Aquestive gears up for Q3 resubmission after FDA CRL on Anaphylm
TL;DR Summary
Aquestive Therapeutics received an FDA Complete Response Letter for Anaphylm Sublingual Film, with deficiencies limited to human factors and a required PK study; no CMC or broad safety issues were raised. The company plans to revise packaging/instructions, conduct a new HF validation and a PK study in parallel, and target resubmission in Q3 2026. Global filings in Europe and Canada are expected in 2026 as well, and the company remains well-capitalized to support approval and pre-launch activities.
Topics:business#anaphylm#fda-complete-response-letter#healthcare#human-factors#pharmacokinetics#resubmission
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