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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 'villain' narrative to frame the company's non-disclosure as intentional concealment.",
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      "kind": "callout",
      "text": "EMA review indicated hypoeosinophilia in 13% of pitolisant patients",
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      "text": "Throughout our investigation, we consistently observed a pattern where Harmony and Bioprojet are evasive and conceal information, particularly in relation to significant adverse events. The EMA’s safety review – buried on page 76 of a 102 page document - noted a startling safety signal absent in the FDA review – “abnormal levels of eosinophils” in pitolisant patients, affecting 16.1% of those in the treatment arm in the Harmony 1 trial. Four of 32 pitolisant patients (13%) “were described as hypoeosinophilia” (sic – hyper). The paper for the Harmony 1 trial, in the paragraph on adverse events, makes no mention of eosinophils, not even indirectly. The EMA appears to have had access to additional data that the FDA didn’t, and then takes the company’s explanation at face value: “This was not associated with any specific adverse events.” In our experience, companies only conceal data that they’re worried about, and are more forthcoming if it’s as innocuous as stated.",
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      "text": "In study Harmony I (P07-03) there was a higher proportion of patients in the pitolisant group with abnormal levels of eosinophils compared to placebo and modafinil groups, at V1 (respectively 16.1% vs 6.7% and 6.1%, p-value=0.454) and at V7 (respectively 16.1% vs 6.7% and 0%, p-value=0.027). The four cases with abnormal levels of eosinophils under pitolisant treatment were described as hypoeosinophilia. This was not associated with any specific adverse events.",
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      "text": "“This was not associated with any specific adverse events.” — EMA assessment report",
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      "text": "Source: https://www.ema.europa.eu/en/documents/assessment-report/wakix-epar-public-assessment-report_en.pdf",
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