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Last year, the Food and Drug Administration refused to consider an application from ImmunityBio to broaden the approved use of Anktiva, its bladder cancer drug, because clinical data were inconclusive and the request breached the agency’s regulatory guidelines.
Later, when ImmunityBio Chairman Patrick Soon-Shiong publicly criticized the FDA for its decision, he mischaracterized the outcome of a face-to-face meeting he had with FDA officials to discuss Anktiva’s development plans.
