Aquestive Therapeutics Inc. (AQST) will know whether or not its lead drug candidate Libervant passes muster with the FDA on December 23. This is Libervant’s second go-around with the regulatory agency. In its Complete Response Letter, issued last September, it was stated that certain weight groups showed a lower drug exposure level than desired.Libervant is a soluble film formulation of diazepam, administered inside of the cheek and is proposed for rapid treatment of acute uncontrolled seizures in refractory patients with epilepsy on stable anti-epileptic drugs.The current standard of care rescue therapy for patients with refractory epilepsy is Diastat, a diazepam based rectal gel that is invasive, inconvenient, and difficult to administer.If approved by the FDA, Libervant will an alternative to Diastat and will be the first oral diazepam-based therapy approved for management of seizure clusters in the population of 1.2 million refractory epilepsy patients.Libervant will also have to compete with Neurelis Inc.’s Valtoco, an intranasal formulation of diazepam, which was approved in January 2020. Valtoco has 7 years of Orphan Drug Exclusivity.AQST closed Friday’s trading at $6.37, up 2.08%.