{
  "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": 233,
  "pageCount": 366,
  "prevPage": 232,
  "nextPage": 234,
  "slideType": "expose_contradiction",
  "function": "expose_contradiction",
  "density": "overcrowded",
  "nDataPoints": 12,
  "notes": "The slide uses a combination of a pie chart and two tables to substantiate claims of trial design flaws.",
  "elementsJson": [
    "paragraph",
    "pie_chart",
    "data_table",
    "footnote"
  ],
  "metadataConfidence": 1,
  "imagePath": null,
  "slideHref": "/slides/019dd923-622c-750b-8b9a-21918ac10c17/233",
  "deckHref": "/decks/019dd923-622c-750b-8b9a-21918ac10c17",
  "deckJsonHref": "/decks/019dd923-622c-750b-8b9a-21918ac10c17.json",
  "deckAnchorHref": "/decks/019dd923-622c-750b-8b9a-21918ac10c17#slide-233",
  "components": [
    {
      "bbox": {
        "h": 0.06,
        "w": 0.45,
        "x": 0.05,
        "y": 0.33
      },
      "kind": "callout",
      "text": "Foreign trial with 40% of patients in Hungary and Argentina – FDA review",
      "attrs": null,
      "subkind": "primary",
      "toolName": null,
      "toolSlug": null,
      "confidence": null,
      "componentId": "528c50c7-7a9b-4400-88a1-2f7e0ab2b246",
      "frameworkName": null,
      "frameworkSlug": null
    },
    {
      "bbox": {
        "h": 0.06,
        "w": 0.45,
        "x": 0.05,
        "y": 0.75
      },
      "kind": "callout",
      "text": "No dose response data provided, even though table in EMA review shows highly variable dosing",
      "attrs": null,
      "subkind": "primary",
      "toolName": null,
      "toolSlug": null,
      "confidence": null,
      "componentId": "7910c2ee-bde4-4dd7-a9c1-f82c694c024d",
      "frameworkName": null,
      "frameworkSlug": null
    },
    {
      "bbox": {
        "h": 0.06,
        "w": 0.45,
        "x": 0.5,
        "y": 0.33
      },
      "kind": "callout",
      "text": "High use of concomitant medications creates a confounding factor – FDA review",
      "attrs": null,
      "subkind": "primary",
      "toolName": null,
      "toolSlug": null,
      "confidence": null,
      "componentId": "ddce5388-bd7e-4303-81a4-d9ab13403341",
      "frameworkName": null,
      "frameworkSlug": null
    },
    {
      "bbox": null,
      "kind": "callout",
      "text": "In addition, HARMONY 1-bis displays all the other red flags as HARMONY 1: questionable foreign jurisdictions, with 40% of trial patients in Hungary and Argentina; pitolisant patients continued taking concomitant narcolepsy medications, creating a confounding factor; dose response data is again withheld, even though dosing was all over the place with 24% of patients on 10mg and 63% on 20mg; protocol violations and amendments, such as what appears to be another trial-size expansion, which the EMA review alludes to with no detail.",
      "attrs": null,
      "subkind": null,
      "toolName": "Visual emphasis",
      "toolSlug": "visual-emphasis",
      "confidence": null,
      "componentId": "019dd953-64d1-73a9-abba-ff441bc1c15f",
      "frameworkName": null,
      "frameworkSlug": null
    },
    {
      "bbox": {
        "h": 0.3,
        "w": 0.45,
        "x": 0.05,
        "y": 0.4
      },
      "kind": "chart",
      "text": "Figure 13: Participants by Country - HARMONY I-bis (P09-15)",
      "attrs": null,
      "subkind": "pie",
      "toolName": null,
      "toolSlug": null,
      "confidence": null,
      "componentId": "9cd0a4c1-69cd-4ca9-aa13-7d23d88635c4",
      "frameworkName": null,
      "frameworkSlug": null
    },
    {
      "bbox": {
        "h": 0.03,
        "w": 0.9,
        "x": 0.05,
        "y": 0.95
      },
      "kind": "source-note",
      "text": "Source: https://www.accessdata.fda.gov/drugsatsfda_docs/nda/2021/211150Orig2s000MedR.pdf; https://www.ema.europa.eu/en/documents/assessment-report/wakix-epar-public-assessment-report_en.pdf",
      "attrs": null,
      "subkind": null,
      "toolName": null,
      "toolSlug": null,
      "confidence": null,
      "componentId": "48062153-2544-4429-b41f-8739f9b07275",
      "frameworkName": null,
      "frameworkSlug": null
    },
    {
      "bbox": {
        "h": 0.1,
        "w": 0.45,
        "x": 0.05,
        "y": 0.82
      },
      "kind": "table",
      "text": "Table 13. Summary of stable dose stage [% (n)] in Harmony Ibis study.",
      "attrs": null,
      "subkind": "data",
      "toolName": null,
      "toolSlug": null,
      "confidence": null,
      "componentId": "38f160b4-36bf-4538-887d-88609564d079",
      "frameworkName": null,
      "frameworkSlug": null
    },
    {
      "bbox": {
        "h": 0.3,
        "w": 0.45,
        "x": 0.5,
        "y": 0.4
      },
      "kind": "table",
      "text": "Table 25: Concomitant Medications - HARMONY I-bis (P09-15)",
      "attrs": null,
      "subkind": "data",
      "toolName": null,
      "toolSlug": null,
      "confidence": null,
      "componentId": "b53fb0ee-df23-4b60-bc90-d61b006334ef",
      "frameworkName": null,
      "frameworkSlug": null
    },
    {
      "bbox": {
        "h": 0.2,
        "w": 0.9,
        "x": 0.05,
        "y": 0.05
      },
      "kind": "title",
      "text": "In addition, HARMONY 1-bis displays all the other red flags as HARMONY 1: questionable foreign jurisdictions, with 40% of trial patients in Hungary and Argentina; pitolisant patients continued taking concomitant narcolepsy medications, creating a confounding factor; dose response data is again withheld, even though dosing was all over the place with 24% of patients on 10mg and 63% on 20mg; protocol violations and amendments, such as what appears to be another trial-size expansion, which the EMA review alludes to with no detail.",
      "attrs": null,
      "subkind": "headline",
      "toolName": null,
      "toolSlug": null,
      "confidence": null,
      "componentId": "fc430a71-12eb-4fd2-8441-57cd261994d5",
      "frameworkName": null,
      "frameworkSlug": null
    }
  ],
  "metrics": [],
  "tools": [],
  "frameworks": [
    {
      "name": "fraud-exposure",
      "slug": null,
      "matchId": "2d7e135d-fcb9-4a7d-a5a2-c39c4a7be9de",
      "evidence": "The slide explicitly lists 'red flags' and 'confounding factors' to challenge the validity of clinical trial data.",
      "confidence": 0.9
    }
  ],
  "arcBeats": [],
  "loops": [],
  "imagePathAlt": null,
  "thumbSrc": null,
  "thumbSrcAlt": null,
  "locked": true
}