FDA Asks Novavax for Commitment on Post-Approval Studies for COVID Vaccine
Novavax said on Wednesday the U.S. Food and Drug Administration has sought a commitment from the COVID-19 vaccine maker for additional clinical data if it approves the shot.
Shares of the biotech rose 13% in premarket trading.
The FDA had missed its deadline for making a decision on traditional approval for the company's protein-based shot earlier this month.
Novavax said it believes that the company's marketing application is "approvable" based on its conversations with the FDA.
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