David Luci: Yes. Well, so it will subject to the data. If the data holds the way the ibezapolstat data has been trending, the people that write the guidelines, the IDSA treatment guidelines suggest the next approved drug to treat C. diff that comes out that makes the recommendation list is going to kind of mean the twilighting of oral vancomycin similar to how metronidazole was twilighted a couple of years ago and is no longer recommended. So that’s kind of where the intelligencia is in the C. diff space. You’re quite right, ridinilazole didn’t make it. There have been a number of things that haven’t made it down the line, fecal transplant, stuff like that. But we think that we would be used frontline, fidaxomicin isn’t a bad drug.
It’s — in my view, it’s better than oral vancomycin in a lot of ways but it’s so prohibitively expensive. And with the Medicare and Medicaid reimbursement rules, it’s therefore used last line. And we don’t expect that to change. And remember that, that’s not a QIDP drug fidaxomicin, was approved before QIDP was a law. And therefore, it wouldn’t qualify for things like the DISARM Act which was put branded antibiotics on equal footing with generics so that hospitals could use the best antibiotic frontline instead of the cheapest antibiotic frontline.
Operator: Our next question is from Ed Arce with H.C. Wainwright.
Unidentified Analyst: This is Thomas asking a couple of questions for Ed. So first, regarding the Phase IIb study, just wondering will patient screening and enrollment continue while the interim review is ongoing?
David Luci: No, I don’t think it will. We’ll put a pause. In other words, we won’t terminate the trial. We’ll put a pause on further enrollment while the evaluation is happening but we don’t expect the evaluation to take a long period of time. It should take a few days, not an extensive period of time.
Unidentified Analyst: Right. Got it. Okay. And then another question on the Phase IIb specifically for the IDMC. Can you tell us how long is this go and the background, does it include anyone with regulatory experience?
David Luci: Absolutely. It’s folks in microbiology, statisticians, significant clinical development. It’s quite a star-studded team. And if you’d like to find out more details about their CV information, we could certainly have an off-line conversation about that and I’m sure we can make you comfortable. It’s a powerful group.
Unidentified Analyst: Okay, sounds good. And then perhaps one last question, the most — you outlined the $11.3 million grants that was filed over. Is this a CARB-X grant and if not, do you give us any other details were space?
David Luci: Yes. It is a CARB-X grant.
Unidentified Analyst: Okay, got it. Thank you so much for taking our questions and looking forward to the Phase II update.
Operator: Our next question is from James Molloy with Alliance Global Partners.
James Molloy: The post interim look, I guess, presuming things go well and you looking it’s an early stoppage for success. What’s the thinking on timing for, I guess, for going forward with the non-inferiority trial or sort of the next steps post that interim look?
David Luci: So after the interim look, we would promptly release top line data and then wait for the database to be locked, data scrubs, final study report and that will be then put into an FDA post-Phase II meeting package and we would meet the FDA to kind of outline and kind of negotiate what Phase III will look like. And that whole process from the time we get the final study report to the time we have the FDA’s concurrence, is probably a 90-day process. And during that time period, we’ll also be going out to kind of recruit more clinical trial centers, probably at least 50 or 75 trial centers to start with, just to get us off the ground for Phase III. And then Phase III would formally start sometime in the first half of 2024.
