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ARS Pharmaceuticals Submits Response To FDA Complete Response Letter For Neffy

Moomoo 24/7 ·  Apr 3 09:04
  • 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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