Company aligned with FDA in August 2023 on both physician labeling and post-market requirements, which included a repeat-dose study of neffy under allergen-induced allergic rhinitis conditions
FDA Advisory Committee (PADAC), held in May 2023, recommended neffy approval based on current data set and without recommending additional trials
FDA now requests repeat-dose study be completed prior to neffy approval as opposed to previously agreed-upon post-marketing requirement
Well-capitalized with anticipated cash, cash equivalents and short-term investments on hand of approximately $195 million at the time of our anticipated neffy launch, if approved in 2H24, following our resubmission to the FDA in 1H24
https://finance.yahoo.com/news/fda-issues-complete-response-letter-024900831.html
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