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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 direct quote from a Lancet letter to undermine the credibility of the HARMONY 1 trial investigators.",
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      "text": "Whatever statements the author is referring to strike us as fiction, as we are aware of no such trial that enrolled drug-free patients.",
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      "text": "Comments published in The Lancet in conjunction with the HARMONY 1 paper critiqued the short 8-week duration of the study – “not a trivial limitation” – in addition to noting that a large percentage of patients remained on anti-cataplectic medications, which meant that “the effect of pitolisant on cataplexy could not be assessed.” The author of the letter, a neuroscientist focused on sleep disorders, stated that the trial investigators “reported that trials...in drug-free patients...are ongoing. The results of these trials will clarify whether pitolisant is a novel alternative treatment for narcolepsy.” Whatever statements the author is referring to strike us as fiction, as we are aware of no such trial that enrolled drug-free patients. Each of the principal trials submitted to the FDA as evidence allowed the use of an extensive array of concomitant medications.",
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      "text": "These results are interesting. However, the short duration of the study (8 weeks) is not a trivial limitation; this short timeframe does not allow assessment of the tolerance that might develop with long-term use. Another crucial point of the study is the assessment of cataplexy: 35% of patients continued their usual anticataplectic medication during the trial, thus the effect of pitolisant on cataplexy could not be fully assessed. The investigators reported that trials assessing the possible anticataplectic activity of pitolisant in drug-free patients as well as long-term trials assessing the effects on EDS are ongoing. The results of these trials will clarify whether pitolisant is a novel alternative treatment for narcolepsy.",
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      "text": "“not a trivial limitation” — The Lancet. “the effect of pitolisant on cataplexy could not be assessed.” — The Lancet. “reported that trials...in drug-free patients...are ongoing. The results of these trials will clarify whether pitolisant is a novel alternative treatment for narcolepsy.” — The Lancet.",
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      "text": "Source: https://www.thelancet.com/pdfs/journals/laneur/PIIS1474-4422(13)70178-9.pdf",
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      "text": "Letter critical of HARMONY 1, published commensurately in The Lancet, 2013",
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