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Re: chas1232123 post# 70918

Tuesday, 02/02/2016 1:29:33 PM

Tuesday, February 02, 2016 1:29:33 PM

Post# of 425648
"Also don’t know exactly how Amarin came up with their 5.9% estimate"

I saw the 5.9% rate in 2013 May FDA's draft for AdCom. But FDA changed it to 5.2% in their November Brief.

The data would be a Time Series, thus the unit to be better to be "subject*year". I.e., 5.9% Subject*Year -- on average, 5.9 CVE are expected occurring in 100 patient during one year timeframe.
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