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  "documentTitle": "Harmony Biosciences (HRMY)",
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  "authorName": "Kir Kahlon",
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  "sourceTypeLabel": "Short seller",
  "presentationDate": "2023-04-03 00:00:00",
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      "text": "Petitioner believes that given the recent i) fatality, ii) hospitalization and near-fatality, iii) 13 fatalities in the pitolisant development program, and iv) the inherent and unavoidable toxicity of H3 receptor antagonists/inverse agonists as a drug class, as indicated supra, it would be a grave mistake to repeat the incremental approach that marked the eventual withdrawal of Seldane.",
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      "text": "In addition, as indicated in Petitioner's report, Wakix's drug-drug interactions and CYP2D6 liability are extensive. Wakix interacts with drugs that are widely prescribed to narcolepsy patients, such as SSRI's.",
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      "text": "In addition to all of the information detailed supra, and incorporated by reference, Petitioner has enclosed with this Citizen Petition (and incorporates herein) a 366-page investigative report and provides it as its statement of grounds (Exhibit A).",
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      "text": "Petitioner believes that given the recent i) fatality, ii) hospitalization and near-fatality, iii) 13 fatalities in the pitolisant development program, and iv) the inherent and unavoidable toxicity of H3 receptor antagonists/inverse agonists as a drug class...",
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      "text": "Petitioner believes it would be regrettable if the FDA opts for a middle-ground in the form of a black box warning, which would accomplish nothing. Petitioner's interviews with Wakix prescribers... indicate that a small number of speakers drive a significant percentage of Wakix sales.",
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      "text": "“those items are just warnings...you're not going to run into those issues hardly ever”; “I've never ordered an EKG...that's what I tell doctors, these are just warnings...technically speaking, you don't have to do anything...you can just prescribe it, which is what we do.”; “I do not run any EKG's...I don't check lab work...remember, most naroleptics are...pretty damned healthy...” — Anonymous high-volume Wakix prescribers",
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