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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": "This slide serves as a critical audit of clinical trial integrity, focusing on statistical manipulation and poor trial design.",
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      "text": "Statistical tricks and obfuscations such as artificially clustering trial sites after the fact to adjust p-values; incoherent, bespoke statistical methodologies meant to be impenetrable.",
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      "text": "9. No histologic endpoints or data is ever presented. Levels of histamine and/or its metabolites were never shown, nor were CSF hypocretin levels, a narcolepsy marker per ICSD diagnostic criteria.\n10. EDS reductions per ESS are modest even in trials gamed to show statistical significance vs. placebo, and final levels are still excessive, indicating results are statistically significant but clinically irrelevant.\n11. Huge placebo effect across trials; no dose response\n12. No combination trials that reflect its real-world use case, as it is almost exclusively used as a 3rd or 4th line drug in a cocktail.\n13. Trials expanded midway, typically a sign of a failing trial that’s scrounging for a small signal by expanding the sample size; other shifting goalposts and endpoint and protocol changes, often undisclosed.\n14. Flexible dosing that’s all over the place, with doses titrated up or down at each investigators whimsy from 5mg to 40mg.\n15. Concomitant medications were allowed, creating a massive confounding factor as patients were generally on cocktails of drugs\n16. Statistical tricks and obfuscations such as artificially clustering trial sites after the fact to adjust p-values; incoherent, bespoke statistical methodologies meant to be impenetrable; shifting intervals and methods for calculating baseline and ending parameters; inconsistent statistical choices like geometric means without any justification",
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      "kind": "title",
      "text": "Summary of red flags common to each trial (cont'd)",
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