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  "documentTitle": "Harmony Biosciences (HRMY)",
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      "text": "QTc prolongation of ~10 msec and ~16 msec at ~175 ng/mL and ~280 ng/ML, respectively",
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      "text": "The effect of pitolisant was evaluated in clinical studies P09-11 (TQT study) and P14-05 (SAD Study) and the agency performed independent analysis of these data...",
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      "text": "Even with using the clearly fraudulent “plasma level average” in the paper, 1/3 of patients would exceed one standard deviation, meaning a significant percentage in the QT danger zone with plasma levels >179 ng/ml...",
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      "text": "there was a clear and direct correlation of pitolisant exposure with QTc prolongation. At supratherapeutic doses, QTc increases greater than 10 msec are anticipated — FDA CDER Clinical Pharmacology Review, Dec 2018",
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