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Silo Pharma, Inc. (NASDAQ:SILO) ("Silo" or the "Company"), a developmental stage biopharmaceutical company focused on novel therapeutics and drug delivery systems, today announced completion of dosing in a U.S. Food and Drug Administration (FDA)-requested 7-day safety and toxicology large animal study of its lead asset SPC-15, and bioanalytical and safety/toxicology results for such study are expected within 60 days.
Two remaining SPC-15 studies are currently in progress or being planned: an IND-enabling GLP (Good Laboratory Practice)-compliant toxicology and toxicokinetic animal study, and a device study of SPC-15's formulation-specific microchip-based nasal spray system.
Silo plans to seek the FDA's 505(b)(2) regulatory pathway for approval of SPC-15, a drug development route that can significantly shorten clinical timelines for FDA approval and reduce drug development costs.
Posted In: SILO
