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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 'villain critique' style to highlight a lack of transparency in clinical trial reporting.",
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      "kind": "callout",
      "text": "Only a single sentence on cardiovascular safety in the papers for the pivotal phase 3 narcolepsy trials, with no data shown",
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      "text": "Harmony CTP: Safety and efficacy of pitolisant on cataplexy in patients with narcolepsy: a randomised, double-blind, placebo-controlled trial. Blood chemistry and haematological or cardiovascular parameters did not change in either group.",
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      "text": "Harmony 1: Pitolisant versus placebo or modafinil in patients with narcolepsy: a double-blind, randomised trial. three patients in the modafinil group. Blood chemistry tests or cardiovascular parameters did not change in the three study group (data not shown).",
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      "text": "Not surprisingly, Bioprojet’s narcolepsy studies fail to disclose cardiovascular safety data. Given that their preclinical papers, such as the in vitro hERG and Purkinje fibre study, asserted zero risk, the failure to showcase this safety profile with clinical data is damning. The Harmony 1 pivotal trial didn’t even conduct ECG’s on treatment groups – just a baseline ECG, presumably to cherry-pick and screen out patients with cardiac issues. The Harmony 1 paper states that “blood chemistry tests or hematological or cardiovascular parameters did not change in the three study groups (data not shown).” The Harmony CTP trial conducted ECG’s at each visit, yet once again no data or discussion is included other than the same sentence above from Harmony 1. The Harmony 3 paper states that ECG’s were conducted at baseline and at 6 and 12 months of dosing, but once again the data is missing and we are left with a single sentence asserting safety.",
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      "text": "Blood chemistry tests or hematological or cardiovascular parameters did not change in the three study groups (data not shown). — Harmony 1 paper",
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      "text": "Source: https://pubmed.ncbi.nlm.nih.gov/24107292/; https://pubmed.ncbi.nlm.nih.gov/28129985/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6802569/pdf/zsz174.pdf",
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