Question-and-Answer Session
Operator
(Operator Instructions) Your first question comes from the line of Joel Sendek of Lazard Capital Markets. Please proceed.
Joel Sendek - Lazard Capital Markets
Thanks. I wanted to further define the couple of potential snares for the PIN trial. So, first of all, I want to understand what the worst case is, would the worst case in your view be a continuation of the trial?
Mitchell Steiner
Okay, yes. So let me just rephrase it. The question Joel is looking into the PIN trial, what would be the worst case scenario, the implication there is that there have been some rumors floating around that the worst case scenario is that the futility analysis. And that for some reason, we are going to get a message back that says, guess what, not only did you not hit your pre-specified statistical significance, but the futility analysis says you have to close down trial.
Another worst case scenario that is sort of floating out there is the concept that, there is a safety issue that would be brought into question. Well. let me remind the group that the data safety monitoring board has reviewed the safety every six months and we've continued to get continuous plan and we've already seen the safety data for the 80 mg in the sicker patient population.
So safety, we've done, that's should not be an issue from the standpoint of news during the interim. And then, so the worst case scenario which is the only case that would happen if we don't hit a positive result is that they tell us to continue the plan as trial. If we continue the trial as planned, remember now the statistical significance of this fiscal hurdle that we need to hit is much more lenient than the final look than in the interim.
Joel Sendek - Lazard Capital Markets
And how about if there is a negative trend, will you know that, or will you relay that to investors if that happens?
Mitchell Steiner
The only information we will get from the independent group is did you hit or did you not hit? We did not hit. All they're going to tell us is continued as plan. The reason for that is that if you can imagine yourself being a patient, and then we told you that we are off by a small fraction, so it looks like for all practical purpose the trend is that we're going to hit in the final analysis, it's going to be very hard to keep the trial blinded. So the company offer the patients and so the way we've specified it is that the independent group will tell us continue the trial as plan, if we don't hit at pre-specified statistical significant level.
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