Aptorum Group completes EOP1 meeting with FDA regarding SACT-1

Aptorum Group announced the completion of an end of Phase 1, or EOP1, meeting with the FDA. SACT-1 is a repurposed small molecule drug formulated in oral suspension targeting neuroblastoma in pediatric patients and has also received orphan drug designation previously from the FDA. The EOP1 meeting was focused on gaining alignment with the FDA regarding the clinical and regulatory pathway for SACT-1 for the treatment of neuroblastoma in pediatric patients aged 2-18. The FDA generally agreed with the chemistry-manufacturing-control strategy and our proposed clinical development plan for Phase 1/2 trials.