Karen Zaderej: Yeah. No, great question. And I think a number of years ago, we did have some challenges, in particular, in OMF, and we certainly learned from that. So today, if I can remind you that today, we have a specialty team that addresses the breast neurotization. Given the complexity of that technique, we’ve decided they still need to have specialists who address that with the surgeons. And as far as the full-line reps who deal with both trauma, OMF, the surgical treatment of pain and compressions, that means, that their call pattern is really focused on hand and plastic surgeons and the oral maxillofacial surgeons. That’s their primary call point. So they still have a focused call point within our core accounts.
And so far, we’ve been really pleased with their ability to balance all of those and make sure that they’re both supporting the planned cases in their core accounts as well as being available for emergent trauma, where a surgeon needs to move through that algorithm. And they’ve been actually quite successful at seeing growth both in, again, OMF and pain as well as continuing to move through the algorithm adoption of the mixed and motor nerve. And so I think we’ve got the right formula here and the right balance of resources.
Chris Pasquale: Okay. That’s helpful. And in the BLA timeline, it looks like it’s been pushed out by about 6 months. I think last quarter, you were targeting submission by year-end. Now we’re looking at completing the submission in 2Q of next year. Is that all the facility? Or are there other issues that came up?
Karen Zaderej: Yeah. Well, first of all, just to remind, we’re a little different than any other submission in that we are commercializing at the same time we’re doing this regulatory submission. So speed is not as critical for us as it is to make sure that we are doing things in a methodical way. And one of the options that’s available for a BLA submission is to do what’s called a rolling submission. So you take the various modules and submit them on different dates, which allows you to space out the interactive Q&A session that you have with the FDA so that you’re not dealing with all the topics at one, but you might be dealing with clinical in one time period and then CMC in another time period and your non-clinical in a different time period.
And just given the workload of that Q&A session, we decided it was prudent to go ahead and ask for a rolling submission. We’ll get confirmation from the FDA following the pre-BLA meeting that we have in the early part of 2024. But anticipating that they are going to accept that, it would extend out the submission period because of doing that rolling submission.
Chris Pasquale: Okay. Thank you.
Operator: Thank you. There are no further questions at this time. I would like to turn the floor back over to Karen Zaderej for any closing comments.
Karen Zaderej: Thank you, Darryl. And I want to thank the AxoGen team who’ve remained committed to our mission of improving nerve function and quality of life for patients with peripheral nerve injuries. We’re happy with our progress, and we remain focused on ensuring our long-term success. I want to thank everyone for joining us this evening, and have a great day.
Operator: Thank you. This does conclude today’s teleconference. You may disconnect your lines at this time. Thank you for your participation, and enjoy the rest of your day.
