Brief: Xspray Pharma Says Stability Studies With Co's Commercially Manufactured Hynap-Dasa Tablets Began On Feb 11

Xspray Pharma publ AB

11/02/2020 17:48

Feb 11 (Reuters) - XSpray Pharma AB (publ)  XSPRAY.ST :
    * STABILITY STUDIES WITH COMPANY'S COMMERCIALLY MANUFACTURED HYNAP-DASA TABLETS BEGAN ON
FEBRUARY
11
    * ABBREVIATED NEW DRUG APPLICATION PLANNED TO BE SUBMITTED TO FDA IN Q3 OF 2020 
    * EXPECT OFFICIAL APPROVAL OF PRODUCTION FACILITY IN MILAN FROM ITALIAN PHARMACEUTICAL
AUTHORITY,
AIFA, WITHIN NEXT FEW MONTHS
    * PIVOTAL CLINICAL BIOEQUIVALENCE STUDIES IN HEALTHY VOLUNTEERS WILL BE INITIATED DURING
SPRING

Source text for Eikon:  ID:nWkrbBPjtV 
Further company coverage:  XSPRAY.ST 

 ((Reuters.Briefs@thomsonreuters.com;))