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  "documentTitle": "Harmony Biosciences (HRMY)",
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  "authorName": "Scorpion Capital",
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  "presentationDate": "2023-03-28 00:00:00",
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  "notes": "The slide uses a specific data table to support a broader narrative of corporate non-transparency regarding PK data.",
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      "kind": "callout",
      "text": "Footnote b indicates the obvious – that Bioprojet is sitting on critical PK data that it has withheld",
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      "text": "Footnote b indicates the obvious - that Bioprojet is sitting on critical PK data that it has withheld",
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      "text": "A 2019 paper for a small open-label, single-dose study in children and adolescents with narcolepsy stated that twenty-four patients were dosed at 17.8 mg – half the max dose. Data is shown for two subgroups – 12 patients age 6 to <12, and 12 from age 12 to <18. Data is also shown for a comparator group of 13 adults (age 18-40), who were not part of the study with a footnote indicating “historical comparison group (data on file).” As we noted, Harmony and Bioprojet’s failure to publish proper PK data is damning, as it is inconceivable that they don’t have the data – and the footnote confirms the obvious.",
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      "text": "In addition to steady-state plasma levels in the a) 2007 pilot study, b) the 2010 cardiac study, and c) the paroxetine study – all of which show levels far higher than the label - we located a fourth paper with telling crumbs of data.",
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      "text": "Historical comparison group (data on file). — Footnote b",
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      "text": "Source: https://pubmed.ncbi.nlm.nih.gov/31978866/",
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      "text": "Pharmacokinetic profile of pitolisant and its major phase 1 inactive metabolite.",
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