In fact, we will be in Washington next week. And so the starting point, Andreas, is the 107,000 folks who died of a drug overdose. There’s different ways that this can be established. We’re talking to folks about — can we think about approving a 2024 start for folks who currently have a C code or a J code and approving them for 2024. And then if you need more time for new folks who might be reimbursed make that a 2025. But those — those are the things that we’re working on right now in real time. I don’t know how to handicap that, other than the chance there’s a better than a zero chance that we’re going to have a positive outcome here, but that’s the best I can tell you as we sit here in February. On the extension, I mean, you guys probably know Chris Christie is on our Board.
And what Chris said to me when we were talking about the timing here is that the government never takes anything that’s working back. So, we have a — what was in the bill was a five-year horizon. It was trimmed back to a three-year horizon. I would tell you that we’re pretty comfortable with that, given the fact that we think that this is going to be a major change and improvement in health care, and that will be very, very difficult for the government to take this back after three years, but we’ll find out. We’re pretty good at working with them too, to show them the benefits. We’ve been able to maintain the ASC reimbursement now since 2018. So, I think we know how to do all these things with the right people representing us in Washington.
Andreas Argyrides: Okay, great. And then just a follow-up on lower extremities. To what extent would the results from the STRIDE study be factored into the FDA here?
Dave Stack: The data is included. The question is, yes, it’s a compilation of both, Chris. The STRIDE study, while it missed its 24-hour endpoint, was the first indication that we had, that we had a p-value of 96 hours. So the difference here in demonstrating even a larger data set to the regulators is that if you take care of the front end, and you use the standard of care that addresses pain in the first 12 to 24 hours, that we can extend the duration here. And that’s what the whole strategy was around the clinical program. So, we will include both of these data sets and the package that goes to the FDA.
Roy Winston: The other thing too is in the STRIDE study that those patients all had a general anesthetic. So when they woke up and actual takes a little longer to set up than the bupivacaine comparator they had. And we never positioned EXPAREL ever as something to help you during the surgery, right? It’s really for postoperative pain management. So that’s why we evolve the next two studies to be patients having regional anesthesia for the surgery, which is really the standard of what’s practice out there today. If you’re having bunionectomy, ankle or a total knee, most of those patients are being done with regional anesthesia for the anesthetic, little sedation along with it and not a general anesthetic. So, I think when you look at the STRIDE study days two, three, four, we demonstrated, again, not the primary endpoint, but we did demonstrate really meaningful pain reduction that was superior to the active comparative bupivacaine for 24 to 96 hours, if that makes sense.
Operator: Our final question today comes from Greg Fraser of Truist Securities. Your line is open. Please go ahead.
Gregory Fraser: On spasticity, can you talk a bit more about the design and size of the registration study? Will that study include or will that not come until the later study? And then on the gross margin, can you quantify the impact this year on the guidance from 340B pricing or discounting program? And how much growth do you need to see in volume over time to get to your longer-term target of mid-80s?
