Aquestive Sees Libervant Application Resubmission By End Of Q2 - Aquestive Therapeutics (NASDAQ:AQST)

The FDA has provided further guidance to Aquestive Therapeutics Inc (NASDAQ: AQST) regarding the information to be included in the marketing application for Libervant to manage seizure clusters.
This guidance FDA addresses the revised weight-based dosing regimen, modeling, and simulation data provided to the Agency in December 2020.
The feedback offers direction on the FDA's expectations for the information and supporting analysis relating to the population pharmacokinetic model.
The agency also guided its expectations around the nature and format of safety data included in the resubmission.
The company plans to resubmit the marketing application around the end of the second quarter of 2021.
Aquestive received a Complete Response Letter from the FDA in September last year citing exposure levels in certain weight groups.
Libervant is a buccally (inside of the cheek) administered soluble film formulation of diazepam, a benzodiazepine, for rapid treatment of acute uncontrolled seizures.
Price Action: AQST shares are 3.74% at $5.28 on the last check Thursday.