William Lis, Chief Executive Officer, Portola Pharmaceuticals, Inc.
Yes. It is not precise, just to let you know. We have been doing this for a long time. It is not precise. It is a little bit of a dialogue that goes in with our executive committee and the folks who read this beforehand. It is that kind of what range is it. That is what you are talking about here as you said. You are talking about ranges here and that is the discussion that will happen. I think that is really what we can say at this point and I really think that is what we can say at this point.
We wish we could give more specificity to it. I think if you want, you can really dig in and take a look at other trials and which ones may have been stopped, which ones have not. You can start to get a sense of it. I think there is a history. There is a rich history of this in the area of thrombosis early in factor Xa inhibitors. The Magellan, adopt. I was involved in some of these trials, Rocket. All had futility analysis associated with them.The ACS clinical trials. The only one I know that was stopped was the BMS Pfizer Eliquis study. It was stopped for futility and safety. That was what? APPRAISE? That was APPRAISE.
Yes. Of all the factor Xa inhibitor trials and there is probably over 20, there is one that has been stopped. It is the BMS Pfizer’s APPRAISE study in acute coronary syndromes. Did that help at all? I know you want detail, but it is not done at that level.
Alexander Gold, Senior Vice President, Clinical Development, Portola Pharmaceuticals, Inc.
That is why to differentiate with the interim analysis, so you were looking for some pre-specified guidance probably and ther1e isn’t such because really the question is, is there enough reason to believe it is futile or not. That is the main question that they are answering. They choose to provide different guidance, as Bill said, but that is not something that is the primary goal of the futility analysis.
William Lis, Chief Executive Officer, Portola Pharmaceuticals, Inc.
They will look at net clinical benefit per se as well. Again, when we get through all these safety checks and we get comfortable or at our bleeding effect. That also makes us comfortable and confident, too, going into futility analysis. We will see. We got more months to wait.
Jason
Can I ask one more question?
William Lis, Chief Executive Officer, Portola Pharmaceuticals, Inc.
Sure, Jason.
Jason
Will you provide some indication of what the parameters were after you passed it? The DSMB says to continue and we now can rule out some effect size after the fact.
William Lis, Chief Executive Officer, Portola Pharmaceuticals, Inc.
We probably will not have enough information to determine that. Again, we are giving them guidance like this. It is going to be difficult to us. We are probably going to be saying the same thing. We passed the first hurdle, we have some win in ourselves and we could still fail but we are feeling positive about moving forward. Maybe I should give some thought to that, too. That is a good question. Maybe I should give some thoughts to that.
Female
Thanks, everybody.
William Lis, Chief Executive Officer, Portola Pharmaceuticals, Inc.
Yes. Great to see everybody. Yeah. Enjoy the rest of your time. We are having a nice weather here, although Jason, you see it all the time.
