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Thursday, April 28, 2022 5:24:21 AM
Look here - this is from STAT NEWS' "The Readout":
What does it take to get Covid treatments past the FDA?
Midway through Novartis’ 90-minute-long earnings call yesterday, CEO Vas Narasimhan casually made some news: The company’s treatment for Covid-19, currently awaiting FDA authorization, might need more data to convince regulators.
That sent shares of Molecular Partners, the company that invented Novartis’ treatment, down nearly 20%. Within hours, the company issued a statement of its own, confirming Narasimhan’s account and adding that Novartis is working with the FDA on the design of a Phase 3 study that might address the agency’s outstanding questions.
The news could signal a shift in the FDA’s standards when it comes to new Covid-19 treatments. Novartis and Molecular Partners were widely expected to win an emergency authorization based on Phase 2 data showing that their treatment significantly reduced patients’ viral load and the rate of hospitalization. If the FDA is now demanding data for larger trials to justify authorization, it could scramble the timelines of a host of companies moving toward the market with therapies of their own.
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