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      "text": "The CDER Clinical Pharmacology Review states the steady-state level is based on an undisclosed “Harmony model” – a black box.",
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      "text": "plasma levels: 35.6 mg/day",
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      "text": "Pitolisant’s purported safety profile hinges on plasma levels not exceeding certain thresholds... The CDER Clinical Pharmacology Review states the steady-state level is based on an undisclosed “Harmony model” – a black box.",
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      "text": "there was a clear and direct correlation of pitolisant exposure with QTc prolongation and that “at supratherapeutic doses, QTc increases greater than 10 msec are anticipated.” — FDA clinical review",
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      "text": "Source: https://www.accessdata.fda.gov/drugs... | https://www.wakix.com/assets/pdf/WAKIX_pitolisant_tablets_PI_Dec_2022.pdf",
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      "text": "Drug exposure at steady state following the therapeutic dosing regimen. The population PK model... demonstrated mean exposures... Mean Cmax = ~73 ng/mL, Mean AUC = 812 ng*hr/mL. The exposures in CYP2D6 PMs were approximately 2-fold higher.",
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