"I have never seen a postive result when the FA is delayed to allow more data to accumulate.  Do you know of any?  I would like to have at least one example so I can rationalize my continuing investment here.  If something good (or even neutral) were evident in the data at 50%, why in the world would anyone withhold that?  That data would cause the value of the company to skyrocket, and the number and quality of potential suitors would also likely increase dramatically."

Noretreat, I am also confused as to why a pre-determined futility analysis at 125 events (50% of events) is now re-visited by the DSMB and Clinical Steering Committee so as to consider delaying the futility analysis to somewhere later in the 50% to 75% range. Clayton's response to me indicated that "The discussions are based solely on statistical analysis factors and not on clinical results." So it could be that the results thus far are looking somewhere in the good to stellar range, but that some combination of variability in drug response, magnitude of drug response, and relatively low numbers (125 events in a cardiovascular outcomes trial (CVOT) is low relative to other CVOTs) is hurting the data statistically. So the DSMB/Clinical Steering Committee may see promising results but don't want an earlier futility analysis to give a premature/misleading conclusion. On the other hand, the data may be looking so good that they may want to wait just a bit longer so as to potentially end the trial early because the drug is working so well! Very unlikely scenario in the latter suggestion, but always a chance. :-)

"All that said, does anyone have any evidence that they have in fact reached 50% and have decided to wait for more data?  If not, perhaps the MACE are happening much more slowly than expected, and the drug is working." 

I have no info to say whether or not they've reached 50% yet. But based on my projections in previous posts, they should be close to 50% of events (125 events) if the BETonMACE patients are showing similar event rates as the diabetic patients in the EXAMINE trial. But, as others have posted....maybe there is a stronger placebo effect than expected that is slowing the overall event rate. Or maybe apabetalone is having a tremendous 50-77% relative risk reduction in 3-point MACE that is slowing the apabetalone arm more than originally anticipated (trial modeled for 30% RRR). 

Wish I could be a fly on the wall in those meetings between the DSMB and Clinical Steering Committee.......

BearDownAZ