This is not one that we anticipate to require a large commercial infrastructure. We expect it to be very modest. It’s a top-down approach based off the key opinion leaders in the nation that drive CRRT guidelines. I think the other important aspect of this is nafamostat is not a new concept to them. Niyad, nafamostat has been used, as we’ve mentioned, for 30 years in separate countries, including Japan and South Korea. The thought leads in the United States cross mingle and share expertise with those outside of the U.S. So nafamostat is a known entity to them. And they’re often asking us when we think we’ll be able to have this available for the U.S. so they can provide this anticoagulant to their at-risk patients. I hope that helps give a bit of a color to it, Thomas.
Pam, do you have anything to add relative to the market research that we’ve conducted most recently relative to CRRT?
Pamela Palmer: No, we’re writing up the data right now. It will be submitted in Q2 and likely published in Q3. And we’re really excited about possibly being able to in very near term address this sort of deficit in the medical treatment of patients during CRRT. I mean, it’s amazing to me that 29% do not get any anticoagulation during CRRT just because of the issues with heparin and citrate.
Vincent Angotti: I would just add, we don’t know — should we receive an EUA. We don’t know when that would come. There’s no specific time frame on the FDA review of that. So we don’t know if that’s going to come in one month or it’s going to come in six months. So to give any expectations on sales would not be a reasonable way to estimate this at this point. I think we can give more detail when we receive an EUA later this year.
Unidentified Analyst : Got it. So, I guess just to clarify, so the decision after the EUA is filed a decision is expected by the end of this year.
Vincent Angotti: Well, you’d hope that they have no firm guidelines on review time lines like they do for classic PDUFA. So as we research EUAs that have been reviewed in the past, month or two months could be longer. So we just can’t give you a defined time line on that. I think what’s important even beyond that, Thomas, and maybe some people are asking about is we are intending even beyond the EUA to move forward with the registrational trial in the second half of this year. And this is a very clear design trial with endpoints already agreed upon by the FDA. So there’s not a lot of, what I’ll call, debate left on how to execute this trial. Pam, maybe you can comment on the preparation we’ve made the endpoints, et cetera, on the trial, so people are clear on how we feel it’s very simple to execute.
Pamela Palmer: Yes, the end of the 160 patients, which is actually quite a small trial. It’s 80 active placebo has already been agreeable to the FDA as is the primary and key secondary endpoints for the trial. And so yes, CRO selection, getting — moving forward with the finalization of the statistics for the protocol and picking clinical sites is what we’re actively doing right now. So and that’s a key part of our Advisory Board coming up.
Vincent Angotti: And Pam, can you also comment on the active versus the control in that trial. So, it will be obviously nafamostat versus.
Pamela Palmer: Versus saline.
Vincent Angotti: Saline. and the primary end point over the first 24 hours is?
Pamela Palmer: Activated clotting time. So, it’s basically a powerful anticoagulant versus saline and then looking at clotting time as your primary endpoint over the first 24 hours of the study. pretty straightforward.
