Silo Pharma Inc. (Nasdaq: SILO) has announced the completion of dosing in a safety study for its PTSD drug candidate, SPC-15. This study was conducted at the request of the U.S. Food and Drug Administration (FDA) and involved a 7-day safety and toxicology assessment in a large animal model. The company anticipates receiving the bioanalytical and safety/toxicology results within 60 days. Silo Pharma is also progressing with two additional preclinical studies: an IND-enabling GLP-compliant toxicology and toxicokinetic animal study, and a device study focused on SPC-15's formulation-specific microchip-based nasal spray system. The company plans to pursue the FDA's 505(b)(2) regulatory pathway to potentially expedite the clinical approval process for SPC-15. Results from these studies are expected to be presented in the future.
免责声明:投资有风险,本文并非投资建议,以上内容不应被视为任何金融产品的购买或出售要约、建议或邀请,作者或其他用户的任何相关讨论、评论或帖子也不应被视为此类内容。本文仅供一般参考,不考虑您的个人投资目标、财务状况或需求。TTM对信息的准确性和完整性不承担任何责任或保证,投资者应自行研究并在投资前寻求专业建议。