Brief: Milestone Pharmaceuticals Receives Refusal To File Letter From U.S. FDA For New Drug Application For Etripamil

Milestone Pharmaceuticals

26/12/2023 12:03

Dec 26 (Reuters) - Milestone Pharmaceuticals Inc
 MIST.O :
    * MILESTONE PHARMACEUTICALS RECEIVES REFUSAL TO FILE LETTER
FROM
U.S. FDA FOR NEW DRUG APPLICATION FOR ETRIPAMIL IN THE TREATMENT
OF PSVT
    * FDA DID NOT EXPRESS CONCERNS ABOUT NATURE OR SEVERITY OF
ADVERSE
EVENTS
    * UPON PRELIMINARY REVIEW, FDA DETERMINED THAT NDA WAS NOT
SUFFICIENTLY COMPLETE TO PERMIT SUBSTANTIVE REVIEW
    * WILL SEEK CLARIFICATION AND IS IN PROCESS OF PLANNING A
MEETING
WITH FDA

Source text for Eikon:  ID:nGNX8Rsrhm 
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