Today, June 20th, 2019, the FDA’s Center for Biologics Evaluation and Research (CBER) confirmed receipt of SymbioCellTech’s Pre-IND Package notifying the company that a decision on scheduling a meeting this summer to discuss human Neo-Islet therapy will be communicated by July 8th.
This Pre-IND submission and interaction with the agency represents another milestone achieved toward SymbioCellTech initiating clinical trials, which are currently planned to begin in 2020.