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Re: oneragman post# 283783

Tuesday, 06/30/2020 4:34:11 PM

Tuesday, June 30, 2020 4:34:11 PM

Post# of 429149
oneragman
You raise a critical point
This patient was extrapolated from saying that the baseline 28 patients had a mean TG level of 300+/-233 mg/dl. We are assuming two standard deviations (not standard error of mean). Then comes the Heineke construct of plausability for the generics: that if there was a spread of data then assuming 2SD's statistically there must have been ONE pt at least above or at 500mg/dl given the 2 SD limit that goes out to 300 plus/minus 233 mg/dl=533 mg/dl. To say that this is stretch of science to fit legal convenience would be a gross understatement!
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