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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 ClinicalTrials.gov entry as evidence of a 'buried' or incomplete study.",
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      "text": "The FDA’s approach to mitigating CYP2D6-related risks – merely suggesting a smaller dose – is therefore naïve and defies clinical and commercial realities.",
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      "text": "Bioprojet Phase 1 PK study in CYP2D6 metabolizers – ClinicalTrials.gov entry",
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      "text": "Study to Assess the Absorption, Distribution, Metabolism and Excretion (ADME) of [14C]-Pitolisant in Healthy Male Volunteers",
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      "text": "However, simply halving the dose does little to alleviate the danger. First, most patients do not know their CYP2D6 phenotype, and our interviews with 20 pitolisant prescribers indicate that no doctors are bothering to genetically test their patients. It is simply inevitable that poor metabolizers are being prescribed the max 35.6 dose – and hence the predictable spike in serious adverse events per the FDA FAERS database. Second, Harmony’s sales reps aggressively push it as an ultra-safe drug, creating even more complacency and danger. The FDA’s approach to mitigating CYP2D6-related risks – merely suggesting a smaller dose – is therefore naïve and defies clinical and commercial realities. Third, the CYP2D6 PK study upon which the FDA relied exhibits numerous red flags, consistent with what we believe to be Bioprojet’s long pattern of scientific and clinical fraud. The study results don’t appear to be published, and the full data appears to be buried and missing from even the EMA and FDA review packages. A Clinical Trials entry contains only a few shreds of basic info:",
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      "text": "Source: https://clinicaltrials.gov/ct2/show/NCT02929342",
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      "text": "Study Design details including Study Type, Enrollment, Allocation, Intervention Model, Masking, Primary Purpose, Official Title, and dates.",
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