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Message: Re: Agm
Agm
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Dec 13, 2017 09:29AM
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Dec 13, 2017 11:38AM

Thanks for the info Polar One. Just to clarify, the futility analysis was originally supposed to be at 50% of the 250 event target. So original FA was expected at 125 events, not 150 events as you had written. There has been a sample size estimate analysis in the plan all along. It may have been even before dosing began (or if not sometime in 2016) that we were told that in addition to the futility analysis that there was a sample size estimate analysis planned. I have in my notes that we were previously told sample size estimate analysis at 175 events, at which time they may increase enrollment to 3600 from 2400. However, the 188 event number relayed to us from those that attended the AGM Q&A is the 75% of 2400 mark and just a wee bit higher than the 175 number that I recall. Seems to me that they aren't renaming the futility analysis to sample size estimate analysis, but instead merging the two individual analyses into one.

Also, Polar One thank you for posting the link to the Kidney International publication that DM talked about yesterday. I tried looking for it online but failed, so thanks for the info. 

BearDownAZ 

 

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