Re: Patient Enrollment Modeling
in response to
by
posted on
Dec 09, 2018 08:04AM
Let's assume 7.9 is the MACE rate per patient year from the EXAMINE trial (which used a 3 point metric for MACE) if all were on placebo in the BETonMACE trial.
For the BETonMACE trial, half the patients are on a placebo plus standard of care. So for half, we should get the 7.9 rate. For the other half, we get the effect of Apabetalone. Let's back calculate RRR rates assuming 2 different MACE rates for the trial.
So if the average MACE rate is 6.9 for the trial, then for the Apabetalone dosed patients, we should be achieving 5.9 rates. Based on Tundup's 7.2 estimate, 6.9 is extremely plausible, as MACE rates are reported to be dropping (as reported by Tundup).
Compared to the 7.9, this should get us to 25% RRR (5.9/7.9).
If we get a MACE rate of 6.5 for the entire trial, that should translate to a 35% RRR (5.1/7.9).
The question is how long it takes us to get to 6.9 or less MACE rates for Apabetalone. Based on BearDownAZ's write up above, we should be getting there any day now. A trial ending after Dec 31 would, I reckon, get us there.
My back of the envelope calculations suggest we should be ending in January, not December (6.9*3600=248 MACE), assuming a 6.9 MACE rate and 3600 patient years.
In short, the 2 key data points are: MACE rate for the placebo (I am assuming 7.9 from the EXAMINE trial), and the final MACE from the BETonMACE trials (whatever they may be). The latter has to be lower than 7.0 to get us to 25% RRR.
As an aside, I found one comment from Tundup very interesting. He said that the MACE rate had dropped to 7.2 (as of June 2018). But as Bear noted, the March 2018 conference had 8.0 as the projected rate, as given by RVX. The fact that the share price rallied quite violently after May 31 2018 could not be a coincidence. Somehow, the market figured this out!
What do you say, Bear?