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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 critical tone to challenge the integrity of the reported clinical trial data.",
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      "text": "Several omissions suggest that the placebo comparison is a contrived attempt to muddy the waters.",
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      "text": "comparable in the two treatment groups. However, in the pitolisant group, four participants (2.2%) demonstrated at least one postdose QT interval (using Fredericia's correction) (QTcF) of > 450 msec and six patients (3.3%) demonstrated one QTcF elongation of ≥ 60 msec, whereas two participants (3.3%) demonstrated QTcF of > 450 msec and three participants (4.9%) demonstrated QTcF elongation of ≥ 60 msec in the placebo group.",
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      "text": "The abstract for HAROSA 1 claims that “no cardiovascular or other significant safety concerns were reported.” However, the results section states that four patients in the pitolisant group (n=183) exhibited “at least one postdose QT interval” of >450 msec and that six patients “demonstrated one QTcF elongation of ≥60 msec.” The paper then downplays the issue by stating that two patients in the placebo group (n=61) also had a QT interval >450 msec and that three had an elongation ≥60 msec – which we find odd given the cardiovascular exclusion criteria. Several omissions suggest that the placebo comparison is a contrived attempt to muddy the waters. First, it says “>450 msec” and “≥ 60 msec” without providing the range or individual values – a classic case of “How To Lie With Statistics.” Did the pitolisant QT intervals spike far higher than with placebo? Second, how many postdose QT intervals >450 msec did the four patients exhibit? Stating that it was “at least one” is flagrant obfuscation.",
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      "text": "“no cardiovascular or other significant safety concerns were reported.” — HAROSA 1 abstract",
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      "text": "Source: https://journal.chestnet.org/action/showPdf?pii=S0012-3692%2820%2935105-9",
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      "text": "HAROSA 1 publication – excerpt from safety discussion",
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