Greetings, and welcome to the Marinus Pharmaceuticals second quarter 2022 financial results and business update call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. If you would like to ask a question during that time, please press star, then one on your telephone keypad. To remove your question, please press star one again. Now it is my pleasure to introduce your host, Sasha Damouni Ellis, Vice President of Corporate Affairs and Investor Relations. You may begin, Miss Damouni Ellis. Thank you, and good morning. With me from Marinus are Dr. Scott Braunstein, Chief Executive Officer, Christy Shafer, Chief Commercial Officer, Dr. Joe Hulihan, Chief Medical Officer, and Steven Pfanstiel, Chief Financial Officer. Before we begin, I would like to remind everyone that some of the statements we are making today are forward-looking statements under the securities laws. These forward-looking statements involve substantial risks and uncertainties that could cause our clinical development programs, future results, performance, or achievements to differ significantly from those expressed or implied by such forward-looking statements. These risks and uncertainties and risks associated with our business are described in the company's reports filed with the Securities and Exchange Commission, including Form 10-K, 10-Q, and 8-K. I will now turn the call over to our CEO, Scott Braunstein. Thank you, Sasha, and welcome to our call. We ended the first quarter with the exciting news that ZTALMY received FDA approval for the treatment of seizures associated with CDKL5 deficiency disorder in patients two years of age and older, and are pleased to now be receiving our first prescription and completed patient enrollment forms. Our sales force has been in the field engaging and educating physicians at CDD Centers of Excellence and national epilepsy centers, and we are encouraged by the strong early interest in ZTALMY. In addition to the April publication of the phase III Marigold results in The Lancet Neurology, the first international consensus recommendation for the assessment and management of individuals with CDKL5 deficiency disorder was published in Frontiers in Neurology in June. Among the survey results in the publication, respondents, which include an international panel of expert clinicians and researchers, all supported offering ZTALMY for the treatment of seizures associated with CDD. Both of the publications are timely for the launch, which Christy will discuss in more detail shortly. I would like to once again thank the patients, families, and investigators who participated in the clinical program for all they have done to help us achieve this momentous milestone. We have a number of other operational updates that we will be sharing during the call, and I would like to start with the first data set from our next generation product development program. We have seen promising initial results in our phase one healthy volunteer study utilizing the first of our next generation formulations, which Joe will discuss in detail later on the call. The PK profile is showing several differentiated features compared to our current oral suspension, which makes us believe that we can ultimately achieve our desired goal in chronic dosing. Key goals of the second generation formulation are to improve bioavailability and to drive higher steady-state blood levels of ganaxolone, which we believe will enhance efficacy. We also believe it will be important to improve upon ZTALMY's dose frequency as we think about the potential for additional new indications that are well suited to address areas of unmet need, including Lennox-Gastaut syndrome. We have several important updates on our late-stage clinical pipeline that I am excited to share. Let me start with the IV program. We've had productive interactions with the FDA and have reached preliminary alignment on our proposed IV ganaxolone formulation change, specifically the modification of the buffer system. The FDA agreed that in principle, a buffer change in ganaxolone IV formulation is acceptable and acknowledged Marinus' plans to transfer the production of IV ganaxolone to a new manufacturing facility for future clinical supplies, including the ongoing RAISE trial in status epilepticus. Importantly, this alignment provides us confidence that our new batches will meet the necessary FDA requirements upon the filing of a new drug application. Early stability assessments of IV ganaxolone using a new buffer has shown promising initial results that are likely to support greater than 24 months of shelf life at room temperature. We expect to begin producing our NDA batches in the fourth quarter of this year, utilizing our new manufacturing site and buffer for our IV formulation. I'm extremely proud of the work done by both our CMC and regulatory teams to continue a productive dialogue and scientific exchange with the FDA. Let me comment on the phase III RAISE trial. As previously communicated, we are implementing important changes to the RAISE protocol, expanding eligibility criteria to accelerate enrollment. The protocol amendment is expected to be adopted across the majority of clinical sites by the end of the third quarter. Moving to our phase III TrustTSC trial in tuberous sclerosis complex. We are pleased to share that the first patient has been randomized and dosed. We continue screening patients at U.S. sites with European activations on track to begin in the third quarter of this year. We are targeting 80 global clinical sites predominantly in the U.S., Western Europe, Canada, and Israel. We continue to believe that the new phase III titration schedule will have a meaningful improvement on tolerability and efficacy and look forward to the anticipated data readout in the first quarter of 2024. We have been actively engaging with the TSC community, including our participation during the recent TSC World Conference. After our team's interactions with both clinicians and families, we continue to believe that there is a significant unmet need for patients suffering with refractory seizures associated with TSC, and ZTALMY has the potential to be an important option for these patients. Finally, some comments on how we plan to bring ZTALMY to patients and families globally. In parallel to the U.S. Commercial activities, we continue to work with regulatory authorities to advance ZTALMY in other key regions. In Europe, we are targeting submitting complete responses to the EMA's Day 120 list of questions to the CDD Marketing Authorization Application by November, which would result in a CHMP opinion by the end of the first quarter of 2023. There have been significant efforts from both the Marinus team and our strategic partner, Orion Corporation, in anticipation of a European commercial launch. In addition, we believe that there is a broader global opportunity to help patients and are exploring further ex U.S. commercial alliances to expand ganaxolone's footprint. Now, I would like to turn the call over to our Chief Commercial Officer, Christy Shafer, for updates on the commercial launch of ZTALMY. Thank you, Scott. Today, I'm excited to share our early progress on the commercial launch of ZTALMY in the U.S. Since the approval in March, we've continued to see a high level of enthusiasm for ZTALMY from both physicians and caregivers, reflecting the need in this community and the potential that ZTALMY could provide in seizure management. In the first two weeks of launch, we are strongly encouraged by the early volume of completed patient enrollment forms and are actively fielding questions regarding enrollment and prescriptions. Initial launch feedback from the field has confirmed strong interest from a unique base of physicians in prescribing ZTALMY. In addition to referrals from the U.S. CDD Centers of Excellence and National Epilepsy Centers, we're also very encouraged by early interest coming from outside our key accounts. Additionally, we continue to establish relationships with key payers representing a large proportion of covered lives in the U.S. and have already begun to see positive coverage criteria being published to support patient access. As a reminder, we shared in June that ZTALMY received a Schedule V designation by the Drug Enforcement Administration, which is the least restrictive schedule. We are pleased with this designation, which further builds our confidence in how parents, healthcare providers, and payers will view ZTALMY as an important treatment option for seizures associated with CDKL5 deficiency disorder in patients two years of age and older. The major strategic objectives of our commercial launch are to continue educating healthcare providers and caregivers on the compelling efficacy and safety profile of ZTALMY and to enable seamless patient access from prescription through fulfillment. Our marketing team has developed a suite of communication tools that provide important information to educate healthcare providers and caregivers about the benefits and important safety information of ZTALMY. These are available at ZTALMY.com patient/caregiver website and ztalmyhcp.com healthcare professional website. Physicians can access information at the HCP website about prescribing ZTALMY and the prescription fulfillment process. We selected Orsini Specialty Pharmacy based on their strong track record and experience, which is aligned with our indication and dedication to the rare disease community. We believe it is critical to have a single specialty pharmacy to provide individualized support to CDD patients and caregivers throughout the patient journey. As part of Marinus' commitment to helping patients who are prescribed ZTALMY receive the support they need, we, in collaboration with Orsini, have launched ZTALMY One, a comprehensive patient support program that facilitates access to treatment and provides ongoing prescription drug support and education throughout the treatment journey. This includes prescription benefit and prior authorization support, medication delivery, financial support programs for patients with no insurance, limited insurance, or gap in coverage, and a co-pay savings program that helps commercially insured eligible patients who meet the program terms and conditions pay as low as $0 per fill for ZTALMY prescriptions. In addition, the ZTALMY One support team includes patient care coordinators available Monday through Friday, with pharmacists available 24/7. Our team of 16 field representatives who have significant rare disease and epilepsies experience are now educating physicians on the efficacy and safety profile of ZTALMY, targeting close to 300 hospitals, large practices, and epilepsy centers, including eight distinct CDD Centers of Excellence and 40 key national epilepsy centers. In parallel to our education outreach, we are also focused on supporting access to ZTALMY for those patients who participated in the Marigold open label extension study and the U.S. Expanded Access Program, being mindful of the individual circumstances of each patient. The availability of the approved label has also allowed us to advance our ZTALMY coverage discussions with payers. As a reminder, we expect approximately 60% of CDD patient population will access coverage through both fee-for-service and managed Medicaid, with the remaining 40% being managed commercially and the top PBMs covering the most U.S. lives. Along with top national and regional commercial payers, we continue to establish relationships with government payers. Our conversations thus far indicate we should be able to achieve broad access to ZTALMY, and based on the level and tone of engagement, we believe payers recognize the impact of the disease on patients and families, limitations within this CDD treatment landscape, and ZTALMY's profile as the first product approved specifically for seizures associated with CDD. Consistent with our expectations, early coverage criteria support a confirmed CDD diagnosis in patients two years of age and older who have failed one or two prior anti-epileptic drugs. Our initial priority is on the 22 states that we believe include the largest concentration of CDD patients and where the centers of excellence are located. The CDD ICD-10 code G40.42, which was established in November 2020, is being increasingly implemented into practice by physicians. Recent healthcare claims data suggests the database is on pace for 20%-30% year-over-year growth of unique patient claims. We believe this consistent and increasing usage of the code will help ensure access alignment with payers. Early ICD-10 code usage shows that 75% of patient visits are in pediatric patients, with 25% in patients 18 years or older. We recognize that coverage determinations can take time during the ZTALMY launch period. Our expectations are that the majority of commercial and state Medicaid policies will be published within 6-8 months. However, we have every expectation to field medical necessity requests prior to and separate from the publication of formal payer policies. As a reminder, as a part of our commitment to patients, ZTALMY One will help support eligible patient access prior to established coverage criteria. We are confident in the road ahead and look forward to continuing to work with patients, caregivers, physicians, and payers over the coming months. I'll now hand the call over to our Chief Medical Officer, Joe Hulihan, to discuss our ongoing development program. Thank you, Christy, and hello, everyone. I'd like to begin with our second-generation formulations, where we've seen promising initial results. We believe the new formulation could be the future of the ganaxolone franchise. The goal is to improve the relationship between the amount of ganaxolone administered and the plasma concentration, allowing greater and more predictable individualization of dosing. The target pharmacokinetic profile includes an increase in overall exposure relative to peak concentration, which could provide the potential for twice-daily dosing with enhanced efficacy and a low rate of dose-related adverse effects. Initial data from a phase I single ascending dose study in healthy volunteers demonstrated encouraging results, which we believe support further clinical development. Study participants received single doses ranging from 100-900 milligrams, with the current oral suspension given as a reference control. Plasma levels were measured through 72 hours following ganaxolone administration. Total exposure was measured by area under the curve, or AUC, and this increased linearly in proportion to the administered dose. In contrast to doses above 600 milligrams with the current oral suspension, the increase in AUC was approximately 37% when escalating doses of the new formulation from 600-900 milligrams without a significant rise in Cmax. Tolerability was consistent with prior ganaxolone studies, with the vast majority of adverse effects being mild in severity. The PK profile of this formulation could allow for further upward titration for efficacy without a concomitant elevation in Cmax-related adverse effects such as somnolence. Next steps in the evolution of this program include additional phase I studies in healthy volunteers with higher single doses above 900 milligrams to determine whether further increases in exposures relative to peak concentration can be achieved. We will also be performing PK modeling to determine next steps, including the need for a study with multiple ascending doses. We currently anticipate selecting one of the second-generation ganaxolone formulations for a phase II study in Lennox-Gastaut syndrome to begin in 2023. Lennox-Gastaut syndrome is a rare epileptic encephalopathy that can result from many structural or genetic causes. It's highly treatment refractory, and we believe the new oral formulation will provide more consistent and predictable exposure to ganaxolone, which should allow physicians to individualize dosing to achieve an optimal response for each patient. Additionally, there are several prodrug candidates that could offer further improvements in efficacy and tolerability, the ease of manufacturing, and dose individualization. Lead oral and IV prodrug candidates have been selected for additional IND-enabling studies, with phase one data targeted for 2024. Now, moving to our IV programs and status epilepticus. I'd like to dive a bit deeper into the RAISE protocol amendment that Scott mentioned and how we believe this will help drive enrollment. First, I'm pleased to share that the results from our phase II trial in refractory status epilepticus were published in Epilepsia in June. As a reminder, this phase II trial enrolled patients who had failed at least one second-line IV AED. None of the patients progressed to third-line IV anesthetics within 24 hours, meeting the primary endpoint in the study. Of note, 11 out of 17 participants were intubated prior to or during the study, and all patients with follow-up data, 16 out of the 17, were successfully extubated. We're optimistic that the phase III study will validate this finding and support the potential for ganaxolone to change the treatment paradigm in refractory status epilepticus. With this in mind, I'd like to discuss the 3 key changes in the RAISE protocol amendment, which is expected to be adopted across the majority of clinical sites in the third quarter. First, RAISE enrollment criteria were amended to allow inclusions of patients who had received IV anesthesia for up to 18 hours during the current episode of status. The original protocol inadvertently excluded many patients who had received IV anesthesia, particularly those transferred from outside hospitals or the emergency department. These patients were an important part of the phase II population and can now be included under the amended protocol. The second key change involves the required number of prior failed treatments. The protocol initially required failure of an IV benzodiazepine and two or more second-line IV AEDs, at least 3 prior agents in total. The amended protocol requires failure of at least 2 treatments rather than 3. Additionally, the investigator must indicate that IV anesthesia would likely be the next line of therapy if study treatment fails to control seizures. The underlying rationale for this change involved two issues. First, more centers are advancing to IV anesthesia after failure of the initial second-line IV AED. Second, patients in the ICU setting may receive a second-line agent without progressing through treatment with a benzodiazepine, usually because they already had received multiple benzodiazepine doses for sedation. As with the first change, this will allow enrollment of patients with a profile similar to those in phase II to enroll in the phase III study. We're confident that this will support a high rate of progression to IV anesthesia in study drug treatment failures. This will expand the pool of clinically appropriate patients who qualify for enrollment. We believe these two changes could potentially increase the sensitivity of the study by fostering progression to IV anesthesia in study drug failures, thereby reducing the placebo response. The third significant protocol change aligns EEG determination of study qualification more closely with clinical workflows. Rather than requiring an investigator to quantify the EEG seizure burden in the 30 minutes immediately prior to administration of study treatment, the protocol now allows an hour for this determination. This is more consistent with usual ICU patient care, in which the physician will diagnose status epilepticus, then arrange for treatment to be administered, which can take 15-30 minutes. This change better aligns with the phase II paradigm and should also facilitate enrollment of clinically appropriate patients. We've received highly positive feedback from our study sites about the potential for increasing the number of eligible patients under this new amendment, and we will be holding an investigators meeting later this month to review and discuss the changes to the protocol. Furthermore, we've established an initiative of executive outreach by our scientific affairs and clinical development leaders to study sites to ensure a smooth transition adopting the amended protocol. Looking to the future of the RAISE trial, we will continue to actively monitor what's working well and how we can further refine enrollment criteria to support the recruitment of additional patients and potentially broaden the ganaxolone label. For example, the trial currently enrolls patients aged 12 and older. We will shortly receive data that may allow us to broaden the entry criteria to include even younger patients. Given the higher incidence of status epilepticus in children, this change could further support timely study enrollment. As previously disclosed, we have the option for an independent data monitoring committee to conduct an interim analysis when two-thirds of participants have completed the study, which would be approximately 82 patients. At that time, the committee would recommend stopping the study for efficacy or continuing to full enrollment. U.S. site activations in the RAISE trial continue to advance, and we anticipate initiating 10 new sites in Canada beginning in the third quarter. We continue to expect top-line data in the second half of 2023. In the phase II RESET study in established status epilepticus, the community consent process, known as exception for informed consent, is well underway. We are pleased to share that we have activated the first site and are on track to begin US enrollment in the second half of the year. We plan to limit site activation initially to four or five to focus on gaining a comprehensive understanding of enrollment trends before making a larger investment. Also, the RAISE II protocol is now finalized. Site selection is ongoing, and we expect enrollment to begin in the second half of 2023. This trial is designed to serve as a critical piece of the European approval strategy, and we believe it also has the potential to further broaden the indication for IV ganaxolone in the US. Now, I'll turn the call over to our CFO, Steven Pfanstiel, who will provide you with a financial update. Thanks, Joe, and good morning to everyone. Before diving into our financial results for the second quarter of 2022, I would like to provide a few highlights on our progress since the prior earnings call. In July, we announced that we have entered into a definitive agreement to sell our rare pediatric disease priority review voucher for $110 million. The sale of the PRV, which is expected to close within the third quarter, significantly strengthens Marinus' financial position and we believe extends our cash runway into the fourth quarter of 2023. Inclusive of the proceeds from the PRV, we have raised well over $200 million of funding over the last 18 months from non-dilutive sources, including our credit agreement with Oaktree, our European commercialization agreement with Orion, and from our federal BARDA contract. These funds have been critical to enabling us to execute on our pipeline, including our phase III trials and reformulation efforts, as well as the commercial launch of ZTALMY. Furthermore, under the Oaktree credit facility, we have the opportunity to further strengthen our cash position through a synthetic royalty monetization agreement related to U.S. sales of ganaxolone and have the option to draw an additional $25 million of funding under the facility subject to achievement of certain clinical and financial milestones. As we look to the balance of 2022 and into 2023, we will focus and prioritize our investments and resources on our key programs, specifically our phase III trials in RSE and TSC, as well as the commercial launch of ZTALMY. These programs are critical to Marinus' future and delivering shareholder value. We want to ensure they remain on track and are funded for success. As an example, we have invested in additional global sites and trial resources for both the phase III RAISE and TrustTSC trials. While we will continue to advance our other investments, such as our earlier stage pipeline programs, these will be a lower overall priority from a timeline and funding perspective. As Christy discussed, we are excited about the launch of ZTALMY. As a reminder, we previously communicated our pricing and dosing expectations for ZTALMY. ZTALMY's wholesale acquisition cost is $2,425 for a 110 milliliter bottle. Our sales force is focused on the pediatric population, and initially we expect the average patient to be approximately 4.5 years old and weigh 16 kilograms. This translates to an average annual wholesale acquisition cost of approximately $133,000, and expected gross net deductions, including mandatory government discounts, are projected to be in the low 20%. As a note, our age and weight estimates are based on our expectations within the pediatric population, with any usage in an adult population representing upside to these projections. As the launch advances, we look forward to providing updates on our progress. Initially, we will be focused on patient enrollment metrics, including completed patient enrollment forms, new patients on therapy, and total active patients on therapy. We will also look to provide average dose-related metrics for the treated patient population, along with relevant prescriber and payer metrics. For the launch, we do not expect a significant stocking impact to occur as we are utilizing a single specialty pharmacy, and we will be coordinating closely with them. Additionally, once patient enrollment forms are complete, initial coverage determinations may take as long as 1-3 months to process. I'll now move to our financial results. For the second quarter of 2022, we recognized $1.8 million and $16 million in total revenue for the three and six months ended 30th June 2022 respectively, as compared to $1.9 million and $3.7 million in each of the same periods in the prior year. Revenues are recognized as a result of both our BARDA federal contract and our European collaboration with Orion Corporation. The increase in 2022 revenue was driven by a one-time revenue recognition of $12.7 million in the first quarter of 2022 related to the previously received upfront payment associated with the Orion collaboration. Excluding the Orion revenue, the company recognized $1.8 million and $3.3 million in BARDA federal contract revenue for the three and six months ended 30th June 2022, respectively, as compared to $1.9 million and $3.7 million for the same periods in the prior year. Research and development expenses increased to $21.5 million and $39.5 million for the three and six months ended 30th June 2022, respectively, as compared to $18.6 million and $37.2 million for the same periods in the prior year. The change was due primarily to costs associated with increased R&D head count and start-up of the phase III TrustTSC trial. General and administrative expenses increased to $17.1 million and $28.8 million for the three and six months ended 30th June 2022, respectively, as compared to $6.8 million and $17.2 million for the same periods in the prior year. The primary drivers of the change were preparation for ZTALMY commercialization and additional support for scale-up of the company's operations. Additionally, during the six months ended 30th June, 2022, a one-time cost of IP license fee of $1.2 million was recognized as expense in the first quarter of 2022 associated with in-licensing of patents and patent applications from Ovid Therapeutics. The company reported net losses of $39.4 million and $58.8 million for the three and six months ended 30th June, 2022, respectively, as compared to net losses of $23.8 million and $51 million for the same periods in the prior year. These totals include non-cash stock-based compensation expense of $3.8 million and $7.2 million for the three and six months ended June 2022, respectively, as compared to $3 million and $8 million for the same periods in the prior year. Cash used in operating activities was $61.3 million for the six months ended 30th June, 2022, as compared to cash used in operating activities of $39.1 million for the same period in the prior year. As of 30th June, 2022, we had cash and cash equivalents of $92.3 million. We believe this balance, when coupled with the expected net proceeds of the PRV sale, will be sufficient to fund our operations into the fourth quarter of 2023 while maintaining the minimum cash balance required under our debt facility. For the fiscal year 2022, we are providing updated guidance with BARDA revenues expected to be in the range of $7 million-$10 million and our GAAP operating expense estimate, inclusive of G&A and R&D expenses, to be in the range of $150 million-$155 million, which includes approximately $15 million of non-cash stock-based compensation. These values represent a slight reduction to our GAAP operating expense estimate, which was previously projected to be between $152 million-$157 million, including approximately $17 million of non-cash stock-based compensation. Now, I'll turn the call back to Scott, who will provide concluding remarks. Thanks, Steve. We are very excited about the first commercial launch of ZTALMY and the results from our second-generation development program, continued advancement of our two ongoing phase III trials, and the strong foundation we've built. We are confident this launch is the first of many to come and will continue to prioritize these critical work streams to allow us to help more patients suffering from seizure disorders. Operator, can you now open the call to questions? Thank you. As a reminder, if you would like to ask a question, please press star then one on your telephone keypad. Our first question is from Andrew Tsai with Jefferies. Your line is open. Okay, thanks. Good morning, and thank you so much for taking my questions. Congrats on the progress, especially the launch recently. Maybe one on CDD first. Thank you. You know, I thought I'd ask is, you know, how many patients, you know, have indeed been treated over the past few weeks, or are a bulk of them still in the coverage form phase? I ask because just curious how we should be thinking about Q3 sales coming up. Thanks. Well, it's a great question, Andrew. As a reminder to everyone, you know, we formally kicked off the launch about two weeks ago. That allowed, physicians to fill out prior authorization forms and prescription forms. As we've talked about, we've expected those prior authorization forms to take up to three months to get approval from insurance coverage. I'll let Christy talk a little bit more about that in terms of Steve and let Steve talk a little bit about the numbers. You know, as a reminder to all, we're really going to share with you, patient numbers on a quarterly basis starting next quarter in terms of new starts, approvals, and we recognize that that's the most important metric that you guys will want to follow. Maybe, Christy, I'll turn it over to you for a little more commentary, and then, Steve to kind of round out what you're going to be talking about in terms of future guidance. Sure. Thanks, Scott. Andrew, thanks so much for the conversation here. We have, again, in the past two weeks, seen really great enthusiasm from a prescription and enrollment standpoint into ZTALMY One. We have every expectation that our payers will start to evaluate us very significantly right now. We have several published policies already. Again, in this early period, we believe that it will take between one and three months to get through that process. We'll be fielding medical necessity requests simultaneously, but again, we think that we'll be having patients on therapy in the near future. Andrew, this is Steve. You know, just to kind of specifically address the question, we'll defer providing patient metrics and enrollment metrics until we get through the end of the quarter. I think it'll be appropriate to do that on a quarterly cadence. But you know, we're absolutely committed to providing kind of the right patient enrollment metrics in terms of, you know, kind of completed patient enrollment forms, new patients on therapy, total active patients on therapy, and we'll provide other payer and associated metrics as well. We look forward to doing that on the quarters on a routine basis. Fantastic. Just a quick follow-up, shifting gears to RSE. Sounds like you had a great FDA discussion about the recent changes. Maybe remind us the latest and greatest, you know, whether you are confident or not a bridging study is needed with the modified IV ganaxolone formulation. Just a little bit more clarity would be great. Thanks. Sure. I'm happy to, Andrew. We, you know, as we have done in the past, we've been very proactive with our interactions with the FDA. I mentioned on the call, you know, we have great CMC team, a terrific addition to the leadership team on that side and our regulatory team. You know, we've been incredibly transparent with the agency, what we want to do, change in our buffer system, new manufacturing facility, and, you know, through their communications with us, they see that as a very reasonable approach. They commented specifically that by their guidelines, the new buffer system is, you know, in the guidelines for SNDAs and reference products. At this point in time, we don't see any reason why we'd need to do a bioequivalent study. In fact, you know, their green light about using this new product in the phase III study, you know, presuming those first batches all hit our specs. You know, that gives us a tremendous amount of confidence, right? It's not as though we're going to only be using our current product and then filing with a new product. They've given us the ability to use this new product in the current phase III. We have a lot of confidence in the manufacturing team, what this new buffer data has looked like very early on. Just a reminder to everyone, the current buffer system is absolutely commercially viable. However, we don't want to launch with a one-year shelf life. The goal of the new buffer system is to really make this commercially much more interesting, from a shelf life perspective, lack of refrigeration perspective. Again, ultimately, we see moving to IV bags over a two or three year period as the final steps in our development process. You know, I think the transparency that we have with the agency we're sharing with you, and we feel very confident that the manufacturing piece of our CMC filing will not be a gating factor for approval of the IV ganaxolone program. Thanks so much for the call. Congrats again. The next question is from Charles Duncan with Cantor Fitzgerald. Your line is open. Hey, good morning, Scott and team. Thanks for taking our questions, and congratulations on a great quarter of progress. Exciting to see first launch. Thanks, Scott. My first question is for you or for Christy. I'm wondering if you could characterize that initial response by both the payer community as well as the prescriber community. Is it in line with what you had expected, or is it beyond what you had expected in terms of the interest in ZTALMY? Well, let me just give a few opening comments, then I'll turn it over to Christy. I think we feel fantastic that going into any payer discussion, we've got a published phase three study. We've got editorials from independent physicians supporting that. We have guidelines in the public domain that also are strongly supportive of the use of ganaxolone ZTALMY. I think going into all of these discussions, we've got a robust scientific package. We certainly had high expectations, but let me turn it over to Christy and let her more specifically. Yeah. Sure. Thanks, Charles, for the question. It's a great question for a commercial person to give some perspective to. Look, I think we all plan for a little bit of the worst that supports some high expectations when the day actually comes. We had a high level of enthusiasm. I'd be remiss if I didn't say that our excitement is pretty robust on the commercial side of the world right now, not only just with the enrollments that we've seen on day 1 through day 14, which is today, but also the payer community has been very supportive of our efforts. We have several known published policies, and it just really is a testament to the two years' worth of work that was done from all sides of the business, medical, CMC, and the commercial side. We're enthused at this point. Okay. Very good. Let me add to Oh, go ahead. I would just add. Please. We put a lot of thought into the pricing work, and that was an organizational effort. I think that's a critical piece here, too, that I think we priced the drug very fairly for the value proposition I think is critically important for these patients. I think the payers are respecting that as well. I'm sorry. Go ahead. Why don't you give us your next question? Yeah, that seems to be the case. Just moving on to the RAISE program, the IV program, and specifically with regard to RAISE, I'm wondering if you could give us a sense of when that interim could occur, obviously between now and second half of 2023. When would you have about 82 patients through the required period to possibly trigger that interim result, that interim look? That's a great way to ask the question, Charles. I think most importantly, the discussions with the FDA gives us the flexibility to pull the trigger on the interim. I think most importantly, we've had, you know, we reinitiated the trial in the main time frame. We knew it would take several weeks for sites to get up and running full gear. We really feel like the vast majority of sites are now up and running full gear. We'll have this protocol amendment coming now at sites currently. We really feel like we're gonna have as much of the winds to our back by the September time frame as we can have in this study. We'll be adding some additional sites in the third and fourth quarter too with Canada as really, you know, an important backup strategy. I think really by year-end, we will make a decision as an organization about where we stand in terms of monthly enrollment, where the TSC study stands in terms of monthly enrollment, how those two studies overlap. I think by early next year, we'll make a corporate decision on what we want to do. But we're not quite there yet, and you know, we're looking forward to the next few months of enrollment trends from both studies. You know, again, having the flexibility in this case creates a lot of opportunities for us to do what's right for the clinical studies, for our investors, and for patients as well. Joe, anything you want to add on or raise? Just a overall commentary about the study. Yeah. Actually, I've been out to some sites recently, and the response to the protocol amendment that we'll be implementing is extremely positive. There's a lot of confidence on the part of sites that that's gonna help them boost enrollment. Like Scott, I'm very confident that we'll by the end of this year be able to see a boost in the enrollment and how the trends are going. The next question is from Douglas Tsao with H.C. Wainwright. Your line is open. Hey, good morning. Thanks for taking the questions. Just as you move into the launch and the remainder of the year, just raising the profile for ganaxolone. I'm just curious about presentations at medical meetings through the rest of the year and in particular AES and what your plans are there. Thanks for the question, Doug. Yeah. Joe, why don't you talk about what's happening on the scientific affairs side with Alex's team and your team, and then we'll pass it over to Christy to give a commercial update. Sure. Well, we'll have a presence at Child Neurology Society, Neurocritical Care Society. There's a conference in Salzburg on status epilepticus in September, where we'll be presenting two posters. Then for AES, we've submitted four posters, four abstracts for presentation at AES. We're going to submit an additional two late-breaking abstracts to the meeting. You know, while we're on the topic of AES, the American Epilepsy Society chose to publish on its website recently on its Clinical Corner page an article on ganaxolone and CBD. The lead author of the Lancet Neurology paper, Elia Pestana-Knight, discussed in a video the use of ZTALMY and CBD with two other epilepsy experts. I'd also mention that international consensus guidelines on CDD treatment were published in June in Frontiers in Neurology. We were glad to see that all of the respondents, when asked whether ganaxolone should be offered for CDD, responded yes. It was a unanimous opinion about use of ganaxolone. Getting back to AES, we expect to have a big presence there overall in addition to the publications. I'll just ask as a quick follow-up. I'll jump in here really quickly. Oh, sorry, Doug. Oh, no. Go ahead, Christy. Sorry. Yeah, I'll just jump in quickly from a commercial perspective. As you can imagine, AES is kind of our coming out party for ZTALMY this year, so we're gonna have a pretty robust commercial presence, that will be including our first commercial conference booth. We will also have a clinical data review by way of a product theater that will be provided by a top KOL. Then as you could imagine, really significant KOL and physician engagement from the commercial team. Okay, great. Then just Christy, I'm just curious, what's the sort of, if there is the most commonly asked questions about ZTALMY in the early engagements? You know, is there generally sort of like accepted awareness of the product? I'm just curious about what people are focusing on from clinicians. That's a great question. I think it is, it's twofold at this point. In this community of physicians and with families that are living with CDD, we kind of are focusing on a push and pull strategy. We know that this is going to be 50% guided by the physician and 50% guided by the families that are treating or that are caring for children with CDD. When you talk about the families, their major concern is access. Right now, these families are dealing with multiple medications for these kids, and it can be quite an arduous process to get their kids the medicines that they need and deserve. That's why we built a very robust ZTALMY One program to make sure that it is seamless access and that anyone that is appropriate for ZTALMY gets the medication. Now, if you're talking about the physician perspective, I think they really wanna understand our mechanism of action. They wanna see how this could be different than how they've treated patients previously, and potentially how this is an additive effect to what they're already on. Those are the two kind of push and pull major questions and things that we address in the field on a daily basis. Okay, great. Just Scott, maybe a quick one on the IV formulation in terms of the two year shelf life. Can you just walk us through how that would be incorporated into the NDA? Would that data, the stability, the 2-year stability data be ready at time of filing, or would that be added later on? It's a great question, Doug. Well, a few different things. One, typically, we wanna have stability data at least a year ahead of the filing so that when you file the NDA, you have one year stability data on hand. That's the big reason that we're gonna make sure that we have a manufacturing batch to begin in the fourth quarter of this year, right? That would give us one year data by the end of 2023, worst case. We have some accelerated models that we've used, that we've already tested with the new formulation, which are showing very strong results. We will be discussing with the agency accelerated models. Remember, from the time of filing, we'll have at least six more months of stability data by the time of the NDA filing decision. You know, this is a back and forth with the agency and one that we're not too worried about. Over the next 18 months, we'll be having those discussions with the agency. As an example, will they take our accelerated filings or accelerated stability data as a proxy for two year shelf life, et cetera. A few different strategies we can explore, having the actual data, again, at the time of approval, I would expect to have a minimum of 18 months of shelf life that would be, you know, quickly amended, or we can use this accelerated approach, which would give us two years plus. I mean, right now, the solubility curves are really logarithmically different for the new buffer. We've got a pretty convincing early data package and don't see it at all as a major concern for us by the time of approval. Okay, great. Thank you so much. Sure. The next question is from Joseph Thome with Cowen. Your line is open. Hi there. Good morning, and thank you for taking my questions. Maybe the first one on RAISE, just in terms of between now and when you can make that decision to take the interim look for the study. I guess, what's gonna go into that decision point? Is it really just a bandwidth on readout between TSC and RAISE, or are you gonna be able to see some unblinded data or look at, you know, kind of the enrollment criteria of the patients that are coming on the study to help make that decision for you? Yes. I would say I think it's right now going to be driven by a corporate decision. Joe can talk about it, but we certainly have a DSMB that's in place that will be reviewing our datasets. Of course, we'll be blinded to that. I don't see any, you know, we can't really allow the blinded data per se to really affect our decision. Of course, I think this is, in my mind, really a corporate decision based on the monthly enrollment trends, the timing of the conclusion of the study, where we are with TSC, and, you know, we'll look at all those factors to make the decision. Again, I think by us asking the agency well in advance, "Can we do this?" just gives us a lot of flexibility. Certainly we feel very good that if we choose to do an interim, we have an 80% power to hit what we think is a key secondary endpoint around ICU days and mechanical ventilation, which, you know, my view going into the launch, Joe, and I haven't talked about this, was that this would be, you know, this study is so incredibly important for the data to drive reimbursement in the hospital, and we all know that's a difficult environment. What's really changed from the time we started this program is our commitment to now run RAISE II. We will now have, you know, two double-blind placebo-controlled trials over the early years of this launch, a bigger dataset. That's also, in my mind, an influence on our decision about how big RAISE needs to be and what type of data we need to generate. I can't say we're not gonna make any decisions, but we're thinking about all of those things. Certainly, I don't know, Joe, if there's anything else you want to comment on from the clinical side, but again, it's hard to imagine we're going to see a lot to push us one way from the dataset itself. Joe? I mean, it takes some time to do the interim. It's an independent statistician that does it. The data's all got to be cleaned and enrollment in studies typically accelerates as they go along. It could be that by the time we got the interim done, there'd be, you know, substantially more enrollment. In that case, we would just likely wait for the final data. As Scott said, it's really a consideration about the rate of enrollment. Perfect. Thank you very much. Maybe a follow-up just on the novel formulation. How much higher do you think you can push the dose here? Maybe what are you looking for specifically to go forward into that LGS study? Are you gonna look at multiple doses? Or do you think you're gonna be able to nail one down to take forward? Thank you. Yeah. I can take that one. There are a lot of decision points along the way. We've got a lot of choices, reformulation candidates and the prodrug. We do hope that and we've seen early promising results that we can increase the overall exposure and blunt the Cmax and keep going. Right now, the highest we go on dosing is at a single dose is 600 mg, and we hope to be able to go over that in individualized dosings, you know, particularly in Lennox-Gastaut and other epileptic encephalopathies. Most patients tolerate the drug very well, and there could be the potential to go higher. Our current label caps daily dosing at 1,800 milligrams per day. We'd hope that the kinetics and efficacy and tolerability would allow us to go higher if patients need it. We're still waiting to see some of the human PK data. For example, we're completing the single ascending dose study with the first reformulation candidate. You know, we'd wanna see multiple ascending dose studies with repeat dosing and then decide whether you know what step to take next, a single arm you know or two-arm phase IIb against placebo. Even potentially go straight to phase III. We don't have the data yet to inform that decision, and it's going to be a few weeks, months till we really know what path we want to take for clinical development in phase II and 3. Yeah. Joe, the only thing I'd add to that from Joe Hulihan is that, you know, our goal when we started this program was to have a formulation and, or a prodrug that could deliver steady-state blood levels of at least 100 nanograms per mL, and certainly critical to be able to go above that. You know, I think our back-of-the-envelope it'd be great to test 150 nanograms per mL as a steady-state blood level and correlate that with seizure reductions and potentially 200 nanograms per mL and correlate that with seizure reductions and tolerability. I think we believe from what we've seen and what our modeling has showed us that we can achieve that with this formulation quite reasonably. We want to replicate that and feel confident about it. I think we have some important decisions to make around dosing and a modified release formulation. Certainly the data to me is encouraging that we may, you know, be able to create a daily formulation with this, a once a day formulation. Right now, I think twice a day is well within our grasp. Certainly now we're really getting to think a little bit harder about where do we want Cmax to land, how much can we bring in Cmax in terms of tolerability. I think now truly a focus on trough levels as well, and really maintaining trough levels where we think they should be. In my mind, this is just incredibly exciting that the data we generated to date is aligning very nicely with what we'd like to perform out of the program. Now, remind everyone, you know, we believe from the Marigold data that blood levels of 150ng are going to, you know, be drive efficacy. That was a strong signal in Marigold. Certainly in our IV program, blood levels drive efficacy quite clearly between 400 and 500 ng. But we haven't proven that. We certainly believe there's a very strong possibility, and I think everyone can imagine that this is a very well-tolerated drug and incrementally higher blood plasma concentrations at a steady state has a very high probability of driving a higher efficacy. You know, that's the full disclosure, but we feel pretty good about the odds of success, where we stand today. Perfect. That's very helpful. Thank you. In the interest of time, we ask that you please limit yourself going forward to just one question. Our next question is from Joon Lee with Truist Securities. Your line is open. Hey. Thanks for taking our questions. Does the use of CDD ICD-10 codes require genetic diagnosis, or is this based on a clinical suspicion? Has the payers required genetic diagnosis of CDD for approval of the drug? Thank you. Chris, do you wanna take the second? You're welcome to take the first too, if you like. Yeah. I'll address the second first. You know, I mentioned earlier that we have seen some early published policies, and each of them is directly in line, at a very, very minimum with our label. We set some expectations that a good payer policy would be in line with our label that is inclusive of patients two years and older, confirmation of a CDD diagnosis that is inclusive of a genetic test and failure of at least 2two AEDs. We have certainly seen published policy that is in line with that, and we've seen policy that is less restrictive of that, including that of a genetic test. Currently right now we have a few, a handful of published policies. Again, we have every determination that we think that all published policies maybe going forward will have a genetic test component to it. However, we've seen a little bit of both. Knowing that it is highly used from a genetic testing component across the United States, it is again, very likely that that would be included. Joon, just to be clear, you know, just to back up for everyone on the call, as a good reminder, you know, we're fortunate to have an ICD-10 in place. That was really the work of our advocacy groups, where Loulou Foundation and IFCR made a strong push for an ICD-10 code for CDKL5. That's been in place for a little bit more than 18 months. What's been so interesting to us is before Marinus was out in the field, with their MSL team, our MSL team first and now our commercial team, we were seeing physicians use that ICD-10 code in increasing numbers. We would expect that to continue to increase, and we certainly will provide additional education in that regard. Us being able to track that ICD-10 code just has been invaluable for our strategic planning about where we wanna go, how we align with the ICD-10 code, our centers of excellence and key epilepsy centers that we would like to make sure that, you know, the commercial team is meeting with. Finally, if we see ICD-10 codes from places that are not on our A list, we have somewhere else to really evaluate. It's really a nice tool in our toolbox that will complement the data sets that we will use for the commercial team. I think, you know, it's a little bit more of a. It's a relatively simple tool to add to the reimbursement form. You know, of course, what we've also seen is that ICD-10 code is identifying patients across all age spectrums, and it has been really interesting to us that right now, about 25% of the patients identified via the ICD-10 codes are adults or young adults. That obviously will have some important implications for the way we're thinking about the business, and ultimately what, you know, what drives the weighted average around our revenue. Hey, Scott. Quick follow-up. What are some of the top differentials that are maybe being coded alongside that CDD ICD-10 code that might give you some hints as to where you might wanna go next? I think the most logical place is that we would, you know, start to look at data sets for other anti-epileptics that, you know, are used in refractory patients as a tool for the commercial team. Quite honestly, Joon, I mean, I think the way. Christy's on the call. I'll let her jump in. I mean, the team's doing fantastic work today. We're going to start our KOL speaker program shortly. You know, I think we're gonna get a great boost. Joe told you that we already have AES helping us talk about the value proposition of ganaxolone. I think that 3-6 months, we're gonna be incredibly busy with what the specific targets that we think are vital to the marketplace. We've said this all along. The only way we can do this with a small sales organization successfully is that we've got these great centers of excellence, that we have a really meaningful number of refractory epilepsy centers. I think the way we're thinking about our continued success in 2023 is by you know, maximizing the data sets available to us to make sure that we're going to the right physicians. Christy, anything you wanna add? Just a small thing here. Joon, it's a great conversation, one that we have quite regularly here on the commercial team. In the past few weeks, again, we are educating on the use of the code. It guides us in our conversations of where to go today. Additionally, because we've had such unique interest across not only our targeted accounts, but also non-targeted accounts, we're learning other codes that are being used that are informing our data team to help some continued mapping to understand and inform our deployment strategy even farther. We have a very distinct education plan on the use of the ICD-10, but then again, we're also learning other codes that are being used that are guiding our mapping even farther. Thank you. The next question is from Jay Olson with Oppenheimer. Your line is open. Oh, hey. Congrats on all the progress, and thank you for taking the question. Our question's related to RSE. Can you talk about any physician feedback you received on the phase II data that was published in Epilepsia? And have you seen any impact on phase III RAISE enrollment rates as a result of the increased awareness from publishing the phase II data? Thank you. Yeah. This is Joe. So- Well, yeah. I mean, the feedback on the phase two study's always been positive. Again, as I said, I've been out visiting sites and we do get into discussing the data. In the context of the amendment that's coming up for the RAISE study, because with these changes in the protocol, it really reflects the population in the phase two study much better. In discussions about the amendment, I do bring that up and the alignment with that population because of the features of the amendment. We do get positive feedback about enrollment. You know, a lot of the patients in the RAISE study, as we mentioned, you know, were intubated either when they came in. 8 were intubated when they came in. Not to the phase two study, I mean. 3 got intubated along the way. We have follow-up for all but one patient, and every patient was extubated. You know, that's, to me, an incredibly positive finding and we haven't quite framed it that way. In discussions moving forward, you know, in the few so far where I've brought up the data in that way, the response has been incredibly positive. This amendment, again, will mirror the population in the phase two study, and we see that as a great recipe for success. Thank you. The next question is from Marc Goodman with SVB. Your line is open. Yeah. Good morning. Just curious, Europe, you mentioned it a little bit. Have you gotten the response from Europe? Are we all set here? Does it look like it's gonna be pretty clean and you'll be able to get approval? Yeah. Marc, we'll formally respond to the list of 128 questions by the end of the third quarter or, you know, early in the fourth quarter. You know, we have. It was a pretty big list of additional studies, almost. Actually all were preclinical in terms of additional requirements. We've talked about it, the Europeans wanted some additional work with our syringes. That was the biggest impact. I think you know, Joe actually has done a great job going back and looking at the data. As you well know, Marc, you know that 50% response rate is incrementally more important in Europeans. You know, we have some really interesting data that we are gonna give to the Europeans about the statistical impact on the maintenance phase in the Marigold study. I think we have done everything we can do to answer the questions that the Europeans are seeking. You know, we're enthusiastic about the outcome early next year. Are you still having discussions with some other regions to license out other regions? Yeah, we, you know, we expect to have another geography, a strategic partner in place by year-end. I think, you know, we would certainly expect to have another significant region in place next year as well. You know, it's a tough one for us, Marc. I mean, in a good way because there's huge demand. Because these indications are more orphan-like, we really are forced to have deals with regional players, and that just creates, you know, a lot of work for our organization. We, you know, we love Orion as a strategic partner in Europe, but it's a lot of work to, you know, teach them what we know. Certainly they're bringing a lot of skills to the table. You know, we are now the authorities on CDKL5 deficiency disorder. I think, you know, that will be the same whether it's Japan or China. I think we're just trying to do this in a measured fashion that brings in some meaningful economics to the company that will support our R&D efforts and our commercial efforts in the short term but doesn't overwhelm the team. You know, I feel pretty confident that China and Japan are gonna be important markets for this drug. Certainly there's, you know, real interest and demand in MENA region and in other regions. We're gonna knock them off one at a time, but we're trying to start with the most meaningful from a patient number standpoint, ones that we can really handle organizationally, and that create some value and, you know, some economic payments that allow us to continue to do all the things we're doing. Yeah, we feel very confident about those discussions of, you know. Also, Scott, in the past, you've talked about potentially doing a royalty deal. I didn't know if that was even something still considered. Is it even necessary anymore? Thanks. Yeah. Hi, this is Steve. I'll answer that one. Yeah, I mean, look, the PRV was critical. We were really excited to get that contract in place. Frankly, with it being at the high end of the range, that gives us the flexibility to look at a number of options. We're really reassessing the royalty option, still very much in play. I think, you know, with the PRV sale, we feel like we've bought some time and flexibility there. Thank you. The next question is from Brian Skorney with Baird. Your line is open. Hey, good morning, everyone. Thanks for taking my question. I guess mine's sort of a combined one for Christy and Steve. I was hoping you could maybe walk us through conversion from a prescription to receipt of ZTALMY and actual booking of revenue here. Is there inventory held at a specialty pharmacy that's recognized as revenue, or is it effectively just-in-time delivery, and will the reported revenue get the pure demand sales? And based on the payer mix, what do you see as sort of the hurdle as far as the average copay is going? How much are you able to offset that through ZTALMY One? Thanks. Yeah, Brian Skorney, so I'll start with a little bit of kind of the revenue recognition piece, and then I'll allow Christy Shafer to chime in as well here. You know, we will sell to the specialty pharm partner who will then, you know, distribute to the patient. We'd expect to recognize that when we sell it to the specialty pharma partner. Obviously, we'll have metrics to be able to estimate gross to nets and account for those appropriately in our gross to net deductions. I would not expect, as we mentioned, any significant stocking impact. We're gonna be coordinating very closely with them, so there's no need for them to order kind of excess inventory or have any of that on hand. It will be not quite just in time, but really not far from that. You know, I think we'll be able to really manage very tightly the expectations and understanding of the gross to net deductions and inventory very closely. Maybe I'll turn it over to Christy now to talk through that conversion process. Sure. Thanks, Brian. For the conversion of a naive patient from the prescription and enrollment into ZTALMY One, it really sparks a very clean line to fulfillment, which is we start a benefit investigation that simultaneously, once enrolled in ZTALMY One, will necessitate the need for what the out-of-pocket would be for patients. After the benefits investigation, we assume that all will need a prior authorization. Once that BI is done, the prior auth will then be initiated through Orsini. Again, simultaneously, that need for any patient services support for commercial patients, for copay, and again, for any patients who have limited insurance or no insurance, that process will also start. Once the PA is through, we determine that those will take in this early period anywhere between 1 and 3 months, just considering we are a new drug to market. When we're talking about what we think that average copay will be You know, you've seen one plan, you've seen one plan. For our Medicaid patients, we think that it'll be a minimal out-of-pocket. For our commercial patients, we think that again, that will be a minimal out-of-pocket. Again, we will be buying down to zero for any patients who are available for that need. Again, a pretty clear line moving with one specialty pharmacy partner right now where patient services are under our one roof. Great. Thanks. That's very helpful. The next question is from Michael Higgins with Ladenburg Thalmann. Your line is open. Thanks. Have a great morning, guys. I'll behave here and try to limit my question to just one topic. Congrats again on the progress with ZTALMY, the amendments, and IV manufacturing. You have a lot going on. With ZTALMY having a launch underway here, if you can remind us what your patient reach is that you're looking at today. You've noted a focus in 22 states, the states where there are centers of excellence. How is that evolving with the new ICD information that you've noted? What are your plans and the timing for expanding that outside of what your reach is today? Thanks. Hi, Michael. I'm happy to take that. Currently today, we estimate, again, two weeks into launch, that we'll probably have about an 80% reach with that. We certainly, with the early data and the ICD-10 that's being increasingly used, that has confirmed that. Again, to my earlier point that other codes, in certain situations are being used, I think will inform that. I personally believe that where we have our reps today, I don't think that we'll need to have any increased reach at that point. We are reaching our top accounts. Again, we have about 300 centers that we're targeting today, both from a CDD center of excellence, national epilepsy centers, but also down to, you know, smaller community accounts, again, that we are being able to target very easily with the sales force that we have. I appreciate that. Christy, you can also say, I mean, the world's different today, right? We don't need a salesperson to help a physician and a family find this drug. We have had that happen already. It's not clear that we need to actually. It'd be nice, but it's not critical for the success or the ability to capture that last 20% by having a sales force call on that physician, right? The team's done an amazing job to make those materials available. They're very straightforward. We've got our great data. I mean, I was in practice for a lot of years and didn't see a sales rep and wrote prescriptions, and I think we're already seeing that today, which is very exciting, and gives us confidence that we are right-sized for this launch. The next question is from Jason Butler with JMP Securities. Your line is open. Hi. Thanks for taking the question. Just one on the RAISE protocol amendment. Obviously, as you said, the IV inclusion of IV anesthesia, you had those patients in the phase II, so should have some level of confidence there. But can you just speak to your level of confidence around the change associated with prior failed agents? Thanks. Sure. Yeah. Well, I think, for a lot of reasons, we're confident about that too. Again, that parallels patients in the phase II study as well. We didn't see a difference in patients who'd taken fewer versus more IV AEDs previously. The other piece of that is, well, it's gonna help enrollment because of, you know, a couple of reasons. Patients in the ICU, they may not get a dose of benzodiazepine, as is required in the current protocol. They may progress right to a second-line IV AED, because they've gotten so much propofol, midazolam, or whatever for ventilator management. That's one. The other is more centers are progressing straight to IV anesthesia earlier in the treatment sequence, after the first failed, second-line IV AED. By just requiring two agents, either a benzodiazepine and one second-line or two second-line IV AEDs, we'll be able to capture more patients. The other piece of it is the current protocol specifies that IV anesthesia mustn't be a contraindication. Now, because we're going earlier in the treatment sequence and wanna treat appropriate patients, it's now an inclusion that were it not for intervention with the study drug, IV anesthesia needs to be the next intervention that they would consider, or likely the next intervention that they would consider. That does a couple of things besides, you know, making sure we're treating patients of appropriate severity for an investigational agent. It also increases the chance that IV anesthesia would be the very next treatment considerably. Since the second co-primary endpoint depends on that, we think this change actually increases the sensitivity of the study rather than decreases it. You know, we're you know. With all these things together, it bolstering enrollment and some of the changes, strengthening the study further, I'm actually optimistic about that in terms of the effect on the study. Yeah. Joe, thanks, Joe. I think that was great. Jason, I'll just add, you know, we powered the study, and we've talked publicly about a 40% placebo number as our powering assumptions. We've also talked that we believe that, you know, this placebo rate much more likely to be closer to 20%, around, the, you know, the progression to general anesthesia. To Joe's point, we really believe that these changes to the protocol have the ability to drive that number even lower, because some of these patients are already going to be on mechanical ventilation. If you turn down their anesthetic agents, they go into status, they either get drug or placebo. If they get placebo when they're still in status, it's gonna be a very easy decision to crank up their anesthesia, right? We feel very good about this only having a potential positive effect for the study and a lower rate of placebo effect overall. That was gonna be our last question. I just wanna thank everyone for being on the call. I know we've run late. We've got a lot going on, and we were happy to take questions around the launch. We're super excited about the new formulation and certainly the progress that we're making on our phase III trial. Thanks everyone for dialing in and have a good day. Operator, back to you. Thank you. Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.