Dale Sander: Yes. Yes, I think we’ve indicated with a relatively concentrated market in level one trauma centers. There are up 200 of them within the United States that we expect the sales force somewhat less than 20 to be able to reach that market. In terms of when that group will be brought on the exact sizing will be probably more specific around that as we get closer to launch. But much of the infrastructure for the sales team is being built right now in terms of the management of that team and complementing our current commercialization group in terms of the actual sales reps. They will be brought on much, much closer to the exact time of approval as opposed to too far in advance. We’ll make a decision as to whether that entire team will be brought on day one to accommodate the launch or whether it will be layered into one or two segments that facilitate the launch that way.
But those are decisions that are under active discussion right now, and we’ll decide as we get close.
Unidentified Analyst: Understood. Thank you. And just one last quick one for me. The NTAP cycle, do you guys believe it’s going to be a 2025 event or 2026? Thank you for taking our questions.
Laura Niklason: So based on the revised rules for when you can file an NTAP application, our earliest that we can file will be October of this year. Typically, decisions are made a couple of quarters after that. And – but then the NTAP reimbursement would be scheduled to kick in, I believe, to the best of my knowledge in October of 2025. Again, we expect an NTAP application to be successful, but the – our earliest date when we can apply is this October.
Operator: Thank you. Our next question is from the line of Allison Bratzel with Piper Sandler. Please proceed with your question.
Allison Bratzel: Hey. Good morning. Congrats on all the progress and thank you for taking my question. Really just one for me. A follow-up on the dialysis vascular access setting. Just on the V007 trial reading out in Q3, could you just remind us kind of what you see as the bar for success that would lead to the HAV being widely adopted for dialysis access. What do you hope to show when that trial reads out? And then just related, how does the ongoing trial in female patients just play into your plans for filing and commercialization in that indication? Thank you.
Laura Niklason: Yes, Allison, thanks for these questions. So again, the V007 trial is a prospective randomized blinded trial that compares the HAV to Fistula in a broad range of patients at more than 20 sites in the U.S. So the primary endpoints for this trial are looking at usability for dialysis and patency at six and 12 months, and this is a superiority trial. Again, we are blinded, and we don’t have topline, so we don’t know how it’s going to go. Obviously, our goal and our hope is that across the board, we will have superiority across the whole trial and for all patient groups. However, it’s possible that we would have subgroups that would show more superiority or increased beneficial effects as compared to other groups.
Again, it’s very hard to predict in advance of the data. And so I don’t want to give specific guidance here, but I would hope that if we had superiority in either across the trial or within a subgroup, that, that clinical data in combination with an already approved HAV product in the trauma indication, our hope that would be – that would be sufficient to file a supplemental BLA perhaps sometime in 2025 for the dialysis indication. As far as the female-only trial, that’s a trial that we’ve very newly initiated that really focuses on – it’s a smaller trial, and it focuses on women comparing the HAV to fistula in women. And again, we’re going to be discussing this more at the KOL event next week. And so I don’t want to get ahead of the information and the story here on this call.
But again, based on our health economic data and looking at the complications that are suffered by dialysis patients, it’s become clear from our work with Frenova that women in general, and there are certain subsets of women that have extraordinarily high complication rates and are extraordinarily expensive system. And we believe that the Frenova data in combination with additional data that we’re going to get on our clinical trials will really help make the health economic case around the HAV in female patients who have very high complication rates.
Allison Bratzel: Excellent. Thanks so much.
Operator: Thank you. Our next question is from the line of Vernon Bernardino with H.C. Wainwright. Please proceed with your questions.
Vernon Bernardino: Hi, Laura and Dale. Thanks for taking my question and congrats on the progress. Definitely looking forward to the approval later this year and launch. Just wanted to follow-up on a few questions. One of them being the expenses rising according to what you said, Dale, this year. You anticipate more – you said there’s probably going to be a ramp down as far as R&D maybe. And so therefore, maybe most of the ramp-up and OpEx would be from G&A? And do you anticipate that will be mostly heavily weighted towards the back of the year, of course, because that’s when the expected launch would be? And then I have a follow-up question.
Dale Sander: Yes, you’re right. Much of – I mean we do have a very meaningful commercial team in place right now, which is undertaking much of the activities that are longer lead time to get ready for a successful launch. And those include the budget impact model and the applications for ICD-10 codes and other activities like that, that are ongoing, but much of the heavy increase in terms of commercialization expenses will come in the second half of the year with the addition of the sales force. And you’re right, there is somewhat of a wind down of certain R&D expenses in part because certain of the clinical trials are winding down and also in part because everything we do from a manufacturing point of view kind of rolls into R&D expense to date.
