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  "documentTitle": "Harmony Biosciences (HRMY)",
  "authorId": "58_Scorpion_Capital",
  "authorName": "Scorpion Capital",
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  "presentationDate": "2023-03-28 00:00:00",
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  "notes": "The slide uses a pie chart to visualize the geographic concentration of trial participants, specifically pointing out the high percentage in Russia to support a claim of data manipulation.",
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      "kind": "callout",
      "text": "38% of study patients were in Russia",
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      "text": "Figure 8: Study Participants by Country - HARMONY CTP (P11-05)",
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      "text": "study participants by country: 38%",
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      "text": "At the point that CTP was conducted, Bioprojet was on thin ice and in need of more convincing data – pitolisant barely reduced ESS scores in HARMONY 1 and showed modafinil to be markedly inferior, and failed to show statistical significance in cataplexy in the absence of post-hoc data games. HARMONY 1-bis results were even worse. The CTP trial was Bioprojet’s last shot and Hail Mary. We think they took no chances and picked trial sites in low-quality foreign jurisdictions where they could simply pay for the results they needed. CTP included no Western European countries: 38% of study participants were in Russia, which along with Ukraine, Turkey, Serbia and Hungary comprised ~90% of patients, in addition to Bulgaria, Poland, Macedonia, and the Czech Republic. The paper for the trial fails to disclose the distribution of patients by country, and charts buried in an FDA review explain the reticence:",
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      "text": "Source: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/211150Orig2s000MedR.pdf; Scorpion Capital estimates and analysis",
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      "kind": "title",
      "text": "HARMONY CTP patients by country, per FDA CDER Clinical Review",
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