Ocugen stated the choice was based mostly on a advice from the U.S. Food and Drug Administration (FDA), which additionally requested extra info and information for the full approval.
The firm stated it expects information from an extra medical 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-developing Covaxin with India-based Bharat Biotech for the U.S. market.
Ocugen 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 had been down about 40% at $5.56 earlier than the bell.