Brief: Sedana Medical: FDA Positive About Combination Registration Of Isoconda And Anaconda In US
10/04/2019 06:42
April 10 (Reuters) - Sedana Medical AB (publ) SEDANA.ST :
* THE ROAD TO REGISTRATION IN THE US CLARIFIED
* FDA DURING A PRE-IND MEETING IS POSITIVE ABOUT COMBINATION
REGISTRATION OF ISOCONDA AND ANACONDA IN US
* MEETING ALSO CONFIRMED SEDANA MEDICAL'S ESTIMATE OF TIME
AND
COST OF A US APPROVAL THAT IS EXPECTED TO OCCUR IN 2024
Source text for Eikon: ID:nWkr36cfh4
Further company coverage: SEDANA.ST
(Gdynia Newsroom)
((gdynia.newsroom@thomsonreuters.com; +48 58 772 0920;))
Recent news on Sedana Medical AB (publ)
See all newsSweden's Sedana Medical Q3 sales rise as growth returns
Brief: Sedana Medical Announces PDUFA Target Action Date
Brief: Sedana Medical Announces FDA Acceptance For Review Of Its New Drug Application In U.S.
Sweden's Sedana Medical Q2 sales flat, EBITDA loss narrows
Brief: Sedana Medical Q2 EBITDA Loss Narrows To SEK 1.9 Mln