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The disorder is caused by a mutation in the gene that tells the body how to make hemoglobin, a protein found in red blood cells that binds to oxygen in the lungs and carries it to tissues throughout the body

The clinical need must be considered in addition to any potential adverse outcomes for the infant

A few commenters also called for CMS to provide plain-language explanations of methodological changes for patients, families, and advocates

The compound has never received market authorization in Canada or anywhere else, and Metabolic Pharmaceuticals terminated clinical development in 2007 after the Phase IIb obesity trial failed