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      "text": "The conclusions in the 60-page report were received were damning and we interpret them as indicating that the claims are fraudulent with red flags, discrepancies, contradictions, and omissions that suggest an intent to mislead the FDA.",
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      "text": "bioavailability: 1.5%",
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      "text": "According to a mass-balance study conducted in 6 healthy male subjects dosed with 20 mg in fasting state, a mean recovery of at least 88% of administered radioactivity was recovered, primarily from urine (approximately 63%) with approximately 25% of the dose excreted through expired air and a small fraction (<3%) recovered in faeces. The absolute bioavailability of pitolisant has not been determined.",
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      "text": "In contrast to the 90% figure claimed by Harmony, pitolisant’s actual bioavailability is a mere 1.5% in mouse, 1.5% in rat, and 27% in monkey. These figures are consistent with data we received from several large pharma companies, who cited lack of bioavailability as one of many fatal flaws that led to the termination of their H3 receptor antagonist/inverse agonist programs, and whose in-house analysis of pitolisant specifically concluded that it suffers from the same issues. We hired a pharmacology consultant, who has conducted hundreds of pharmacokinetic and bioavailability studies, to examine Bioprojet/Harmony’s methodology and claims. The conclusions in the 60-page report were received were damning and we interpret them as indicating that the claims are fraudulent with red flags, discrepancies, contradictions, and omissions that suggest an intent to mislead the FDA. The consultant further pointed to a telling statement in the EMA review: “the absolute bioavailability of pitolisant has not been determined.”",
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      "text": "the absolute bioavailability of pitolisant has not been determined. — EMA review of pitolisant, 2015",
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      "text": "Source: https://www.ema.europa.eu/en/documents/assessment-report/wakix-epar-public-assessment-report_en.pdf",
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