Brief: Achieve Life Sciences Conducts Pre-New Drug Application Meeting With FDA For Drug Product, Cytisinicline

Achieve Life Sciences

11/12/2023 21:53

Dec 11 (Reuters) - Achieve Life Sciences Inc  ACHV.O :
    * ACHIEVE LIFE SCIENCES INC - RECENTLY CONDUCTED PRE-NEW
DRUG
APPLICATION MEETING WITH FDA FOR COMPANY'S DRUG PRODUCT
CANDIDATE, CYTISINICLINE
    * ACHIEVE LIFE SCIENCES: IN ONGOING TALKS WITH FDA TO
CLARIFY
REQUIREMENTS AND TIMING FOR LONG-TERM EXPOSURE SAFETY DATA TO
SUPPORT NDA SUBMISSION
    * ACHIEVE LIFE SCIENCES INC - COMPANY'S NDA FILING TIMING
MAY BE
DELAYED TO ADDRESS FDA FEEDBACK

Further company coverage:  ACHV.O 

 ((Reuters.Briefs@thomsonreuters.com))