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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 Pharmicals提供了与美国食品药品管理局就提交 NRX-101 保密协议的途径进行互动的最新进展；表示看来NRX Pharmicals已就其拟议的注册制造计划与美国食品药品管理局达成一致。
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.

临床阶段的中枢神经系统（CNS）生物制药公司nRX Pharmicals, Inc.（纳斯达克股票代码：NRXP）（“nRx Pharmicals”，“公司”）今天宣布，上周就其主要化合物 NRX-101 举行了会议，并收到了美国食品药品监督管理局（FDA）的书面答复。nRX Pharmicals 提供了与 FDA 在 NRX-101 保密协议提交途径方面的互动的最新进展作为对 NRX-101 计划化学、制造和控制 (CMC) 方面的 C 型指导的请求，美国食品和药物管理局于 1 月 10 日提供了书面答复。正如之前在 2022 年 10 月宣布的那样，已提交更新的 NRX-101 模块 3，以将预期的商业制造商添加到 IND 中。根据美国食品药品管理局的书面答复，NRx Pharmicals似乎已就其拟议的注册生产计划与美国食品药品管理局达成一致。与美国食品和药物管理局的B型会议于2023年1月11日举行。会议纪要预计将在大约 30 天后公布。

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