Ocugen stated the choice was based mostly on a advice from the U.S. Food and Drug Administration (FDA), which additionally requested extra data and knowledge for full approval.
The firm stated it expects knowledge from an extra scientific trial shall be required to help the advertising utility submission for Covaxin.
“While this will extend our timelines, we are committed to bringing COVAXIN to the U.S.,” Ocugen Chief Executive Officer Dr Shankar Musunuri stated.
The firm is co-growing 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 Health Canada for regulatory approval, it stated.
The firm’s shares have been down about 40% at $5.56 earlier than the bell.