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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 pie chart to highlight that 38% of study participants were in Russia, suggesting a lack of geographic diversity and potential data manipulation.",
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      "kind": "callout",
      "text": "38% of study patients were in Russia",
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      "text": "38% of study participants were in Russia, which along with Ukraine, Turkey, Serbia and Hungary comprised ~90%.",
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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": "While the two previous trials included sleep centers in South America and Hungary, the majority of patients were still enrolled in western Europe. However, CTP appears to have dispensed with western European sleep centers entirely in favor of Russia, Serbia, Turkey, Ukraine, Bulgaria, Poland, Macedonia, Czech Republic, and Hungary. The paper for the trial fails to disclose the distribution of patients by country, and charts buried in an FDA review explain the reticence: 38% of study participants were in Russia, which along with Ukraine, Turkey, Serbia and Hungary comprised ~90%.",
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      "text": "After the abysmal results in these two trials, we suspect Bioprojet went into whatever-it-takes mode and conducted HARMONY CTP in countries where - in our opinion - it simply purchased the outcome it needed.",
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      "kind": "source-note",
      "text": "Source: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/211150Orig2s000MedR.pdf; Scorpion Capital estimates and analysis",
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      "text": "HARMONY CTP patients by country, per FDA CDER Clinical Review",
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