BioMedNewsBreaks — NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) Completes FDA Type C Meeting for NRX-100 NDA Pathway
NRx Pharmaceuticals (NASDAQ: NRXP) announced completion of an in-person Type C guidance meeting with the U.S. Food and Drug Administration, attended by leadership from the Division of Psychiatry Products, Office of Neuroscience and Center for Drug Evaluation and Research. Based on oral guidance, the company believes it has a path to file a New Drug Application for NRX-100, a preservative-free ketamine formulation, supported by existing adequate and well-controlled trials and confirmatory evidence from more than 65,000 patients in a Real World Evidence dataset, while also seeking a broader indication for treatment-resistant depression with suicidality. The FDA advised that no additional nonclinical or bridging studies would be required, and…











