Correction: Sedana Medical receives positive opinion from EMA’s Pediatric Committee on reduced pediatric study design
Correction refers to change of category of press release from non-regulatory to regulatory. All other information is unchanged relative to previous version.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.