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1. 標題：
Ocugen to file for full U.S. approval of COVID-19 shot instead of EUA

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.

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簡單說,OCGN透過EUA進入US市場的夢想破滅了
散戶瘋狂出逃中
也是有人在趁機會撿便宜的

出逃的理由是:現在一堆疫苗了 誰還給你慢慢審 等審完都沒肉吃了
抄底的理由是:反正印度還是很嚴重 又常常在變種 美國市場能進多少是多少

兩方正在交戰中...

不過這會不會讓其他疫苗公司進入美國市場的夢醒呢?

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