Minerva Neurosciences, Inc. (NASDAQ:NERV) Q4 2022 Earnings Call Transcript

Douglas Tsao : So you are still simply pursuing — trying to get the existing data set approved?

Remy Luthringer : Exactly. So I mean we are not discussing about an additional study. We have opened the door since long to do a post-approval studies. But I mean what we are trying to understand is what they need as additional analysis in our data set we have currently. And what we are also discussing is that if you go according to the guidance of Refuse to File, the reason I mentioned at the beginning of this call are not part of a Refuse to File. So what we are trying to understand is what the FDA needs with our data package in order to, how to say, part review. And I think more advancing more becomes clear that indeed, I mean, we have the data needed. So give us a little bit time, and we will give you an update on what is the outcome of this, I think, constructive discussions going on currently.

Operator: I’m showing no further questions at this time. I’d like to hand the conference back over to Dr. Luthringer for closing remarks.

Remy Luthringer : Yes, thank you so much. And really thank you, Andrew, and Doug for these important questions. I hope it really clarified that we really have a very, very important dialogue still going on that we will get clarity very soon about what are the next steps. But I mean I think as I tried to explain, we have really a very important data package, which needs to an in-depth review by the FDA, and we are confident that this will happen. And if this review starts, I think everybody will understand that roluperidone is really an important drug to address a huge unmet medical need with no approved treatment in the U.S. So I’m really looking forward to really update you as soon as we have more clarity about the dialogue going on currently with the FDA. Thank you so much for your — for being with us today.

Operator: Thank you. This concludes today’s conference call. Thank you for your participation. You may now disconnect. Everyone, have a wonderful day.