Movers and SHAKERS
Start of COVAXIN Clinical Trial Delayed by FDA Hold
Ocugen Inc is a clinical stage biopharmaceutical company. It is focused on discovering, developing and commercializing a pipeline of innovative therapies that address rare and underserved eye diseases. Ocugen offers a diversified ophthalmology portfolio that includes novel gene therapies, biologics, and small molecules and targets a broad range of high-need retinal and ocular surface diseases.
Robert LeBoyer, Senior Research Analyst, Noble Capital Markets, Inc.
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Clinical Hold Delays Trial. Ocugen announced that the FDA has issued a Clinical Hold for its Investigational New Drug Application for COVAXIN, its vaccine for protection from COVID-19. The IND delays the start of a bridging study designed to verify that the immune response in the US population is comparable to the Phase 3 study population. This Phase 3 data was submitted for marketing approval.
Reason For The Hold Were Not Specified. Ocugen announced the IND submission on October 27, and began preparing for the clinical study. An IND becomes effective unless the FDA responds with questions or rejection within 30 days. The notification to Ocugen comes at the end of this 30-day period, but no reasons were provided. Based on previous cases, we believe the FDA could be taking extra ...
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