Accelerated approval application was based on Phase 2 trial showing amyloid plaque lowering
Complete response letter based on limited number of patients with 12-month drug exposure data in the accelerated approval submission; no other deficiencies were identified
Definitive Phase 3 readout and submission for traditional approval remain on track for mid-year 2023
https://finance.yahoo.com/news/u-food-drug-administration-issues-230000623.html
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