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We did not propose updates to the burden estimates because of the forthcoming changes

Oral administration of sodium butyrate attenuates inflammation and mucosal lesion in experimental acute ulcerative colitis

In this case, the method of preparation may comprise admixing a solution of the pharmacologically active BPC peptide salt and further, if necessary, a solution of the additive or adding the additive in a powder form to a solution of the pharmacologically active BPC peptide salt or any other combination of adequate procedures

Said differently, the severe supply chain disruption rebate reduction would be limited to 8 consecutive calendar quarters total per Part B rebatable biosimilar biological product per CMS determination of a severe supply chain disruption