Pete Mariani: Yes. It’s – this is mainly about rep productivity. We continue to believe we have a lot of opportunity to drive growth through rep productivity in our accounts, these reps have been in their accounts, most of them have been in accounts for years now. And we’ve got good connections with surgeons, good connections with the support staff within the hospitals and their ability to continue to drive growth along with the data that we’ve come out with recently. I think allows them to continue to drive their own increased productivity and do so within their core accounts. And so we could see a mix of both increase of core accounts as well as revenue per core account across 2023.
Kyle Rose: Okay. Thank you. And then obviously, the ramp of the manufacturing facility and the submission and eventual regulatory decision on the BLA, those are big milestones for the company. So I’m just wondering, can you frame out any interim, I guess, things that need to happen along the way before your manufacturer is fully up certified and running? And then also similarly on the BLA filing, just making sure that investors understand all the milestones over the course of the next, call it, 2 years?
Karen Zaderej: Yes. So we are initially transitioning Avance into the new manufacturing facility as a tissue product. So that’s the first milestone, and that’s the work that we’re doing right now. So that transition will be completed here in the first half of the year. We then revalidate as a biological product. And I know that sounds like double work, but we did spend a lot of time in conjunction with the FDA trying to figure out the best way to do this validation and decided a two stage validation, just made it cleaner. So we will revalidate the facility as a biologic. Again, there’s no specific process changes, but the data on how you gather data is different between the two validations. That’s probably the biggest milestone for filing the deal – what is the long lead time item and the biggest milestone for filing the BLA yet this year.
We do expect to get the BLA completed by the end of the year and submitted. And then it’s into the FDA process. So I’m not sure that there will be milestones that we can really see until they come.
Kyle Rose: Great. Thank you for taking the questions.
Operator: Our next question is from the line of Ryan Zimmerman with BTIG. Please proceed with your questions.
Ryan Zimmerman: Good morning. Karen and Pete. Thanks for taking my questions. Just following up on Kyle’s question about the BLA. I just want to understand kind of your confidence level in getting the BLA. And after it’s submitted, is it – remind me, is a 180 days that they have to respond? How long just as we kind of think about ’24 and where that could come in?
Karen Zaderej: Yes. So confidence is we passed our primary – our endpoint in our pivotal study. So we feel pretty confident in this process. Now there’s a lot of information that we are compiling and providing to the FDA, including this manufacturing facility, but we’re far enough along in the manufacturing facility. I feel very comfortable that it’s – while it’s a big project, it’s just making sure we have all the documentation right. The – actually the facility is beautiful. So we think it will be a very effective biologics processing center. In terms of the submission time, I’m going to hesitate a bit. We do technically have the RMAT designation, which gives us an accelerated review. I’m not – I think we have to be flexible on that because I’m not sure all the timings have been as accelerated, but FDA has been catching up. So if we get that, then we should see something with a six month clock. If not, it may be a little longer.
