{
  "docId": "019dd923-622c-750b-8b9a-17a662f06f5c",
  "docSlug": "883b7cfa22f5",
  "documentTitle": "Harmony Biosciences (HRMY)",
  "authorId": "58_Scorpion_Capital",
  "authorName": "Kir Kahlon",
  "documentKindSlug": "regulatory-filing",
  "documentKindLabel": "Regulatory filing",
  "sourceTypeSlug": "short_seller",
  "sourceTypeLabel": "Short seller",
  "presentationDate": "2023-04-03 00:00:00",
  "orientation": "portrait",
  "aspectRatio": 0.77272725,
  "pageNumber": 5,
  "pageCount": 10,
  "prevPage": 4,
  "nextPage": 6,
  "slideType": "demand_list",
  "function": "state_demand",
  "density": "dense",
  "nDataPoints": 0,
  "notes": "This is a page from a Citizen Petition document.",
  "elementsJson": [
    "paragraph",
    "numbered_list"
  ],
  "metadataConfidence": 0.95,
  "imagePath": null,
  "slideHref": "/slides/019dd923-622c-750b-8b9a-17a662f06f5c/5",
  "deckHref": "/decks/019dd923-622c-750b-8b9a-17a662f06f5c",
  "deckJsonHref": "/decks/019dd923-622c-750b-8b9a-17a662f06f5c.json",
  "deckAnchorHref": "/decks/019dd923-622c-750b-8b9a-17a662f06f5c#slide-5",
  "components": [
    {
      "bbox": null,
      "kind": "callout",
      "text": "This petition requests that the FDA take the following actions: 1. Withdraw FDA approval of pitolisant for all current and future indications.",
      "attrs": null,
      "subkind": null,
      "toolName": "Visual emphasis",
      "toolSlug": "visual-emphasis",
      "confidence": null,
      "componentId": "019dd953-14dd-72ca-b990-27d6e0ce585e",
      "frameworkName": null,
      "frameworkSlug": null
    },
    {
      "bbox": {
        "h": 0.28,
        "w": 0.77,
        "x": 0.116,
        "y": 0.468
      },
      "kind": "list",
      "text": "1. Withdraw FDA approval of pitolisant for all current and future indications. 2. Require Harmony Biosciences to distribute an immediate alert to all Wakix prescribers. 3. Transition Wakix to a compassionate use program in conjunction with a REMS protocol.",
      "attrs": null,
      "subkind": "numbered",
      "toolName": null,
      "toolSlug": null,
      "confidence": null,
      "componentId": "b5784476-6127-43ec-884a-9cae52d1de6e",
      "frameworkName": null,
      "frameworkSlug": null
    },
    {
      "bbox": {
        "h": 0.112,
        "w": 0.77,
        "x": 0.116,
        "y": 0.782
      },
      "kind": "paragraph",
      "text": "Petitioner believes it may be helpful for the FDA to convene an Ad Comm to discuss the issues raised in the attached report as well as the actions requested in this Citizen Petition.",
      "attrs": null,
      "subkind": "paragraph",
      "toolName": null,
      "toolSlug": null,
      "confidence": null,
      "componentId": "5bbd6cc7-6157-4629-9e2e-dce0b42eae58",
      "frameworkName": null,
      "frameworkSlug": null
    },
    {
      "bbox": {
        "h": 0.014,
        "w": 0.435,
        "x": 0.116,
        "y": 0.441
      },
      "kind": "paragraph",
      "text": "This petition requests that the FDA take the following actions:",
      "attrs": null,
      "subkind": "paragraph",
      "toolName": null,
      "toolSlug": null,
      "confidence": null,
      "componentId": "6e024c84-f06b-4310-b9a8-506b035fe81d",
      "frameworkName": null,
      "frameworkSlug": null
    },
    {
      "bbox": null,
      "kind": "quote",
      "text": "Your application for Wakix was not referred to an FDA advisory committee because the application did not raise significant safety or efficacy issues that were unexpected for a drug in the intended population. — FDA NDA approval letter",
      "attrs": null,
      "subkind": null,
      "toolName": "Authority citation",
      "toolSlug": "authority-citation",
      "confidence": null,
      "componentId": "019dd953-14dd-72ca-b990-29d094ec8186",
      "frameworkName": null,
      "frameworkSlug": null
    },
    {
      "bbox": {
        "h": 0.018,
        "w": 0.155,
        "x": 0.116,
        "y": 0.412
      },
      "kind": "title",
      "text": "A. Action Requested",
      "attrs": null,
      "subkind": "headline",
      "toolName": null,
      "toolSlug": null,
      "confidence": null,
      "componentId": "ebda65df-492b-4be8-b80f-9b0b6ecc8222",
      "frameworkName": null,
      "frameworkSlug": null
    }
  ],
  "metrics": [],
  "tools": [],
  "frameworks": [],
  "arcBeats": [
    {
      "to": 6,
      "from": 5,
      "beatId": "159a809a-a1c8-4993-bb9f-37b2f27f6bd6",
      "arcName": "Problem-Agitate-Solution",
      "arcSlug": "problem-agitate-solution",
      "beatName": "Evidence",
      "beatSlug": "evidence",
      "evidence": "Petitioner provides grounds and supporting documentation",
      "position": 1,
      "confidence": 0.8,
      "parentBeatName": null,
      "parentBeatSlug": null
    }
  ],
  "loops": [
    {
      "to": 6,
      "from": 5,
      "name": "Cost Of Inaction",
      "slug": "27-cost-of-inaction",
      "bestFor": "Urgent budget requests, compliance, risk mitigation",
      "matchId": "a4ac9998-f558-4157-ba65-d7cc5f4dc860",
      "evidence": "Action Requested and Statement Of Grounds",
      "position": 1,
      "objective": "Highlighting the potential consequences of not taking action against Wakix",
      "structure": "The Status Quo -> The Hidden Costs Accumulating -> The Future State of Inaction -> The Tipping Point",
      "confidence": 0.6,
      "description": "Quantify what happens if the audience does nothing"
    }
  ],
  "imagePathAlt": null,
  "thumbSrc": null,
  "thumbSrcAlt": null,
  "locked": true
}