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Re: jessellivermore post# 31198

Saturday, 07/26/2014 7:51:43 PM

Saturday, July 26, 2014 7:51:43 PM

Post# of 428944
JL,

My assumption behind 5,0%:
- around March, at least 4.000 was enrolled (since they submitted sNDA)
- they increased the TG (from 150 to 200) due to lower than expected (5,2%) event rate and I think if they thought the modification is necessary the difference was significant (0,5%) so the event rate was 4,7%
- March 13 - YTD add. enrollment is app. 3.250 and rate for these is 5,4%

Total event rate: 5,01% as (4.000*0,047 + 3.250*0,054) / 7.250
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