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Investigational New Drug application operates on passive approval logic

Planned surgery may require pausing medication days before the procedure

Another commenter expressed concern that less publicized extraordinary circumstances will not prompt CMS to issue an ECE without request, and that the process to submit an ECE request via the HQR portal, email, or secure fax may be unavailable if an emergency event severely disrupts operations for months

This ensures that those with significant health risks beyond their weight have access to effective treatment

Key Differences: Efficacy and Dosage *SURMOUNT-5 head-to-head trial, NEJM 2025

Sergey Terushkin, MD, FACS No long drives or waiting rooms