Brief: Cyclopharm Says U.S. FDA Unable To Approve NDA For Technegastm In Present Form
28/06/2021 02:08
June 28 (Reuters) - Cyclopharm Ltd CYC.AX :
* US FDA DETERMINED IT IS UNABLE TO APPROVE NDA FOR
TECHNEGASTM IN
ITS PRESENT FORM
* USFDA PROVIDED DEFINITIVE LIST OF RECOMMENDATIONS FOR
OUTSTANDING ELEMENTS TO BE ADDRESSED WITHIN 12-MONTH PERIOD
* EXPECTS TO RESOLVE ALL ELEMENTS WITH VIEW TO SECURING
APPROVAL
FOR COMMERCIAL SALES OF TECHNEGASTM IN US MARKET IN 2022
Source text for Eikon: ID:nASX3Lgp2Y
Further company coverage: CYC.AX
((Reuters.Briefs@thomsonreuters.com;))
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