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Replies to post #233975 on Biotech Values
miljenko
07/30/20 5:28 PM
#233977 RE: miljenko #233975
DewDiligence
09/28/20 7:12 AM
#234786 RE: miljenko #233975
INOVIO…announced that the U.S. Food and Drug Administration (FDA) has notified the company it has 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 is on partial clinical hold. The company is actively working to address the FDA's questions and plans to respond in October, after which the FDA will have up to 30 days to notify INOVIO of its decision as to whether the trial may proceed.