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We believe these proposed policies would appropriately adapt the proposed quality ASM performance category scoring policies so that ASM participants would not be penalized for changes or errors in the measure and associated submitted data that would be outside the control of the ASM participant

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Eric Topol of Scripps Research Translational Institute was more direct: "These peptides have no data to support their safety and efficacy." The clinical proponents argue that the FDA's safety concerns — immunogenicity risk, impurity risk, organ toxicity — are theoretically valid but speculative in practice