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

NRx together with Osmind, Inc. conducted an in-person meeting attended by leadership of the FDA Division of Psychiatry Products and leadership of the FDA Center for Drug Evaluation and Research (CDER)Oral guidance received at the meeting provides a path to filing an application for New Drug Approval of NRX-100 under already-awarded Fast Track Designation based on existing clinical trial data and Real World EvidenceBased on the guidance, NRx will seek a broader proposed indication for NRX-100 to serve patien ...