Ocugen mentioned the choice was primarily based on a advice from the U.S. Food and Drug Administration (FDA), which additionally requested extra info and knowledge for the full approval.
The firm mentioned it expects knowledge from an extra medical trial will probably be required to help the advertising utility submission for Covaxin.
“While it will prolong our timelines, we’re dedicated to bringing COVAXIN to the U.S.,” Ocugen Chief Executive Officer Dr Shankar Musunuri mentioned.
The firm 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 Health Canada for regulatory approval, it mentioned.
The firm’s shares had been down about 40% at $5.56 earlier than the bell.