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

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...