Re-Affirms Plan to File IND Application by the End of 1Q21, Begin Phase 1 Study in Early 2Q21
Oragenics, Inc. (NYSE American: OGEN) (“Oragenics” or the “Company”) announced receipt of feedback to its Type B Pre-IND Meeting Request from the U.S. Food and Drug Administration (“FDA”) that it is in broad agreement with the Company’s planned approach to clinical development of 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 the end of the first quarter of 2021 and commence patient enrollment in the Phase 1 clinical study early in the second quarter of 2021.
“We are very pleased with the FDA’s response to our Type B Pre-IND meeting request as it permits us to maintain an aggressive