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There is definitely an interest in advanced therapies, such as cell and gene therapy, plasmids, mRNA, and viral vectors. or 2x, that is definitely seen as a success and [worth] being explored through an oral route. We are certainly seeing requests or demands for large molecules to be explored for oral delivery.
11 The role of patient-centered evidence in the renegotiation process also requires greater definition. Although the statute references therapeutic benefit and unmet need, the draft guidance is silent on how CMS will gather and weigh patient-reported outcomes, registry data, or treatment experience narratives.
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