Jay Olson: Hi, guys, thanks for the update. And thanks for the question. First question is for Cedric. Could you please talk about any due diligence that you did prior to making your decision to join Relmada? And what do you learn from your peers or KOLs that you may have spoken to about REL-1017? And what do you consider to be the most important capabilities for the Chief Medical Officer to optimize the probability of success for MDD clinical trials? And then I have a follow-on, if I could, please.
Cedric O’Gorman: Thank you for that question. And I’m delighted to be part of the Relmada team. They’re very thoughtful professional group of people. I’ve only been here since January 6, but I already feel part of the family. And when Sergio first reached out to me and asked would I be interested in taking the role, you’re absolutely right. I did want to look at the data under CDA and understand what went wrong in the study and if I still believe that the drug had efficacy potential. And if it did, what could I reasonably come in and suggest be changed in order to optimize the signal. So it was very obvious in my mind, and the key opinion leaders and thought leaders that you mentioned that when I looked at the placebo response, one and all acknowledge that this was an uncontrolled placebo response, and it’s very hard to draw any conclusions if you hadn’t kept it to about 10 points, you really couldn’t say one way or the other about the drug.
So then I wanted to look at the protocols as they were run and see if I had ideas coming into the design of the trial that I feel I could actually be of help or benefit to them. And so I think that by everything that we’re trying to do right now, streamlining the protocols, I believe that can be achieved. And was that — was there a second part to your question?
Jay Olson: No, I think that’s everything. That’s super helpful. I did have one follow-up question on RELIANCE II when you see the results. How do you plan to evaluate patients who enrolled pre versus post protocol? And then, and is the study powered for a subgroup analysis of pre versus post protocol amendment? And what influence do you expect to see on the results on the protocol amendment. Thank you.
Sergio Traversa: What is the review? Do you want to answer that?
Cedric O’Gorman: Well, the second part first, the effect on the results, I’m hoping to control for placebo response because I won’t feel like I succeeded in my job unless I can bring placebo response down and that will — that should widen the delta, the drug placebo difference because one thing that REL-1017 has had in common across all the trials is the same magnitude and trajectory of improvement. And so if we can keep placebo down, I would expect to see a nice separation. And the first part of the question related to — remind me.
Jay Olson: Evaluating patients pre versus post protocol.
Cedric O’Gorman: Yes. I mean, we are definitely looking at that and intend to do that as part of the analysis plan, but the specifics of that, I just wouldn’t be ready to get into detail of it just yet with you. But it’s a great and important demarcation in terms of data announcement.
Sergio Traversa: Jay, we did — Sergio here. We did — we made a conservative assumption on the first 1/3 of the patients. We assume that the data will be similar to what we have seen in 301. And we also made assumption conservative on what the next 2/3 of the trial patients should be to make the study successful and reach the conclusion that it’s definitely worth to move forward and complete the trial.
