Brief: Sedana Medical Informs About Adjusted US Submission Plan Following FDA Interaction

Sedana Medical AB (publ)

12/07/2023 07:59

July 12 (Reuters) - Sedana Medical AB (publ)
 SEDANA.ST :
    * SEDANA MEDICAL INFORMS ABOUT ADJUSTED US SUBMISSION PLAN
FOLLOWING FDA INTERACTION
    * FDA REQUESTED COMPANY TO INCLUDE LONG-TERM OUTCOMES DATA
IN
CLINICAL STUDY REPORT (CSR) OF INSPIRE-ICU TRIALS BEFORE NEW
DRUG APPLICATION (NDA) CAN BE SUBMITTED
    * FDA REQUEST EXPECTED TO MOVE FILING DATE BY APPROXIMATELY
ONE
YEAR TO Q1 2025
    * FDA REQUEST IS NOT EXPECTED TO MATERIALLY IMPACT OVERALL
COST
FOR CLINICAL PROGRAM

Source text for Eikon:  ID:nWkr34dDM4 
Further company coverage:  SEDANA.ST 

 (Gdansk Newsroom)
 ((gdansk.newsroom@thomsonreuters.com;))