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ARS Pharmaceuticals Submits Response To FDA Complete Response Letter For neffy

Author: Benzinga Newsdesk | April 03, 2024 09:04am
  • Response addresses all additional requests in FDA CRL, including positive data from a repeat dose PK/PD study of neffy under nasal allergen challenge (NAC) conditions, and updated testing that detected no measurable nitrosamine levels, conducted per August 2023 FDA Guidance
  • Submission of CRL response triggers up to six-month review period by the FDA

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