{
  "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": 169,
  "pageCount": 366,
  "prevPage": 168,
  "nextPage": 170,
  "slideType": "expose_contradiction",
  "function": "expose_contradiction",
  "density": "dense",
  "nDataPoints": 0,
  "notes": "The slide uses a direct quote from an FDA clinical review to demonstrate a lack of oversight regarding a specific medical signal.",
  "elementsJson": [
    "paragraph",
    "footnote"
  ],
  "metadataConfidence": 1,
  "imagePath": null,
  "slideHref": "/slides/019dd923-622c-750b-8b9a-21918ac10c17/169",
  "deckHref": "/decks/019dd923-622c-750b-8b9a-21918ac10c17",
  "deckJsonHref": "/decks/019dd923-622c-750b-8b9a-21918ac10c17.json",
  "deckAnchorHref": "/decks/019dd923-622c-750b-8b9a-21918ac10c17#slide-169",
  "components": [
    {
      "bbox": null,
      "kind": "callout",
      "text": "The FDA’s review exhibited zero awareness of the hypereosinophilia signal and failed to draw any potential link: “No clear association between pitolisant and pulmonary edema is apparent in this narrative.”",
      "attrs": null,
      "subkind": null,
      "toolName": "Visual emphasis",
      "toolSlug": "visual-emphasis",
      "confidence": null,
      "componentId": "019dd953-64d0-7099-9cd6-85f6ecdf4fe9",
      "frameworkName": null,
      "frameworkSlug": null
    },
    {
      "bbox": {
        "h": 0.15,
        "w": 0.86,
        "x": 0.07,
        "y": 0.31
      },
      "kind": "paragraph",
      "text": "Patient (b)(6) A 61-year-old male patient with a medical history of narcolepsy, sleep apnea, diabetes, hypertension, and overweight died of pulmonary edema. The patient began receiving pitolisant on (b)(6), and was receiving a dose of 35.6 mg. The patient’s concomitant medications included venlafaxine, modafinil, clonazepam, metformin, and nebivolol. Death occurred on (b)(6). No autopsy was performed. The Investigator assessed the event as unrelated to pitolisant.",
      "attrs": null,
      "subkind": "paragraph",
      "toolName": null,
      "toolSlug": null,
      "confidence": null,
      "componentId": "1d62c159-c222-45b2-ac1e-7468a1b2e07d",
      "frameworkName": null,
      "frameworkSlug": null
    },
    {
      "bbox": {
        "h": 0.3,
        "w": 0.86,
        "x": 0.07,
        "y": 0.51
      },
      "kind": "paragraph",
      "text": "Reviewer Comment: Since the original NDA review, two deaths have occurred in pitolisant-treated patients with narcolepsy. The patient who died by suicide had previously experienced a relapse of bipolar disorder symptoms a month after initiating treatment with pitolisant. However, he reportedly recovered from the exacerbation of bipolar symptoms and continued pitolisant treatment without complications for almost 1 year afterwards. The suicide occurred in the context significant life stressors. The information in the case narrative does not suggest a clear link between pitolisant treatment and the suicide. The second patient died of pulmonary edema. The patient had other co-occurring conditions that could have plausibly increased the risk of developing pulmonary edema. No clear association between pitolisant and pulmonary edema is apparent in this narrative.",
      "attrs": null,
      "subkind": "paragraph",
      "toolName": null,
      "toolSlug": null,
      "confidence": null,
      "componentId": "d4567dfe-5926-42e7-8981-03c04296fbe0",
      "frameworkName": null,
      "frameworkSlug": null
    },
    {
      "bbox": null,
      "kind": "quote",
      "text": "“No clear association between pitolisant and pulmonary edema is apparent in this narrative.” — FDA CDER Clinical Review (Solages, Sep 28, 2020)",
      "attrs": null,
      "subkind": null,
      "toolName": "Authority citation",
      "toolSlug": "authority-citation",
      "confidence": null,
      "componentId": "019dd953-64d0-7099-9cd6-89b488331fd2",
      "frameworkName": null,
      "frameworkSlug": null
    },
    {
      "bbox": {
        "h": 0.02,
        "w": 0.45,
        "x": 0.07,
        "y": 0.95
      },
      "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": "0bfe8f87-c78d-4b8c-85d8-58a30f560ca5",
      "frameworkName": null,
      "frameworkSlug": null
    },
    {
      "bbox": {
        "h": 0.03,
        "w": 0.35,
        "x": 0.07,
        "y": 0.26
      },
      "kind": "source-note",
      "text": "FDA CDER Clinical Review (Solages, Sep 28, 2020), p11-12",
      "attrs": null,
      "subkind": null,
      "toolName": null,
      "toolSlug": null,
      "confidence": null,
      "componentId": "61d36881-f556-4e97-9ed6-1105bb4004d7",
      "frameworkName": null,
      "frameworkSlug": null
    },
    {
      "bbox": {
        "h": 0.15,
        "w": 0.86,
        "x": 0.07,
        "y": 0.07
      },
      "kind": "title",
      "text": "A seventh fatality was due to “pulmonary edema,” a textbook symptom of hypereosinophilia. The FDA’s review exhibited zero awareness of the hypereosinophilia signal and failed to draw any potential link: “No clear association between pitolisant and pulmonary edema is apparent in this narrative.”",
      "attrs": null,
      "subkind": "action-title",
      "toolName": null,
      "toolSlug": null,
      "confidence": null,
      "componentId": "783e7d42-cf16-4a32-bf5d-2dc1dd8b8818",
      "frameworkName": null,
      "frameworkSlug": null
    }
  ],
  "metrics": [],
  "tools": [],
  "frameworks": [
    {
      "name": "fraud-exposure",
      "slug": null,
      "matchId": "217ef5a1-e045-4a5d-9af9-674688e04831",
      "evidence": "The slide explicitly contrasts a medical fact (pulmonary edema as a symptom of hypereosinophilia) with the FDA's failure to acknowledge the link, framing it as a regulatory oversight or failure.",
      "confidence": 0.9
    }
  ],
  "arcBeats": [],
  "loops": [],
  "imagePathAlt": null,
  "thumbSrc": null,
  "thumbSrcAlt": null,
  "locked": true
}