Unidentified Analyst: This is for Balaji. You mentioned that it took about 22 months to recruit 990 patients for SHIELD I and for SHIELD II given that the patient eligibility criteria could be different for the 2 trials. What is your expectation on timing of the patient enrollment for SHIELD II?
Dikla Akselbrad: So thank you for this question. We were very clear on that. So we expect that the recruitment time will be 12 months. And this is also what we’ve done here — we’ve also looked at the pace of recruitment of patients in SHIELD I. Those specific, more focused population, what was the pace during SHIELD I and how fast we got to those numbers and extract from that. By the way, we are hopeful that we’ll have a faster rate. Although, again, our assumptions were based on what we’ve seen in SHIELD I, because we need to remember, SHIELD I was completely conducted during the COVID time, which obviously slowed down processes in terms of opening centers as well as patients going and taking surgeries and having laparoscopy test and then getting surgery when needed.
So all of those points have slowed down recruitment. But still, at the end of the recruitment, we had around 250 patients per quarter and close to 45% out of those patients were patients with incision length of over 20 centimeters. So this can give you a sense of what our expectation was in terms of recruitment at the peak.
Operator: . And your next question comes from the line of Roy Buchanan from JMP Securities. .
Douglas Buchanan: I guess just a follow up on the last few questions. Just want to make sure I’m clear on the — what’s the prespecified patient group for the primary endpoint in SHIELD II. Incision over 20 centimeters, are there any other criteria? And then I think you just said, Dikla, but I kind of missed it. So I think you had about 200 patients in SHIELD II and 40 with the large incision, so it implies about 20% with the appropriate criteria? Is that accurate?
Dikla Akselbrad: So first, yes, this is right. We had about 20% of SHIELD II meeting the prespecified criteria or the more focused population that we are targeting in SHIELD II. I’ll just remind everyone that SHIELD II originally had a broader eligibility criteria. It wasn’t just open abdominal colorectal, but also minimally invasive. So it makes sense that you wouldn’t see the same ratio of large incision that we’ve seen in SHIELD I. And this is why in SHIELD I, we had around 45% of the patients having longer incision. And in SHIELD II, with the 200, it’s about 20%. But now that we are focusing the trial based on the FDA feedback, we expect to see this number growing. Now you had another point that you wanted to cover, Roy? Did you get it? .
Douglas Buchanan: Yes, exactly.
Dikla Akselbrad: So same type of surgery, same patient population that we had in SHIELD II, we are just focusing on the subgroup, the prespecified sub group that we had in SHIELD I, which was the longer incision where we received a p-value of 0.0032 and also discussed this with the FDA and the FDA view it as a supportive data and recommended that we add additional data focusing on this group.
Douglas Buchanan: Okay. Great. And then a couple on the interim. On SHIELD I, you had a max enrollment threshold, does that also apply for the unblinded interim in SHIELD II? And you mentioned some blinded assessments prior to the unblinded assessment. Do you have a sense of when you can expect the first blinded assessment to occur?
Dikla Akselbrad: So those are — first of all, there is — the blinded assessments are done internally on an ongoing basis. There is no real point to do that until the point we have sufficient patient where we can actually get some understanding, but this is something that was done in SHIELD I and will be done in SHIELD II on an ongoing basis. It’s something that helps us see that we are within the statistical plan, within the underlying assumption, obviously, there is no blinding here, so nothing about the effect. But an idea about the overall management of the trial and that things are going well. With regards to the interim, we do have, in the interim, the possibility to have a sample size reassessment. I think it is a bit early to go into those details because the blinded assessment, what we are doing is around the SSI or, I would say, the primary endpoint, the understanding of the primary endpoint versus a — overall versus our underlying assumption.
And once we’ll start to see how this is progressing, we can discuss in more detail, but we do have the possibility, if needed, to have a sample size reassessment.
Douglas Buchanan: Okay. Great. I guess — sorry, a couple of more. You had partnering discussions ongoing for D-PLEX100 previously. Are those pretty much continuing? Or do you kind of have to hit reset with the SHIELD I data? And then what about OncoPLEX, what about partnering that? It seems like it’s going to be kind of on hold for a year or more as you deal with D-PLEX100? Is that true any way to get that advanced maybe more expeditiously?
