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

Reuters2021-05-27

May 26 (Reuters) - Ocugen Inc :

* 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

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((Reuters.Briefs@thomsonreuters.com;))

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