Aquestive Therapeutics, Inc. · NASDAQ:AQST
Aquestive Therapeutics — Corporate Update (December 2024)
7 slides from Aquestive Therapeutics's corporate update, Dec 2, 2024
Slide 1: Anaphylm Pre-NDA Meeting Supplemental Material
Advancing medicines. Solving problems. Improving lives. September 2024 Advancing medicines. Solving problems. Improving lives. Advancing medicines. Solving problems. Improving lives. 1 Anaphylm Pre-NDA Meeting Supplemental Material December 2, 2024
Slide 2: Disclaimer
© 2024 Aquestive Therapeutics, Inc. 2 ® Disclaimer This presentation has been prepared by Aquestive Therapeutics, Inc. (“Aquestive”, the “Company”, “our” or “us”) and contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “believ
Slide 3: Anaphylm Briefing Book Highlights
3 • Aquestive highlighted the continued unmet need for a non-device based medical product for the treatment of severe allergic reactions, including anaphylaxis • Aquestive provided an overview of all studies to date including pharmacokinetic (PK), pharmacodynamic (PD), and safety analysis • Aquestiv
Slide 4: Anaphylm Pre-NDA Questions
4 Anaphlym Pre-NDA Questions Aquestive Briefing Book Questions to FDA FDA response Does the Agency consider the Sponsor’s planned safety evaluation reasonable for the Anaphylm NDA? FDA agreed. The FDA recommended a few updates to the proposed data groupings. Aquestive views none of these updates as
Slide 5: Additional FDA Comments
5 Additional FDA Comments Additional Unsolicited FDA Comments Aquestive viewpoint FDA noted that the non-allergen exposure arm for Anaphylm in the OASIS allergen challenge study was lower than the allergen exposure arm. FDA also noted that all treatment arms in the self-administration study were at
Slide 6: Advisory Committee Guidance
6 Advisory Committee Guidance FDA Comment Aquestive viewpoint FDA noted that due to the new route of administration and the data supporting this route of administration, an advisory committee meeting “may be necessary.” Aquestive welcomes the opportunity to present its data at an advisory committee
Slide 7: Thank You
<< Aquestive’ Thank You
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