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There will be an evidentiary hearing on May 14, 2025
First, the quality of the PCOS GLP-1 evidence is generally moderate to low: trials are small, short, heterogeneous in design and comparator, and often use surrogate rather than hard reproductive endpoints, so even the class with actual PCOS data is not on firm regulatory footing for this use
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It is still investigational and is not approved by the FDA
Improved glycemic control and reduced bodyweight with exenatide: a double-blind, randomized, phase 3 study in Japanese patients with suboptimally con-trolled type 2 diabetes over 24 weeks
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