SymbioCellTech Completes Pre-IND Meeting with FDA: Critical Step Toward Human Trials

SALT LAKE CITY, September 5th. SymbioCellTech (SCT) and the FDA completed a successful Pre-IND meeting pertaining to SCT’s proprietary “NeoIslet”cell therapy for Type I Diabetes. The regulatory pathway for cellular therapy is long and complicated, requiring extensive in vitro and in vivo pre-clinical studies. SCT has completed much of this work in preparation for upcoming clinical trials and has taken the next step in the pathway by presenting it’s data and plan to the FDA. Feedback from this meeting will shape the regulatory course taken by SCT moving forward. SymbioCellTech is optimistic that First in Human (FIH) clinical trials could begin as early as 2022.