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FDA staff stated the compound lacks sufficient information to know whether the drug would cause harm when administered to humans. The committees public docket drew approximately 1,860 comments before the July 23-24 hearing, reflecting broad interest from patients, clinicians, and compounding pharmacists

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Mechanisms underlying neuroprotection include enhanced cerebral angiogenesis supporting tissue oxygenation, anti-inflammatory effects reducing secondary injury, antioxidant activity limiting free radical damage, and modulation of neurotransmitter systems including the dopamine/glutamate/NO system

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