Kelsee,

As Don has pointed out in past presentations, the degree relative risk reduction (RRR) elicited to RVX-208 in such a short time frame (6 months), especially in low-HDL, diabetic patients, is unprecedented. For RVX to already indicate that this is an events-driven trial sounds to me like they are designing a trial to allow for a trial stoppage if these solid conclusions can be reached prior to the full 104 months. However, I don't think that this would mean that the placebo group would then be switched to RVX-208. I anticipate that if the trial was ended early, it would simply allow for a faster drug approval process.

Now we must also realize that RVX wants to do the Phase III right the first time. Most Phase III cardio trials seems to go for a lot longer. For example, the ongoing CETP inhibitor trial ACCELERATE (evacetrapib): 12,000 patients up to 4 years, completion estimated July 2016; REVEAL (anacetrapib): >30,000 patients up to 4 years, completion estimate January 2017. However, the Phase II trials for these CETP inhibitors may have lacked the efficacy at reducing MACE achieved by RVX-208. So RVX-208 may be in unchartered waters in terms of how FDA/EMA/etc. deals with a potentially blockbuster drug that so profoundly reduceds MACE. I can see them going either way. Perhaps this is an area of contention with the ongoing discussions with FDA/EMA?

BDAZ