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  "docSlug": "f3db2294dcf9",
  "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 highlights a discrepancy between the trial paper's log-scale chart and the actual linear-scale data, suggesting data manipulation or misleading presentation.",
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      "kind": "callout",
      "text": "Chart of Weekly Rate of Cataplexy in trial paper for CTP uses a misleading log scale for Y-axis to exaggerate separation vs. placebo; we re-plotted raw data from a table in FDA biometrics review",
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      "text": "Using a linear Y-axis shows bulk of purported treatment effect occurred instantly, with no further separation vs. placebo during final 4-week stable dosing period",
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      "text": "Corrected linear scale chart",
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      "text": "On the surface, conducting HARMONY CTP in Russia, Serbia, etc. seemed to get Bioprojet what they couldn't from HARMONY 1 and 1-bis: stunning success on the primary endpoint of weekly rate of cataplexies (WRC), declining from 9.2 to 2.3 on pitolisant vs. 7.3 to 4.5 in placebo; and an ESS score reduction of -3.5 vs. placebo, better than the -2.4 in HARMONY 1 and no ESS effect in 1-bis. The sudden turnaround on the cataplexy rate in CTP vs.1-bis disaster is particularly remarkable – the rate of cataplexy in 1-bis actually worsened dramatically in the pitolisant arm (defined as daily rate in that trial vs. weekly in CTP), doubling from 0.84 to 1.69, per a nugget buried in the EMA review. The results strike us as unusually good vs. the previous trials, and the red flags are just as obvious. First, the placebo effect was massive, with a quick 62% reduction in WRC. Second, the bulk of the effect occurred within a week for both pitolisant and placebo. The key chart in the trial paper is highly misleading, using a log scale for the Y-axis to exaggerate separation vs. placebo, as it was minimal after the first two weeks.",
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      "text": "Source: https://www.accessdata.fda.gov/drugs...",
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