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Message: Re: BETonMACE Enrollment
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Mar 21, 2017 04:22PM
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Mar 24, 2017 03:15PM
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Mar 25, 2017 10:41AM

SanFran.....I think management would only know about enrollment, not number of events. 

Noretreat, no offense but for the purpose of my calcuations, I'm going to stick with the "hard" statements made during webcasts, slides or press releases regarding enrollment numbers and not second hand comments. 

Noretreat wrote "Regarding the anticipated rate of MACE, your information is exhaustive and the arithmetic to get to the "expected" event level of 125 still eludes me...but I will give it another whirl."

Using the enrollment numbers from the first message in this thread (based upon statements in webcast statements, slides or news releases), I had a starting estimate for how many patients had been enrolled at certain date cut offs. I arbitrarily chose end of September 2017 and roughly calculated how long each wave of enrollments would have been in the trial. Although enrollment is continuous, for the purpose of my math I used the average time in between enrollment updates as the reference point.  For example, dosing started 11/15/15 and next enrollment update was 600 patients (Group 1) on 9/12/16. That's a span of 10 months. So for this group of 600 patients I assumed their average time in trial was going to be 17 months at end of September 2017. The next enrollment update I used was 12/15/16 at 800 patients. So 800-600 patients is another 200 patients (Group 2), that will have an average time in trial of 10.5 months at end of September 2017. Next update was 3/17/17 at 1200 patients. So 1200-800 is another 400 patients (Group 3) that will have an average time in trial of 7.5 months at the end of September 2017. Lastly, I conservatively estimates that another 600 patients (Group 4) would be added between 3/17/17 and 9/30/17, with an average time in trial of 3 months at the end of September 2017. Based on noretreat's personal communications with management, this last estimate may be underestimating here. I'm also conservatively assuming only 125 patients/month being enrolled between 3/17/17 and end of 2017 to get to the target of 2400 patients. 

I then looked at the cumulative MACE event graph over time from the EXAMINE trial and tried to match the appropriate event rate from the EXAMINE curve with each respective enrollment wave. I chose EXAMINE event rates of 18 months for Group 1 (~11%), 12 months for Group 2 (~8%), 6 months for Group 3 (~5%), and 3 months for Group 4 (~2.5%). Multiply the number of patients in each wave with the estimated event rate and I get 117 events by end of Sept 2017. That is why I made September 2017 the anchor point.

Importantly, as I described earlier in this thread, this assumes no effect of RVX-208 and no effect of low-HDL. As described earlier, if low-HDL greatly increases event rate things move up a bit. If RVX-208 works to reduce MACE, things move back. If both low-HDL and RVX-208 effects happen, they cancel one another out and one gets same estimate as no low-HDL/no RVX-208 effect.

I hope that helps you understand my fuzzy math.

BDAZ

 

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