Sedana Medical receives positive opinion from EMA’s Pediatric Committee on reduced pediatric study design
Sedana Medical AB (publ) (SEDANA: FN Stockholm) reports a positive outcome from its interaction with the European Medicines Agency’s Pediatric Committee (PDCO), aimed at modifying the agreed Pediatric Investigation Plan (PIP) for the company’s ongoing pediatric phase III clinical study in Europe (IsoCOMFORT). The change will enable faster study completion, earlier approval of the pediatric indication and reduced investments. Completion of the study according to the PIP is a requirement for obtaining a pediatric indication for the Sedaconda therapy in Europe and for securing 10-year data