Covaxin - June 10 -- Ocugen Inc said on Thursday that it would no longer pursue an emergency use authorization for its covied 19 vaccine candidate, Ovacogen, and instead aim to file for a full US approval of the shot.
Ocugen said the decision was based on a recommendation by the US Food and Drug Administration that also requested more information and data for the full approval.
The company said it expects data from an additional clinical trial will be required to support the marketing application submission for Covaxin.
While this extension of timelines is necessary, we are committed to bringing COVAXIN to the US. Chief Executive Dr Shankar Musunuri said.
It is co-developing Covaxin with the US market to India-based Bharat Biotech.
Ocugen advanced the expansion of the vaccine in Canada last year and has opened discussions with Health Canada for being issued exclusive rights, it said.
Before the bell, shareholders of the company had down about 40% at $5.56. How long it will be, if I can’t see and put it that way?