1) DISCUSSION: Please discuss your evaluation of the mortality imbalance observed in the CREDIBLE-CR study with respect to the overall risk benefit assessment for cefiderocol and provide recommendations for labeling and/or need for additional studies.

2) VOTE: Has the applicant provided substantial evidence of the efficacy and sufficient evidence of the safety of cefiderocol for the treatment of complicated urinary tract infections (cUTI) including pyelonephritis in patients with limited or no alternative treatment options?

a. If yes, please provide any recommendations concerning labeling.

b. If no, what additional studies/analyses are needed?

Possible Mortality Imbalance For Shionogi's Cefiderocol On US FDA Panel Agenda

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