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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 screenshot of the ESS website to undermine the credibility of the clinical trial endpoint.",
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      "text": "The ESS is available for license at www.epworthsleepinessscale.com",
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      "text": "ESS - the entire foundation of Harmony’s clinical trials and the key “evidence” of its purported efficacy - is a highly unreliable, unvalidated, subjective, patient-reported questionnaire that assesses chances of falling asleep in different settings.",
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      "text": "We begin with HARMONY 1, a phase 3 RCT that compared pitolisant versus placebo or modafinil. The primary endpoint was change in Epworth Sleepiness Scale (ESS) scores between the pitolisant and placebo groups after 8 weeks of treatment. ESS – the entire foundation of Harmony’s clinical trials and the key “evidence” of its purported efficacy - is a highly unreliable, unvalidated, subjective, patient-reported questionnaire that assesses chances of falling asleep in different settings. The FDA’s review indicated its skittishness at the use of ESS, but allowed it given the exceptional leniency of the accelerated approval pathway and its past use in other trials in the sleep space: “The Division acknowledges the limitations of this endpoint, as it relies on patients to provide hypothetical responses about how they would respond in different situations and is vulnerable to recall bias.” The Epworth Sleep Scale was written in 1990 by a promotional Australian doctor in private practice, who still shills it online.",
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      "text": "The Division acknowledges the limitations of this endpoint, as it relies on patients to provide hypothetical responses about how they would respond in different situations and is vulnerable to recall bias. — FDA Review",
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      "text": "Source:https://epworthsleepinessscale.com/about-the-ess/",
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