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  "notes": "The slide uses a 'red flag' narrative to challenge the integrity of clinical trial data reporting.",
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      "kind": "callout",
      "text": "Up to four-fold change in plasma levels at 90% confidence interval in poor CYP2D6 metabolizers despite only testing 3 patients",
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      "text": "Figure 3: Pitolisant Pharmacokinetics in CYP2D6 Poor Metabolizers",
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      "text": "Pitolisant full prescribing information from the label, section 12.3, p13",
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      "text": "One section in the label says that “in CYP2D6 poor metabolizers, the Cmax of pitolisant is 153 (151 to 157) ng/mL” – a range so tight that it strains credibility, leading us to wonder if Bioprojet simply chose the plasma levels they wanted and phenotyped those patients in hindsight. And then, while one part of the label asserts this impossibly tight range of 151 to 157 ng/mL, a chart above it is more telling with a FOUR-FOLD higher plasma level, a dangerous level of variability across just three patients. Moreover, the chart is misleading, as it uses a log scale which makes the plasma level variability in poor metabolizers look less dramatic. We note that studies have shown 30-40 fold variability in plasma levels in CYP2D6-metabolized drugs.",
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      "text": "in CYP2D6 poor metabolizers, the Cmax of pitolisant is 153 (151 to 157) ng/mL — a range so tight that it strains credibility, leading us to wonder if Bioprojet simply chose the plasma levels they wanted and phenotyped those patients in hindsight. — Scorpion Capital",
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      "text": "Source: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211150Orig1s000ClinPharmR.pdf",
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      "text": "The third red flag: the ranges for the asserted plasma level in poor metabolizers are inconsistent.",
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