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The approach we are finalizing, basing the payment limit of the biosimilar on the volume-weighted average of the its own most recently available positive manufacturer's ASP data from a previous quarter and an add-on payment amount determined under section 1847A(b)(4) of the Act for the reference biological product, is most consistent with section 1847A(c)(5)(B) of the Act, which directs the Secretary to update quarterly a drug's ASP payment limit using manufacturer's ASP data from the most recent calendar quarter for which such data are available

Tier 3 patients often experience significant improvements in energy levels and brain fog within 2-4 weeks, with substantial weight loss and metabolic improvements within 8-12 weeks, and continued progress over 6-12 months

Hair typically regrows fully 6-12 months after weight stabilizes

Patient and physician-rated belly appearance and belly profile continued to improve in the T-T groups, however, these improvements regressed in T-P groups [3]