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Todays approval represents a significant step forward in enabling children to be treated with Brineura as early as possible, when we can have the greatest impact in altering the natural course of disease, Hank Fuchs, president of worldwide research and development at BioMarin, said in a statement

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Whether the delivered amount crosses the threshold for therapeutic effect in any given individual also remains unknown

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more serious and/or complex investigations are handled by the appropriate MCIO

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