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7g, h), excluding the possibility that this phenomenon is only seen in immortalized cells

AOD-9604 is generally well-tolerated with a favorable safety profile based on clinical research involving approximately 900 participants across six studies

Further, as discussed in the CY 2025 PFS proposed rule (89 FR 61957), in considering whether consistency across CMS programs is critical, we believe that consideration for the completeness of data, as discussed above, should be prioritized over consistency across program timelines