SymbioCellTech Greenlighted to Submit FDA Pre-IND to CBER

SymbioCellTech received written notification from the U.S. Food & Drug Administration yesterday that the current state of their Neo-Islet technology was such that an INTERACT meeting was not necessary and SymbioCellTech’s regulatory questions for the agency could be discussed in the context of a Pre-IND meeting. “This represents a significant step toward SCT advancing through the arduous FDA regulatory pathway for biologics and securing additional funding for our upcoming human trials planned to begin in late 2020,” states Russ Reiss, MD, Chief Operating Officer for SymbioCellTech.