Silo Pharma Inc. (Nasdaq: SILO), a developmental stage biopharmaceutical company, has announced that it is progressing with its regulatory review process for its lead asset, SPC-15, a novel intranasal prophylactic designed to target Post-Traumatic Stress Disorder (PTSD). The company expects to receive pre-clinical study data within the next 90 days, which will inform the initiation of their Investigational New Drug $(IND.AU)$ application for SPC-15, planned for submission by the end of 2025. If the IND application is approved by the U.S. Food and Drug Administration (FDA) within the standard 30-day review period, Silo Pharma could commence a Phase 1 clinical trial before the end of 2026. The company is also pursuing the FDA's 505(b)(2) regulatory pathway to potentially expedite the clinical timeline and reduce development costs. This initiative marks a significant step forward in addressing the unmet needs for PTSD treatment, as there have been no new drug approvals for the condition in nearly 25 years. Currently, there is no mention of grant or funding obtained from multiple organizations in this announcement.
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