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That regulators are sitting on it for patent or profit reasons

First, Graf and Kastin (1984) [4] describe a U-shaped activity curve for both dose and infusion duration, meaning there are optimal windows of effect rather than a monotonic dose-response relationship

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The FDA's April 2025 roadmap starts with monoclonal antibodies, where animal immunogenicity poorly predicts human response, and signals a stepwise reduction in routine animal testing (US Food and Drug Administration [FDA], 2025)