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Key safety observations from available trial data include: Elevated resting heart rate in a dose-dependent manner Gastrointestinal adverse effects (nausea, vomiting, diarrhoea) as the most common side effects, consistent with the GLP-1 receptor agonist class [1] [3] No clinically significant QT interval prolongation was reported in available data, though the extent of formal thorough QT assessment has not been fully detailed in published sources
The FDA then has 60 days to decide whether to accept the application for review (called the "filing decision")
The bridge between these two measurements is concentration
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