{
  "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": 193,
  "pageCount": 366,
  "prevPage": 192,
  "nextPage": 194,
  "slideType": "expose_contradiction",
  "function": "expose_contradiction",
  "density": "dense",
  "nDataPoints": 0,
  "notes": "The slide uses a narrative structure to expose a potential cover-up or reporting failure regarding a serious adverse event.",
  "elementsJson": [
    "paragraph",
    "footnote"
  ],
  "metadataConfidence": 1,
  "imagePath": null,
  "slideHref": "/slides/019dd923-622c-750b-8b9a-21918ac10c17/193",
  "deckHref": "/decks/019dd923-622c-750b-8b9a-21918ac10c17",
  "deckJsonHref": "/decks/019dd923-622c-750b-8b9a-21918ac10c17.json",
  "deckAnchorHref": "/decks/019dd923-622c-750b-8b9a-21918ac10c17#slide-193",
  "components": [
    {
      "bbox": null,
      "kind": "callout",
      "text": "The sequence of events suggests a potential attempt to conceal the severity of the event, as the initial adverse event report by the physician and company did not appear to mention the patient was hospitalized.",
      "attrs": null,
      "subkind": null,
      "toolName": "Visual emphasis",
      "toolSlug": "visual-emphasis",
      "confidence": null,
      "componentId": "019dd953-64d1-73a9-abb4-7b95d7983a16",
      "frameworkName": null,
      "frameworkSlug": null
    },
    {
      "bbox": {
        "h": 0.35,
        "w": 0.86,
        "x": 0.07,
        "y": 0.11
      },
      "kind": "paragraph",
      "text": "17 year old female patient on 17.8mg. Four to five weeks after starting pitolisant, patient was hospitalized for a disassociative/bipolar state with anxiety. Patient was treated with risperdone, an anti-psychotic medication. Symptoms persisted for a week after pitolisant was terminated. “Based on the temporal relationship, the known risk of anxiety and bipolar disorder associated with WAKIX, and the improvement of symptoms following discontinuation, a causal association with WAKIX cannot be ruled out.” The sequence of events suggests a potential attempt to conceal the severity of the event, as the initial adverse event report by the physician and company did not appear to mention the patient was hospitalized. However, the patient’s mother “reported that her daughter was in the hospital due to side effects of the medication,” and the physician then confirmed that this was the same patient as “it was not known at the time [of the mother’s report] that this patient was the same case reported by the physician.”",
      "attrs": null,
      "subkind": "paragraph",
      "toolName": null,
      "toolSlug": null,
      "confidence": null,
      "componentId": "0fc861a8-ff9b-4f98-b887-7bd3d08c0500",
      "frameworkName": null,
      "frameworkSlug": null
    },
    {
      "bbox": {
        "h": 0.35,
        "w": 0.86,
        "x": 0.07,
        "y": 0.59
      },
      "kind": "paragraph",
      "text": "Event/Problem Narrative: On 30-MAR-2021, a spontaneous report was received from a physician regarding a 17-year-old female who was treated with WAKIX (pitolisant). On 06-APR-2021, additional information was received from the patient#s mother via a company representative, and based on the information, the case was assessed as serious and unexpected. On 13-APR-2021, additional information was received from the physician. Medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient started treatment with WAKIX for the treatment of narcolepsy with cataplexy. The physician reported that 4 to 5 weeks after starting WAKIX, the patient developed either an anxiety episode which was #new for her,# or what appeared to be a possible dissociation/bipolar-like state. The reporting physician noted that alternatively, since she had a positive response to WAKIX, that a mood disorder state is emerging more obviously with improved energy and less excessive daytime sleepiness. As of 30-MAR-2021, the action taken with WAKIX, and the outcome of the anxiety, dissociation, bipolar-like state, and mood disorder were not reported. No additional information was reported. On (b)(6)*****, a patient#s mother reported that her daughter was in the hospital due to #side effects# of the medication (presumed to be WAKIX 17.8 mg once daily). It was not known at the time that this patient was the same case reported by the physician on 30-MAR-2021. On 13-APR-2021, the physician confirmed this was the same patient. The physician reported that treatment with WAKIX was withdrawn on an unspecified date and the symptoms persisted for more than one week after discontinuing WAKIX. The patient#s symptoms stabilized with treatment, which included risperidone. She was discharged from hospital during the weekend of (b)(6)********. As of 13-APR-2021, the outcome of the events was reported as improved. No additional information was reported. Comment: Four to five weeks after the start of WAKIX for the treatment of narcolepsy with cataplexy, a 17-year-old female developed either an anxiety episode, possible dissociation/bipolar-like state, or symptoms of a mood disorder for which she was hospitalized. The symptoms persisted for more than one week after WAKIX was discontinued but stabilized with treatment, which included risperidone. As of the last report, the patient had been discharged from the hospital and the outcome of the events was reported as improved. Based on the temporal relationship, the known risk of anxiety and bipolar disorder associated with WAKIX, and the improvement of symptoms following discontinuation, a causal association with WAKIX cannot be ruled out. The patient also received treatment with an antipsychotic following WAKIX discontinuation, likely contributing to the improvement in her symptoms.",
      "attrs": null,
      "subkind": "paragraph",
      "toolName": null,
      "toolSlug": null,
      "confidence": null,
      "componentId": "1e12ecd4-57a5-44aa-9419-3f4b4af8174b",
      "frameworkName": null,
      "frameworkSlug": null
    },
    {
      "bbox": null,
      "kind": "quote",
      "text": "Based on the temporal relationship, the known risk of anxiety and bipolar disorder associated with WAKIX, and the improvement of symptoms following discontinuation, a causal association with WAKIX cannot be ruled out. — FDA FAERS – FOIA Case Report Information",
      "attrs": null,
      "subkind": null,
      "toolName": "Authority citation",
      "toolSlug": "authority-citation",
      "confidence": null,
      "componentId": "019dd953-64d1-73a9-abb4-7eafc886bddd",
      "frameworkName": null,
      "frameworkSlug": null
    },
    {
      "bbox": {
        "h": 0.02,
        "w": 0.25,
        "x": 0.07,
        "y": 0.95
      },
      "kind": "source-note",
      "text": "Source: FDA FAERS – FOIA Case Report Information",
      "attrs": null,
      "subkind": null,
      "toolName": null,
      "toolSlug": null,
      "confidence": null,
      "componentId": "33a64845-14f9-40f0-8d83-2b1b1ee63713",
      "frameworkName": null,
      "frameworkSlug": null
    },
    {
      "bbox": {
        "h": 0.03,
        "w": 0.45,
        "x": 0.07,
        "y": 0.07
      },
      "kind": "title",
      "text": "Case ID: 19164134, Event date: 2021",
      "attrs": null,
      "subkind": "headline",
      "toolName": null,
      "toolSlug": null,
      "confidence": null,
      "componentId": "d49067a4-ede6-493e-bd54-e908790f580e",
      "frameworkName": null,
      "frameworkSlug": null
    }
  ],
  "metrics": [],
  "tools": [],
  "frameworks": [],
  "arcBeats": [],
  "loops": [],
  "imagePathAlt": null,
  "thumbSrc": null,
  "thumbSrcAlt": null,
  "locked": true
}