Aldeyra Therapeutics, Inc. (ALDX) Earnings Call Transcript & Summary

Hello, and welcome to the Aldeyra Therapeutics conference call to discuss regulatory update on reproxalap in dry eye disease. My name is Alex and I'll be coordinating the call today. [Operator Instructions] I'll now hand over to your host, David Burke, Head of Investor Relations. Please go ahead.

Thank you, and good morning, everyone. With me today is Dr. Todd Brady, President and Chief Executive Officer of Aldeyra. Yesterday, on November 27, we issued a press release announcing receipt of a complete response letter for reproxalap for the treatment of dry eye disease as well as Aldeyra's expectations regarding the timing and cost of an additional clinical trial and potential NDA resubmission. A copy of the press release is available on the Investor and Media section of our website, www.aldeyra.com. The press release contains important information and should be read and considered in conjunction with the slides presented and the prepared remarks made on today's call. Turning to Slide 2, this presentation and various remarks which may be made during this presentation contain forward-looking statements regarding Aldeyra, its investigational drug candidate reproxalap, and its plans, expectations and opportunities including potential clinical trials and regulatory activities. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Aldeyra's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These statements are based upon the information available to Aldeyra today, reflect Aldeyra's current views with respect to future events and are based on assumptions and subject to risks and uncertainties, including the development, clinical and regulatory plans or expectations for Aldeyra's investigational drugs, including reproxalap. The risks that result from earlier clinical trials or portions of clinical trials may not accurately predict the results of future trials or the remainder of a clinical trial. Aldeyra assumes no obligation to update these statements as circumstances change. Future events and actual results could differ materially from those projected in the company's forward-looking statements, including the results of operations and financial position. Additional information concerning factors that could cause results to differ materially from our forward-looking statements are described in greater detail in the press release issued this morning and in our filings with the Securities and Exchange Commission. I would now like to turn your attention to Slide 3, and I introduce Dr. Todd Brady.

Thank you, David. Yesterday, on November 27, and consistent with the 8-K we filed on October 16 of this year, we received a complete response letter notification from the FDA that the reproxalap new drug application for the treatment of dry eye disease was not approved due to the need for an additional clinical trial to demonstrate the activity of reproxalap in improving the symptoms of dry eye disease. In particular, the letter stated that the NDA did not demonstrate efficacy in treating ocular symptoms associated with dry eyes, and that at least one additional adequate well-controlled study to demonstrate a positive effect on the treatment of ocular symptoms of dry eye should be conducted. Per FDA draft dry eye disease guidance, efficacy may be demonstrated with 2 clinical trials demonstrating activity in improving symptoms and 2 clinical trials demonstrating activity in improving signs. Among other clinical trials, Aldeyra previously conducted 2 trials for ocular redness, a dry eye disease sign, as well as a dry eye disease symptom trial. No chemistry, manufacturing and controls or safety issues were identified in the complete response letter. As is summarized on Slide 4, based on FDA feedback subsequent to the late-cycle review meeting, we believe that a single dry eye chamber crossover clinical trial, or the proposed trial, substantially similar to the crossover chamber trial announced in July of last year, would be sufficient, if successful, to allow for potential resubmission of the NDA as soon as the first half of 2024. On November 16, we submitted a special protocol assessment, or SPA, feedback from which we expect next month based on the 45-day SPA review guidelines. The proposed trial, the primary endpoints of which are symptoms, is expected to cost less than $2 million, with top line results expected in the first half of next year. If successful, the proposed trial could potentially enable NDA resubmission in the first half of next year. NDA review is expected to be 6 months. If the SPA and proposed clinical trial results are successful and the resubmitted NDA is approved, we expect that reproxalap, and the reproxalap label, could represent the first label with acute and chronic symptomatic benefit as well as acute improvement in ocular redness, which is potentially the only dry eye disease sign of importance to patients. Illustrated on Slide 5 is the proposed trial design, which in all material respects is identical to the previously completed dry eye chamber crossover clinical trial announced last year. The crossover design consists of 2 days of 1 treatment, followed by a 7 to 14 day washout period of no treatment, followed by 2 days of the other treatment, for a total per patient duration of approximately 3 weeks. In the proposed trial, patients are equally randomized to receive either reproxalap first or vehicle first. Approximately 70 patients are expected to be randomized in total, half to receive reproxalap followed by vehicle and half to receive vehicle followed by reproxalap. As was the case in all previously disclosed dry eye chamber clinical trials of reproxalap, each visit is expected to consist of 2 days; 4 doses of test article on day 1, followed by a 90-minute dry eye chamber on day 2. For day 2, ocular symptoms are expected to be measured approximately every 10 minutes in the dry eye chamber, and test article is to be administered just before the chamber and 45 minutes after chamber entry to assess prophylactic and treatment activity, respectively. The dry eye chamber, which is described in draft FDA guidance on dry eye disease, is an acute exposure to temperature- and flow-controlled low or no humidity air during forced visual tasking. In contrast to the previously completed dry eye chamber trial, the primary endpoints of the proposed trial are patient-reported dry eye symptoms, in particular eye dryness score and ocular discomfort score, the 2 most important symptoms reported by dry eye disease patients. The Hochberg procedure is expected to be used to control for multiplicity across the 2 symptom endpoints, and across both endpoints, the trial is expected to be more than 90% powered. Other symptoms, burning, grittiness and stinging, will be assessed as secondary endpoints. The dry eye symptom results, which were secondary endpoints in the previously announced crossover dry eye chamber trial, are presented on Slide 6. The secondary symptom endpoints were achieved for all dry eye disease symptoms assessed within and before and after the dry eye chamber. Both prophylactic and treatment effects were demonstrated for all symptoms tested in the dry eye chamber, and the overall effect within the chamber was highly statistically significant in favor of reproxalap over vehicle, with p-values ranging from 0.0068 to less than 0.0001. For every symptom measured in the dry eye chamber, reproxalap was numerically lower than vehicle at each time point, including the first time point assessed 10 minutes after chamber entry. The results of the previously completed crossover trial suggest the symptomatic activity of reproxalap in the trial was rapid, statistically reducing a wide range of symptoms within 90 minutes in the dry eye chamber. Slide 7 summarizes the potential path to NDA resubmission. Earlier this month, we reported $143 million as of September 30, 2023, in cash, cash equivalents and marketable securities, which we believe positions us favorably against an expected clinical trial cost of less than $2 million. Previous run rate guidance which had assumed an approval and launch of reproxalap this year was extended into late 2025, including clinical trial costs associated with the potential NDA resubmission, the initial commercialization and launch plans for reproxalap was approved during the second half of 2024, and continued early in late-stage development of our product candidates in ocular and systemic immune-mediated diseases. The runway guidance excludes any potential product or licensing revenue associated with reproxalap. We look forward to SPA feedback, which we expect next month, and, pending SPA feedback, top line results from the proposed trial in the first half of next year. Assuming successful outcomes with the SPA and the proposed trial, we expect a potential NDA resubmission in the first half of next year, followed by a 6-month NDA review. Operator, at this time, I'd now like to open the call for questions.

[Operator Instructions] Our first question for today comes from Tom Shrader of BTIG.

This is Sung on for Tom. For reproxalap, I actually had a question regarding allergic conjunctivitis. I understand that a Type C meeting is planned for first half '24. But given that the potential NDA resubmission for dry eye disease may happen at a similar time frame, could you maybe elaborate on what strategy were being considered for optimizing the use of data from the INVIGORATE trial?

As you point out, reproxalap is also in development for allergic conjunctivitis. The INVIGORATE-2 Phase III results were reported earlier this year, and as we said in the press release issued yesterday, we intend to go speak with the agency about remaining requirements for submission of an NDA in allergic conjunctivitis. I think it's important, though, to consider that dry eye disease at this point is in pole position in terms of our regulatory strategy. Our goals are to, first, allow a resubmission of the NDA in dry eye disease. And our conversations with the agency about allergic conjunctivitis are obviously secondary to whatever happens in dry eye. As you point out, I think there is a lot of synergy between the 2 diseases. Many patients have both of these diseases; approximately half of dry eye patients also exhibit some form of ocular allergy and vice versa. I think that clinical fact is an important consideration with the FDA, and how we approach getting reproxalap in the hands of both sets of patients will be important going forward as we continue our conversations with the FDA.

Our next question comes from Marc Goodman of Leerink.

Todd, can you talk about the comment in the press release about chronic and acute being on the label and what makes you think you can get that? And have you had any discussions with FDA before about that? Is that in the SPA, such that you'll know soon whether that can possibly be in the label? And how important do you think that is?

That's a great question. I want to clarify that by chronic and acute, we're referring to data. That is, the label we would intend to submit, pending a positive SPA and trial results, would include data that exhibit both chronic and acute activity of reproxalap. And now as we've disclosed previously, reproxalap has completed a couple of 12-week field trials. Obviously, those data are chronic. But the data that I referred to this morning and referenced on Slide 6 is obviously acute. That's dry eye chamber data, the first time point being measured 10 minutes after a dose and the entire symptom data being measured over 90 minutes. A massive problem in dry eye disease is the drugs we have today, that are available today, do not work quickly -- and by quickly I mean within minutes, which is a major complaint among dry eye patients. No one wants to take a drug for weeks before deciding whether or not that drug is effective. And reproxalap theoretically offers a new kind of therapy that allows for rapid assessment of activity and, from the patient's perspective, rapid relief. And that's what I'm hoping would wind up on the label in terms of data in the clinical section of the label.

Our next question comes from Kelly Shi of Jefferies.

Firstly, I'm curious what the criteria is actually for being granted for a special protocol assessment? And if the current trial design is not accepted by FDA, what is the plan B?

Kelly, always nice to have plan B. I think your point about the SPA is a good one. These days, my understanding is that to even submit an SPA, there has to be some agreement with the agency about the kind of trial that's going to be submitted, and I think technically the sponsor and the agency are supposed to have a meeting that then grants the sponsor the opportunity to submit an SPA. I think the good news is that, based on the late cycle review meeting regarding the dry eye disease NDA for reproxalap and subsequent communications with the agency following that meeting, we were permitted to submit an SPA, which, as was disclosed in the press release yesterday, was submitted on the 16th of November. Obviously, we are being proactive. I think it's quite unique to submit an SPA even prior to receiving a complete response letter. But the communications from the agency were very clear, as we had disclosed in October via an 8-K, that another trial was needed. We immediately initiated communications with the agency to define the parameters of said trial, and hence an SPA was submitted previously. I think the review for the SPA is 45 days, and we should know next month where the FDA is. I do not expect there will be major issues with the trial itself. We have used a chamber crossover design previously, those are the data that I presented this morning. And our expectation is that we will have sufficient feedback next month to go ahead and initiate that trial, which, in theory, could provide data, and the potential NDA resubmission, if the data are positive, in the first half of next year. So what is plan B? Plan B is if the chamber trial is not acceptable or the crossover design is not acceptable, I think we have other tools in our toolkit. As I mentioned previously in response to Marc's question, we've run a 12-week field trials. The good news in those trials is the separation between drug and vehicle, reproxalap and vehicle, occurred at relatively early in the process; I think we could be in a position to run a shorter field trial, perhaps 6 weeks. But all this is speculation at this point. I think, first, we need to hear that from the agency on the SPA -- obviously, we're optimistic about the SPA process given the dialogue we've had with the agency -- and then we can go from there.

Our next question comes from Yigal Nochomovitz of Citi.

So it seems like the FDA is making a very technical distinction here between what you've submitted with the original NDA and what they've now requested. I mean, after all, you followed the recipe basically to the T in terms of 2 signs, 2 symptoms, albeit the second set of symptoms was secondary endpoints, and now they're basically saying do another one, do another crossover trial with making some of those primary, which I think is this distinction, if I'm correct. So it would be helpful if you could elaborate a little bit on why that happened, especially given how transparent ophthalmology division, obviously, always is, and if one of the chambers says do x, y, and z and the company does x, y and z, and then those studies work, then you're good. So it would be helpful if you could just elaborate a little bit on how their stance changed and why this is [indiscernible]. Obviously you followed the recipe as directed by the guidance.

Yes. Yigal, a couple of points I would make at the outset. As you know, we submitted 2 12-week field trials. One of those trials was the RENEW trial, announced in 2019 I believe. The co-primary endpoint for that trial was symptoms and staining. Staining is a sign of dry eye disease. We hit symptoms and we missed staining. And while the symptoms data were remarkably positive -- in fact, in the RENEW trial we hit every symptom, presenting, I think, some of the largest effect sizes ever presented in dry eye disease in terms of symptomatic control -- we technically didn't hit the primary itself because the primary was comprised of 2 endpoints, that is symptoms and staining. Staining was not hit over 12 weeks. It was hit over 4 weeks, but not over 12 weeks. And so there is a technical distinction between achieving the primary endpoint of RENEW and not. And when a co-primary is in place for the trial to be "successful," both primaries need to be achieved, which was not the case in RENEW. I think the division drew a distinction there for the RENEW data. The data from the trial I've reviewed this morning, the crossover chamber trial announced in July of last year, as you pointed out, those endpoints are secondary endpoints. So technically, what the division is asking for is a prospectively designed trial where symptoms are specified as primary endpoints, and that trial would need to be successful to confirm activities in symptoms.

Okay. And then with regard to AbbVie, can you comment at all there in terms of their disposition as far as pursuing the partnership? Are they waiting for this SPA agreement application to be accepted by the agency before they're willing to commit further capital? Or what is their stance currently?

The AbbVie option agreement, which was recently disclosed in a press release and also in more detail in an 8-K, specifies that on December -- or by December 15, AbbVie makes a decision to extend the option or not. The extension, the fee due by December 15 if AbbVie elects to extend, is $5 million. My impression is that, that December 15 date allows AbbVie sufficient time to review the results of PDUFA. But as you're aware, we've disclosed the need for an additional clinical trial as part of this NDA well before we disclosed the relationship with AbbVie in terms of the option with AbbVie. So AbbVie, prior to executing the option, or I should say initiating the option agreement, and also as part of the current ongoing option agreement, is well up to speed regarding our conversations with the agency. So I think the next step for the AbbVie relationship is on December 15, Yigal.

Our next question comes from Justin Kim of Oppenheimer.

Maybe just a clarification question, but given the cycle of 45 days for the SPA, does that potentially allow for an update to slip into the early part of next year?

Well, it's an interesting question, Justin, because I think the SPA process in theory is an iterative process where they're -- the information's shared back and forth between the sponsor and the agency during the 45-day SPA review. So in theory, we'll have some feedback before the end of December. But nominally, the FDA would get back to us 45 days from the 16th of November, which is prior to the end of the year. If agreement is reached or there's a sufficient amount of positive feedback that we can go ahead and initiate the proposed trial described this morning, then I would expect we would announce that. If there is, on the other hand, continued dialogue between the agency and Aldeyra regarding the trial or there's certain critical disagreements on the various aspects of the trial and that negotiation is ongoing, I think you wouldn't hear from us by the end of the year. Either way, though, Justin, I think, per my previous comments today, we would expect that the basic trial design, the basic way of assessing our endpoints and so forth, are more or less pre-agreed just given what we've already submitted in the NDA itself. As you know, the proposed trial is more or less a replicate of a trial that has been thoroughly reviewed by the agency as part of the NDA review process.

Okay. Understood. And just in terms of the execution of this additional study, is there sort of a time frame in which you would anticipate enrollment being concluded to maybe not necessarily run into sort of seasonality effects that maybe have been previously highlighted before in dry eye?

Well, the good news is our best data in dry eye occur during the winter months. The reason for that, as you point out, is this concept of seasonality, whereby pollen, in particular, exacerbates the dry eye disease. To some of the comments I've made earlier in the Q&A session, there is this significant comorbidity between ocular allergy and dry eye disease that they exacerbate each other. And so when you're testing patients that are suffering from both conditions at once, I think elucidating drug effect becomes more complicated. The good news is, just given the SPA, the timelines you were asking about, our expectation is that we'll be able to enroll more or less the entire trial during winter months, again, which would allow us to present data to the Street in the first half of next year, and, assuming that the SPA and trial feedback or the trial is positive, then resubmit in the first half of next year as well.

Got it. Got it. Maybe if I could just squeeze in one final one. In terms of the option agreement and a discussion with AbbVie, what has been sort of the, I guess, feedback or interest in AC as part of maybe that sort of broader overall interest?

Well, I can't speak for AbbVie directly, but I can tell you that AbbVie is acutely aware of all of our clinical data with reproxalap. And ultimately, whoever commercializes a reproxalap, whether it be AbbVie or Aldeyra, I think the decision needs to be made, per Sung's question at the beginning of the Q&A session, about how do we integrate dry eye disease with allergic conjunctivitis. That I'm aware, there is no dry eye disease drug, possibly except for steroids, that has any activity in allergy. And that allows for a tremendous market opportunity, not only in terms of differentiation in dry eye disease, but also in terms of the number of patients that could be treated. About 1/3 of allergic conjunctivitis patients do not adequately respond to antihistamines, which are sort of the market leader in ocular allergy. And so how reproxalap is commercialized with regard to those 2 diseases, I think, is to be worked out. As I mentioned previously, our first and foremost concern is navigating the regulatory environment for dry eye disease, and then allergic conjunctivitis, I think, represents upside relative to whatever happens with dry eye.

Our next question comes from Yale Jen of Laidlaw & Co.

Just two questions here. The first one is that, in comparison to your prior chamber study for the [ design ], as well as the RENEW study, this proposed study seems to have a much smaller patient size. So is there any rationale behind that? And then I have a follow-up.

Yale, I think you've surfaced a very interesting phenomenon with dry eye disease. At least acutely -- when we're speaking of symptoms, at least acutely, I think the patient-to-patient difference is substantial, meaning that what is important to you may be less important to me. A score of 30 for you may be a score of 90 for me. And the way to get around that, and again, I'm talking from an acute symptomatic standpoint, is to compare each patient to his or her self. That is the crossover design, where each patient is exposed to reproxalap and vehicle in a randomized order and the interpatient variability, that is, comparing you to me, is minimized, and the intrapatient, that is, within each patient, effect size is what matters statistically comparing the drug to vehicle. The crossover design is a very effective way of minimizing interpatient variability. And I think in dry eye disease, Aldeyra was the first to demonstrate that a crossover trial, at least as it relates to acute assessment in a dry eye chamber, is a very effective way of testing patients for all the reasons that I just mentioned. A field trial is more difficult to do in a crossover setting, and that's because you have to test patients chronically. To Marc's point about chronic and acute data on the label, a field trial is chronic data. To cross over a patient after 12 weeks of therapy with some washout period would require a very long period of time across many seasons, several seasons probably, throughout the year. And I just think it would be less feasible to cross over patients in a field setting. Thus, because of the interpatient variability in a field setting, more patients are required. And that, Yale, is why you see more patients in a field trial than you would for a crossover trial.

Okay. Great. That is very helpful and clear. Maybe one more question here, which is you have a co-primary endpoint. I understand the dryness -- eye dryness scores. Just curious why you'd choose ocular discomfort scores, and what others will be used for secondary endpoints?

I want to distinguish between a co-primary endpoint and 2 primary endpoints. To Yigal's question about the RENEW trial, the RENEW trial had a co-primary, and for that setup to be successful, both primaries have to be met. That's not what we're proposing for the new crossover trial. For the new crossover trial, we have 2 primaries, either one of which could satisfy or could allow achievement of the primary endpoint of the trial. And the way that's possible is adjustment of multiplicity, that is, your alpha or your statistical significance is adjusted because you have 2 endpoints. It's something called the Hochberg procedure, which I mentioned in my comments this morning that it's sort of a ranking of p-values, and if both endpoints are less than 0.05 and both endpoints are met, you can claim success for either endpoint. If one endpoint fails, that is, higher than 0.05 in the p-value, then the next endpoint needs to be assessed at 0.025 and alpha 0.025. Either way, it allows the potential for one or more endpoints to be deemed successful in a clinical trial. Your question about why discomfort is interesting, as you can see on Slide 7 -- I'm sorry, on Slide 6, our discomfort data in the prior crossover trial were more statistically significant than our dryness data. My understanding from the FDA is that symptoms are important and the actual symptom is less important. By that I mean, what you might call dryness I might call discomfort, or what I might call stinging you might call burning. I think the primary concern of the agency is did symptoms improve, rather than does a particular symptom improve. We'll know more once the SPA feedback is received. The good news is, whether it's dryness or whether it's discomfort, the data from the prior trial were remarkably positive and we would anticipate to see something similar in the next trial.

Our next question comes from Catherine Novack of Jones Research.

So I just kind of wanted to ask, there was so much focus in the prior studies on getting significance on signs with dry eye. Was there at any point when you questioned the strength of the data for symptoms? And then, was -- is there any indication whether the issue with the data is not just about Phase III RENEW, but also regarding data from the formulation Phase II, which you have mentioned with another study using -- you were using for ocular dryness?

Right, Catherine. I think you've correctly summarized our position going into the NDA review, which is our symptom data appeared to be quite strong. We had the RENEW data, we had the formulation Phase II data that you just mentioned, we had the secondary symptom endpoints that I presented this morning. From a totality or preponderance standpoint, our assumption, again, prior to the NDA review, was that our symptom data were quite strong, and we were quite eager to see where the FDA came out on the signs. I don't think that there were any review issues associated with the formulation Phase II. Those symptoms data were very strong, number one; and number two, the only primary endpoint of that trial was symptoms. And that primary endpoint was achieved. The FDA has told us in writing previously that the formulation used in the formulation Phase II, which is slightly different than the proposed commercial formulation, in their eyes would be deemed substantially similar. That is, they don't distinguish between the formulations we used across our clinical trials, which is good news. So I didn't see any -- I'm not aware of any issues with the formulation Phase II. I think it was simply a matter of prespecifying a single primary endpoint or primary endpoints associated with symptoms running that prospectively in a trial and achieving that endpoint.

Okay. That makes sense. And I just wanted to clarify, from a previous comment, you have 2 primary endpoints for the crossover chamber trial. But both of the studies from the previous package submitted were for ocular dryness. Why include the ocular discomfort score? Do you have data from a previous study for that?

Right. The discomfort data from the crossover chamber trial that I presented this morning were remarkably robust. They were more robust than the dryness data. And as I mentioned in response to Yale's question about dryness versus discomfort, I don't have the understanding at this point that the FDA is likely to distinguish between dryness and discomfort. All that could change. We do not have SPA feedback yet, obviously. We're eager to hear what the division says about dryness versus discomfort. But my understanding based on previous conversations with the agency is that symptoms matter to patients and the agency appears to be less concerned about particular symptoms. And as I said in response to Yale's question, I think the reason for that is fairly clear, and that is what one patient may describe in terms of words -- discomfort, dryness, stinging, burning -- may be different from what another patient describes in terms of words. But the bottom line is that both patients are symptomatic. Dry eye disease is not a comfortable disease. Patients never present to health care providers arguing about symptoms or complaining -- I'm sorry, complaining about signs, but they do complain about symptoms. My eye hurts, it doesn't feel well. It feels like sandpaper every time I blink. I'm constantly stinging. I'm constantly aware of my eye in terms of discomfort. The word discomfort comes up frequently when discussing symptoms with dry eye patients. That may be a little less clear to individual patients what dryness means. Does my eye feel dry? In reality, I think for most patients, their eye is uncomfortable, and maybe that's why the effect size of discomfort, again, that I described from the crossover trial released last year, is greater than that for dryness. But either way, as I mentioned to Yale's question -- in response to Yale's question, we're in a good place regarding dryness or discomfort and we'll adjust it need be pending SPA feedback.

[Operator Instructions] Our next question comes from Matthew Caufield of H.C. Wainwright.

Todd, can you hear me okay?

Yes.

Yes. Great. Okay. We appreciate the update today, so thank you for all the clarity. So one question we had, so if the trial design is ultimately needed that differs the dry eye chamber crossover design from Slide 6, would you still be prioritizing the clinical demonstration of both the chronic and acute symptom benefit for, as you mentioned, the differentiated prospective labeling? And, based on different potential trial designs, is there any scenario where the chronic and acute labeling becomes less of a priority?

Matt, I think the answer to that question depends on the SPA feedback. And I thought Kelly made an excellent point about plan B. If the FDA comes back to us and has some sort of fundamental issue with the crossover chamber designs, [ which ] I do not expect, again, based on what has been previously reviewed as part of the original NDA submission, then we can always go back to the field trials. As I mentioned, the RENEW trial and the formulation Phase II trial or 12-week trial, [ thought ] the separation, that is the improvement noted with reproxalap relative to vehicle, appeared relatively soon, and I would say within 2 to 4 weeks of treatment. So that may allow us to run a shorter field trial. It may allow us to highlight improvement in drug relative to vehicle that occurs relatively soon. And in that sense, I wouldn't exactly call the data acute, but the data would occur within a week or so, ideally, after drug administration, and that's a potential route we can go if we're in the position of repeating another field trial. Again, just based on the fact that we were allowed to submit an SPA, I think there is likely going to be general agreement between Aldeyra and the FDA on the chamber design. I think the crossover aspect is important, back to Yale's question about sample size and the advantages of crossover. My previous comments I would reiterate regarding interpatient differences, that is, patient-to-patient differences in describing symptoms are likely very significant in terms of acute symptomatology, and that's why a crossover trial would be optimal in this situation. And I think the data from the crossover trial announced last year that I reviewed this morning are certainly important in that regard.

Thank you. At this time, we currently have no further questions for today. So that concludes today's conference call. Thank you all for joining. You may now disconnect your lines.