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The FDA's Category 2 classification makes clinical development in the United States more difficult, not less
FDA GRAS determination (2007): The FDA reviewed AOD-9604's toxicology data and granted Generally Recognized As Safe status for oral use as a food ingredient
Protocol 4: nasal spray approach Goal: Needle-free administration with acceptable bioavailability trade-off Duration: 20 days active, then 4-6 months off Schedule: Days 1-20: 10-15 mg epitalon intranasally, divided into 2-3 daily doses Days 21-180: Off cycle Repeat 1-2 times per year Formulation: Reconstitute in saline with 3 percent DMSO for improved nasal absorption
Both of these are achieved by providing intravenous fluids
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