So we’ll see how it goes. Again, it’s a dialogue. It’s nice to be knowing we’re talking about potential labelling benefits. So that’s how we took it. These remember — these receptors are activated in milliseconds. So it doesn’t take much time to get them moving in the first instance.
Operator: [Operator instructions] Our next question comes from the line of Tim Lugo with William Blair. Please proceed with your question.
Tim Lugo: Thanks for the question and congratulations on the progress. For fasedienol, given a non-systemic, non-abusable profile and with a positive PAL-2 trial, could you look to gain breakthrough status with the agency? Is it something you’re exploring? If you were to get breakthrough status, is it something that could impact your development path at all? And in your discussions with the agency, do you have enough maybe I guess preclinical data around abusability or enough animal data around abusability to have that included in the label?
Shawn Singh: Thanks Tim. Appreciate those questions. So, first as to BTD or breakthrough, look, that’s always an aspiration of any company that’s got something in a space that we’ve got. It’s always an advocacy matter with the agency. I think, like I said, we just got done doing something we don’t think anybody else has ever done that we’ve seen and we’ve certainly got a product profile potential that is different than anything that we see out there. We know the agency is worried about the potential high abuse of benzodiazepines given their drug safety communication on that during COVID. We also know that unfortunately social anxiety disorder and other anxiety disorders lead to depression and then lead, unfortunately, with increasing prevalence that we are seeing to suicidal ideation.
So we already know we have fast-track. It doesn’t mean that you necessarily fall into breakthrough, but certainly something on our mind. And you’re right too that it is important whether or not we see this drug as potentially being scheduled. As we addressed a while back, especially with a drug that is administered intranasally, one might think, well, is it is there some abuse potential there? As we know from the preclinical work we’ve done and that we submitted to the FDA and also clinical work, a large body of work, including the open label study about 500 subjects with over 30,000 doses, we just were not seeing TEAEs or any certainly no SAEs that are usually associated with abuse liability, even in the longer-term open label. Mechanistically, it makes sense because the drug isn’t taken up systemically and most importantly, based on the GABA study that we did preclinically and the C14 studies that we did, there’s not tissue distribution and direct activity on the abuse liability receptors in the brain, opiate, nicotine, dopamine and the like and not potentiating GABA, like say a benzo would also worked in our favor.
So I think we’re very confident as we continue to see clinical data support the preclinical data and the whole package that says this is a differentiated safety profile because of the MOA. We’re confident in a go-forward where patients could have the ability to access the drug online on a recurring basis with the drug potentially not being scheduled, no REMS. So we’ll see how that continues to go, but what we saw in PALISADE-2, again, no TEA, more prevalent than 2%. In the large open label study, nothing more prevalent than 5% other than headache at 8.7%. So that’s remarkably different than what we often hear when we’re listening to commercials and side effects that are associated with particular therapeutic options.
Operator: There are no further questions in the queue. I’d like to hand the call back to Mark McPartland for closing remarks.
Mark McPartland: Thank you again, everyone for participating on the call today. Again, if you have any additional questions, please do not hesitate to contact us by email at ir@vistagen.com or contacting the individuals listed in our press release issued earlier today or the contact section of our website. Again, we also encourage you to register for email updates on our website to stay connected with the latest news from Vistagen and any future events. Thank you for participating on the call today. We appreciate everyone’s interest and support. We look forward to keeping you current on our continued progress. This concludes the call. Have a tremendous day.
Operator: Ladies and gentlemen, this does include today’s teleconference. Thank you for your participation. You may disconnect your lines at this time and have a wonderful day.
