Remy Luthringer : So I think we cannot be clear about the timing. I mean the dialogue is ongoing, and we hope, obviously, to have the shortest time line. But as we mentioned, I mean this will happen in the next coming few months or few weeks, let me put it like this, basically. But I think if you allow me an additional comment, what we are trying to really bring over as a message, and I think it’s a completely fair message, is that we have a lot of information in our NDA. For example, what I was mentioning just before about comparability between U.S. and non-U.S. patients, so we have a lot of information about the functional improvement of the patients because if you remember, PSP, the key primary we had in the Phase 3 was the total score of PSP.
But I mean you have 4 sub scores, and we have analyzed the 4 sub scores in details, which again confirms that I mean the drug is improving, functioning in patients. So what we are trying to really bring over as a message to the FDA that the reasons, I mean, I gave you before are no reason to reset high, but our topics, which, first of all, need an in-depth review, an in-depth analysis of our NDA, a dialogue with a sponsor to really go into the details of all the data we have to show that roluperidone is an effective drug for patients suffering from negative symptoms and having a diagnostic of schizophrenia. So this is the dialogue ongoing and in terms of timing networks, they cannot give you more details.
Andrew Tsai : That makes sense. Makes sense. And very last question, to the extent you can share, who at the FDA has been overseeing the NDA application? I’m just curious if it was Billy Dunn. And if so, does this departure change your calculus on anything as it pertains to the NDA?
Remy Luthringer : That was a great question as well. So clearly, I mean, as you know, when you’re submitting your NDA and those Type C or Type A meetings are mostly with the psychotic division. That’s because, I mean, the decision for Refuse to File is coming from the division, yes, I mean, basically, clearly, I mean, the main dialogue has been with the psychotic division. This side, indeed, Dr. Dunn was also involved, obviously, because he was a person overlooking psychotic division and the other divisions of the neuroscience divisions like already one, two, three years. So yes, indeed, I mean I think what I can say is that Dr. Dunn is known to be a person who is really open to developments or to indications with no approved treatment.
And also what is very important is that Dr. Dunn is very keen to not only have a P-value, but is to see a function of improvement, which we have with roluperidone. So clearly, I mean I don’t think that, I mean, it will be a problem for us on Dr. Dunn left. But it’s clear that he understood that the function of the improvement is important. So I’m confident that the other people still at the FDA will understand. And I think the person who has been nominated in the place of Dr. Dunn is also a person who is very, how to say, knowledgeable and open to innovation. So that’s not a problem, but seems to people set in place, we continue to work along the lines to Dr. Dunn has proposed in the past.
Andrew Tsai : Very good. Thanks so much, Remy, for all the updates. Best of luck.
Operator: Our next question comes from the line of Douglas Tsao with H.C. Wainwright.
Douglas Tsao : So just as a follow-up. Obviously, there’s still some uncertainty. But when you envision the path forward for roluperidone and your interactions with the agency, do you think that one study would potentially be sufficient to address their concerns? Or would you need to potentially run both a monotherapy as well as an adjunct therapy study? Or could that potentially be carried out in one trial?
Remy Luthringer : Like always, a great question. Yes. So to be very clear, I mean the FDA never asked us to run an additional study. I mean so that they asked us, as I already think discussed with you, is that, I mean, they wanted us to continue to feed them with additional information. And as we speak, I mean, this is exactly what we are doing. And your comment about monotherapy and add-on is an interesting one. So clearly, we developed roluperidone in monotherapy for several reasons. As you know, the first reason is to demonstrate that, I mean, we have a specific improvement of negative symptoms because this monotherapy versus placebo is the only way to do it is. I mean you cannot do it if you put, for example, antipsychotic on board because you don’t know exactly what is going on here in order to claim the drug-specific effect.
And second, I mean, you will unblind the study immediately because I mean you have the side effects of antipsychotics. So this was one of the reasons. The second reason is very important, I think, for patients at the end of the day is that the scientific community and the medical community is now more and more saying that, I mean, all the patients with the diagnostic of schizophrenia should not be treated continuously with antipsychotic. And even more importantly, I mean, there are now data coming out really showing that there is a significant part of the patients with the diagnostic of schizophrenia who do not need continuous treatment with antipsychotics. So this is exactly the patient population we have targeted. Remember, we targeted patients, whereas I needed to have a minimum score of negative symptoms on the PANSS.
Just to show the impairment is there, this had to be stable over the last six months and as they needed to have stable positive symptoms. And I mean, when you’re looking to our data, what you see that, yes, we have this improvement of negative symptoms of PSP. But I mean these patients stay extremely stable on positive symptoms and in an extremely low level, yes. I mean they are at 14 points when the end of the study, and there are 14 points when they go out of the study. And as you know, the minimum score if you have no symptoms, if you have no positive symptoms, is 7 points. I mean so these patients are completely stable in terms of positive symptoms. And remember as well, I presented also the relapse rates. And the relapse rate we have there is very low, I mean, around 12% over a period of one year, which is below what you see in the placebo randomized withdrawal studies with antipsychotics.
So clearly, I think we have demonstrated that, I mean, at minimum, the patient population, we have included does not need continuous treatment with antipsychotics. So I cannot go into the details because we never disclose it, but we have provided also evidence to the FDA that if a patient really needs antipsychotics, he’s responding extremely well to antipsychotics. So long story short, to answer to your question about the study, an additional study monotherapy or a study where we are combining monotherapy plus a combination with antipsychotics, obviously, we have worked on this. We thought about it since the beginning of the development of roluperidone. But I think these are really questions you’re asking yourself or you’re doing after, I mean, you have a complete in-depth review by the FDA of our NDA.
And this is usually what the companies have to do post approval. So here, we obviously, as we know, we’re completely open for post approval trials. And last but not least, just I mean when you’re looking to what we are proposing as labeling, clearly, I mean the labeling is monotherapy for the specific patient population we targeted in our trials. And what we are proposing here, and again, we have data and we have shown this data to the FDA that, if I mean, a patient has a relapse and needs an antipsychotic, the antipsychotic is doing the job, yes, basically. So again, a long story here, but this is a logic. So all what is needed in order to better characterize on and all these kind of things, I think, is post-approval work because we have two well controlled and well adequate studies, and this is normally the basis of an NDA review.
Douglas Tsao : So Remy, I hear your point, but I guess I’m just wondering, and I asked you, I mean, does there come a point where sort of pragmatism needs to rule just because while, yes, there may be a path forward with the existing data set, clearly, the agency has expressed reservations. And if you — so from an efficiency standpoint, just carrying out another study might just be the most efficient way to go even to some extent, maybe financially at this point. I mean, if we step back and think about when we had the first result from that Phase 3, if you had pivoted to run a follow-up study, that study would have probably read out by now. And then you would be able to go back to the agency or go to the agency with an incontrovertible data set, nothing for them to really question. So I mean, I guess, I don’t know if that’s — so I guess at what point do you feel you’ve exhausted those options?
Remy Luthringer : So clearly, I mean, I hear you very well. And I mean you’re not the only one telling us just go on and run another study, but which kind of study do you run? And you started by saying, okay, monotherapy are done. So the question here, and that’s the reason why we try really to get complete clarity, again, don’t understand something wrong. I mean, I’m convinced that the package we have is enough. Yes. I mean that if I mean, we think about an additional study, we need complete clarity about the study. We need the complete blessing from the FDA about the study because there are some precedents where companies have run a study, thinking that they are doing the right thing. And basically, when they came back with a positive study, this is one of the studies they had to carry out.
That’s — or the FDA did not completely agree to this. So we are looking to really get the complete clarity, and I think it is what is driving us. But again, I think we have a package for the FDA jump and redoing our NDA.
Douglas Tsao : But Remy, just to clarify that final point, just to make sure, so everybody can understand because I think it is very important, so as part of your current interactions with the agency, part of that discussion is to get clarity from them on what potential additional studies may be needed?
Remy Luthringer : The answer is no. Yes. What we have clarified…
