FDA Broadly Supports Oragenics’ Pre-IND Development Program for Its SARS-CoV-2 Vaccine (Business Wire)

FDA Broadly Supports Oragenics’ Pre-IND Development Program for Its SARS-CoV-2 Vaccine

UF startup and UF Innovate | Sid Martin Biotech graduate company Oragenics, Inc., a leader in the development of new antibiotics against infectious diseases and effective treatments for oral mucositis, 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 Phase 1 clinical study early in the second quarter of 2021.

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