ARS Pharma receives FDA Complete Response Letter for neffy; plans appeal, resubmission H1 2024

ARS Pharmaceuticals, Inc.

FDA CRL requests a repeat-dose PK/PD study in allergen-induced allergic rhinitis conditions for approval.
Company will file a Formal Dispute Resolution Request to appeal the CRL; advisory committee voted 16-6/17-5 in favor May 2023.
CRL also asks for nitrosamine impurity testing; company says not rate-limiting for resubmission.
Resubmission expected first half 2024 with FDA action target second half 2024.
Prior FDA alignment on the repeat-dose study as a post-marketing commitment; CRL now requires it for approval.

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