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1a): (1) standard high glucose media (25 mM glucose, glc), (2) galactose media in which the glucose is replaced by the same concentration of galactose (25 mM galactose, gal), (3) full media with 100 nM antimycin (antimycin), and (4) full glucose media but lacking pyruvate (pyruvate)

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Several decisions were close, and the committee heard substantial disagreement about chemical characterization, peptide-related impurities, immunogenicity, carcinogenicity signals or uncertainty, the limited quantity and quality of human evidence, and whether existing FDA-approved therapies already address the proposed uses

Kim JJ, Sears DD

Life Sci 2012, 90 (56), 200205

K.et al (2003)