The US FDA seeks input on the validity of the clinical outcome scale used in the sole pivotal trial, whether treatment benefit can be ascertained, and the robustness of the confirmatory evidence in Nieman-Pick disease type C.
The US FDA seeks input on the validity of the clinical outcome scale used in the sole pivotal trial, whether treatment benefit can be ascertained, and the robustness of the confirmatory evidence in Nieman-Pick disease type C.
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