HOPE Therapeutics, Inc. and NRx Pharmaceuticals, Inc. (Nasdaq:NRXP) Announce Alignment with FDA on Pediatric Study Plan for NRX-100 (ketamine)

https://www.prnewswire.com/news-releases/hope-therapeutics-inc-and-nrx-pharmaceuticals-inc-nasdaqnrxp-announce-alignment-with-fda-on-pediatric-study-plan-for-nrx-100-ketamine-302208338.html

RADNOR, Pa., July 29, 2024 /PRNewswire/ — NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (“NRx Pharmaceuticals”, the “Company”), a clinical stage pharmaceutical company, today announced a communication from the US Food and Drug Administration (FDA) providing feedback and alignment on NRx’s proposed initial Pediatric Study Plan (iPSP) for NRX-100 (ketamine) in the treatment of suicidal depression. Congress required the submission of an iPSP as a precondition to filing a New Drug Application in the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA).[1]

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