And what we saw in that data was that, not only did we have a larger number, greater than a 100 aggregate patients, pass the primary endpoint and saw many of the endpoints improving in actually clinically meaningful levels, but there weren’t patients lost a follow up and there was actually arguably a reduced variation in some of the baseline measures than we would’ve expected. So, there’s some interesting things here, and I don’t wanna oversell this. This is, reading tea leaves to a degree, but the implementation of the adaptive statistical analysis plan, will rightsize the trial and if we are — if we are already there, we will then pivot to completing the trial and going after approval and commercial. And if we’re not, we will be continuing the trial.
The enrolment is looks like it’s taking up nicely, but it’s not done till it’s done. And I guess the last thing I’d share, as you think about this adaptive statistical analysis plan, we’ve gotten all of the data clean going into it. So even if we don’t have the trial halted early for efficacy, this next DSMB review is going to be done on very, very clean data. So it’ll be even more meaningful on its own.
Kumaraguru Raja: That’s very helpful. Thanks so much.
Peter Altman: Appreciate you being on the call. Thank you.
Operator: Our next question will come from James Molloy with Alliance Global Partners. Please go ahead.
James Molloy: Hey guys, thanks for taking my questions. I was — I know we talked you through it a little bit, but can you sort of game out the expectations for Friday’s call or is that something you wouldn’t want to do in advance of the call, any more detail? And then on O2, you said you get the 10 patients consented for the roll in. What’s you expect — what’s the next steps on that and are we still anticipating the first 100 in O2 trial potentially in 2025?
Peter Altman: So James, thank you for being on the call and great questions. We’re all walking around here wondering what we’re going to be doing on Friday’s call as well. So, we have clarity on the design that we have before us. I will provide a little bit more color. So we are expecting today written comments from the agency. And those comments have not yet come to us. We will — we have a whole series of meetings with a whole series of high profile folks to review those comments and to prepare for the conversation with the agency as well as you might expect calls scheduled for after the call to digest what the feedback was and to address any outstanding issues here. Implementing an adaptive statistical analysis plan is — has no safety ramifications.
It’s really a trial design issue. And we fully expect that the agency will say that that they’re not comfortable with a smaller trial for approval. They like to see a certain level of data with respect to patient safety. But, that’s one of the reasons why we have the folks coming into the conversation with us. And it’s also a nice feature. Just remind us that we have this breakthrough designation that lets us conduct additional safety data after the completion of the trial. So, that’s sort of the color on it right now. We have been spending an enormous amount of time on it, and I could probably recite verbatim all of the details in the adaptive statistical analysis plan on the call. But, as things may change, I think it’s best let us get it dialled in and implement it and we’ll share more likely on the other side.
