That starts things off and then the ability to interact more frequently with sites in person all that’s important when you’re trying to generate rigorous adherence to the study protocol. I think also what we’ll see is better predictability about site staff in general. The depth of the set the staff’s, the more consistent execution — ability to execute between studies, study visits I should say or predictably planned them. So a lot of things that are essential to be able to execute a protocol such as we’ve got in place for the successful PAL-2 study. And as we bring that into PAL-3 and 4 even more confidence in the overall environment than was the case in 2022.
Andrew Tsai : Thank you. And maybe last one for me. I want to be respectful of the other colleagues here. Can you give us a flavor of what additional data will be presented at your medical conferences tomorrow for those that are not diagnosed? And I think there’s another asset that’s where there’s data being presented. So what would be the key takeaways that we should take home for these presentations? Thank you.
Shawn Singh: Thanks. Well, a key effort right now is to obviously raise awareness of what the clinical audience hasn’t seen in many, many years in this indication. So to be able — you’ll see mostly from those presentations on the top line results from PALISADE-2 as well some data from our open-label study which is remarkable. Given the number of doses and the number of subjects exposed to the drug in an anxiety disorder, you still see it and then some data from our PH80 study. So key to what we are doing now, obviously, is to raise awareness of what’s been achieved as well as to raise awareness of what’s ahead not only in the markets, but also within the clinical communities that we know ultimately will be key pieces of the puzzle downstream.
Andrew Tsai: Great. Thank you very much.
Shawn Singh: All right. Thanks Andrew.
Operator: Our next question comes from Tim Lugo with William Blair.
Tim Lugo: Thanks for taking the question. Can you update us on the lack of abuse potential for fasedienol? I think, I got that right. I know you have some preclinical data around that but I’m wondering if there’s anything incremental coming out of PAL-2, and just maybe your interactions with the agency as well.
Shawn Singh: Yeah. Thanks Tim. Good to hear from you. Obviously the data that we teed up to the agency back in 2022 was focused on whether or not there were signals and had been any signals at that time of abuse liability potential given that this is a nasal spray and a lot of folks were wondering well what happens when you put something in the nose is it become addictive? And the uniqueness of this mechanism of action that we have with fasedienol and the rest of the variants is important to note, because what we’re dealing with and we’ve done multiple studies not only on the clinical side, but some important preclinical ones associated with the reality that there’s no potentiation of GABA for example as you see with benzodiazepines.
Radio labeling the drug showed no systemic exposure. So the drugs these variants don’t have to get into the brain and act directly on CNS neurons in the brain, including the abuse liability receptors that are typically out there. So we put a whole body of work to the agency at the time and asked the question what came back from as we reported was they didn’t see any reason for us to have to do a human abuse liability study at that time. Since then what’s been delivered is all of the data from the open-label study, which had 481 subjects and the adverse event profile in that study was remarkable especially again for drug and neuropsychiatry where the most common adverse effect was our adverse event was headache and that was reported and really only 17% overall, but 8.7% were drug-related and beyond COVID-19, which was 0% drug-related there was no other treatment emergent adverse effect in more than 5% of the participants.
