AQST - Aquestive resubmits marketing application for Libervant Buccal Film

syahrir maulana/iStock via Getty Images In response to the complete response letter ((CRL)) received in September, Aquestive Therapeutics ([[AQST]] +7.0%) has submitted its New Drug Application ((NDA)) to the FDA for Libervant (diazepam) Buccal Film for the management of seizure clusters. CRL in September was followed by a Type A meeting with the FDA in November 2020 leading to further guidance from the federal agency in February, according to Aquestive. “The submission included additional statistical modeling and supporting analyses of the existing clinical data,” based on the regulatory guidance, the company said adding that with a six-month review process, the NDA is likely to have an FDA action date in late 2021. Seeking Alpha contributor Biologics with a bullish rating on Aquestive notes: “If the FDA accepts the NDA and informs the company they will get the orphan drug designation, I will look for an opportunity to buy on dips or sell

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Aquestive resubmits marketing application for Libervant Buccal Film