Good day, ladies and gentlemen, and welcome to the ACADIA Pharmaceuticals conference call. My name is Latif, and I will be your coordinator for today. At this time, all participants are in a listen-only mode. We will be facilitating a question- and- answer session towards the end of today's call. If at any time during the call you require assistance, please press star followed by zero, and the coordinator will be happy to assist you. I would now like to turn the presentation over to Mark Johnson, Vice President of Investor Relations at ACADIA. Please proceed.
Thank you, Latif. Good afternoon, and thank you for joining us. On today's call, Steve Davis, our Chief Executive Officer, will discuss our plan to resubmit the supplemental NDA for pimavanserin. After which, Dr. Serge Stankovic, our president, will provide further detail on our resubmission strategy. Following Steve's closing remarks, we will conduct a question and answer session. Mark Schneyer, our Chief Financial Officer, and Brendan Teehan, our Chief Operating Officer and Head of Commercial, will also be available for questions and answers. I would also like to point out that we're using supplemental slides, which are available on the events and presentation section of our website. Please turn to slide two. Before we proceed, I would first like to remind you that during our call today, we'll be making a number of forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.
These forward-looking statements, including goals, expectations, plans, prospects, growth potential, timing of events or future results are based on current information, assumptions and expectations that are inherently subject to change and involve a number of risks and uncertainties that may cause actual results to differ materially. These factors and other risks associated with our business can be found in our filings made with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which are made only as of today's date. I'll now turn the call over to Steve Davis, our Chief Executive Officer.
Thank you, Mark. Good afternoon, everyone, and thank you for joining us today. Let me start with slide four. We are pleased to be sharing with you today that in the first quarter of 2022, we will be resubmitting our supplemental new drug application or sNDA for pimavanserin. The resubmission will be focused on Alzheimer's disease psychosis or ADP, the largest subgroup of dementia. Based on feedback from the FDA, our resubmission will include data we believe demonstrates the positive benefit risk profile we have observed with pimavanserin in patients with ADP across multiple clinical studies. These observations include an improvement of psychosis symptoms and a reduction in the risk of relapse of psychosis, and importantly, no negative impact on cognition or motor function. Before I turn it over to Serge, I'd like to level set by providing a brief overview of where we stand today with the FDA.
Please turn to slide five. Since receiving our CRL in April of this year, we have now had three productive meetings with the FDA, including in each meeting the Division of Psychiatry and the Office of Neuroscience. In our Type A end of review meeting, the FDA made it clear they are evaluating pimavanserin on a subgroup by subgroup basis. In addition, they also shared their opinion that the best way to obtain compelling data is to conduct an additional study for each subtype we're interested in pursuing. However, we were able to gain traction on a potential resubmission strategy without additional clinical work based on new analyses we have completed, which we believe demonstrate the consistency of effect of patients taking pimavanserin across subgroups. We subsequently had a meeting to discuss FDA's consideration of withdrawing pimavanserin's Breakthrough Therapy Designation for dementia-related psychosis.
At this meeting, the discussion quickly turned to a continuation of our previous discussion on additional analyses of subgroup data, including the ADP subgroup. In our most recent meeting, we presented additional analyses that is focused on Alzheimer's disease psychosis. As I previously described, our objectives for this third meeting were to present this data, to understand the FDA's position on what would be a reviewable resubmission in ADP, and to come out of this meeting with a decision on whether we would resubmit or run another clinical study in ADP. Based on these interactions and the analyses we have conducted, we've made the decision to resubmit based on analyses from existing clinical studies. Overcoming a CRL is a tall order, as we all know, but we are confident in our decision to resubmit. I want to be clear.
The FDA has not, at this point, agreed with all of our arguments or said they will approve pimavanserin for ADP. What they have said is they will consider our arguments and the detailed data to see if they can be convinced. They have indicated they will review our new analyses, and they've clearly been very engaged, which gives us the best chance to put forward what we believe to be a strong case for approval of pimavanserin for the treatment of Alzheimer's disease psychosis. As such, we plan to resubmit in the first quarter of 2022 and expect a six-month review period. I'll now turn the call over to Serge.
Thank you, Steve. Let's discuss in greater detail the unmet need and the supplemental NDA data package with additional analysis that gives us confidence in our resubmission. Please turn to slide seven. Over 6 million Americans suffer from Alzheimer's disease in the United States alone, which represents approximately 60%-80% of all dementia diagnoses. Furthermore, approximately 30% or 1.8 million Alzheimer's patients experience psychosis, and about half of them are diagnosed. The symptoms of psychosis can be very challenging for dementia patients, their caregivers and family members. ADP is associated with higher caregiver burden, increased likelihood of nursing home placement, and higher progression to severe dementia. The currently available multireceptor antipsychotics used off-label today offer little to no proven efficacy while introducing a host of safety concerns, most notably an acceleration of cognitive decline and motor impairment.
Our resubmission will be focused primarily on additional analysis from two separate positive placebo-controlled studies. First, the clinically meaningful results in the AD dementia subgroup in reduction of relapse of psychosis in the HARMONY study, and second, statistically significant reduction in the severity and frequency of symptoms of psychosis in the 019 study in ADP patients. It is important to emphasize that all additional analysis in the HARMONY and 019 study will be submitted in the context of these two positive studies that met their prospectively defined primary endpoint, thus lending validity and credibility to the benefits observed. Of particular relevance here is the clear lack of negative impact on cognitive and motor function replicated in multiple pimavanserin studies. Let's review the two studies and additional analysis we plan to include in our resubmission, starting with the HARMONY study on slide eight.
On the left side of the slide is an overview of pimavanserin's antipsychotic efficacy observed overall and in the AD subgroups in the open label period of the HARMONY study, as well as in the primary efficacy outcome in the double-blind period of the study. We have previously noted, in agreement with the FDA at the time of the study design, HARMONY was not powered to show statistical significance by dementia subgroup. We did prospectively plan exploratory efficacy analysis of dementia subgroups. In the Alzheimer's disease subgroup, we see that Alzheimer's disease subjects who remained on pimavanserin were approximately 40% less likely to experience a relapse of psychotic symptoms compared with those on placebo, as shown with hazard ratio of 0.62.
For context, this magnitude of effect is in line with what has been observed in numerous relapse prevention studies of comparable design for approved drugs in various psychiatric indications such as schizophrenia or depression. I would also like to point out that exploratory analysis of the pimavanserin 34 mg dose group, the dose currently approved for treating PDP patients, demonstrate an even stronger effect and approximately 50% reduction, risk reduction with a hazard ratio of 0.47. Pimavanserin's efficacy is further evidenced by a number of complementary analysis, some examples of which are listed on the right-hand side of this slide, and all of which will be included in the resubmission.
These analyses consistently show the antipsychotic efficacy across different endpoints within the AD subgroup, which we believe clearly support the overall conclusion of the clinically meaningful benefit that pimavanserin demonstrated in the treatment of pimavanserin patients with ADP. Let's review some of these additional analyses further continuing on slide 9. As discussed on this slide is the responder analysis from the HARMONY study, which demonstrate how ADP patients performed on SAPS-H+D compared to placebo. This is looking at the maximum worsening of symptoms following randomization in the double-blind period of the study. Here we observe that patients who were switched to placebo had a significantly higher incidence of worsening of symptoms. This differentiation was observed at each individual threshold level as well as overall and met nominal statistical significance. Notice again the even higher effect observed with the 34 mg ADP patient group.
Please turn to slide 10. I also mentioned that we presented an exposure-response analysis to the FDA and will include in our resubmission. Here are the main takeaways from this graph. First, it is important to recognize that exposure-response relationship is an indication of a true drug response as opposed to a spurious finding and help validate the clinical benefit observed in the study. Second, for ADP, we clearly observed a decrease in relapse rates associated with a higher exposure to pimavanserin. Finally, the exposure-response relationship in the ADP subgroup tracks consistently with what was observed in the overall DRP population on the primary endpoint. Please turn to slide 11. In regard to the HARMONY, I would like to make one last point, which is important as we seek to address the concerns the FDA stated in the CRL.
That is, in the HARMONY study, we observed a very consistent efficacy response across all subgroups of dementia for patients when being treated with pimavanserin. This was observed in the open label and double-blind periods of the study for patients on pimavanserin. The only differential response we observed was in the patients who were switched to placebo in the double-blind randomized period of the study. Here, patients on dopaminergic agents tended to relapse much faster, which of course was mostly concentrated to the Parkinson's disease dementia patients. We discussed these findings with the FDA and will be an important part of our upcoming resubmission. Now let's discuss the 019 study starting on slide 12. In our resubmission, we will also include additional analysis further supporting the validity of our 019 study.
As a reminder, the primary efficacy outcome was positive with a P value equal to 0.045. In a pre-specified analysis of Alzheimer's disease subjects with more severe psychotic symptoms, the magnitude of efficacy more than doubled with a P value equal to 0.011. The responder analysis shown below demonstrates a consistent pattern of efficacy at the various thresholds. As you can clearly see on the right-hand side of the slide, pimavanserin had even greater magnitude of response in those patients with a higher severity of psychosis at baseline. Let's turn to slide 13.
In the CRL, the FDA stated that they considered the 019 study to not be adequate and well controlled, citing that it was a single-center study with no type I error control of secondary endpoint, as well as certain protocol deviations which occurred during the study conduct. In response to these issues, we conducted multiple additional analyses that we believe support the validity of the primary efficacy conclusion of the 019 study and which we agreed with the FDA would be provided for their review in the upcoming resubmission. To recap, pimavanserin has demonstrated clinically meaningful efficacy in ADP across two independent clinical studies and has been very, very well tolerated, and importantly, has not shown impairment on cognition or motor function. With that, I'll now turn the call back over to Steve for closing remarks.
Thank you, Serge. Please turn to slide 15. Before opening up the call for questions, I'd like to take a moment to summarize. In the first quarter of 2022, we will be resubmitting our sNDA for pimavanserin focused on ADP. We expect this to be a six-month review. Second, in the resubmission, we look forward to having an opportunity to make our case to the FDA that pimavanserin, with its attractive efficacy and safety profile, should be the first drug approved to treat Alzheimer's disease psychosis, addressing this high unmet need. Finally, it is important to recognize that ADP patients are often frail and elderly, and there's a real safety concern using the off-label options. We have lots of data on pimavanserin, both in placebo-controlled clinical studies and post-marketing pharmacovigilance data to support our safety profile in this at-risk population. Please turn to slide 16.
In closing, I'd like to remind everyone that we also recently announced positive results from our pivotal phase III LAVENDER study evaluating trofinetide to treat Rett syndrome. Therefore, our teams are currently planning for two regulatory submissions in 2022 from our late-stage development pipeline. In addition, we look forward to keeping you updated on our commercial progress in PDP, as well as the advancement of the rest of our programs. With that, I'll now turn the call over to the operator for questions.
Ladies and gentlemen, if you wish to ask a question, please press star followed by one on your touch-tone telephone. If your question has been answered or you wish to withdraw your question, press the pound key. Please limit yourself to one question. I repeat, please limit yourself to one question. Press star one to begin. Please stand by for your first question. Your first question comes from Cory Kasimov of J.P. Morgan. Your line is open.
Hi, this is Gavin on for Cory. Thanks for taking our question. I'm just curious on the level of input and/or feedback from FDA that gives you confidence in this resubmission strategy. I mean, did they suggest they would convene an ad com, or was there any discussion on that as part of this filing strategy? Thank you.
Yeah. Thanks, Gavin. Serge, you wanna take that question?
Yes. I would start by saying, you know, as presented on the slide, we have had three very productive meetings with the FDA with a strong engagement from both the Division of Psychiatry and Office of Neuroscience. You know, the FDA engaged clearly with us on the resubmission strategy. We discussed the content of the submission, the new analysis that we are proposing for the resubmission. FDA expressed a willingness to review the analysis that we are proposing, as well as, you know, interest in reviewing the data that we will be putting together for the resubmission.
The resubmission for us will be opportunity to make the case for ADP and provide detailed data to see if we can reach alignment within the FDA for a potential approval in ADP. As far as the advisory committee goes, that is obviously the decision for the division. I mean, for us, it would be inappropriate or premature to make any comments in that regard other than I would say if such a decision is made, we will be ready for the advisory committee.
Thank you. Our next question comes from Charles Duncan of Cantor Fitzgerald. Your line is open.
Yeah, good afternoon. Thanks for taking the questions, Steve and Serge. I like the strategy. Hoping it will work out this time. I wanted to ask you a question regarding, you know, if you had to just pick one observation that you think is new that provides you confidence, would it be one observation from HARMONY, or would be a question addressing a concern on 019? What would that observation be? Regarding another trial, have you discussed the challenges of conducting another trial in this population with the FDA? Thanks.
Serge, you wanna take that?
Yes. Thanks, Charles. It's a great question. We do not believe that it was any one particular analysis that would be a silver bullet in the mind of the FDA, but rather really the totality of what we have presented that included actually, most importantly, a consistency in the observations of benefit across different time points and different measurements and across different studies. You know, the purpose for us was not to find just one supportive analysis, but actually to probe the data to see how consistent it was. Actually, that consistency is indication of the true drug response and true benefit, true relationship of the benefit we are observing with the treatment rather than some spurious finding on one or two particular outcome measures.
What we have seen throughout this cumulative analysis of all of these studies is a very consistent effect, and that support the drug effect versus a spurious finding.
That makes sense.
Charles, in regard to yours, the second part of your question, I don't think it'd be productive for us to get into a discussion of, you know, what we said or what the FDA said, et cetera. What I will say is that, you know, certainly as we continue to be in a pandemic that ebbs and flows, it does make enrollment in clinical studies more challenging, and particularly for the kinds of elderly patients that have Alzheimer's disease psychosis.
For sure it would. Thanks for taking our question.
Thank you. Our next question comes from Neena Bitritto-Garg of Citi. Your line is open.
Hey, guys. Thanks for taking the question. I was just, you know, kind of to follow on to Charles's question. Was there any noticeable kind of shift in the FDA's stance over the course of the last kinda three meetings in terms of specifically maybe their attitude towards the 019 study? I mean, have you gotten a sense from them if they do feel like that is now, you know, kind of a more robust study than previously? Thanks.
Sure. Serge, you wanna take that?
Yes. Thanks, Neena. A great question. I you know, I would say that in the course of three meetings, I couldn't characterize that there was any particular dramatic shift in the position of FDA. Well, they started from the position that one would expect that the best path forward would be to generate a new data in the new clinical study in the subgroup, dementia subgroup of interest. They continue, which again was completely understandable to maintain that position that would probably be the best path forward from their perspective. In the course of our discussions in the three meetings, they were also increasingly interested in the arguments that we were making and the data analysis that we were proposing on the basis of existing data.
We had a very productive discussions in that regard, and they were, you know, expressing the willingness to look at that data. They expressed the position that they would consider that data reviewable application and that they would be interested in looking at that data. Of course, as Steve mentioned, you know, everything is a subject to review, and they are not in a position on the basis of the meeting to make any definitive decisions in that respect. They clearly expressed interest in looking at that data and in reviewing the resubmission as we prepare it.
Got it. Thank you.
You know, I would just echo what Serge said and probably just add on to that. I think the right way to think about this is, as Serge mentioned, the FDA has indicated a willingness to hear our case. The resubmission process gives us an opportunity to go in and try to make our case.
Got it. Thanks.
Thank you. Our next question comes from Yatin Suneja of Guggenheim Securities. Your question, please.
Hey, guys. Thank you for taking my question. Just two questions from me. Any comments from the agency on the stats that you have run? Because, you know, some of the, you know, if you look at the upper bound of the confidence interval in some of these endpoints is above one. So what is their thinking on that? Is there any or do they have any threshold for effect? And then the second question is, I think when you received the CRL, the FDA clearly mentioned that Study 019 is not adequately controlled. There is this, you know, it doesn't have, like, no type one error control for secondary endpoint. Like how would you remedy that?
Serge?
Yes. Thanks, Yatin. On the first part related to the threshold, I think the whole argument that we have presented and that have been discussed is really in the consistency of clinical benefit observed across variety of different analytical approaches to the data from the 045 study as relates to the Alzheimer's disease psychosis subgroup specifically. You know, the point being here, some of this analysis may be and have been nominally significant, statistically significant. Some were not statistically significant. The main more important point there is that consistency that you see across that and the clinical meaningfulness of the benefit that is seen as measured by a variety of parameters. That's what I would underscore. That was a core of the discussion.
Of course, again, I would say it is a matter of the FDA's review ultimately when we resubmit all of this data to make a final decisions on that. This was a core of the discussion related to the new analysis that we were presented and the arguments that we made. In regard to 019 study, you know, in these meetings, we reviewed with the FDA a variety of first of all kind of information related to both their concerns on the single center study and the requirements for adequate and well-controlled study. There was a discussion in that regard and of course that will be part of the resubmission as well.
Then specifically, we discussed the deviations that FDA expressed concerns around, along with a number of the analysis that we performed, all essentially underscoring that the main conclusions or the primary conclusions of the study are not impacted by this analysis. While we acknowledge the deviations that exist and discuss them in the meetings and will be included in the submission, we are making the case that, based on our analytical approaches and review of these deviations, they have not impacted and would not impact the conclusions, positive conclusions of the benefit observed in this study. These are the discussions we had. This is the approach we will be taking in the resubmission.
Again, of course, that will be part of the review process, and FDA, you know, said so.
Thank you. Our next question comes from Jason Butler of JMP Securities. Please go ahead.
Hi. Thanks for taking the question. I guess to what extent will you prepare the commercial organization to for a launch I guess in the second half of next year? I guess maybe I missed this, Serge, but the piece on PDD and the differential response in placebo patients, to what extent is that discussion relevant in the context of an ADP label? Thanks.
Yeah. Brendan, if you could take the commercial launch prep question, and then we'll circle back to Serge on PDD.
Sure, Steve. Thank you, Jason, for your question. I guess the first way to characterize it is we will absolutely be ready at the time of launch. It would be worth noting that earlier this year, we would have been gearing up for DRP at the end of the first quarter. We will continue to review those elements of the launch strategy, and we'll reengage in the prep at the appropriate time.
Serge, you wanna speak to PDD analysis?
It's a great question, Jason. You know, let me just pull back a little and just start from saying to remind everybody that one of the concerns by the FDA expressed with a complete response letter was that, look, you have a differential response and differential efficacy between different dementia subgroups by Parkinson's disease dementia patients having this extraordinary tremendous efficacy, while we don't see that in the other subgroups, specifically in Alzheimer disease psychosis. The question for them in their mind was, does pimavanserin work differently in different subgroups of dementia? So addressing that question and in our discussion with them, that had quite a bit of, I would say that had some traction in that discussion.
We were trying to address that concern and actually to demonstrate that the efficacy of pimavanserin, an active treatment, when you look in the response to pimavanserin in more different subgroups, is very homogeneous, very similar. While actually the only difference comes when you look in the patients that are switched to placebo and then in the rapidity, speed, and frequency of relapses, specifically in the Parkinson's disease dementia subgroup. We ask the question, why is that? You know, one of the confoundings that rose up in our analysis and review was, well, all of these patients are on the dopamine-stimulating therapy that in itself is force-pushing patients towards psychotic symptoms.
Once you remove a successful treatment, those patients fast return to their psychotic symptoms. We did also do some analysis in a very few patients, but there were some patients that are not Parkinson patients but were on dopaminergic therapy, and we found very similar pattern of the relapses. We presented that data to the FDA, had some discussion, and they are interested for that data to be a part of the data. The point being that the all of the findings of the benefit we see across different subgroups is then lending a strength to the evidence that also a benefit we see in Alzheimer's disease group is a real and meaningful benefit.
Great. Thanks. Thanks for that.
I'm gonna add two quick additional thoughts. One is, as Serge mentioned, I do think this is a pretty important point that we discussed with FDA. Second, you know, you might ask the question, "Well, why does that matter today? If we're focused on ADP, why does it matter how patients that were PDD patients responded?" Then by the way, these PDD patients are truly comorbid patients, right? They have both Parkinson's disease, and they have frank dementias. That was a population we had not previously studied. The answer is, again, what we've seen through multiple cross-sectional analyses is a very consistent response with pimavanserin when patients with ADP are treated with pimavanserin. Where we saw an inconsistency in those PDD comorbid patients was in the placebo patients. After we withdrew successful therapy with pimavanserin, they relapsed faster.
Understanding that inconsistency in the placebo group so that we can then assess the consistency of results in the drug treated group was an important point of our discussions with FDA.
Thanks, Steve.
Thank you. Our next question comes from Jay Olson of Oppenheimer. Your line is open.
Oh, hey, thanks for this update and thanks for taking the question. Can you talk about feedback that you received from payers when you were preparing for the DRP launch and if that feedback might change or be the same for a potential ADP indication? Thank you.
Yeah, thanks for the question, Jay. Brendan, you wanna take that?
Sure. Yes, Jay, thanks for the question. As a reminder, NUPLAZID currently enjoys broad access on formularies for PDP. Recognizing that ADP, or if you wanted to refer to DRP originally, is a line extension and that NUPLAZID has a protected class status, payers are likely to add usage criteria for ADP on NUPLAZID's existing formulary status. We feel like we're well-established and in a good position for a line extension, if and when ADP is approved.
Great. Thank you.
Thank you. Our next question comes from Ritu Baral of Cowen. Your line is open.
Hi, guys. Thanks for taking the question. Apologies for the background noise. Can you confirm that this is a class 2 resubmission that you're gonna make to FDA? Is this going to be again for full approval or was a potential accelerated approval discussed, either brought up by you guys or floated by FDA? Thanks.
Serge, do you wanna take that?
Yeah. This will be a complete response resubmission to a complete response letter. It's a six-month review. We do not believe that this resubmission would meet any criteria for accelerated approval. There wasn't any discussion in that respect.
Got it. Thanks.
Thank you. Our next question comes from Sumant Kulkarni of Canaccord. Please go ahead.
Hi, good afternoon. Thanks for taking my question. Given FDA's restated advice that an additional study in ADP is the best way forward, is it fair to assume that you currently have a high degree of confidence that the FDA will specifically accept your sNDA for filing? I guess if there's any thoughts on that, I'll appreciate it.
Yeah, thanks much for the question. You know, look, I just don't think it would be productive or prudent for us to comment on, you know, likelihood of success with this submission. What I will though say is, I would just guide you to the slide that we have that we presented today that outlines the sequence of discussions that we've had with FDA. We try to track as closely as possible the exact language in our minutes from those meetings. I think what we've laid out there is, and what we've tried to communicate today, is we think we have an opportunity to make our case with FDA regarding the efficacy, safety and overall benefit risk of pimavanserin in AD patients.
Thanks.
Thank you. Our next question comes from Jeff Hung of Morgan Stanley. Your question please.
Thanks for taking the question. You've indicated that FDA hasn't agreed with all of your arguments. Can you give us a flavor for the types of arguments you're referring to?
Well, I'll start and Serge, feel free to chime in as well. You know, look, I would just simply say that, you know, we've had three meetings with the FDA. They were very productive. The FDA was very engaged. I think we made progress in terms of trying to position ourselves so that we can make our case through this resubmission. Having said that, you know, these meetings of course we're presenting summaries of analyses that we've done, but they obviously need to get into the detailed analyses themselves and ultimately reach an alignment whether they agree with us or not.
I would just simply say that we obviously, you know, don't wanna be presumptuous in terms of what their ultimate conclusions will be, but we feel like we have a very strong case supporting efficacy, safety and positive benefit-risk profile of the drug. We're in a position now where we need to submit all of that data to FDA and allow them to assess it themselves.
Thanks.
Thank you. Our next question comes from Paul Matteis of Stifel. Your line is open.
Hi, this is Katie on for Paul. I guess just to follow up on a comment you made earlier, noting your enrollment concerns, due to COVID, as you guys said earlier, if conditions improve over the next few months, do you think there's a chance that you'd run another study concurrently, especially as the FDA reiterated this is the recommended pathway? Thank you.
Yeah, thanks much for the question, Katie. I'll just simply repeat that at this point in time, we do not have intentions to run an additional study in ADP.
Thank you.
Thank you. Next question comes from Gregory Renza of RBC Capital Markets. Please go ahead.
Hey, Steve and team. Thanks for the update and for taking my question. Maybe, Steve, just building on the previous ones already asked, how difficult of a decision was this for you to pursue the resubmission now, certainly in light of the confidence that you've reiterated, but also the FDA stance on the additional trial, and especially just given that this entails really establishing and deploying your resources and energy to this effort now? Maybe just building on that, if there's any spend color or change to use of cash that you could allude to, that would be great. Thanks.
Yeah. Thanks much for the question, Greg . Look, the starting place for this, I think, is just the recognition of the dramatic unmet need that we have today. There is no drug approved to treat Alzheimer's disease psychosis. Drugs that are used off-label today to treat it have minimal to questionable or no efficacy, but they do have very dramatic side effects. So there's a significant unmet need. We all know the history in terms of our phase III program designed to explore dementia-related psychosis. We did not design or power the study to look at individual subgroups. When we step back and look at the totality of the data that we have, we think we have a very strong case, as I've mentioned before.
We recognize that it is not the typical package, because we didn't set out to study ADP at the beginning of our phase III program. Having said that, we again believe that it is a very strong package, and we're looking forward to an opportunity to make our case and for FDA to hear our arguments through the resubmission.
Will, thank you.
Address the cash point in a second.
Yeah. I'm sorry, Mark. Yeah, please go ahead.
Yeah. Great. Thanks, Greg . I guess the short answer is no impact on cash management for the company, and we have sufficient resources to fund various cases that we may pursue with the company. I think as we continue to expand our R&D or invest in more business development, that may change our position for cash and potential cash needs. You know, nothing from this decision impacts cash one way or the other.
Great. Thank you very much.
Thank you. Our next question comes from Vamil Divan of Mizuho Securities. Your line is open.
Great. Thanks for taking my question. Thanks for hosting this call. Just one question, maybe more of a sort of disclosure communication perspective, just given the sort of unusual situation here. Do you have plans, some of the additional analysis that you sort of walked through today, do you have any plans to try and get these submitted, either published or maybe presented at a medical conference between now and, say, middle of next year, just to give investors, analysts a little bit more, details on all this and also, just in terms of prepping the market and having physicians get a little more understanding of the data and kind of the additional analysis you've done prior to the drug actually getting approved?
Yeah. Thanks much for the question. You know, look, I think, you know, for understandable reasons, when we go into a submission, and as most companies do, we won't be able to speak a lot to the, you know, day-to-day interactions that we're having with FDA. We do look forward to getting data from the analysis we've done into the medical community, and that'll happen in due course. You know, we'll be somewhat constrained as, again, as companies typically are as we go through the review process with FDA.
Okay. All right. Thank you.
Thank you. Our next question comes from Ami Fadia of Needham. Your line is open.
Hey, this is Chen for Ami. Our questions are, what is your level of confidence that the resubmission will result in an approval? Did FDA indicate that it no longer believes that additional trial is necessary for ADP? How did you think about the trade-off between a resubmission and running another trial in ADP in parallel? Thank you.
Sure. Serge, do you want to take that?
Yeah. You know, it's as we mentioned earlier, it would be inappropriate for us, and we will not engage in speculating and trying to interpret what FDA is specifically thinking on a particular analysis or on a particular approaches is beyond what we discuss with them and the you know understanding and agreements that we reached with them. So I wouldn't speculate on the level of confidence that we will receive approval.
I will say and repeat that we are very confident ourselves in the data that we prepared, in the analysis that we prepared, and that those analysis point to, what they clearly suggest, clinically meaningful benefit in this specific subgroup in the context of two positive studies that were designed to demonstrate the same benefit in the Alzheimer's disease population and in the broader population of DRP. This situation is a little bit different than what we usually see following a negative pivotal trial. The sponsors are trying to produce a number of additional analysis, subgroup analysis, demonstrated benefit in a specific subgroup or subpopulation study. In our case, we are doing this in the context of the positive study that met its primary endpoint.
That in itself lends a validity and credibility of additional look into the subgroups of patients that were not designed to show statistical significance. You're looking at the consistency, at the size of the effect, the benefit that you're seeing, and how across time and across measures and outcomes, we are seeing that consistency of benefit. From that is what gives us the confidence in the data that we have and that we will be submitting in our resubmission package.
Thank you. How would you think about the tradeoff between a resubmission and running another trial in ADP in parallel?
Yeah. I'll just repeat what Steve said earlier, and that is, at this point, we do not have plans to run a new trial in Alzheimer's disease psychosis.
Okay. Thank you.
Thank you. Mr. Davis, please proceed to closing remarks.
Great. Thank you, operator. Thanks to all of you for participating in this call. We look forward to updating you as we pursue our mission to elevate life.
Thank you for your participation in today's conference call. This concludes the presentation. You may now disconnect. Good day.