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  "documentTitle": "Harmony Biosciences (HRMY)",
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  "presentationDate": "2023-03-28 00:00:00",
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  "notes": "The slide uses a direct quote from an FDA clinical review to contradict the company's safety claims, supported by a table of clinical data.",
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      "text": "QTc prolongation of ~10 msec and ~16 msec at ~175 ng/mL and ~280 ng/ML, respectively",
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      "text": "FDA CDER Clinical Pharmacology Review, Dec 2018. The effect of pitolisant was evaluated in clinical studies P09-11 (TQT study) and P14-05 (SAD Study)...",
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      "text": "there was a clear and direct correlation of pitolisant exposure with QTc prolongation — FDA Clinical Pharmacology Review",
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      "text": "Source: https://www.accessdata.fda.gov/drugs/atfda_docs/nda/2019/211150Orig1s000ClinPharmR.pdf",
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      "text": "Table 6: The Point Estimates and the 90% CIs for ΔΔQTcF (ms) increases at therapeutic and supra-therapeutic dose levels",
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      "text": "Pitolisant is a highly cardiotoxic drug, and the QTc/cardiac safety studies which Harmony submitted to the FDA are misleading and grossly understate the risk of QT prolongation and associated cardiovascular danger.",
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