No. You are making unwarranted assumptions. Think of things from the perspective of the very risk adverse FDA. Clinical data always trumps preclinical data, but if the FDA is sitting on the fence deciding if to approve Bisantrene or not you don’t want to have not done something that would make them feel more comfortable.
Everything you do in drug development is about risk mitigation and making the regulators feel safe saying yes rather than their default position of no.
Ann: Race Initiates Extramedullary AML Preclinical Study, page-65
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