Former FDAer: Data On COVID-19 Antibody Cocktails Insufficient For EUA

By Kelly Lienhard / October 9, 2020 at 5:43 PM
A former FDA official believes that Regeneron Pharmaceuticals has not collected enough clinical data for its investigational antibody cocktail, REGN-COV2, to wisely be given an emergency use authorization, despite President Donald Trump’s recent calls for FDA to quickly authorize the treatment for COVID-19 patients. “I think granting an EUA based on a press release describing a sub analysis [seronegatives only] in which the clinical outcomes do not reach statistical significance is not advisable,” Peter Lurie, president of the Center...

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