OGEN - FDA backs Oragenics' Pre-IND development program for SARS-CoV-2 vaccine

Oragenics (OGEN) jumps 19% premarket after receiving feedback to Type B Pre-IND Meeting Request from the FDA that the Agency is in broad agreement with the Company’s clinical development program for its SARS-CoV-2 vaccine, Terra CoV-2.As a result, the Company believes its timelines for both filing an Investigational New Drug ((IND)) application and the commencement of the Phase 1 study will proceed on schedule.Oragenics expects to file the IND by end of Q1 2021 and commence patient enrollment in the Phase 1 study early in Q2 2021. The FDA has requested additional preclinical animal data for inclusion in the IND and plans to provide final comments upon reviewing that data and the Phase 1 trial protocol.

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FDA backs Oragenics' Pre-IND development program for SARS-CoV-2 vaccine