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NRx Pharmaceuticals Provided Progress Update on Interactions With the FDA Regarding Path to NDA Submission for NRX-101; Said It Appears That NRX Pharmaceuticals Has Reached Alignment With The Fda Regarding Its Proposed Registration Manufacturing Plan.

Benzinga Real-time News ·  Jan 19, 2023 06:53

NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage central nervous system (CNS) biopharmaceutical company, today announced that it had a meeting and a written response from the Food and Drug Administration (FDA) last week regarding its lead compound, NRX-101. NRx Pharmaceuticals Provides Progress Update on Interactions with the FDA regarding Path to NDA Submission for NRX-101 In response to a request for Type C guidance on the chemistry, manufacturing and controls (CMC) aspects of the NRX-101 program, FDA provided Written Responses on January 10th. As previously announced in October 2022, an updated NRX-101 module 3 was submitted to add the intended commercial manufacturer to the IND. With FDA's written response, it appears that NRx Pharmaceuticals has reached alignment with the FDA regarding its proposed registration manufacturing plan. A Type B meeting with the FDA was held on January 11, 2023. Minutes of the meeting are expected to be available in approximately 30 days.

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