NRx Pharmaceuticals (Nasdaq:NRXP) Confirms Path to New Drug Application with Real World Data and Broader Proposed Indication for NRX-100 (ketamine) Following Type C FDA Meeting

NRx has received confirmatory FDA minutes from in-person Type C meeting attended by leadership of FDA Division of Psychiatry, FDA Office of Neuroscience, and FDA Center for Drug Evaluation and Research.Minutes are consistent with previously announced oral guidance outlining a path to New Drug Approval of NRX-100 for a broadened indication of treating depression, including patients with suicidality.FDA confirmed willingness to review existing Adequate and Well Controlled Clinical Trial data as Substantial Ev ...