaceuticals Holding Corp. (TNXP) announced that the FDA will not require an Advisory Committee meeting regarding the New Drug Application (NDA) for TNX-102 SL for the management of fibromyalgia. An Advisory Committee meeting is scheduled when the FDA needs expert input regarding some or all aspects of the NDA. The fact that the FDA will not require Advisory Committee meeting is a indicative that the FDA has sufficient information to render a decision on TNX-102 SL. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 15, 2025 for a decision on the NDA. TNX-102 SL has the potential to become the first new treatment for fibromyalgia in more than 15 years.