ARS Pharmaceuticals Submits Response To FDA Complete Response Letter For neffy
- 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