Golfyeti wrote "yet Resverlogix is mid-way through a so-far-100%-safe Phase III trial in the same population group and the trial may be stopped by the DSMB if RVX208 doesn't hit its end-points of 25-30% RRR on 3-point mace?  How can this be? Say at 18 months RVX-208 shows 18% RRR, our trial gets stopped for efficacy concerns?!?"

A hypothetical futility call would be based on the statistical view that there is no difference between the two groups. However, if BETonMACE achieves a statistically significant RRR of any value, even if below 25-30%, there would not be a futility call in my opinion. Of course, we want 25-30% or higher, but lower is still acceptable. The key is statistical significance. What we want is efficacy AND statistical significance. 18% RRR in your example is still efficacious.

BearDownAZ