Brief: Xbrane Biopharma Received Complete Response Letter From FDA

Xbrane Biopharma AB

22/04/2024 06:12

April 22(Reuters) - Xbrane Biopharma AB  XBRANE.ST :
    * ON SUNDAY SAID FDA HAD ISSUED A COMPLETE RESPONSE LETTER 
TO THE
COMPANY'S BIOLOGICS LICENSE APPLICATION
    * ISSUES RELATE PRIMARILY TO THE REFERENCE STANDARD AND
PRE-APPROVAL INSPECTIONS OF MANUFACTURING PARTNERS' SITES
    * WILL CONTINUE TO WORK CLOSELY WITH ITS PARTNERS TO
IMPLEMENT THE
PROPOSED IMPROVEMENTS PROVIDED IN THE RESPONSES TO THE
INSPECTIONS PERFORMED BY FDA
    * TO DATE, FDA HAS NOT REQUESTED RE-INSPECTIONS OF ANY SITES
    * FDA HAS NOT REQUESTED ANY ADDITIONAL CLINICAL TRIALS NOR
ANY
FURTHER STUDIES TO DEMONSTRATE BIOSIMILARITY

        
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