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The 505(b)(2) pathway is the sophisticated middle ground

Higher doses (8-12mg weekly) cost $7,200-12,000 annually

Judging a dose's effectiveness before steady state leads to premature escalation

News Release: Lilly's oral GLP-1, orforglipron, demonstrated statistically significant efficacy results and a safety profile consistent with injectable GLP-1 medicines in successful Phase 3 trial

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Peptides have short half-life, and metabolize quickly, leaving short detection windows in urine