Core Points - NRx Pharmaceuticals has filed for the FDA's newly announced Commissioner's National Priority Voucher program for its NRX-100, a preservative-free formulation of ketamine for intravenous use [1][7] - The FDA's new approval pathway aims to expedite the review process for drugs addressing national health priorities, reducing the review time from approximately 10-12 months to 1-2 months [2][3] - The FDA has identified suicidal depression and PTSD as national health crises, aligning with NRx's focus on innovative treatments for these conditions [5][9] Company Developments - NRx has already submitted the chemistry, manufacturing, and controls (CMC) portion of the application for NRX-100 and received FDA feedback [3][6] - The company is preparing a citizen petition to withdraw preservative-containing forms of ketamine due to toxicity concerns, which could enhance its market position in the $750 million generic ketamine market projected to reach $3-5 billion annually by 2033 [9][11] - NRx has received Fast Track Designation from the FDA for NRX-100, indicating its potential to address unmet medical needs [5][11] Market Context - The FDA plans to issue a limited number of vouchers in the first year of the CNPV program to companies that align with U.S. national health priorities [3][4] - NRx's innovative manufacturing approach aims to reduce reliance on foreign sources for ketamine supply, enhancing domestic drug manufacturing as a national security issue [4][8] - The company anticipates decisions on drug approval by year-end 2025, consistent with the timelines announced for the CNPV program [7][9]