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If another manufacturer were to seek FDA approval for adjuvant use of sargramostim, the available single-dose 250-mcg vial presentation of Leukine would likely not be optimized for the small doses being studied in these trials

J Biol Chem 281:3562435632 Ronnebaum SM, Ilkayeva O, Burgess SC et al (2006) A pyruvate cycling pathway involving cytosolic NADP-dependent isocitrate dehydrogenase regulates glucose-stimulated insulin secretion