Stuart Arbuckle: David, so kind of building on what I said about this being a disease state which unfortunately for patients is characterized by polypharmacy and so patients are often seeking superior pain relief to what they are getting. It is heavily influenced and/or treated by specialists for DPN and indeed for LSR as well. And so for both of those pain states within PNP overall, we believe we can achieve success commercially with a specialty sales force as a result of wanting to go alone commercially we’re going to be doing the studies in DPN and hopefully in LSR Phase 3 studies are successful in Phase 2 ourselves as well.
Reshma Kewalramani: And David to round it out with your questions on acute pain. We have thought through very carefully as we did in the Phase 2 portion of the study, the same in the Phase 3 portion of the acute pain studies, about the use of rescue medicines and how to consider the statistical analysis plan in that light. And there are, it’s been very well considered in there. So I don’t have much more to say other than the use of rescue medicines, of course, will be disclosed in the publications and when we share the results. But how to think about it has been deeply considered and well accounted for just as it was in Phase 2. I think there was a question in there about Phase 3 and the peripheral neuropathic pain structure.
I’ll focus my comments on DPN. That one will be designed with the FDA. We haven’t yet had our end of Phase 2 meeting, and therefore I can’t give you specifics on what that program will look like, but that’s exactly what will be the next step once we have the Phase 2 DPN results, assuming they are positive.
David Risinger: Thank you.
Reshma Kewalramani: You bet.
Operator: The next question will come from Evan Seigerman with BMO Capital Markets. Please go ahead.
Evan Seigerman: Hi all, thank you so much for taking my question and congrats on the progress as always. I wanted to talk about the implications of the recently released UK NICE appraisal of TRIKAFTA, essentially indicating that was not cost-effective for the UK system. So, that was under the impression that this was settled in 2019. Could you maybe expand on the impact to UK franchise and steps to resolve to ensure access in the UK? Thank you.
Stuart Arbuckle: Yeah, Evan, so the first thing I’ll say about the ongoing NICE review is that, this was an expected part of the contract that we negotiated with the NHS in 2019, so this isn’t a surprise that NICE is reviewing our medicines after four years on the market. So that’s the first thing to say. As a part of the original contract, we agreed with the NHSE and with NICE that we would collect and submit data after a period of being on the market. And we have done just that. We submitted clinical trial data, open label extension data, and real world data from the UK. And I think it’s unusual, I think, to see a medicine, which is what I think we’ve seen with TRIKAFTA that performs perhaps even better in the real world than you expected having seen the Phase 3 results, because the results we’ve seen in the real world, as you well know, are absolutely extraordinary, including things like reductions in exacerbations, increases in life expectancy, reductions in hospitalizations, a virtual elimination of lung transplants.
So we’re pretty disappointed it’s fair to say with the draft guidance from NICE. It is just that though, it’s draft guidance. There was a period of consultation. There’s going to be a second NICE committee meeting, and I certainly feel confident that the full value of our medicines will be reflected at the end of this process.
Evan Seigerman: Great, thank you.
Operator: The next question will come from Liisa Bayko with Evercore ISI. Please go ahead.
