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  "documentTitle": "Harmony Biosciences (HRMY)",
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  "presentationDate": "2023-03-28 00:00:00",
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      "text": "Nine of the deaths are noted in a table on p10 of the CDER review. Six were sudden deaths (four found dead at home) that could have been due to heart failure – no autopsies were performed.",
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      "text": "Six were sudden deaths (four found dead at home) that could have been due to heart failure – no autopsies were performed. Of these six, two were officially classified as cardiac events. The list includes: 1) 64-year old female who “went into cardiac and respiratory arrest 4 days after starting pitolisant”; 2) 58-year old male “found dead at home 2.5 months after the initiation of treatment” due to “acute cardiac and pulmonary insufficiency”; 3) 73-year old female “found dead at home” where oddly the “investigator thought patient death could be related to hot weather”; 4) 53-year old died at home after reporting dyspnea; 5) 39-year old “found dead at home 2 months after randomization” with “several empty boxes of medication”; 6) 71-year old male who died 31 days after discontinuing pitolisant, due to acute respiratory distress, after already being hospitalized, without the report stating when the hospitalization occurred with respect to pitolisant treatment.",
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      "text": "Source: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/211150Orig2s000MedR.pdf",
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      "text": "Nine of the deaths are noted in a table on p10 of the CDER review.",
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      "text": "Table 4: Deaths in the Pitolisant Development Program (All Indications) by 120-Day Safety Update, FDA CDER Clinical Review (Solages, Sep 28, 2020), p10-11",
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