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The inclusion of products such as Imbruvica, used in CLL and other hematologic malignancies with orphan indications, demonstrates that even rare and oncology assets are not insulated from mandated discounts

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Human relevance would require sufficient published, peer-reviewed controlled human studies, safety evaluation, pharmacokinetic understanding, toxicology data, and regulatory reviewevidence that has not yet been established at the level required for clinical or consumer-use conclusions

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