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The FDA also noted major evidence gaps for subcutaneous, topical, and nasal exposure, so the trial record does not establish safety for those routes
They are not intended to represent clinical evidence in humans, and AOD-9604 has not been approved by the FDA, EMA, or any other regulatory authority for any indication
Monitoring Progress and Adjusting Protocols Objective assessment of AOD-9604s effects requires proper measurement tools and regular evaluation
Therapeutics 33 (3), 358371.e2
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