Is There Any Hope for Ocugen?
Some investors have been betting on Ocugen (NASDAQ: OCGN) as one of the next companies to enter the coronavirus vaccine market. Last year, the biotech gained rights to co-commercialize Bharat Biotech's Covaxin in the U.S. The shares soared more than 700% in only a few weeks on the news. Ocugen later added rights in Canada to the agreement. Since, the company has been trying to gain authorization of Covaxin in these markets.
The path hasn't been easy. The U.S. Food and Drug Administration (FDA) wouldn't base a regulatory decision uniquely on Bharat's pivotal trial in India. That means Ocugen must conduct a new phase 3 trial in the U.S. But the FDA placed that new trial on clinical hold before it even started. And Canadian regulators in December requested more information from Ocugen before continuing their review. The latest blow: The FDA rejected Ocugen's authorization request for pediatric use of the vaccine. Now, investors are surely wondering: Is there any hope for Ocugen? Let's find out.
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Source Fool.com
