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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...
Preparing to submit response to the FDA’s CRL for neffy ® (epinephrine nasal spray) in Type I allergic reactions in early Q2 2024, following successful completion of neffy repeat dose nasal allergen challenge study and nitrosamine assessments, with ...
Significant unmet need with 80-90% of patients with current epinephrine Rx not using as directed, and only ~15% of diagnosed severe Type I allergy population with a current epinephrine prescription Multiple favorable attributes and potential best-in-class profile of neffy highlighted ...