Great response Tada! I don't have much to add.

The RRR is not typically revealed until the full data set is released, and this comes after the top-line data. Most likely top-line data will indicate whether we met the primary outcome of showing a significant reduction in 3-point MACE relative to controls. But the actual RRR and results details would come later at a major scientific conference, for example. 

The SSRA is triggered at 188 adjudicated events. As I posted about not too long ago, Amarin is an example of a company that gave a couple status updates even after their 80% of total events triggered their interim analysis. So maybe we'll get additional updates after the SSRA for BETonMACE, which I expect to only indicate that 188 events have been adjudicated. As Tada wrote: Stop, Add, or Continue.

With the relatively small size (2400 patients) and short length (average dosing 18 months) for BETonMACE, I don't see it being stopped early. The company has stated on more than one occasion that they do not want to stop early for efficacy so that they can best show the safety profile over time. With how small and short the trial is compared to most CVOT trials, they need as many patient years as possible from these original 2400 patients. From what I understand, even if the DSMB recommends stopping early, the company doesn't have to take the recommendation. Maybe I'm wrong here, that's what I remember hearing. Someone correct me if I'm wrong here.

Lastly, Growacet asked "What if someone in the dosed group who's only just started taking 208, what if they suffer an event around just 1 week.  Is it cut and dried....it counts as a MACE among the dosed group?  Or is there room for some subjectivity?" That's just how the ball bounces. Patients are randomized. Could happen with a placebo patient. Could happen with a 208 patient. 

BearDownAZ