Jonathan Aschoff : Okay. And just two quick boring questions. With the top and SG&A in the fourth quarter, what — can you help us out, what does SG&A look like for 2024?
Chad Kolean : Total expense I guess, for SG&A alone. I’m going to defer that a little bit until we actually look at that breakdown a little bit more. I don’t think you’re going to see much of a change in the trend as we go into ’24 from what you saw in the fourth quarter, to your point. We won’t see that really change dramatically until we get later in the year.
Jim Caruso : And so what I’ll add to that Jonathan — yeah, what I’ll add to that, Jonathan, as you kind of think about how we would invest in the WM space. Shane is building out a very targeted organization and where you would typically see, I think, an OpEx for a commercial specialty launch in early years when you’re really driving trial use and adoption this kind of $50 million to $70 million OpEx. I believe, Shane has a targeted — very targeted focused strategic plan that we really like leverage with smart data. And Shane, I believe that’s in and around a $25 million.
Shane Lea: Correct.
Jonathan Aschoff : Thank you very much, guys.
Jim Caruso : All right. Thank you, Jonathan.
Operator: Thank you. Our next question comes from the line of Jeff Jones at Oppenheimer. Please go ahead. Your line is open.
Jeff Jones : Thank you, operator. And congrats on the great year guys and all the progress you’ve made. I guess, starting off on — following on what Jonathan was asking on sort of the operational G&A program. Can you speak to how — what’s your thinking about in terms of the commercial organization at launch for sales rep MSL structure?
Jim Caruso : Sure. I’m going to turn that over to Shane and his team that have done just a really nice job from a preparation perspective. As you know, Jeff, I’ve spent a lot of years in commercialization space and marketing in both large multinational pharmaceutical companies as well as small biotech. And Shane has done as good or better of a job that I have historically observed in the past. So I’ll let give him an opportunity to kind of talk through some of his thinking.
Shane Lea: Yeah. Thanks, Jim, and thanks for the question. When we look at the build of our go-to-market model, it’s really focused on two things, right? One is what are we doing to influence brand choice, building awareness, leveraging the key attributes for Iopofosine and the second piece of it is more operational in nature as we think about how do we target our efforts in the right locations, especially since this market is very concentrated. And the other key piece of this is focused around the radiotherapy enablement process. So looking at the opportunity. We want to make sure that it’s one which is very targeted in nature and one which is also scalable. And I believe that we have the opportunity to do that since it is a concentrated market.
So when you look at the go-to-market model, we’ll have roles, which will help to support the pull-through of those two key things. First, having proper marketing capabilities, proper data capabilities to help drive choice and decision making. We will have a team, will be dedicated to the site activation and radiotherapeutic enablement process in these very targeted accounts. And we’ll have a traditional sales role, which will be focused on driving trial and use and building awareness. Also supporting those teams will be a focus group in the sales to support medical information inquiries and provide further enrichment and education around Iopofosine. And we also have a dedicated team that will be supporting all of our market access initiatives.
We want to ensure that in our focused approach, we leave no patient behind because there is significant unmet need in this space. And we believe with Iopofosine’s profile, we have a unique opportunity here to capture share in all of these key segments of the market, which we’ve illustrated as part of the shared basket slide that you saw today.
Jeff Jones : Thanks, Shane. Could you speak to how you’re looking at Europe, both from a regulatory and commercial perspective?
Jarrod Longcor: Absolutely, Jeff. For those that may not recognize my voice, this is Jarrod. So from a — let me start from a regulatory perspective. As I think many folks are aware — last year, we did receive PRIME designation in Europe. The PRIME designation for Europe is essentially the equivalent of like the breakthrough designation here in the U.S., it does provide you with increased engagement with the agency, it provides you with a more rapid pathway to launch, and it provides actually encourages the cross communication between those two agencies. So EMA and FDA actually behind the scenes start to align and get their sort of requirements in harmonization with one another for the same product. With that said, so that sort of feeds that up.
Our timeline or our expectation is that we will push forward here rapidly with the EMA to rapidly follow approval in the U.S. It won’t be at the exact same time as the U.S. launch, but we’re in discussions right now to determine exactly what that timeline will look like in for European launch. Now with that said, we, as Cellectar are do not plan to be the party to commercialize in Europe. What we are looking to do and what we have a number of ongoing discussions with various partners is to have a partner take over the commercialization and functionality of the product in Europe. We will continue to control the sort of supply chain and make sure that they receive product as necessary, but they will be the drivers for the commercialization.
Jeff Jones : Great. Thank you, Jarrod. I guess last question for me, and you spoke to it a little bit really providing some interesting data on the diversity of therapies used by line in these patients. So any update on your thinking about the label indication you would propose to the agency being at third line plus BTKi refractory, et cetera?
