The sponsor behind PRN-4011 has not yet filed for Orphan Drug Designation (ODD), though analysts suggest it is a viable candidate for SAH or pediatric TBI.
A meeting with the U.S. Food and Drug Administration (FDA) has reportedly taken place. The FDA provided guidance on the required chronic toxicology studies necessary to support a Phase 1 first-in-human (FIH) trial. prn-4011
Failover (N+1), Auto Recovery Backup (ARB), Dual Hot-Swap Power Supplies High-Fidelity Performance and Bandwidth Optimization The sponsor behind PRN-4011 has not yet filed