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  "documentTitle": "Harmony Biosciences (HRMY)",
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  "authorName": "Scorpion Capital",
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  "notes": "Includes a linear regression equation Y=14.62*X+53.34 and a scatter plot with error bars.",
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      "text": "So, no, there is no safety margin using the actual data and anticipated steady state level (2.3 accumulation ratio).",
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      "text": "“I graphed all of the single dose plasma levels vs change in TQT and created a linear regression line. The resulting equation is Y=14.62 x “X”+53.34. Solving for X (the TQT change) one can then determine the correct TQT for a certain plasma level (“Y”). The plasma levels at steady state were determined from the single dose plasma levels by multiplying by 2.3. Solving for “Y” at both the mean and the upper limit of the 95% CI (2SD). I used 51% for the plasma variability as I do not believe the other values but could easily assess using them. By this method, the actual TQT at steady state is 4.7, 22, 24, 32 and 41 ms (mean) at doses of 40, 120, 160, 200 and 240 mg. At the upper CI the TQT at steady state is 14, 49, 53, 69 and 86 ms at doses of 40, 120, 160, 200 and 240 mg, respectively at steady state. So, no, there is no safety margin using the actual data and anticipated steady state level (2.3 accumulation ratio).” – Pharmacology consultant engaged by Scorpion Capital",
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      "text": "Methodology and regression model used to correct single-dose QT data to steady-state plasma levels",
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      "text": "“there is no safety margin using the actual data and anticipated steady state level....” — Pharmacology consultant engaged by Scorpion Capital",
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      "text": "Source: https://pubmed.ncbi.nlm.nih.gov/26879827/",
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      "text": "We note the consultant’s blunt conclusion: “there is no safety margin using the actual data and anticipated steady state level....”",
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      "text": "We detail below the methodology used by our pharmacology consultant to correct the plasma levels used by the FDA in assessing cardiotoxicity, as well the simple regression model based on data tables from Harmony’s two QT studies.",
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