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  "documentTitle": "Harmony Biosciences (HRMY)",
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  "authorName": "Scorpion Capital",
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  "presentationDate": "2023-03-28 00:00:00",
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  "notes": "The slide uses a combination of narrative argument and a direct quote from a consultant to build a case against the company's transparency.",
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      "text": "Data this basic is only withheld if it is damning.",
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      "text": "Common sense indicates that the “gaps” the EMA mentions in “the basic pharmacokinetic properties of pitolisant” are not accidental. Data this basic is only withheld if it is damning. There is zero chance, in our opinion, that Bioprojet and/or Harmony are not in possession of this PK information. It is always collected, particularly given Bioprojet’s prolific papers and trials over a multi-decade effort to conjure up a successful H3R drug. As part of our investigation, we engaged a consultant who specializes in pharmacokinetic analysis, who echoed the EMA’s comments and expressed shock at the lack of basic PK data across pitolisant papers and studies. The consultant stated that this was the first time in decades she could not locate published plasma concentration curves for an approved drug, even from animal studies much less humans: “I don’t know how Harmony got away with this, honestly”; “the lack of data in this regard is a huge red flag given that 2D6 is the primary p450 involved in the elimination of pitolisant”; “it is hard to believe it was approved without it.”",
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      "text": "PK expert we engaged expressed shock at lack of pharmacokinetic data for pitolisant\n“There are no plasma concentration curves to actually compare it meaningfully to preclinical data. I have never seen this before when researching any approved clinical agent. One can find bazillions of plasma curves. Why did they not measure plasma levels in their trials - say 1 week after stable dose initiation at Tmax/3 hr when steady state? Why are there no published PK curves even for the animal studies? Especially with the weird subjective stable dose selection criteria used routinely in these trials and now in patients? We don’t know what the peak plasma levels are and I do not take anybody’s word - show me the data. They say 75 ng/mL is the max level like that is a stable number - it is not. The lack of data in this regard is a huge red flag given that 2D6 is the primary p450 involved in the elimination of pitolisant – it’s hard to believe it was approved without this.”",
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      "text": "“There are no plasma concentration curves to actually compare it meaningfully to preclinical data. I have never seen this before when researching any approved clinical agent... the lack of data in this regard is a huge red flag given that 2D6 is the primary p450 involved in the elimination of pitolisant – it’s hard to believe it was approved without this.” — Pharmacokinetic expert engaged by Scorpion Capital",
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      "text": "Source: Pharmacokinetic analysis commissioned by Scorpion Capital",
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