ImmunityBio and its chairman Patrick Soon-Shiong have faced criticism from the FDA for inaccurately characterizing the results of negotiations with the agency regarding the bladder cancer drug Anktiva[1]. Last year, the FDA refused to accept a request to expand Anktiva's approved use because the clinical data were inconclusive and the request violated the agency's regulatory guidelines[1]. Soon-Shiong publicly criticized the FDA's decision, but his statements about the proceedings of the meeting with agency officials were misleading[1]. ImmunityBio objected to the alleged inconsistency of the FDA, which approved Anktiva with BCG for patients with papillary disease with CIS, but rejected the application for patients with papillary disease without CIS, even though both groups came from the same clinical trial[2]. In the QUILT-3.032 study, Anktiva in combination with BCG demonstrated a complete response rate of 71% and a median duration of response of 26.6 months[6]. After discussions with the FDA, the company was advised to submit additional information to support a possible resubmission without the need for a new clinical trial[5].