Brief: Aquestive Therapeutics Announces Completion Of FDA End-Of-Phase 2 Meeting For Aqst-109 (Epinephrine Sublingual Film)
22/12/2022 13:03
Dec 22 (Reuters) - Aquestive Therapeutics Inc AQST.O :
* AQUESTIVE THERAPEUTICS ANNOUNCES COMPLETION OF FDA
END-OF-PHASE
2 MEETING FOR AQST-109 (EPINEPHRINE SUBLINGUAL FILM)
* FDA CONTINUES TO INDICATE THAT COMPANY CAN CONDUCT A
COMPARABILITY STUDY RATHER THAN EFFICACY STUDIES
* FDA PROVIDES CLEAR GUIDANCE ON APPROVABILITY EXPECTATIONS
FOR
PHARMACOKINETIC PERFORMANCE, PATIENT ADMINISTRATION ATTRIBUTES
* CONTINUES TO ANTICIPATE A POTENTIAL PRODUCT LAUNCH IN 2025
WITH
AN NDA SUBMISSION IN FIRST HALF OF 2024
Source text for Eikon: ID:nGNX8v2n4v
Further company coverage: AQST.O
((Reuters.Briefs@thomsonreuters.com))
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