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Message: Re: What would a successful BETonMACE Top-Line Data Announcement Look Like?
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Aug 10, 2019 10:09PM

I’m no expert either and we may need Bear to further clarify but there are two things to consider.  

1.  The %RRR is related to comparing the results at the end of the trial between the different sets of sub groups with the goal being 25-30% reduction in MACE events or better.   But to statistically conclude this, you need time and patient hours on the drug to statistically compare the results to placebo.   So the more cumulative patient time in the trial, the greater the statistical confidence of the results.  

So the initial BoM trial was designed to ensure a certain amount of patients and also a predetermined planned trial length of time in order to achieve a statistical confidence level of 80%.  

So any additional patients in the trial and or additional cumulative time in the trial in terms of patient hours would therefore provide for greater than 80% confidence.   But the 25-30% RRR remains the same regardless.  

One caveat is that if the drug does work, then the more patients and the more time the better.  Tic toc...  

10BagR

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