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Message: 600 patients....doing the math

Led,

The news release stated "The trial has already attained one quarter enrollment of the planned 2,400 patients and remains on track with internal projections." If they say they are on track, that means that they are still on track to complete the original 2400 patient enrollment by Q1 2017. Keep in mind that it took some time to get all of the study sites activated. Now that most, if not all, of the originally planned study sites are active, the recruitment is going much faster than when the trial started. Will they get 2400 patients by Q1 2017? Maybe, maybe not. But your 30 month estimate is way off. We're 7 months from end of Q1 2017. Even a quarter more and end of Q2 2017 is 10 months away. In the Q2 2016 update, they anticipated a meeting with FDA by years end to discuss adding BETonMACE centers in US, and they stated "At the time of this meeting safety data from over 1,000 patients in the BETonMACE trial will be available, additional dose response work, MOA and liver biology work will be complete." My guess is Q2 2017 for full enrollment (assuming they stick with the 2400 patient target).

As for dosing and event rates, I think you are right, that it was 1 patient dosed with RVX-208 for every patient dosed with placebo. Half of the patients (RVX-208 or placebo) are on Crestor(rosuvastatin) and the other half on lipitor(atorvastatin). The trial was designed expecting a 10.5% event rate at 18 months for the placebo group and a 30% reduction in events in the RVX-208 group. So your 75% math is flawed because there is no time compenent there. They anticipate hitting the 125 event mark mid-2017 based on their original projections. But if recruitment takes longer than expected (taking into Q2 2017 instead of Q1 2017), or the overall event rate is lower than expected, it could take longer to hit the 125 event mark.

BearDownAZ

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