Hope therapeutics, inc. and nrx pharmaceuticals, inc. (nasdaq:nrxp) announce alignment with fda on pediatric study plan for nrx-100 (ketamine)

Fda response highlights the importance of addressing suicidal depression in adolescents age 9-17 alignment on initial pediatric study plan (ipsp) is a gating requirement for the upcoming filing of an nrx-100 new drug application (nda) for suicidal depression nrx remains on track to file the nda for nrx-100 in q4 2024 with anticipated pdufa date in q2 2025 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.
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