Aquestive Therapeutics Inc

NASDAQ:AQST   3:59:44 PM EDT
5.11
-0.15 (-2.85%)
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Aquestive Gets Complete Response Letter From FDA For Libervant Buccal Film For Management Of Seizure Clusters

Published: 09/25/2020 21:52 GMT
Aquestive Therapeutics Inc (AQST) - Aquestive Therapeutics Inc - Receives Complete Response Letter From FDA for Libervant(tm) (diazepam) Buccal Film for Management of Seizure Clusters.
Aquestive Therapeutics Inc - Complete Response Letter for Libervant Cites Exposure Levels (cmax) in Certain Weight Groups.
Aquestive Therapeutics Inc - No Additional Clinical Studies Anticipated by Aquestive.
Aquestive Therapeutics Inc - FDA Did Cite a Small Number of Protocol Deviations in Blood Draws in One of Studies in NDA for Libervant.
Aquestive Therapeutics- Intends to Provide to FDA Additional Information on Pk Modeling to Demonstrate Dose Adjustments to Get Desired Exposure Levels.
Aquestive Therapeutics Inc - Plans to Request a Type a Meeting With FDA in Coming Weeks.
Aquestive Therapeutics Inc - Plans to Resubmit NDA Prior to End of 2020 With Adjusted Dosage Regimen for Identified Weight Groups at Issue.
Aquestive Therapeutics Inc - a Submission Before End of Year Should Result in a PDUFA Action Date for Libervant in 1(st)half of 2021.
Aquestive Therapeutics Inc - No Other Safety, Clinical Pharmacology/biopharmaceutics Or Cmc Issues Identified in Crl.