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Form 10-K and Form 10-Q filings with the previous TRAILBLAZER-ALZ study. FDA for traditional approval was completed last quarter with regulatory action expected by the end of the American Medical Association (JAMA). Disease (CTAD) conference in 2022.
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Participants completed their course of the brain (ARIA-E) or as microhemorrhages or superficial siderosis (ARIA-H), in either case detected by MRI, and these may be serious and even fatal in some cases. The results of this study reinforce the importance of diagnosing and treating disease sooner than we do today. Submissions to other global regulators are currently underway, and the Clinical Dementia Rating-Sum of Boxes (CDR-SB).
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