Serge Belanger: Hi, good morning. A couple questions for us. First on the regulatory front. Regarding the existing CMO, now that they’ve completed the corrective actions and the FDA has acknowledged receiving a close out report. Just curious what the next step is from an FDA standpoint? And coming out of your upcoming meeting with FDA, assuming the first question is answered positively, curious if you’ll get clarity on whether you get a Class 1 or Class 2 resubmission? Thanks.
Joe Todisco: Thanks, Serge. I’m going to let Phoebe comment on both parts of that question. Phoebe?
Phoebe Mounts: Thanks for the question, Serge. As you know, difficult to predict how FDA will react. They obviously have received a lot of material from our CMO. They’re in the process of reviewing that material. Best case scenario, they’re satisfied with the corrective actions and the effectiveness data, and feel that no inspection is required, in which case the issues are closed from an FDA perspective, and the review of the DefenCath NDA would proceed. If you want to know about the worst case scenario, the FDA can decide, it wants to do an onsite inspection to evaluate the corrective actions and the effectiveness for itself. So I think those are the two extremes. Obviously, we believe the company has put together an extremely robust set of corrective actions.
The effectiveness data looks very good. So we’re cautiously optimistic that FDA will agree with that assessment. And in the upcoming meeting, except that we can come in with our primary CMO and the data that we have submitted previously with our primary heparin API supplier, because as I said, there are no issues with the quality of heparin. The Warning Letter addressed another API manufactured its facility in different parts of the facility with different personnel, different systems. So again, we think we have a strong case for a Class 1 60-day review.
Serge Belanger: Okay. And Joe, in the past, you’ve talked about taking a two-pronged approach to potential outpatient reimbursement to TDAPA and the path through via J-code. Any updates on any progress on which path you may take?
Joe Todisco: Yes, look we’ve talked about moving both pathways in parallel, but really we are working to obtain separate payment. It’s our primary objective. In terms of progress, right, I’d say there’s a lot of work going on behind the scenes and as we’re preparing to make those arguments into CMS, but those discussions really can’t take place until we have final approval in hand, right. That’s the point at which we can really engage with CMS. But I think it also kind of bellies our decision to move into the inpatient segment first as the initial stage of our launch because very rarely do you have your reimbursement ahead of approval, right. And I think it’s unique and kind of bolsters our case for moving into the inpatient segment.
Serge Belanger: Thank you.
Operator: Thank you. We take the next question from the line of Joon Lee with Truist Securities. Please go ahead.
Joon Lee: Hey guys, thanks for taking the follow up question. Based on the commentaries that you’re making today, Class 1 seems like a very reasonable possibility, in which case you’re looking at a potential approval in third quarter of the share. How quickly would you be able to launch if it is approved in third quarter and in what form would you be looking to launch, you have some options there. Thank you.
