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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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      "text": "Harmony shows no citations, papers, or studies in support of the claim that pitolisant “increases histamine levels in the brain.”",
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      "text": "EMA review\nIn vivo studies showed that pitolisant enhanced the activity of histaminergic neurons as shown by the increase in brain levels of t-MeHA with oral ED50 values reaching 1.6-2.6 mg/kg in mice and 3 mg/kg in rats.",
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      "text": "Harmony shows no citations, papers, or studies in support of the claim that pitolisant “increases histamine levels in the brain.” Nor could we locate any discussion of the claim in any of the FDA review documents...",
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      "text": "FDA CDER Clinical Review\n1. Background\nPitolisant is a histamine 3 (H3) receptor antagonist and inverse agonist. Pitolisant purportedly inhibits the negative feedback mechanism for histamine, resulting in increased histamine release.",
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      "text": "“Pitolisant purportedly inhibits the negative feedback mechanism for histamine, resulting in increasing histamine release.” — FDA CDER Clinical Review",
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      "text": "Source: https://www.accessdata.fda.gov/drugs...",
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