Greetings. Welcome to VistaGen Therapeutics third quarter fiscal year 2023 results conference call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note this conference is being recorded. I will now turn the conference over to Mark Flather, Vice President of Investor Relations. Thank you. You may begin. Thank you, Sherry. Hello, and welcome to VistaGen's conference call covering our third quarter of fiscal year 2023 financial results and a business update. Thank you for joining us today, and welcome to our stockholders, analysts, and anyone taking an interest in VistaGen. Joining me today are Shawn Singh, our Chief Executive Officer, and Jerry Dotson, our Chief Financial Officer. The format for this call will consist of prepared remarks from management, followed by a brief opportunity for questions from sell-side analysts. This call is being webcasted and will be available for replay. The link to access the replay can be found in the Investors, Events section of our website, vistagen.com. On today's call, we will make forward-looking statements regarding our business based on our current expectations and current information. The forward-looking statements speak only as of today. Except as required by law, we do not assume any duty to update in the future any forward-looking statement made today. Of course, forward-looking statements involve risks and uncertainties, and our actual results could differ materially from those anticipated by any forward-looking statements that we may make today. Additional information concerning risks and factors that could affect our business and financial results is included in our most recent quarterly report on Form 10-Q, filed earlier today with the Securities and Exchange Commission, or SEC, and in future filings that we make with the SEC from time to time, all of which are or will be available on our website and the SEC's website. Now I'd like to turn the call over to our Chief Executive Officer, Shawn Singh. Thank you, Mark. Good afternoon, everyone. Thank you for joining the call. There is an active and growing need for new, faster-acting treatment options for anxiety and depression disorders. Treatment options without negative side effects and safety concerns that are often associated with the currently approved medicines. We remain focused on addressing the significant mental health care need for individuals across a broad range of demographics and in communities across the globe. Our team is committed to developing and commercializing multiple differentiated treatments that align with our mission to shift the treatment paradigm for anxiety and depression disorders and improve the trajectory of mental health care one mind at a time. We'll start this call with a brief update on PH94B and our phase III program in social anxiety disorder or SAD. During the quarter, we further analyzed PALISADE-1 to obtain a better understanding of the unexpected results from that study. As a reminder, the study involved only a single dose of PH94B to subjects who were randomized to the treatment arm in the study. All subjects were given a highly provocative public speaking challenge conducted only in a clinical setting before a group of strangers, and their change in the Subjective Units of Distress or SUDS score was determined and measured as the primary endpoint. We moved forward with this study, this study methodology following our discussions with the FDA back in mid-2020 during the early phase of the COVID-19 pandemic when the world was sheltered in place and social interactions and even exposure to the outside world were not encouraged. Following are among the hypotheses we believe are potential explanations for the unexpected outcome in PALISADE-1. Study was conducted through surges of the COVID-19 pandemic, introducing significant additional variability in terms of changing social dynamics, subject stress, study site and CRO personnel turnover, mask-wearing, and scheduling and monitoring complexities. The public speaking challenge study design may not have been scalable to a large phase III study, especially during the pandemic, given the various complexities of consistently administering the highly provocative challenge and requirements for rigorous adherence to the study protocol across numerous sites and over an extended period. Some subjects in the study may have had a reduced response to PH94B due to impaired olfactory cell function, potentially caused by the COVID-19 virus or even nasal swab testing for COVID-19 or influenza. After receiving the top-line results from PALISADE-1, we paused PALISADE-2, which involves the same single-dose post-randomization public speaking challenge methodology as PALISADE-1. We engaged independent biostatisticians to conduct an interim analysis of available data from the 140 subjects randomized in the study at that time. Based on their independent review of the unblinded data from those 140 subjects, data we've not yet seen, independent statisticians recommended that we continue PALISADE-2 as planned. During the quarter, we submitted protocol amendments to the PALISADE-2 study protocol to the FDA. Amendments that are aimed at minimizing the potential issues that may have played a part in the unexpected results that we saw in PALISADE-1. Should we decide to resume PALISADE-2, we believe these protocol changes could considerably increase the probability of favorable results in the remaining third of the trial subjects. A new and another important factor to note regarding our considerations for potentially resuming PALISADE-1 is that in December 2022, only a couple of months ago, two of our peers announced top-line results of their recently completed SAD studies using a single administration public speaking challenge study design with SUDS as the primary endpoint. Neither study achieved its primary efficacy endpoint. After reviewing the information and data available to us at this time, we believe it is not yet advisable to resume PALISADE-2 before discussing our broader phase III development plan for PH94B in SAD with the FDA and assessing the results of the other two recently completed SAD public speaking challenges conducted during the pandemic that also did not achieve their primary efficacy endpoints. We remain confident in PH94B's potential to be a game-changer for individuals affected by social anxiety disorder. We have been and will continue to explore all of our options for what we believe will be the best path forward with the highest probability of success for our phase III program in SAD. We are currently preparing to meet with the FDA to discuss our broader phase III development plan, which includes the possibility of conducting a multiple administration randomized double-blind, placebo-controlled phase III study of PH94B in adults using the Liebowitz Social Anxiety Scale, or LSAS, as the primary measure to evaluate the efficacy of PH94B over time in patients with SAD to support a potential PH94B NDA for treatment of SAD. Unlike the PALISADE-1 and -2 phase III studies, which involved assessment after only a single administration of PH94B in a clinic-based public speaking challenge with SUDS as the primary outcome measure, the phase II study contemplated as part of our broader plan would involve multiple administrations of PH94B on an as-needed basis, up to 4 x a day, in a real-world setting over multiple weeks, with the LSAS as the primary efficacy endpoint. Using the LSAS would be consistent with the design of all registration trials supporting the FDA's 3 precedent-setting approvals of treatments for SAD. Given that the LSAS measures overall improvement in disease severity by measuring both the reduction in fear and anxiety over time about social and performance situations, as well as the reduction in avoidance of those anxiety-provoking situations, we believe the LSAS is appropriate to measure and reflect the true impact of PH94B on patients' daily lives. We expect to announce our plan for PALISADE-2 concurrently with other updates to our broader PH94B phase III development plan for SAD. Another important component of our phase III program in SAD is the PALISADE open label study, which we initiated back in October 2021 to evaluate the safety and tolerability of PH94B in adult subjects with SAD taken as needed prior to anxiety-provoking social and performance situations in daily life over a period of up to 12 months. In addition to assessing safety and tolerability of PH94B in that study, we also included several exploratory objectives, including PH94B's potential to achieve overall symptom reduction and improvement in severity of SAD as measured by the LSAS. Again, it's the primary endpoint as required by the FDA for all prior SAD approvals. In August 2022, we closed recruitment and enrollment in PALISADE open label study. A preliminary analysis of the final data set observing nearly 400 subjects in that study is encouraging. Although from an open label study when considered with our prior placebo-controlled multiple assessment phase II study of PH94B in a real-world setting, that study has helped inform many important aspects of our broader phase II development plan for PH94B and SAD. The open label study results reinforce our belief in the potential of PH94B used over time as needed, up to 4 x per day in daily life, to provide rapid onset, clinically meaningful, and sustained response with a favorable safety and tolerability profile. We expect to have the final data readout of observations from this study in the first quarter of calendar 2023. Moving next to our exploratory target indication for PH94B, adjustment disorder with anxiety. We've completed our small phase IIA double-blind, placebo-controlled clinical trial to evaluate the efficacy, safety, and tolerability of PH94B as a potential treatment of adults with adjustment disorder with anxiety. Subjects self-administered PH94B at prescribed intervals 4x per day for 28 days. We anticipate announcing top-line data from this exploratory phase IIA trial by the end of the first quarter of calendar 2023. During the recent months, we achieved several milestones in our PH10 program in major depressive disorder, or MDD. We submitted our U.S. IND and subsequently received the FDA's green light to conduct the phase I randomized double-blind placebo-controlled safety study in healthy volunteers. That study is now underway and is intended to both confirm the favorable safety profile of PH10 established in three previous clinical studies conducted in Mexico, including positive published phase IIA study of PH10 for the treatment of MDD, as well as to facilitate our plans for phase IIB development of PH10 in the U.S. as a novel standalone treatment for MDD. We anticipate completing that study, phase I study, by the end of the 1st quarter of 2023. In all clinical studies to date, PH10, like PH94B, has been well-tolerated, has not caused psychological side effects such as dissociation, hallucinations, and the like, or other safety concerns that may be associated with other rapid onset depression therapies such as ketamine. Also of note, we recently received the FDA's Fast Track designation for development of PH10 for MDD. Similar to the large and growing anxiety market, there are significant unmet need for patients with MDD, where the current treatments are either undesirable or inadequate. With a differentiated mechanism of action that is designed to be fast-acting, non-systemic and non-sedating, we believe that PH10 has potential to shift the treatment paradigm for MDD considerably. Having PH10 in the clinic in the U.S. and under the FDA's Fast Track designation are important recent milestones in our plan to bring PH10 to the many individuals battling MDD and potentially other depression disorders. AV-101, our phase IB drug-drug interaction clinical study with oral probenecid is ongoing. We anticipate completing that study during the second quarter of calendar 2023. After its conclusion, assuming no unexpected safety issues, we will crystallize the final components of our plan for exploratory phase IIA development of AV-101, alone or in combination with probenecid and on our own or with a collaborator as potential oral treatment for one or more CNS disorders involving the NMDA receptor. I'd like to make a few comments about our recent acquisition of Pherin Pharmaceuticals. Now that this transaction has been completed, we have full ownership of worldwide intellectual property rights to PH94B and PH10, which previously were under exclusive licenses to us from Pherin that included customary milestone and royalty payment obligations over time. As a result of the acquisition, we've eliminated all future royalty and milestone payment obligations for PH94B and PH10, which significantly improves the potential commercial profile of these late-stage assets had they be approved downstream. In addition, we will retain all licensing revenues, including pre-commercial licensing revenues, should we enter into such transactions as we have in the past. Further, as a result of the Pherin acquisition, we've added three early clinical stage Pherin product candidates to our pipeline. PH15 for cognition improvement, PH80 for migraine and hot flashes, and PH284 for appetite related disorders. Of note, VistaGen did not assume any debt as part of this transaction, any other liabilities from Pherin, nor did we bring on any Pherin employees or take on any Pherin facilities. I would now like our CFO, Jerry Dotson, to summarize some highlights from our financial results for the third quarter of our fiscal year 2023. Jerry. Thank you, Sean. As Sean mentioned, I'd like to highlight a few of the financial results from the third quarter of our fiscal year 2023. I would also encourage everyone to review our quarterly report on Form 10-Q that we filed with the SEC earlier this afternoon for additional details and disclosures. During the three months ended December 31, 2022, we recognized $179,600 of revenue related to the AffaMed agreement, compared to recognizing $357,900 of revenue for the three months ended December 31, 2021. As a reminder, the revenue recognized in both of those periods is non-cash in accordance with the applicable accounting standards. We received the related cash from AffaMed back in August 2020. Research and development expense decreased by $0.9 million from $7.9 million- $6.9 million for the quarters ended December 31, 2021 and 2022, respectively. This decrease is primarily due to reduced expenses related to the PALISADE phase III program for PH94B, which, as Sean has described, includes PALISADE-1, PALISADE-2, and the PALISADE open label study, as well as the PH94B phase IIA study in adjustment disorder with anxiety and other non-clinical development, regulatory, and outsourced manufacturing activities for both PH94B and PH10. We expect R&D expense in the final quarter of our fiscal 2023 to decrease as well as we wind down the trials that Sean has mentioned earlier. Our general and administrative expense was flat at approximately $3.1 million for each of the quarters ended December 31, 2022 and 2021. Our net loss attributable to common stockholders for the quarter ended December 31, 2022, was approximately $9.8 million versus a net loss of approximately $10.7 million for the quarter ended December 31, 2021. At December 31, 2022, the company had cash and cash equivalents of approximately $25.0 million. Again, please refer to our quarterly report on Form 10-Q filed earlier today with the SEC for additional details and disclosures. I'll now turn the call back to Shawn. Thanks, Jerry. We remain unwavering in our core mission to improve mental health and well-being worldwide. As we continue to advance the next stage of our corporate development, we move forward with a strong team, a strong pipeline, and a strong mission that drives us to innovate better solutions for mental health disorders, all with significant unmet need. This is an exciting endeavor for our company, and we believe that we are very well positioned for 2023. On behalf of the VistaGen team, I want to thank you for the privilege and the opportunity to make a difference one mind at a time. Thank you, Sean. This concludes our prepared remarks. Sherry, we would like to now open the call up for questions from sell-side analysts. Thank you. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up the handset before pressing the star keys. Our first question is from Andrew Tsai with Jefferies. Please proceed. Thanks. Hi, everyone. Good afternoon. Appreciate you taking the questions. First one is your upcoming FDA meeting in terms of discussing a possible pivot in the phase III design, using LSAS and then multi-dosing over a longer period of time. Can you kind of talk about the scenarios here? If the FDA says, "Okay, do a pivot," what would you do with PALISADE-II? If the FDA says, no, what would you do with PALISADE-II? Basically, what I'm trying to get at is, in what scenario could we see the PALISADE-II results at the end of the day? Even though it hasn't finished, you did see a signal in the interim analysis. That's why I ask. Thanks. Thanks, Andrew. Good question. look, we still have to assess really what would be the best path forward after not only we take a look further at what happened in the peer studies. you know, there are questions associated with scaling up that methodology and executing on what is a very highly provocative challenge that requires exquisite adherence to protocol recipe. We've submitted some protocol amendments to the FDA, we'll see what their feedback is on that. Things that we think can overcome some of those methodological challenges. We'll see what their opinion is on that, as well as which direction things go in the meeting where we're discussing a potential next step forward with LSAS as the basis, just like with the 3 approvals. It's possible that we would simply unblind PALISADE-2 as it is and end the study there and see what we find from those unblinded data on 140 subjects. Could be stat sig, could be soft trend, could be positive signal, decent effect size, could be a lot of things. We know what the interim analysis said, but we haven't seen the data. It's also possible of resuming PALISADE-2, depending on which direction things go with the FDA. You know, look, the good thing going into the discussions with the FDA is that there is a lot of evidence already. There's phase II placebo-controlled studies in PH94B and SAD that have substantial evidence showing its rapid onset of effect following the acute administration. We talked about that study quite a bit. The placebo-controlled crossover study that was two weeks of real-world use. That amplified by what we've seen so far, we haven't yet reported, but will soon, observations from the long-term safety study and the LSAS component of that study in particular. There's a lot of things to ask the FDA, there's a lot of things to get feedback from the FDA on, and we'll make some decisions on the basis of that interaction as well as what we might learn more about. We need to do some work again with sites. We need to figure out, you know, some more information about, you know, what sites are around and are willing to be involved. If we were going to resume, would we want changes to be made that they may or may not be able to execute depending on staffing, and expertise? We'll just have to see. Right. Okay. very, very helpful. Speaking of the open label data coming up, what exactly do you plan to share with us? Basically, how much data can we expect to see in the top line release? Secondly, pardon my this long kind of question, but, you know, one of the issues, underlying issues in general of an open label study is there's no placebo. We don't necessarily know where the placebo would trend. That said, you know, I can think of the epilepsy space where there is, you know, an efficacy measure called seizure freedom. You know, because placebo can barely achieve seizure freedom in epilepsy. That is perhaps why looking at seizure freedom rates in an OLE could make sense. As we get back to the social anxiety space, I guess the question is what percentage of placebo patients can achieve remission in theory over, let's just say, 6-12 months? I guess, would you agree, looking at remission rates could be valuable of a data point, basically? Yeah. Yeah, that's something we can discuss with the FDA. All of the approval studies were registrational studies for, the three antidepressants approved for SAD. Those were all 12-week studies. Again, you know, look, we obviously acknowledge the absence of a control group in any open label study, by definition. The data from, again, I noted this before, nearly 400 subjects observed in that study. They provide very important additional information regarding PRN dosing of 94B. When we take that together with the data from the placebo-controlled phase II studyWhere the real world study, those studies provide a lot of evidence on how SAD patients would use 94B. For example, the frequency of use in the real-world setting and the appropriateness also of assessing improvement in SAD over time, utilizing the LSAS obviously as the key measurement for that, given that that's the historical precedent, that's the historical comparative, three of them now. We know each SAD patient is different. We know SAD treatment is individualized and tailored to the situations that patients encounter in their daily lives. We think PRN use is the most appropriate dosing strategy for the treatment of SAD. Unlike the single highly provocative administration assessment that was in the PAL 1 and PAL 2 studies. These, you know, these feared situations that people encounter, they're very predictable and are awaited with fearful and anxious anticipation. The LSAS which, you know, again, long established by Dr. Liebowitz, who's the PI of the phase II studies and also currently working with us, that remains the most appropriate outcome measure for the type of study we might next do, right? That a double-blind, placebo-controlled study that evaluates the efficacy of as needed use of 94B but over time for the treatment. What we're trying to essentially do is reset the mind, similar to how cognitive behavioral therapy works. Rather than taking, say, a snapshot with SUDS and with the public speaking challenge, the LSAS is more like a movie assessing the improvement of the patient over time. Again, having those, having the LSAS as the primary endpoint is consistent with the registrational trials for the existing approved treatment. It may be prudent, as you said, to follow beyond 12 weeks. We know this is a chronic disorder, so repeat dosing is exactly the way we've long envisioned using PH94B to help people. A lot of the reason we moved into the PAL one was where the world was at the time in the middle of 2020 when we last met with the agency about phase II study design, that you couldn't even go outside, as you all remember. Exposing people to stressors over a long period of time, six weeks, was probably what we would see in a phase II study. Given the way that PH94B's onset is rapid, what we would see, say, in a six-week study would be really what the, what the antidepressants achieved in the 12-week period, since they have a long onset of action. There, what we would show, to your first part is, we would certainly want to show improvement on the LSAS at least one month, and probably two months, given that we're aiming for a study design somewhere in the four to six week range. What we're looking for there is, are we seeing a significant drop? Again, this is observed data. It's. We understand it's not a control group, but it definitely informs when you have nearly 400 subjects. It gives us a lot of information to tack on top of, really the other crossroad we were at back in 2020. We could have gone to the real world study then, for the fact that we were in COVID. Now I think we have that opportunity given that the world settled down a bit, vaccines are okay, and we have a lot more understanding of the safety associated with having people record their stressful events and having LSAS assessments for a long period of time. Right. thanks. Last one and then I'll hop in the queue is on the adjustment disorder data, and coming up, it is also dosed chronically, placebo-controlled, 40 subjects, I believe. Mm-hmm. I think the primary endpoint is day 28 HAM-A scores. Can you kind of give us a reminder what existing drugs show at four weeks? Just so we can have a comparator when that data comes. Yeah. Not a lot of comparators. That's a challenge with this disorder. It's in DSM-5, but there really aren't a lot of controlled studies. That's why this really lands in the exploratory study zone. HAM-A, you had to have somewhere around 20 to be enrolled, and people had to be on if they were on anything, they were stable background antidepressants. You know, it's an exploratory study. It's a small study, as you said, around 40 subjects. We're looking for a signal, as you'd expect from a two-way study. It's not, you know, it's not heavily powered as you'd expect with the exploratory design. We'll see. You know. Okay. The standard meds are used, unfortunately, it's the same sort of collection of meds that we see in social anxiety disorder that folks that had never really had experience with anxiety, but for in most cases, something here associated with the chaos, the domino effect, from COVID, job loss, relationship loss, isolation, those things started to impair their functioning. That's adjustment disorder and anxiety that disrupted routines and so forth. Benzos, beta blockers, antidepressants, alcohol, you know, all kinds of things that really aren't optimal for SAD are also not optimal for adjustment disorder. Mm-hmm. Thanks, Shawn. Appreciate the progress. All right, Andrew. Thank you. Our next question is from Tim Lugo with William Blair. Please proceed. Thanks for taking the question. For the upcoming adjustment disorder study, can you remind me how many doses these patients are taking per day? I guess following up with the prior question, do you have a sense of what the placebo rate is in this setting? I guess, you know, if there's any sort of historical studies you can compare to. I'll take that part first, Tim. There just isn't a lot of traffic historically in this disorder, I can't really give you a well-grounded number. In terms of the dosing regimen, we had, again, that tox support early on showed a lot of safety from PH94B, taken up to 4x a day. We sort of forced that into this exploratory study. There wasn't a lot grounded that necessarily said 4x is what was needed, but part of it was to also establish safety associated with taking the drug 4x a day, because that crosses over into thoughts about safety related to taking PH94B 4x a day in multiple different SAD-related, anxiety-provoking episodes. There was a little bit of crossover intention by that study regimen. In this one, it's 4x a day. It's recommended to be spaced out an hour or so between doses, in morning, late morning, early afternoon, and evening. 4x kind of spread out for an hour or so in between. We know 94B has a rapid onset. We also know it has a fairly short duration of effect. That's part of the benefit of it being, sort of a better benzo without the baggage, right? Rapid onset, but without the lingering cognitive impairment. So. Okay. It's 4 x a day, split by a few hours, over 28 days. Okay. Thank you. It's helpful. Outside of the, you know, upcoming PH94B meeting, you know, it sounds like you got a couple assets through the Pherin acquisition, you know, PH80, specifically. Could you just, you know, outside of PH94B, can you rank kind of where the rest of the pipeline is in terms of priorities for the company? Yeah, sure. Well, 94B, of course, way top of the list and across multiple indications in the two that we've acted on in the clinic, SAD and adjustment disorder, PH10 following right after that. We have a 2A that was done outside the U.S. That's the POC study for that asset in major depressive disorder. We had to bring it back to the U.S., do a full IND enabling program, optimize the formulation a bit. The small phase I that we're doing should be done here within a few months, and we'll announce on that probably early second quarter. That lets us hopefully move right back into late stage phase IIB development with that asset as a standalone treatment option for MDD, with the rapid onset and the same similar features, in terms of no systemic uptake and no sedation as 94B. Then it's, then it's kind of leveled out. There are early, there's early clinical data for 15 80 and 284, done again outside the U.S. in most cases, in some cases here. We're going to need to do some IND enabling work for those three assets, similar to what we had to do for PH10. We expect to be able to achieve some grant support for that work. That was non-clinical work that gets us back into the clinic. AV-101, we see probably more advanced than PH80, PH15, and PH284 at this point, because if we see the safety that we're hoping with this combination, we have a lot of preclinical data, really solid preclinical data across a few indications involved in the NMDA receptor. levodopa-induced dyskinesia, neuropathic pain, some of the models that we've done in MPTP monkeys, as well as in models for pain against Lyrica and gabapentin. We'll have to decide which direction we wanna go, but I think 2A would be the next priority after PH10 for 2B, with AV-101, and then we'll see how things go. We haven't had our hands on the new Pherin assets for too long, so we wanna do a little more digging into the datasets that exist. There are data, clinical data across all of those that are fairly encouraging, and we just need to get more direct touch on all three of those as we see what we might wanna do there. There's a lot of grant opportunities for those assets. The core focus, however, predominantly is on 94B, followed then by 10. Thank you. That's helpful. As a reminder, just star one on your telephone keypad if you would like to ask a question. We will pause for a brief moment to poll for questions. We do have a follow-up question from Andrew Tsai with Jefferies. Please proceed. Thanks, operator. Speaking of the PH94B, you know, you did mention earlier some competitors reported some SAD top line data. My understanding is one of them, the competitors, did in fact see a signal when they, depending on how they analyze the data, they'll talk to the FDA, is how I understand it. I guess the question is, if the FDA buys into their SUDS, long story short, whereas the FDA buys into your LSAS, let's just say that scenario happens. How do you guys decide to proceed? Because presumably you would have two options to go with here. Well, we already know where the FDA is on SUDS. There's no question about that. It's a valid endpoint. The public speaking challenge is a solid methodology. I have no issues about either of those. The question is, can you scale it effectively and into the size of a study that's necessary to be a registrational study? That's what we're trying to assess at the moment, right? We know the challenges that are associated with the protocol, with the methodology. That was, for example, you know, is it the surveillance to whether or not you have the right raters that are changed as you move from the different visits, making sure that people, you know, don't inhale the drug. Making sure that people haven't destroyed the cells associated with where we need the drug to land. There's a lot of things that land on that one single administration assessment, and it's a very provocative trigger. I mean, those phase II studies that Pherin did are phase II studies. It's a whole different ballgame when you move into scaling that methodology up to the size and quality necessary to support a registration study. That's what we're assessing. It may be possible with the changes we've proposed to the FDA, or it may be something that we say just isn't worth that risk and isn't necessary. You know, if PALISADE-2, at the end of the day, goes all the way and what we end up having is a positive signal with a good effect size, but it's not stat sig, well, then that isn't going to support an NDA. If we think that there is going to be rigorous adherence to the protocol, the sites that would be involved, that, you know, the macro environment would be right, those all go into the thinking. The fact that it's very unusual for 3 studies with the same methodology, but distinct drugs within a 6-month period of time would not hit their primary endpoint, stat sig on their primary endpoint. That's part of our thinking. The other side of it is, as to the LSAS, A, we know there's historical comparators there. Although we don't think there's a regulatory risk with SUDS based on our prior interactions with the agency, there are three historical comparators that support LSAS as the primary endpoint for all six registration studies. All of the registration studies, by the way, for SAD using the LSAS, all of them were positive, stat sig positive. Not a single one wasn't. That says a lot as well, right? In terms of downstream, risk assessment, discipline used to cash and resources. We'll just have to make a decision about what's the best way to put time, talent, and cash towards ultimately what we want. We want an NDA that is approved. We want study designs that fit the way we think the drug best fits how we think people can be helped by it in the world. Right. There is a lot of confidence behind the. If you look at those same drugs in depression, Paxil, Zoloft, Effexor, there weren't a steady string of successes. There were multiple failures and multiple successes. Interestingly, in SAD, for the registrational studies, all were positive and all used only the LSAS as the primary efficacy endpoint. With a bit of a changed world now, where COVID's under control and a lot of other factors that we would improve on, that some lessons learned from PALISADE-1 that transport into what we would do if the direction forward is a phase III study with LSAS as the primary. you know, the. Yeah. The odds stack pretty nicely. Right. Last question then is if you ultimately, if you do proceed with LSAS, how fast can you get two phase III studies up and running and you know, having generated the data? Can you kind of walk us through the timelines? Yeah. Well, of course, a lot of that depends on funding, right? Right now, we're not sitting on funding that supports all the way through those data readouts. In a optimal scenario, we would be in a mode in about six months it takes to get going for the types of study that we'd want to launch with the sites we would want to be involved. Now we've been involved with, you know, now around almost 40 sites across the two studies. We know the landscape very well. SAD is back in motion as something that's being studied. It hadn't really been before we brought it back with PALISADE-1. Those studies, if we would start them sometime before the end of the year, we could see readouts in the fourth quarter of 2024. It'd be a staggered start. Two studies running in parallel, both a little bit of a staggered start, as we did with PAL-1, PAL-2. The LSAS-based studies would run next to each other. We think we could see readouts, by the end of the fourth quarter of 2024 if we get going here within the next several months. Great. All right. Thanks again for taking these questions. Very helpful. You bet. There are no further questions at this time. Thanks so much. If you have any additional questions, please do not hesitate to get in touch with us by emailing ir@vistagen.com or contacting the individuals listed on our press release issued today. We also encourage you to sign up on our website to stay connected with the latest news from VistaGen. Thank you for tuning in. We appreciate everyone's attention and support. We look forward to keeping you current on our continuing progress. This concludes our call. Have a great day. You may all disconnect