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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.

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.

NRX 製藥提供了與 FDA 有關 NRX-101 NDA 提交途徑的相互作用的進展更新；表示 NRX 製藥似乎已就其提議的註冊製造計劃達到與 FDA 保持一致。
Benzinga Real-time News ·  2023/01/19 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.

NRX 製藥公司（NASDAQ：NRXP）（「NRX 製藥」，「公司」）是臨床階段中樞神經系統（CNS）生物製藥公司，今天宣布，上週召開了一次會議和書面回應食品和藥物管理局（FDA）就其鉛化合物 NRX-101。NRX 製藥提供有關 NRX-101 NDA 提交途徑與 FDA 相互作用的最新進展。為了回應有關 NRX-101 計劃化學，製造和控制（CMC）方面的 C 型指導的請求，FDA 於 1 月 10 日提供了書面回應。正如之前在 2022 年 10 月宣布的那樣，提交了更新的 NRX-101 模塊 3，以將預期的商業製造商添加到 IND 中。根據 FDA 的書面回應，NRX 製藥似乎與 FDA 就其提議的註冊製造計劃達到了一致。與食品和藥物管理局的 B 型會議於 2023 年 1 月 11 日舉行。預計會議記錄將在大約 30 天內提供。

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