Laura Niklason: So as part of the BLA filing, we are going to apply for priority review, which, as you may know, would entitle us to a six-months review period in PDUFA date as opposed to a standard 10-months, which is more typical for biologics. So, it’s my understanding that once we file that within 60 days, the agency comes back to us with the acceptance of the file and also with a determination at that time as whether or not they’ve granted priority review. So, I would expect 60 days after we file, we’ll know if we have a priority pathway. Again, I would hope and expect that we do because of the RMAT and also because of the priority designation from the Defense Department. The priority review provides a speedier review process.
I’m not sure that it really changes the amount of interaction you have with the agency. Certainly, once you file a BLA, the amount of interaction and the back and forth and the discussion is always really robust. So, I think it’s more about speed.
Unidentified Analyst: Understood. That’s great. And then sticking with vascular trauma, with the target you have here submitting the BLA in 4Q, could you tell us what steps remain for the process before you actually make that submission?
Laura Niklason: Well, without providing too much detail that we haven’t provided already in a public forum, I can say that a BLA is thousands of pages and that it’s a complex document. But I can say that much of the BLA has actually been largely ready for some time. Our Module 3, which is really the description of the manufacturing pieces, has been in a fairly final form for many months now because we transitioned to our commercial stage manufacturing actually in 2021. Also, our preclinical work is essentially — has been done for years practically. And that’s Module 4. So, there are really five modules to the BLA. I would submit that two of them have been done or mostly done for a while, and it’s really about wrapping up the clinical modules and some of the labeling. So, we do not anticipate that there will be any difficulties filing this quarter. We see ourselves as completely on track.
Unidentified Analyst: Understood. Thank you for that, and thank you for taking the questions.
Operator: Our next question comes from Matthew O’Brien of Piper Sandler. Your line is open.
Unidentified Analyst: Hi. This is Samantha on for Matt. We just have a couple of questions for you. I guess, first off, we were wondering if you thought about providing humanitarian efforts during the Gaza conflict like you have in the past?
Laura Niklason: Yes. That’s a very interesting question. I think it’s an excellent question. It is a topic that’s come up amongst our leadership. In the Ukraine conflict, we had surgeons reach out to us and ask for access to the HAVs as part of treating patients who were injured in the conflict. To date, we have not yet received any request from surgeons in Israel along these same lines. I think it may be that the Israeli healthcare system is perhaps better equipped to handle the casualties that they’re seeing. I honestly don’t know. Certainly, if we had requests come in inbound from surgeons in Israel, we would certainly consider them and work with our regulatory and clinical teams and work with the FDA to consider those requests.
Unidentified Analyst: That’s great. Thank you. And then, I guess, on another note, maybe you could talk a little bit about launch preparations that are ongoing for the HAV, maybe in terms of hiring sales reps and how you anticipate launching this product?
