{
  "docId": "019dd923-622c-750b-8b9a-21918ac10c17",
  "docSlug": "f3db2294dcf9",
  "documentTitle": "Harmony Biosciences (HRMY)",
  "authorId": "58_Scorpion_Capital",
  "authorName": "Scorpion Capital",
  "documentKindSlug": "research-note",
  "documentKindLabel": "Research note",
  "sourceTypeSlug": "short_seller",
  "sourceTypeLabel": "Short seller",
  "presentationDate": "2023-03-28 00:00:00",
  "orientation": "landscape",
  "aspectRatio": 1.3333334,
  "pageNumber": 154,
  "pageCount": 366,
  "prevPage": 153,
  "nextPage": 155,
  "slideType": "expose_contradiction",
  "function": "expose_contradiction",
  "density": "dense",
  "nDataPoints": 2,
  "notes": "The slide uses a 'villain critique' style to frame the FDA's approval as flawed and the drug's safety as compromised.",
  "elementsJson": [
    "paragraph",
    "footnote"
  ],
  "metadataConfidence": 0.95,
  "imagePath": null,
  "slideHref": "/slides/019dd923-622c-750b-8b9a-21918ac10c17/154",
  "deckHref": "/decks/019dd923-622c-750b-8b9a-21918ac10c17",
  "deckJsonHref": "/decks/019dd923-622c-750b-8b9a-21918ac10c17.json",
  "deckAnchorHref": "/decks/019dd923-622c-750b-8b9a-21918ac10c17#slide-154",
  "components": [
    {
      "bbox": null,
      "kind": "callout",
      "text": "A key early warning sign was the occurrence of 13 deaths during the pitolisant development program, as noted by the FDA in its safety review.",
      "attrs": null,
      "subkind": null,
      "toolName": "Visual emphasis",
      "toolSlug": "visual-emphasis",
      "confidence": null,
      "componentId": "019dd953-64d0-7099-9cd5-5101f74c0367",
      "frameworkName": null,
      "frameworkSlug": null
    },
    {
      "bbox": {
        "h": 0.1,
        "w": 0.7,
        "x": 0.07,
        "y": 0.55
      },
      "kind": "list",
      "text": "9 deaths through NDA data cutoff date in 2019 – all deaths were on pitolisant and none on placebo, per FDA CDER Clinical Review (Solages, Sep 28, 2020)",
      "attrs": null,
      "subkind": "bullet",
      "toolName": null,
      "toolSlug": null,
      "confidence": null,
      "componentId": "f3871c87-a0b8-458d-be44-7a813a8ddbb2",
      "frameworkName": null,
      "frameworkSlug": null
    },
    {
      "bbox": {
        "h": 0.05,
        "w": 0.7,
        "x": 0.07,
        "y": 0.8
      },
      "kind": "list",
      "text": "4 additional deaths through March 2020, per same review",
      "attrs": null,
      "subkind": "bullet",
      "toolName": null,
      "toolSlug": null,
      "confidence": null,
      "componentId": "fe89f247-ab29-4528-8f98-f1f952620ac6",
      "frameworkName": null,
      "frameworkSlug": null
    },
    {
      "bbox": {
        "h": 0.15,
        "w": 0.7,
        "x": 0.07,
        "y": 0.65
      },
      "kind": "paragraph",
      "text": "The Sponsor submitted narrative summaries for all deaths that occurred in the clinical development program in the NDA and submitted an update (with one additional death) in the 120-day safety report. Nine deaths occurred in the pitolisant development program; all occurred in patients receiving pitolisant (Table 35). Of the nine deaths, six occurred in male patients. One death occurred in the open-label, long-term safety narcolepsy study (HARMONY",
      "attrs": null,
      "subkind": "paragraph",
      "toolName": null,
      "toolSlug": null,
      "confidence": null,
      "componentId": "4ab5036a-7bee-4e9a-b241-b9b7cfe7894e",
      "frameworkName": null,
      "frameworkSlug": null
    },
    {
      "bbox": {
        "h": 0.45,
        "w": 0.86,
        "x": 0.07,
        "y": 0.07
      },
      "kind": "paragraph",
      "text": "A key early warning sign was the occurrence of 13 deaths during the pitolisant development program, as noted by the FDA in its safety review. The FDA noted 9 deaths as of the NDA data cutoff date in Feb 2019, and 4 thereafter as of March 2020...",
      "attrs": null,
      "subkind": "paragraph",
      "toolName": null,
      "toolSlug": null,
      "confidence": null,
      "componentId": "9da6e23a-7c9d-4bfd-9435-b8fe5039be64",
      "frameworkName": null,
      "frameworkSlug": null
    },
    {
      "bbox": {
        "h": 0.1,
        "w": 0.7,
        "x": 0.07,
        "y": 0.85
      },
      "kind": "paragraph",
      "text": "The Applicant has provided case narratives for four additional deaths that have occurred since the 120-day safety update. One death was reported in the U.S. EAP, one death was reported in Study P15-11 (the European Post-Authorization Safety Study), and two deaths were reported in the Study P15-13 (the ongoing phase 3 efficacy and safety study in patients with OSA).",
      "attrs": null,
      "subkind": "paragraph",
      "toolName": null,
      "toolSlug": null,
      "confidence": null,
      "componentId": "d362ecf9-7aba-488a-a18e-178c4fa633d8",
      "frameworkName": null,
      "frameworkSlug": null
    },
    {
      "bbox": null,
      "kind": "quote",
      "text": "nine deaths occurred in the pitolisant development program; all occurred in patients receiving pitolisant — that is,100% of fatalities were in the treatment arm and none for patients on placebo. — FDA CDER Clinical Review (Solages, Sep 28, 2020)",
      "attrs": null,
      "subkind": null,
      "toolName": "Authority citation",
      "toolSlug": "authority-citation",
      "confidence": null,
      "componentId": "019dd953-64d0-7099-9cd5-55d12438b58b",
      "frameworkName": null,
      "frameworkSlug": null
    },
    {
      "bbox": {
        "h": 0.03,
        "w": 0.5,
        "x": 0.07,
        "y": 0.96
      },
      "kind": "source-note",
      "text": "Source: https://www.accessdata.fda.gov/drugsatsfda_docs/nda/2021/211150Orig2s000MedR.pdf",
      "attrs": null,
      "subkind": null,
      "toolName": null,
      "toolSlug": null,
      "confidence": null,
      "componentId": "c09ac1f1-9e9c-4fe8-9f0f-21238b2b38b5",
      "frameworkName": null,
      "frameworkSlug": null
    }
  ],
  "metrics": [],
  "tools": [],
  "frameworks": [
    {
      "name": "fraud-exposure",
      "slug": null,
      "matchId": "47e261e4-b47a-4a81-97ba-32f7977f0518",
      "evidence": "The slide explicitly frames the data as an 'early warning sign' and critiques the 'flawed nature' of the approval process.",
      "confidence": 0.85
    }
  ],
  "arcBeats": [],
  "loops": [],
  "imagePathAlt": null,
  "thumbSrc": null,
  "thumbSrcAlt": null,
  "locked": true
}