Core Viewpoint - NRx Pharmaceuticals has licensed Real World Evidence (RWE) from over 70,000 patients to support its application for Accelerated Approval of NRX-100, a preservative-free ketamine treatment for suicidal ideation in depression and bipolar depression, addressing a significant unmet medical need [1][4][5] Group 1: Company Overview - NRx Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing therapeutics for central nervous system disorders, including suicidal depression, chronic pain, and PTSD [6] - The company is developing NRX-100 (preservative-free intravenous ketamine) and NRX-101 (oral D-cycloserine/lurasidone), with NRX-100 receiving Fast Track Designation for treating suicidal ideation in depression [6][7] Group 2: Real World Evidence and Collaboration - The RWE is provided by Osmind, a neuropsychiatry technology platform, which supplies regulatory-grade data to the FDA to support NRx's application for NRX-100 [2][3] - Osmind's dataset includes nearly one million treatment sessions and hundreds of millions of data points, offering a comprehensive view of ketamine and esketamine's effectiveness and safety [3] Group 3: Clinical Insights and Regulatory Context - Preliminary analysis of a subset of patients indicated a favorable clinical response compared to currently approved products, with optimism for meaningful results from the full dataset [4][7] - The FDA's recent policy change allows the submission of de-identified RWE, facilitating NRx's application process [4] Group 4: Market Need and Access - The company highlights the urgent need for effective treatments, noting that a suicide occurs every 11 minutes in the U.S., and ketamine is increasingly used off-label to reduce suicidal ideation [5] - Current access to ketamine is limited primarily to military and veterans' communities, with broader insurance coverage needed for wider patient access [5]