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On the basis of these new preclinical results with LentiGlobin vector BB305 and the sustained positive outcome for a patient with the parental LentiGlobin vector HPV569 [170], both the ANSM (French) and the RAC/FDA (Recombinant DNA Advisory Committee/Federal Drug Administration, US) granted us approval, in 2013 and 2014, for three new clinical trials using LentiGlobin vector BB305 sponsored by the biotechnology company bluebird bio: (1) Trial NCT02151526 (HGB-205) in France, for both beta-thalassemia and sickle cell disease, (2) Trial NCT01745120 (HGB-204) at multiple centers in the US, Australia and Thailand, for beta-thalassemia, and (3) Trial NCT02140554 (HGB-206), at multiple centers in the US, for sickle cell disease

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Several commenters criticized the lack of adequate risk adjustment for social and demographic factors, noting that hospitals serving higher-risk, underserved, or rural populations could be unfairly affected despite delivering high-quality care