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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 'fraud-exposure' or 'investigative' tone to question the lack of public data on a specific study.",
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      "text": "FDA review indicated hepatic enzyme elevation in one of eight patients",
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      "text": "A total of eight patients completed study HBS-101-CL-003, “An Open-Label, Phase 1 Study to Assess the Steady State Pharmacokinetics of Pitolisant in a Predefined Population of Pediatric Patients with Prader-Willi Syndrome.” TEAEs of nasopharyngitis (two patients), upper respiratory infection (one patient), and hepatic enzyme increased (one patient) were reported. The patient who experienced hepatic enzyme elevation recovered after an over-the-counter supplement was discontinued.",
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      "text": "Additional evidence of pitolisant’s liver toxicity is buried in the FDA review, in a brief discussion of a pitolisant phase 1 PK study for Prader-Willi Syndrome. One of eight pediatric patients “experienced hepatic enzyme elevation.” Like other Harmony/Bioprojet PK studies, we can locate no further information on the study much less a paper. The study doesn’t even to have a ClinicalTrials.gov entry, making it impossible to know which enzyme, the dose that triggered it, how long after treatment, or when the study was undertaken",
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      "text": "“experienced hepatic enzyme elevation.” — FDA review",
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      "text": "Source: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/211150Orig2s000MedR.pdf",
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      "text": "HBS-101-CL-003: Pharmacokinetic Study in Pediatric Patients with PWS",
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