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Its Phase 3 program places weight, A1C, tolerability, and long term cardiometabolic risk within populations living with overlapping metabolic disease

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Clinical Update 7/15/2024 Cocoa & Afib Did high-flavanol cocoa supplementation impact the risk of developing atrial fibrillation, a heart rhythm disorder, in a major study

BLA submitted: Q1 2027 Standard review reaches PDUFA date: Q1Q2 2028 Complete Response Letter issued instead of approval Additional data requested and resubmitted: 618 months Approval: Late 2028 or 2029 Launch: Early-to-mid 2029 After BLA Submission: The FDA Review Process Month 02: Filing Decision (60 Days) The FDA reviews the application for completeness