On Sept. 28, 2020, INOVIO announced the U.S. Food and Drug Administration (FDA) had notified the company that it had additional questions about the company’s planned Phase 2/3 trial of its COVID-19 vaccine candidate INO-4800, including its CELLECTRA 2000 delivery device to be used in the trial.

Until the FDA’s questions have been satisfactorily addressed, INOVIO’s Investigational New Drug Application (IND) for the Phase 2/3 trial was on partial clinical hold.