{
  "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": 156,
  "pageCount": 366,
  "prevPage": 155,
  "nextPage": 157,
  "slideType": "expose_contradiction",
  "function": "expose_contradiction",
  "density": "dense",
  "nDataPoints": 4,
  "notes": "The slide uses a combination of narrative analysis and a specific case study excerpt to challenge the safety profile of pitolisant.",
  "elementsJson": [
    "paragraph",
    "callout_box",
    "footnote"
  ],
  "metadataConfidence": 0.95,
  "imagePath": null,
  "slideHref": "/slides/019dd923-622c-750b-8b9a-21918ac10c17/156",
  "deckHref": "/decks/019dd923-622c-750b-8b9a-21918ac10c17",
  "deckJsonHref": "/decks/019dd923-622c-750b-8b9a-21918ac10c17.json",
  "deckAnchorHref": "/decks/019dd923-622c-750b-8b9a-21918ac10c17#slide-156",
  "components": [
    {
      "bbox": {
        "h": 0.07,
        "w": 0.86,
        "x": 0.07,
        "y": 0.45
      },
      "kind": "callout",
      "text": "FDA comments on 4 additional deaths after 120-day safety update, FDA CDER Clinical Review (Solages, Sep 28, 2020), p11-12; case narrative of sudden death of a 43-year old on pitolisant",
      "attrs": null,
      "subkind": "primary",
      "toolName": null,
      "toolSlug": null,
      "confidence": null,
      "componentId": "df8b62db-3d2c-4272-9650-2b998e28ae20",
      "frameworkName": null,
      "frameworkSlug": null
    },
    {
      "bbox": null,
      "kind": "callout",
      "text": "Of the 2 other deaths, one was a 62-year old who died of pulmonary edema and a 38-year old who committed suicide. Although the reviewer indicated “no clear association” with pitolisant, we note an alarming number of similar adverse events since approval, per the FAERS database, whether pulmonary edema or psychiatric ones such as suicidal fixation.",
      "attrs": null,
      "subkind": null,
      "toolName": "Visual emphasis",
      "toolSlug": "visual-emphasis",
      "confidence": null,
      "componentId": "019dd953-64d0-7099-9cd7-0afd6e7e296c",
      "frameworkName": null,
      "frameworkSlug": null
    },
    {
      "bbox": {
        "h": 0.22,
        "w": 0.86,
        "x": 0.07,
        "y": 0.68
      },
      "kind": "list",
      "text": "Sudden death was reported in a 43-year-old female with a medical history of obstructive sleep apnea and obesity. No concomitant medications were reported...",
      "attrs": null,
      "subkind": "bullet",
      "toolName": null,
      "toolSlug": null,
      "confidence": null,
      "componentId": "ac2fee0b-291a-4ba2-ba79-cc943462e264",
      "frameworkName": null,
      "frameworkSlug": null
    },
    {
      "bbox": {
        "h": 0.12,
        "w": 0.86,
        "x": 0.07,
        "y": 0.53
      },
      "kind": "paragraph",
      "text": "Two additional deaths occurred in patients in the OSA development program; a total of 5 deaths have occurred in the OSA program. Although these patients had co-morbid health conditions...",
      "attrs": null,
      "subkind": "paragraph",
      "toolName": null,
      "toolSlug": null,
      "confidence": null,
      "componentId": "05669afa-96a7-4458-a54f-1ec33de6315e",
      "frameworkName": null,
      "frameworkSlug": null
    },
    {
      "bbox": {
        "h": 0.35,
        "w": 0.86,
        "x": 0.07,
        "y": 0.07
      },
      "kind": "paragraph",
      "text": "Of the 4 additional deaths, 2 were sudden deaths that could also have been heart failure, with all 4 patients on the highest dose of pitolisant (35.6mg)...",
      "attrs": null,
      "subkind": "paragraph",
      "toolName": null,
      "toolSlug": null,
      "confidence": null,
      "componentId": "268175e5-f51f-404e-a161-5534afc00bb7",
      "frameworkName": null,
      "frameworkSlug": null
    },
    {
      "bbox": null,
      "kind": "quote",
      "text": "“an association with pitolisant cannot be ruled out.” — FDA reviewer",
      "attrs": null,
      "subkind": null,
      "toolName": "Authority citation",
      "toolSlug": "authority-citation",
      "confidence": null,
      "componentId": "019dd953-64d0-7099-9cd7-0c1e4cd89cba",
      "frameworkName": null,
      "frameworkSlug": null
    },
    {
      "bbox": {
        "h": 0.03,
        "w": 0.4,
        "x": 0.07,
        "y": 0.94
      },
      "kind": "source-note",
      "text": "Source: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/211150Orig2s000MedR.pdf",
      "attrs": null,
      "subkind": null,
      "toolName": null,
      "toolSlug": null,
      "confidence": null,
      "componentId": "78a60bae-a389-4888-bc42-b49244935145",
      "frameworkName": null,
      "frameworkSlug": null
    }
  ],
  "metrics": [],
  "tools": [],
  "frameworks": [
    {
      "name": "fraud-exposure",
      "slug": null,
      "matchId": "9825cc3c-debf-427b-ba8c-77ab2785cdc6",
      "evidence": "The slide explicitly contrasts investigator claims of 'not related' with FDA reviewer concerns and external FAERS data to expose potential safety risks.",
      "confidence": 0.85
    }
  ],
  "arcBeats": [],
  "loops": [],
  "imagePathAlt": null,
  "thumbSrc": null,
  "thumbSrcAlt": null,
  "locked": true
}