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  "documentTitle": "Harmony Biosciences (HRMY)",
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      "text": "Thirteen deaths during the pitolisant development program, in the pre-approval period, of which 12 occurred in the foreign clinical trials. The deaths were briefly summarized in a table in the CDER review but otherwise dismissed – a grave error.",
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      "text": "A 57-year old male patient on pitolisant who experienced “seizures and blacking out.” ... A male patient of unreported age ... A 25-year old male patient ... A 27-year old female ... An 18-year old male ... A 42-year old female",
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      "text": "physician indicated that he had 10 patients on Wakix; all but 2 discontinued after he alerted them to the adverse event. We note key features of the case...",
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      "text": "Petitioner notes a number of other troubling case narratives, obtained via FOIA. A few are highlighted below...",
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      "text": "Nonetheless, the deaths are notable for two reasons. First, 100% of the fatalities were in patients on the drug and none in the placebo arms...",
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      "text": "The postmarketing data should also be monitored for sudden deaths and cardiovascular and respiratory adverse reactions. — Petitioner",
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