Pre-IND Package Submitted to Center for Biologics Evaluation and Research (CBER) by SymbioCellTech
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.