Silo Pharma (SILO) announced first dosing in an investigational new drug-enabling GLP-compliant toxicology and toxicokinetics study of its lead asset, SPC-15, an intranasal prophylactic treatment for post-traumatic stress disorder. Silo Pharma completed a pre-IND meeting in September 2024 to align with the FDA on the 505(b)(2) regulatory pathway for approval of SPC-15 and review the Company’s proposed plan to support opening an IND. The FDA’s 505(b)(2) drug development route can significantly shorten clinical timelines for FDA approval and reduce drug development costs.
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