Moberg Pharma receives approval from the EMA’s Paediatric Committee
Moberg Pharma AB (OMX: MOB) today announces that it has received approval of the pediatric plan for MOB-015 from EMA’s paediatric committee (PDCO). This approval enables the company to pursue a full marketing authorization application providing up to ten years of exclusivity in Europe following approval. The company´s timeline remains, with planned submission for MOB-015 in Europe this year and expected market approval in 2023.Today´s positive decision means that Moberg Pharma will conduct a pediatric study during and after the approval process for MOB-015. The study includes 30 children, 6