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MetE protein formulated with AS01™ adjuvant generated a robust Th1-biased CD4+ T cell response, characterized by antigen-specific IFN-γ, TNF-α, and IL-2 production ( Figures 6A, B ), alongside a broad humoral response with statistically significantly elevated IgG1, IgG2a, IgG2b, and IgG2c levels compared to naïve group ( Figure 6C )

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The FDA will require Biogen to conduct a new, large clinical trial to determine the drug's benefit, and reserves the right to rescind the approval in the future