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Message: Probability of Phase 3 trial success

Welcome to the board Sikong. A lot of resources can be found in the link library, which can be found here or on the left side bar. A great deal of information about Agoracom, Resverlogix, BETonMACE and apabetalone can be found in this introductory message. There are a lot of signs from prior clinical and pre-clinical data for apabetalone that indicate it could show huge benefit in BETonMACE. However, there is always risk. No guarantee of success. Best to do some due diligence. In addition to the introductory message, I put together a couple other compilation posts here and here that summarize a lot of the history.

Many folks on this board (some repeatedly) have asked about current estimations of patient years, discontinuation rate, projection of placebo event rate and projection of apabetalone effect size. I could summarize a lot of the stuff that others including myself have posted over the years. But I won't. The truth is there are a lot of unknowns. One could paint several rosy scenarios, but that is only fair if one acknowledges that there are also some stinker scenarios too. Too many unknowns in my opinion to see too clearly into that crystal ball. 

Iconoclast asked in this post "When the Phase 3 trial was initially designed, do we know what the assumed MACE rate for the placebo and the dosed patient group was?  They assumed the trial would finish by November 2018, so clearly something in their assumptions went haywire."

See this post and this post for past discussion on this. The AHA poster from 2018 also summarized some projections. Projected placebo event rate was influenced by EXAMINE and ELIXA trials (which also had diabetic recent ACS patients) and projected effect of apabetalone was 30% RRR. In my opinion, a delay in the accumulation of patient years due to enrollment and/or discontinuation was the main factor in slowing down the trial. But as addressed above, there are a lot of unknowns. The placebo event rate may have been lower than projected, the apabetalone effect size may have been greater than projected, the enrollment and/or discontinuation may have slowed things down. These could all be factors in slowing down the trial.

Topcoin cited this paper and offered a sloppy description of event rates in this post earlier in this thread. Topcoin's post could create a lot of confusion, as evidenced by Cabel's response. It is very important to define what events you are talking about AND to also indicate the time factor. BETonMACE is focused on first occurrence of 3-point MACE event. Are the event rates Topcoin is drawing from that paper first occurrence 3-point MACE? Are Topcoin's quoted event rates per 100 patient years or are they event rates at the median dosing/follow up period in a certain trial? These are very different things and are only interchangeable under certain circumstances. One needs to state a time factor for an event rate to be useful. 

BearDownAZ

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