1. 標題：
Ocugen to file for full U.S. approval of COVID-19 shot instead of EUA
2. 來源：路透 (公司名、網站名)
3. 網址：https://reut.rs/2SotDQP
4. 內文：
Ocugen Inc (OCGN.O) said on Thursday it would no longer pursue an emergency
use authorization for its COVID-19 vaccine candidate, Covaxin, and would
instead aim to file for a full U.S. approval of the shot.
Ocugen said the decision was based on a recommendation from the U.S. Food and
Drug Administration (FDA), which 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 will extend our timelines, we are committed to bringing COVAXIN
to the U.S.," Ocugen Chief Executive Officer Dr Shankar Musunuri said.
The company is co-developing Covaxin with India-based Bharat Biotech for the
U.S. market.
Ocugen recently secured exclusive rights to market the vaccine in Canada and
has started discussions with Health Canada for regulatory approval, it said.
The company's shares were down about 40% at $5.56 before the bell.