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We believe that the information required in a 506C notification submitted to FDA would not be sufficient to make a rebate reduction determination because while 506C notifications must include information related to permanent discontinuances or manufacturing interruptions of a drug, they are not required to include information about other changes in production or distribution that may be relevant for CMS' determination of whether a severe supply chain disruption has occurred

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thus, GCL is considered the rate-limiting enzyme [6]

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Cells were counted using a DxH 500 hematology analyzer (Beckman Coulter) and adjusted to 1010 6 cells/mL in 1 PBS