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Message: Resverlogix Announces Publication on Apabetalone in Clinical Epigenetics

Thanks Bear.  This makes a lot more sense to me now.

First, my own earlier estimates showed a patient year total of 5100 as of April 1 2019.  I derived this using updates provided by RVX, making straight line filling in of data in between data release dates, and assumed (incorrectly but more conservatively) that there were 1900 patients (10% drop out rate would mean 2150 patients; which adds another 100 patient years at least) in the trial as of April 1 2019.  What threw me off completely was Tundup's write up which claimed 2,400 patient years as of June 21 2018.  My own estimates were 3400 as of June 1 2018.  So a 5,000 total patient years as of April 1 2019 tallies with my figures very nicely.  So either Tundup wrote it down incorrectly, or the person giving him the data misled Tundup.

Second, this means the overall MACE rate for Phase 3 is now running somewhere around 5 to 5.4 (total MACE of 250 to 270; 5,000 patient years).  This is far below the 5 & 7 MACE rates assumed for dosed and placebo patients.  How does one explain this? I have 2 guesses.  The first guess is that since these trials are being conducted in countries outside the USA, what passes for standard of care in the US is not the same elsewhere.  Although these patients are very sick, even they must have benefited from what turned out to be better medical care post MACE (and thanks to the trial), as well as a come to Jesus comment in taking care of themselves (diligently taking pills for example).  I remember DM telling me that part of the reason the earrlier trials "failed" was because of this standard of care issue in other countries.  My second guess, is somewhat speculative.  After a place gets hit by a 9.0 Earthquake, it highly unlikely that it will get hit with another quake for some time.  A MACE is like that big quake.  Not sure if the analog applies, but my intuition would imply that.

Third, even if you assume a 6 MACE rate for placebo, then RRR comes out at 27% for 5000 patient years. 

Fourth, if 3600 patient years gives you an 80% power, then a 5000 patient years is far higher in power.  How much I don't know, but a 95% rate is not a bad guess.  That is a 50% increase in patient years, so your factor of reliability goes up that much more exponentially.  Highly statistically significant.      

All in all, this data point from Dr Kulikowski has pretty much told us that Phase 3 is set to be an outstanding success.  The only unknown is by how much.  

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