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
https://ir.nrxpharma.com/2024-07-29-HOPE-Ther...0-ketamine
#PharmaNews #mentalillness #mentalhealth #depression #ketamine #stress #PTSD #bipolar #NRX100 #NRX101 $NRXP