Brief: Sedana Medical Gets Positive Opinion From EMA's Pediatric Committee On Reduced Pediatric Study Design

Sedana Medical AB (publ)

23/12/2022 07:08

Dec 23 (Reuters) - Sedana Medical AB (publ)  SEDANA.ST :
    * SEDANA MEDICAL RECEIVES POSITIVE OPINION FROM EMA'S
PEDIATRIC
COMMITTEE ON REDUCED PEDIATRIC STUDY DESIGN
    * CHANGE WILL ENABLE FASTER STUDY COMPLETION, EARLIER
APPROVAL OF
PEDIATRIC INDICATION AND REDUCED INVESTMENTS
    * EXPECTS TO CONCLUDE STUDY BASED ON APPROXIMATELY 90
PATIENTS,
INSTEAD OF 160 PATIENTS PREVIOUSLY.
    * NOW EXPECTS EUROPEAN APPROVAL OF PEDIATRIC INDICATION IN A
DECENTRALIZED PROCEDURE IN Q4 2023 OR Q1 2024

Source text for Eikon:  ID:nWkr3lwVP2 
Further company coverage:  SEDANA.ST 
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