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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 FDA biometrics review data to challenge the efficacy timeline of the drug Wakix (pitolisant).",
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      "kind": "callout",
      "text": "No separation vs. placebo after weeks 2 and 3 (visits 4 and 5), whether looking at absolute ESS scores or the decline from baseline to final outcome",
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      "text": "No separation vs. placebo after weeks 2 and 3, whether looking at absolute ESS scores or the decline from baseline to final outcome",
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      "text": "ESS scores: -3.7",
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      "text": "Moreover, pitolisant showed no separation from placebo after week 2 - in fact a small reversal in separation. The bulk of the treatment effect in the trial occurred within weeks 2 and 3, contradicting the Wakix label which indicates it may take 8 weeks to achieve an effect.",
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      "text": "Source: https://www.accessdata.fda.gov/drugsattda_docs/nda/2021/211150Orig2s000StatR.pdf; Scorpion Capital analysis and estimates",
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      "text": "Table 13: Summary of ESS Scores [Mean +/- SD] by Visit and Treatment Group - HARMONY 1 (ITT Population)",
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      "text": "FDA biometrics review for pitolisant – HARMONY 1 table of ESS scores by week",
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