Drew Ranieri : Gary, maybe just for you to start with. We’ve been getting a few more questions recently on maybe expectations for the upcoming proposed PFS coming up in July. I mean, we’ve talked before about CMS wanting to move to a bundled payment. But I think it might be helpful for, maybe for you to kind of reflect on what might happen if that is the case, if it does move to a bundled payment? I mean, if we look back to when the hospital settings shifted over a decade ago, I think ORGO at the time was a one product company. I mean, a lot has changed over the last decade plus. So maybe just how should investors kind of think about the potential impacts or any type of framework to think about what the bundled payment might mean for you and for the business on top of maybe this proposed LCD?
Gary Gillheeney: Sure. So, I think the bundled payment system is probably the kind of the final step in really putting the final pieces of controlling and managing this market. So it will allow for, I think, more clinically focused market. We won’t have the large swings in ASP that you see out there now. So from that perspective, having a clinical focus, which is where we like to compete, we think is very positive from our perspective and I think positive for the space. That step in the process which may not happen in 2025 with all of these changes, it may move to ’26 or some other period, we don’t know, but it clearly is another piece that’s necessary to actually control the spending in this space. And it will make the bar higher to get into the bundle.
And right now, that bar isn’t very high to get on the market. It will make it a little bit higher, both clinically. And from a pricing perspective, those products are going to have to be priced in the market and not really drive the market or disrupt the market. So, from that perspective, I think the bundle is an important piece. Now it needs to be structured appropriately to provide access, so we’re not eliminating patient access. So there’s some thoughtful design that needs to go into it, but structurally, it’s an important piece.
Drew Ranieri : And maybe just on ReNu, to ask maybe kind of next steps and milestones. I heard that you’re, by the end of May, you’re looking to complete the data analysis. Can you maybe just give a date or time frame in mind for FDA meeting and kind of the path forward of whether the second Phase III would be required or not? Just trying to get a better sense of how you’re thinking about approval, commercialization and kind of really building some commercial momentum maybe into approval? Thanks for taking the questions.
Gary Gillheeney: Sure, Drew. So, our expectation is that we’re going to be requesting a meeting around June 3rd. We expect that we would have a meeting. I believe there’s a 60-day requirement to establish that meeting. So, sometime early August, that we would be meeting with the FDA, and then they have, I believe, 30 days to actually summarize the meeting and the meeting minutes. If that schedule holds by the end of September, we would probably be able to announce the results of that meeting. And we’ll have a better sense on whether we move forward with one study or two studies. If we move forward with two studies, I think as we said before, our expectation is we’d be submitting the BLA in Q2 of ’26 with expected approval in Q2 of ’27.
If we’re successful in only needing one study, and perhaps an interim analysis of the second study, we would cut one year off of those timelines. So, Q2 of ’25 and commercializing in Q2 of ’26 with, again, that one study or one study and an interim analysis of the second study.
Operator: Thank you. We are currently showing no remaining questions in the queue at this time. That does conclude our conference for today. Thank you for your participation.
