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Accounting for clustering ensures that we do not overstate our effective sample size by failing to account for the fact that the performance of participants in a market may not be fully independent of one another

Regarding the suggestion we adopt a flexible approach in its review of FMV documentation, because we did not propose a policy for CMS's review of reasonable assumptions, this comment is out of scope

its safety and tolerability have not been fully clarified, and breakthroughs are still needed in production process optimization and raw material supply

The reality

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