Ocugen Inc

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Products, Other Pre-Announcement

Ocugen Says On Track To Submit EUA Application To U.S. FDA For Its COVID-19 Vaccine Candidate, Covaxin

Published: 05/27/2021 00:33 GMT
Ocugen Inc (OCGN) - Ocugen on Track to Submit Emergency Use Authorization Application to U.S. FDA for Its Covid-19 Vaccine Candidate, Covaxin.
Active Discussions With FDA Related to Covaxin Initiated Late Last Year.
Master File Submitted to FDA on March 26, 2021; Awaiting Feedback From FDA.
Confirmed Its Plan to Submit Its Eua Application for Covaxin to U.S. Food & Drug Administration (fda) in June.
Believe That FDA's New Guidance Confirms That Ocugen Continues to Meet All Criteria for Submission of an Eua.
Once Eua Application Has Been Submitted, Ocugen Intends to Commence Pre-biologics License Application Discussions With FDA.