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  "documentTitle": "Harmony Biosciences (HRMY)",
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  "notes": "The slide highlights a specific discrepancy in an FDA review document (page 32) where the graph title claims 'steady state Cmax' but the underlying data is from a single dose.",
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      "text": "FDA review incorrectly infers QT safety margins, stating they are based upon “steady state Cmax” when they are actually based on plasma levels after a single dose",
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      "text": "FDA review incorrectly infers QT safety margins, stating they are based upon \"steady state Cmax\" when they are actually based on plasma levels after a single dose",
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      "text": "Figure 15: Goodness-of-fit plot for QTc vs steady state Cmax",
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      "text": "Shockingly, the FDA CDER Clinical Pharmacology Review, in a section on pages 31 and 32 devoted to QT increases, includes a plot developed by its staff that shows QT interval increases at various plasma levels. The title of the graph states that it shows “QTc vs. steady state Cmax” – however, the data is based upon plasma levels after a SINGLE DOSE, NOT STEADY-STATE levels which are 2.3 times higher, and which means the graph is incorrect.",
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      "text": "The title of the graph states that it shows “QTc vs. steady state Cmax” – however, the data is based upon plasma levels after a SINGLE DOSE, NOT STEADY-STATE levels which are 2.3 times higher, and which means the graph is incorrect. — Scorpion Capital",
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      "text": "Source: IRT Review (Darrts- IRT Report, Jose Vicente Ruiz et. al., 3/22/2019).",
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      "text": "We believe the FDA made a grave error in relying upon single-dose plasma levels to infer safety margins for QT prolongation, versus using steady-state levels which are 2.3 times higher.",
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