Gary Gillheeney: Sure. So if, in fact, our phase €“ our first Phase 3 trial with the 200-patient study was accepted, we would expect BLA approval in the first half of 2025. To answer your question, if the second study is required, which we are initiating, our next submission €“ or discussion rather with the FDA would be to use the first Phase 3 trial and the interim analysis of the second Phase 3 trial. And if accepted, that would be a BLA approval in Q1 of 2026. If the second trial has to go all the way through the end for 100% efficacy data, we are looking at the second half of 2026 for BLA approval.
Ryan Zimmerman: Very helpful on that. And then if I could squeeze a couple more in.
Gary Gillheeney: Sure.
Ryan Zimmerman: Competitive pressures, I think, were supposed to abate after the fourth quarter. CMS published a number of new products into the first quarter, yet they are persisting into 2023. And just help us understand kind of the line of sight and your current thinking around what happens now in terms of competitive pressure. Do you think this gets better over one more quarter, the entirety of the year? Just curious to get your perspective there.
Gary Gillheeney: Sure. So CMS did publish 41 additional products on the list. I believe they have removed several, which has created some confusion. And I think just the whole process has created confusion, which is why we still see €“ expect to see some impact in the market clearly in the first quarter. Now if CMS publishes the rest of those products, we would expect to see that competitive impact start to get much better for us once that information is absorbed in the market. But one of the other trends that we’re seeing is even with the competitive noise, we’re starting to see some of the customers actually, even with those rebating programs out there, reverting back to some of our technology because perhaps they are not getting the results.
So we’re starting to see some improvement in just recruiting those customers back. And as we launch on a national basis with Affinity and now XT, there is €“ you have that competitive noise in accounts that we haven’t been in with those products. We’re starting to see some inroads a little earlier. So that tells me that clinicians are seeing the benefits of our products and perhaps not so much in some of the other products they are using on the dehydrated side. So we think it gets better, Ryan. We think it gets better because efficacy is going to win. We think it gets better because eventually, some of these others will get published. So to answer your question, we think it improves. But right now, it’s €“ we see it €“ the noise is the same and the confusion is the same.
Though our trends in 2023 so far are encouraging.
Ryan Zimmerman: Right. That’s helpful. And then €“ and I apologize, I’m bouncing around a little bit here. But the last question for me, and I’ll hop back in queue, given the guidance on the top line, implied expenses are up modestly, but there is €“ I mean they are essentially in line with kind of where your sales are, and I know some of these are non-cash. But that said, how are you thinking about kind of your spend into €˜23? And what are your levers to control that and get a little bit more adjusted EBITDA, net income? Because it is going to be down year-over-year based on the guidance.
