Jula Inrig: Yeah. Thanks, Joe. Just to clarify you’re correct. We have greater than 90% power to detect a difference in slope of 2.9 mL per minute per year with 380 patients. And that’s how we originally powered the trial that was based on historical data and you’re correct achieving at least a 30% difference in proteinuria which we did achieve. So we now have additional data as you pointed out the interim analysis for example, our interim data and we achieved a 41% relative reduction in proteinuria, which was as you said greater than we predicted. So we did conditional power calculations based on the available interim eGFR data as well as trial-level analysis, which gave us a high level of confidence that will achieve a clinically meaningful and statistically significant effect at two years and this data did support our accelerated approval.
I did want to clarify one thing is that we didn’t repower, but we did over recruit. So we do continue to have a high level of confidence that we will achieve both clinically meaningful and statistically significant effects. And I will just also add that, yes, I don’t think we need to hit as high based on the additional data of what we originally powered on. It’s based on the treatment effect and variability. But we remain highly confident that we will hit statistical significance at two years.
Joseph Schwartz: Thank you very much.
Operator: We will take the next question from the line of Maurice Raycroft of Jefferies. Maurice Raycroft, your line is open.
Maurice Raycroft: Hi. Congrats on the progress and thanks for taking my question. I was wondering what are your latest thoughts on FILSPARI revenue for the full year 2023 as it relates to the consensus number for the year which you’ve commented on in the past. And also wondering separately what feedback you’re getting related to REMS and REMS implementation? And how is this impacting access or PSF conversions?
Eric Dube: Maurice, thanks for the question. Why don’t I start with the FILSPARI revenue for the full year. I think we’ve been very pleased with what we saw in the first half. And I think with the demand that we are seeing generated launch to-date that we fully expect to see an acceleration of revenue in the second half of this year. With consensus, I think, largely in line with how other first year rare renal sales have gone, we think that we’re in a good position there. So I think that we believe that we’re going to see a strong second half of the year including some of the potential seasonality in the summer months that we’ve seen with other rare renal launches to date. So I think we’re well-positioned for a strong launch.
And again, this first year is really about setting the foundation for us to become a blockbuster in the foundational therapy in the treatment paradigm. I’ll turn it over to Peter to give some feedback on what he’s hearing in terms of REMS certification and what this means for conversions.
Peter Heerma: Yes. Happy to do so Eric. And Maurice thanks for the question. I would say, let me start by referring to the demand that we were able to generate for FILSPARI in the first half. These 563 patient start forms are generated considering the REMS program. And what we are seeing is that when the physician appreciates the strong efficacy and safety profile of FILSPARI in combination with the urgency to treat, the doctor will have the conversation with his or her patient that is at risk of rapid progression. And so I think it really comes back to focusing on the long fundamentals Eric was talking about building the foundation in the first year the first six months to nine months that we have outlined before. So this comes back to really like educating the nephrology community on FILSPARI’s efficacy and safety profile and novel mode of action as well as ensuring a positive first experience.
