Ocugen mentioned the choice was based mostly on a suggestion from the U.S. Meals and Drug Administration (FDA), which additionally requested extra info and knowledge for the total approval.
The corporate mentioned it expects knowledge from an extra scientific trial might be required to help the advertising and marketing software submission for Covaxin.
“Whereas this may lengthen our timelines, we’re dedicated to bringing COVAXIN to the U.S.,” Ocugen Chief Govt Officer Dr Shankar Musunuri mentioned.
The corporate is co-developing Covaxin with India-based Bharat Biotech for the U.S. market.
Ocugen just lately secured unique rights to market the vaccine in Canada and has began discussions with Well being Canada for regulatory approval, it mentioned.
The corporate’s shares had been down about 40% at $5.56 earlier than the bell.