Alex Thompson: Great. Thanks for taking my questions and congrats on the progress. I guess, two for me. Firstly, on the QD formulation, I wonder if you could comment on what has been driving the delay here from the midyear update to Q4 and how much more buffer you have to get a QD formulation for Phase 3 studies next year. And then for the two Phase 2s for ulcerative colitis and psoriasis, I wonder if you could comment on whether discontinuation rates are tracking within your expectations? Thanks.
Raju Mohan: Yes. So outside the disclosure of the data, our goal is always to complete the development by the end of the year, Alex, and leave ample buffers. So you got ample buffer to complete the prototype development. The real actual selection of Phase 3 QD tablet happens after the data comes out from Phase 2 to understand exactly where we line up with the doses and dose for Phase 3. So we’ve always built that in. There’s plenty of buffer. Now, as we outlined in the R&D Day, when we introduced the program to you guys that we had a strategy that sort of iterative process you build and test in humans or establish a relationship between the ER dose, ER prototypes and the IR dose across multiple formulations that we’re doing and testing them in human studies, right?
It’s really important for us to get it nailed, to have the right final formulation, before we begin to make disclosures, as we expect, this formulation will be the drug that we take into Phase 3, and that’s the goal and some reg approval, clinical trial work all worked out. So first of all, there’s plenty of buffer. We always plan to get this done by the end of the year, in time with the Phase 2 data coming out, and then use that prototype to then actually get the actual tablet manufactured, regulatory stability ready for Phase 3 start. So there’s no impact on Phase 3 start. And so we’re really confident in the process. We believe we have progress towards achieving the target profile. But honestly, we recognize that our earlier timing of data release was probably a little overoptimistic.
So we’re looking forward to sharing more details with you in Q4. But the key emphasis is there’s no impact to Phase 3. We always build in the buffer. And that includes manufacturing, regulatory stability, packaging and mailing. So just stay tuned for an update somewhere between now and when we have the Phase 2 data, probably closer to more of — when the Phase 2 comes out.
Alex Thompson: And on the discontinuation rate?
Bill Sandborn: Yes. So I think it wouldn’t be appropriate to give granular, really clinical trial data which was what a specific conversation about that would be. What I would say is these are both sort of shorter-term or induction trials, if you will. The ulcerative colitis trial is 13 weeks in duration to the primary endpoint. And the psoriasis trial was 16 weeks. From a interpretability standpoint, what is typical from a statistical standpoint is if you have patients that discontinued therapy prematurely, and typically both ulcerative colitis trials and psoriasis trials will have some of those, for the dichotomous outcome measures, the patients with missing data are treated as failures. So you actually don’t lose any statistical power in the analyses with any patients that do require discontinuation. So I think we’re well set up in a very conventional fashion to manage any patients that would discontinue, but we won’t make any comments beyond that.
Alex Thompson: Great. Thank you.
Operator: Thank you. Our next question will come from Vikram Purohit with Morgan Stanley.
