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If not, it looks like they have to wait until 2028 at least and likely until 2032

no consistent signal for organ toxicity or long-term harm across decades of use Special Populations: Clinical experience exists in elderly patients with dementia and stroke patients, populations where safety data is particularly valuable IV Administration Considerations: Requires clinical administration setting for intravenous dosing, which limits convenience but ensures medical oversight Dihexa: Unknown Human Safety Profile Dihexa has never been administered to humans in any controlled setting, creating a complete absence of human safety data: No Human Pharmacokinetics: Absorption, distribution, metabolism, and excretion parameters are unknown in humans Theoretical c-Met Oncogenesis Concern: The c-Met/HGF pathway is implicated in cancer progression aberrant c-Met signaling promotes tumor growth, metastasis, and angiogenesis in multiple cancer types

Theriogenology 234:101109 Prajapati SK, Jain A, Bajpai M (2025) Lipid-based nanoformulations in onychomycosis therapy: addressing challenges of current therapies and advancing treatment

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Endothelium-derived relaxing factor from cultured human endothelial cells inhibits aggregation of human platelets