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  "documentTitle": "Harmony Biosciences (HRMY)",
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  "notes": "The slide uses a red box to highlight a specific data point (40mg dose) in a table to support the argument of inconsistent reporting.",
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      "kind": "callout",
      "text": "2015 paper indicates even higher plasma levels than prior papers and label – table excerpt",
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      "text": "As this was a single dose, the steady state level after 7 days (with an accumulation ratio 2.3) is 122 ng/mL +/- 54 ng/mL, far higher than both the 73 ng/mL on the label and the 101 ng/mL in the 2007 pilot study - and indicates patients with 230 ng/mL and 284 ng/mL within two and three standard deviations.",
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      "text": "Cmax (ng/mL): 281.63",
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      "kind": "paragraph",
      "text": "The company submitted two cardiac safety studies to the FDA (“P09-11 and P14-05”) – both absurd, as we shall show. Neither study appears to be published, but we located a 2015 paper that excerpted some data from each.",
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      "text": "Can an early phase clinical pharmacology study replace a thorough QT study? Experience with a novel H3-receptor antagonist/inverse agonist — Eur J Clin Pharmacol (2016) 72:533–543",
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      "text": "Table 2: Pitolisant pharmacokinetic parameters in the male subjects in the two studies",
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