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  "documentTitle": "Harmony Biosciences (HRMY)",
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  "notes": "The slide highlights a discrepancy between raw ESS scores and adjusted LS means, accusing the sponsor of data manipulation.",
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      "kind": "callout",
      "text": "A 1 point change in actual ESS scores (left table) vs. placebo magically converted to -2.19 by making placebo look worse and pitolisant look better",
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      "text": "The actual reduction vs. placebo was only 1 point, which Bioprojet then tried to inflate via a statistical “method” that made the placebo ESS reduction ~1 point worse and the pitolisant reduction 1.4 points better.",
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      "text": "no significant difference in the daily cataplexy rate was found among patients in the three treatment groups. — FDA",
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      "text": "Source: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/211150Orig2s000StatR.pdf",
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      "text": "Table 27: Summary of ESS Scores",
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      "text": "The ESS reduction in the pitolisant arm in HARMONY 1-bis was far worse than the already mediocre results in HARMONY 1.",
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