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      "text": "We note comments from a pharmacology consultant who we engaged to review the materials upon which the FDA relied, who expressed concern that the risk of high blood concentration and potential complications “are downplayed across the board”...",
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      "text": "The FDA’s assessment of CYP2D6 safety issues and resulting dosage adjustments are based on highly misleading data from Harmony, which we believe flagrantly misrepresents the potential for elevated plasma levels of pitolisant and associated cardiovascular and other toxicity.",
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      "text": "Pitolisant is mostly metabolized by CYP450 2D6 and the metabolic phenotype of this enzyme varies widely across individuals... plasma concentrations due to the polymorphic expression of CYP2D6... the potential for changes in pitolisant levels and associated cardiovascular complications are downplayed across the board.",
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      "text": "“Pitolisant is mostly metabolized by CYP450 2D6 and the metabolic phenotype of this enzyme varies widely across individuals (ultra-low, normal, high and ultra-high metabolizers)... the potential for changes in pitolisant levels and associated cardiovascular complications are downplayed across the board.” — Pharmacology consultant engaged by Scorpion Capital",
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