Operator: Your next question comes from the line of Gregory Renza from RBC Capital Markets. Your line is open.
Gregory Renza: Forward to the decision coming up and…
Joseph Todisco: Hi, Greg, can you start over? Can you start over? We didn’t hear the first part of what you’re saying?
Gregory Renza: Yes. Just adding my congrats on the progress, Joe, and I just mentioned that we’re looking forward to tomorrow or the decision coming up. And maybe, Joe, just my question, maybe to build on some of your mention of the potential government shutdown. I just wanted to ask if you’re considering certainly on the eve of a potential decision or approval, any other macro factors that are part of your consideration in the strategy to really roll out DefenCath. It’s helpful to hear about the government proceedings, but also if it comes to the labor and the hires and even some of the stakeholder engagement, to what extent are you now considering it now that we’re sort of at the doorstep of a potential approval here? And then I have a follow-up.
Joseph Todisco: Look, as I — thanks, Greg, and I appreciate the congratulations. And as I somewhat mentioned in the prepared comments, we’ve been ramping up and accelerating over the past couple of months. I’d say since we got visibility of the inspection, you’ve likely seen us posting a number of hires, adding new roles, continuing our engagement with key stakeholders. So the government shutdown if it happens, it will be unfortunate. I think we were talking today about the longest shutdown that’s happened is only several weeks. So we don’t think that it’s going to be overall devastating, but hopefully, it can be minimized by the government and nothing more than a blip if it does happen at all. But we’re just focused on operational execution right now. Assuming a positive, we get a positive outcome from FDA tomorrow, we’re doing everything we need to be doing to execute on our launch plan.
Gregory Renza: Yes, that’s great. Very helpful. Maybe just one quick one, just coming back to the clinical value proposition and also the ability for DefenCath to really be the first approved product in this area. Just remind us of that value proposition, really what the landscape looks like when it comes to infection prevention. And I’m just curious how you sort of think about the practice and care standard variability out there and how this could be a solution in the space? Thanks so much and congrats. Looking forward to tomorrow.
Joseph Todisco: Sure thing. Thanks, Greg. I appreciate it. Certainly, our Phase 3 clinical results demonstrated in our primary endpoint, a 71% reduction with risk associated with CRBSI for hemodialysis patients with CVC. There is nothing currently FDA approved as a drug product for the prevention of CRBSI in this patient population or in any patient population for that matter. So this truly is a first-in-class therapy. As you point out, we were looking to change the paradigm from one where infections are treated after the fact, right? You have a disease state with an incredibly high incidence rate, we’ve got upwards of 1/3 of hemodialysis patients with a catheter will get a CRBSI. Half of those infections happen in the first 90 days that they have a catheter, so they happen fast, they happen frequently.
And they’re fatal 25% of the time. So I would say that this is absolutely a critical unmet medical need. And we’re looking forward to providing this option for prescribers and physicians and health systems for their patients.
Gregory Renza: That’s great. Thanks again.
Joseph Todisco: Thank you.
Operator: And at this time, I would like to turn it back to Dan Ferry from LifeSci Advisors for additional written questions from the audience.
Daniel Ferry: Thank you, operator. Joe, we have a few here from the audience that were written in here. The first one is, you mentioned that the company is pleased with the outcome of the PAI, preauthorized — preapproval inspections. Can you elaborate what is meant by that?
Joseph Todisco: Yes. Thanks, Dan. And I assume that’s directed at the preapproval inspection for the — for our primary CDMO, which we’ve announced is ROVI. Yes. So typically, when an inspection concludes, it takes about 90 days for an EIR issue, and we’re still waiting on that EIR. But we’re very happy with the way the inspection progressed at the close of the inspection. The inspector verbally communicated that she’d be recommending voluntary action indicated status. And if you’re familiar, it means that they will allow — new approvals can proceed from that facility. Also, I’d say, over the last couple of days, our manufacturing partner, ROVI, recently announced that another sponsor received approval of an application of a registration from the same facility where we intend to make DefenCath. So from a compliance standpoint, that gives us a lot of comfort.
Daniel Ferry: Okay. Great, Joe. Just a few more here. You described during the call a potential launch in Q1 2024. Can you give some color regarding, one, what investors can expect to see some revenue? Two, what metrics CorMedix intends to report related to the launch in the form of maybe hospitals or patients? Can you give us some color here?
