Delcath Systems Inc (DCTH) 2021 Q4 法說會逐字稿

Good day, ladies and gentlemen, and welcome to the Delcath fourth-quarter 2021 earnings call. (Operator Instructions) It is now my pleasure to turn the floor over to your host, David Hofmann, Delcath General Counsel. Sir, the floor is yours.

Thank you. And once again, welcome to Delcath Systems' fourth-quarter 2021 earnings call. With me on the call are Gerard Michel, Chief Executive Officer; Dr. Johnny John, Senior Vice President of Medical Affairs and Clinical Development; Kevin Muir, Vice President of Commercial Operations; John Purpura, Chief Operating Officer; and Anthony Dias, Vice President of Finance.

I'd like to begin the call by reading the Safe Harbor statement. This statement is made pursuant to the Safe Harbor for forward-looking statements described in the Private Securities Litigation Reform Act of 1995. All statements made on this call with the exception of historical facts may be considered forward-looking statements within the meaning of 27A of Securities Act, 1933, and Section 21E of the Securities Exchange Act of 1934.

Although the company believes that expectations and assumptions reflected in these forward-looking statements are reasonable, it makes no assurance that such expectations will prove to have been correct. Actual results may differ materially from those expressed or implied in forward-looking statements due to various risks and uncertainties.

For a discussion of such risks and uncertainties, which could cause actual results to differ from those expressed or implied in the forward-looking statements, please see risk factors detailed in the company's annual report on Form 10-K. Those contained in subsequently filed quarterly reports on Form 10-Q as well as in other reports that the company files from time to time with the Securities and Exchange Commission.

Any forward-looking statements included in this earnings call are made only as of the date of this call. We do not undertake any obligation to update or supplement any forward-looking statements to reflect subsequent knowledge, events, or circumstances.

Now, I would like to turn the call over to Gerard Michel. Gerard, please proceed.

Thank you, everyone, for joining today. We have had a very productive four months since our last earnings call. Since that call, we've released additional secondary and exploratory efficacy endpoints from the Phase 3 FOCUS study, hosted a comprehensive virtual investor update meeting, made important strides towards filing our NDA for the treatment of metastatic ocular melanoma, and continued our discussions of medical oncologists regarding further development and additional indications.

Starting with FOCUS study data, we believe the totality of the efficacy data we released last year provides strong support for the clinical benefit of HEPZATO for patients with metastatic ocular melanoma. The 31.4% objective response rate in the intent-to-treat population, including a 6.9% complete response rate meaningfully exceeds response rates reported in published studies in this difficult to treat disease. Notably, it far exceeds the 5.5% objective response rate from the meta-analysis of immune-oncology agents, which we use to [power] the study.

Importantly, the responses seen in the trial are durable with a clinically meaningful duration of response of 14 months, and the categories response -- of response ranging from progression of disease to complete response correlate with increased median overall survival. The overall survival of 20.5 months in this patient population compares favorably the published studies in metastatic ocular melanoma.

As we have previously reported, supportive predefined exploratory analyses were conducted comparing patients in HEPZATO arm versus a best alternative care, or BAC arm. As a reminder, the BAC arm was comprised of 42 patients originally randomized the FOCUS trial prior to its amendment in consultation with FDA to a single-arm pivotal study in 2018.

These predefined exploratory analyses between the BAC arm and HEPZATO show statistically significant treatment advantages and objective response rate, disease control rate, and progression-free survival. Specifically in patients who received one or more treatments, objective response rate was almost triple BAC, at 35.2% versus 12.5%; almost double the disease control rate, it's 73.6% versus 37.5%; and almost triple the progression-free survival, that nine months versus 3.1 months.

Further, while survival data has not fully matured, a six-month median overall survival trend in favor of HEPZATO is observed. In an important post-hoc analysis, survival at 12 months in the evaluable patients was 75% in the HEPZATO arm versus 47% for BAC, a statistically significant and clinically meaningful difference. Further statistical plan, a predefined exploratory survival analysis versus BAC will be conducted at 24 months after last patient last treatment which incurred in May of last year. We will provide future overall survival analysis updates as patient follow-up continues, and the Kaplan-Meier analysis matures.

In the HEPZATO safety population, the most commonly reported treatment emergent serious adverse events were anemia, 29.7% of patients; thrombocytopenia, [26.4%] of patients; and neutropenia, 19.8% of patients, which are well manageable and transient. 5.3% of patients experienced a treatment emergent serious cardiac adverse event, all of those events resolved with no ongoing complications. There were no treatment-related deaths in the trial.

This adverse event profile is similar to many commonly prescribed cytotoxic agents. We are excited to share these and other data with the FDA and are on track to submit the Class 2 resubmission to the agency in midyear. I'm glad to be able to announce they were close to having 100% of the patient data monitored. We have requested a pre-NDA meeting with the FDA and are scheduled to meet with the agency in the late April. Last year, an outside firm completed a mock audit of our Queensbury, New York medical device manufacturing facility in anticipation of the submission and of an eventual FDA pre-approval inspection.

While we recently achieved a medical device regulation or MDR certification from our notified body for CHEMOSAT under the new European Medical Devices regulation, we recognize that an FDA pre-approval inspection has a distinct set of standards, and therefore, hired this outside firm to conduct the mock audit. I am pleased to announce that based on the findings from the audit and our ongoing activities, we are confident that we will be well prepared for the anticipated FDA inspection, hopefully sometime in late summer or fall.

We announced last month that we were resuming direct responsibility for sales, marketing, and distribution activities of CHEMOSAT in all of Europe. Since December 2018, medac, a privately held company based in Germany, had been the licensee for CHEMOSAT in the EU, the UK, Norway, and Switzerland. We resumed direct sales, marketing, and distribution earlier this month and currently have four customer-facing employees in sales, marketing, and medical affairs working with healthcare providers in the UK, Germany, and Netherlands, and anticipate hiring several more this year to further support healthcare providers and patients in those markets as well as expand use throughout broader Europe.

Importantly, we anticipate our first submissions for national coverage will occur by the end of the year, including in the United Kingdom. In December, we hosted a distinguished panel of 12 US and European physicians who discuss their respective experience with HEPZATO in the FOCUS trial, commercial experience with CHEMOSAT in Europe, and the unmet need in the treatment of liver metastases and the possible role of CHEMOSAT and HEPZATO, if approved to treat those patients.

We were able to gather this large group of distinguished experts for three reasons: first, the compelling nature of the FOCUS trial results for HEPZATO's treatment of metastatic ocular melanoma patients; second, the existence of approximately 10 years of real-world experience in the -- demonstrated the utility of the PHP platform; and finally, the large unmet need for improved treatments for patients with hepatic-dominant disease.

If you haven't had a chance to watch the December 2 virtual investor update presentation, I recommend you take the time to get a treating physician's view on HEPZATO and CHEMOSAT as well as their perspective on the need for better treatments for patients suffering from liver-dominant cancers. Related to the real-world experience shared during that virtual update presentation by some of the European healthcare, [well], last month, we were pleased to see results from a single institution retrospective study published in the journal, Melanoma Research. The study was conducted by University Hospital Southampton, NHS Foundation Trust in England on the use of CHEMOSAT for the treatment of patients with liver-dominant metastatic uveal melanoma. And it was authored by Dr. Sachin Modi and his colleagues.

The study evaluated the safety and efficacy of CHEMOSAT in 81 patients for liver-dominant metastatic uveal melanoma treated with CHEMOSAT between 2012 and 2020. Approximately, half of the patients have received other treatments, either systemic or liver-directed before CHEMOSAT treatment; similar to the trial-- similar to the FOCUS trial that included first line patients and patients who had failed prior lines of therapy.

250 PHP patients were performed -- procedures were performed in 81 patients with a median of three per patient. The analysis demonstrated that hepatic disease control rate of 88.9%, hepatic response rate of 66.7%, which included a hepatic complete response rate of 12.3% and an overall response rate of 60.5%. After a median follow-up of 12.9 months, median overall progression-free survival and median overall survival are 8.4 and 14.9 months, respectively.

Treatment-emergent adverse events of grade three or four occurred in 27.7% of the patients. The most common grade three or four hematological toxicities were anemia observed in 13.3% of patients and thrombocytopenia observed in 12% of patients. There were no fatal treatment-related adverse events.

The authors concluded that CHEMOSAT provides excellent response rates and progression-free survival compared with other available treatments and noted that combination therapy with systemic agents may be viable to further advance overall survival. These results are consistent with numerous other publications out of Europe and add to the growing body of published research document and the efficacy of our CHEMOSAT system in the European commercial setting.

Shifting gears, we also strengthened our leadership team with two appointments in early 2022. We announced Anthony Dias as our new Vice President, Finance. Tony brings over 20 years of experience leading finance and operational teams of pharmaceutical, medical device, and technology companies. Tony will oversee all financial aspects of the company, including financial planning and analysis, financial reporting, accounting and control, tax and treasury.

We also announced David Hoffman as General Counsel and Corporate Secretary. David will also serve as Delcath's Chief Compliance Officer. He brings over 20 years of experience advising biotechnology companies with a focus on the commercialization of therapies.

Most recently, he served as Associate General Counsel and Chief Compliance Officer at Vericel Corporation, where he was responsible for legal and compliance matters and supported the launch and growth of products in the advanced cell therapy and biologic space. David has considerable expertise in pharmaceutical law and regulation, business development, commercial business transactions, IP, and compliance.

Both hires bolster our management team at a critical juncture as we approach commercialization in the US and resume direct commercial operations in the EU. Regarding US commercialization, a key goal is to have 10 expanded access sites open by the time of launch, and it -- ensure that the mix of sites are appropriately located to enable reasonable access, regardless of a patient's location. To date, well over 10 sites have expressed interest in participating, and we should have two sites in a position to start accepting patients within a month.

In addition, we are actively developing key documentation to support reimbursement, such as a value dossier and an NTAP submission, as well as holding advisory boards with treating physicians to better understand the patient journey.

Finally, we continue to plan on expanding the PHP platform into other indications. An important part of that is garnering further inputs from both medical oncologists and interventional oncologists to ensure that there is broad interest in sites and any trial can recruit patients. As hopefully was evident from the virtual investor update presentation, there is real interest in investigating the US -- the use of PHP platform in a variety of other cancers, specifically both intrahepatic cholangiocarcinoma and colorectal carcinoma.

We have scheduled a series of further advisory boards to review proposed protocols for each indication after which we will start formal discussions with sites and prepare any required regulatory submissions. Given our first priority remains submitting the NDA and launching in the US, Delcath is primarily focused on those regulatory and commercial goals. However, these expanded indications are still a core part of our strategy, and our efforts will continue in parallel.

In summary, fiscal year 2021 and nearly a quarter into 2022, we've taken important steps towards commercialization of our PHP system in our initial indication and expansion into new areas. We have brought in key personnel and continue to be supported by a growing body of data as demonstrated by our positive Phase 3 results in the study at South Hampton. Ahead of refiling our NDA planned for mid-2022, we are excited to conduct a pre-NDA meeting in coming weeks.

I look forward to taking questions, but first, we'll turn the call over to Tony to review the financials. Tony?

Thank you, Gerard, and I'm happy to be joining the company during this exciting time. Product revenue for the three months ended December 31, 2021, was approximately $246,000 compared to $379,000 for the prior year quarter from sales of CHEMOSAT in Europe. Other income for the quarter was $1.9 million compared to $129,000 in the prior year quarter, with an increase primarily due to the acceleration of deferred revenue caused by the termination of medac license agreement.

Research and development expenses for the quarter was $3.6 million compared to $2.7 million in the prior year quarter. Selling, general, and administrative expenses for the quarter were approximately $3 million compared to $4.6 million -- sorry, $4.5 million in the prior year quarter. Total operating expenses for the quarter was $6.6 million compared with $7.3 million in the prior year quarter. Expenses for the quarter included approximately $1.6 million stock option expense compared to $3.5 million in the prior year quarter.

The company recorded a net loss for three months ended December 31, 2021, of $5.3 million compared to a net loss of $7 million for the same period in 2020. On December 31, 2021, the company had cash, cash equivalents, and restricted cash totaling $27 million as compared to cash, cash equivalents, and restricted cash totaling $28.7 million on December 31, 2020.

During the three months ended December 31, 2021, and December 31, 2020, we used $6.4 million and $5 million, respectively of cash in our operating activities. During the fourth quarter of 2021, we raised approximately $4 million pursuant to the ATM offering, predominantly from a single trade.

That concludes my financial remarks, and I ask the operator to open the phone lines for Q&A. Can you please check for questions?

(Operator Instructions) Marie Thibault.

Hi. Thank you for taking the questions. This is Marie Thibault from BTIG. Congrats on the progress over the last several months and glad to meet a few other members of the team. I just wanted to hear what we might hear out of this pre-NDA meeting you have coming up at the end of April, if there's potential for any surprises or any changes to the timing.

I don't think there's much potential for any surprises. These meetings are fairly, I wouldn't say ministerial, but it really is trying to get confirmation from the FDA that the body of data we have is adequate for them to review which it should be.

There are a couple of technical questions in terms of in what way would you like to see the data. But John, do you want to chime in a bit and any -- certainly, there won't be any surprises, we want to give a little more detail on the purpose of these meetings and what we need to hear from them.

Sure, Gerard, thank you. So we don't expect surprises. We do have a vast body of data coming off of the prior complete response letter that we are answering as well as data on the safety and efficacy side from the FOCUS trial. It is really the first display of our dataset in totality, along with our complete response letter responses, as we will see all in one place. So we're asking for their guidance on how they would like to see all that compiled into the NDA resubmission plus the, as Gerard said, asking some technical questions about the presentation of those data.

Thanks, that's very helpful. Thank you for that. I'll ask my follow-up here on Europe. Curious to hear a little bit more about how the transition to the direct sales force is going. You mentioned some hiring as well as the progress you're making on the reimbursement efforts there, I know that you mentioned you expect to submit for some national coverage plan by end of year. And thanks for taking the questions.

Sure. So the transition was fairly smooth, I think for two reasons. One is I think both parties, medac and ourselves, obviously wanted to make sure that there was no disruption in the supply of product to the institutions and for the patients. And my hats off to medac for being very professional in the transition.

Second is there was not a lot of promotion ongoing that we were aware of. We were very much aware of in terms of trying to open many new sites. We're very much aware -- given our continued role in medical affairs, we're very much aware of where the treating physicians were, even to some cases when patients were being scheduled. So it wasn't very difficult for us to pick it up.

In terms of putting more customer-facing people in Europe, I'm pretty much once you have a site up and running, really what we -- there's not a lot of support that's necessary. We do like to check in just to make sure that the procedures are being done according to the protocol that we think is best for the patient. So we'd like to be available, but there isn't a lot to be done. Really new reps will really be one of two things. One is try to find sites that are surveilling these patients and get them referred to the treating sites. And the second thing will be opening new sites.

So I don't see a great disruption to the kind of the base -- the very modest base business that's there. What will occur with us being out there now is going to be -- it will take a bit of time, but I think a resumption in growth that we saw in that business through the end of 2018, then it dropped and plateaued. Now in terms of national coverage submissions, we're targeting to try to get something in CHEMOSAT this year in the UK. We're leveraging a lot of the work we're doing in the US for the value dossier that's also required or helpful in the US. Little less required, but more helpful there.

I'm a big part of that in terms of describing alternative treatment regimes, literature search and stuff is common between Europe and the -- European submissions and the US. So we're leveraging that. The only one that I'm bit confident that we're going to get it or mostly confident we're going to get it in the UK. We'll look at other trying to get others in. Every country has their different calendar and process. We're going to try to get the one that's due in the fall in the UK, so we're working quite hard towards that.

All right. Good luck with it. Thanks for taking my questions.

Thank you.

Yale Jen.

Good morning. This is Yale from Laidlaw & Company. Just want to follow up the earlier question a little bit in terms of in Europe that; what should we anticipate potentially from the revenue perspective compared to this year -- the last few years? Would we anticipate, if successful, a more meaningful increase or there will be a learning period before things start to take off?

I think it will take several quarters, i.e. the balance of this year before we see a meaningful inflection. I would hope by the fourth quarter, we start seeing a difference. I think, as you know, that the biggest -- the two biggest drivers to -- there are three drivers really to increase revenue. One is increasing patient referrals, and that'll take some bodies on the ground and finding where those patients are being surveilled.

The second is opening new sites, both within countries, but more importantly in other countries. And that clearly will take some time. Then the third is the reimbursement submissions for national coverage, and those have their own clock. So it will take time, but I think we will see multiples. If we execute appropriately and put the right focus on it, which as a single product company, we will, I think even before national reimbursement comes in, well before that we'll see an uptick in revenue. But I think the fourth quarter is the time we'll start seeing a meaningful increase in volume and revenue.

Okay. That's very helpful. Maybe, are you guys going to build a head office in Europe or those sales will be dispersed in their respective territories?

We have an office right now in Galway that does some packaging in Ireland. So that's technically on paper our head office, but we're not going to open up a head office with a fair amount of people located in it. I think this will be a virtual -- kind of a virtual business in Europe outside of the manufacturing facility. That seems to be the way the world works at the moment.

Okay, great. Maybe the last question here is what is considered to be the gating factor at this point before you're ready to file in midyear this year? And thanks.

I think it's finish -- it really is the medical writing is really the gating factor, hands down. It's a tremendous amount of information put together, whether or not it's the results of the FOCUS trial or it was a rather long list on the CRL side to document all that. But it really is the internal medical writing. And, John, anything else you want to add to that, or you agree it's pretty much the medical writing?

Yeah, it's the consolidation, Gerard, of an enormous amount of data in the way the NDA requires. But also, as you pointed out, some of the questions in the complete response letter require data analysis of that data set in the NDA. So it's a huge amount of data and medical writing is quite challenging, yes.

There's a bit of cleanup. There's still a bit of monitoring going on at the sites, but very little. That's no longer gating. It really is just getting it out the door, which most companies -- you know, the standard is about four months between data lock, and we don't technically have data lock -- final data lock yet because we're monitoring a few more patients. For most companies, it's about four months between data lock and being able to get an NDA, and we're going to try to do it in about two months.

Okay. So therefore, there's no data remain to be collected or unclear at this point, is that right?

There's nothing to be collected. We're shooting for 100% monitoring. If monitoring ends up becoming gaiting again and we're at 99.2, we'll go with 99.2, which per the industry that's just fine. I mean, many times things go out without totally 100%, but we'll be close to it.

Okay, great. Thanks a lot, and best of luck.

Thank you.

Scott Henry.

Thank you, and good morning. I'm from ROTH Capital. Just a couple questions. First, you talked about being in 10 expanded access centers at the time of US launch. What is the total number of US centers we should think about that account for the bulk of procedures here?

Kevin, do you want to handle that?

Sure, Gerard. I don't want to put a specific number on it, but it's not a very large number. This is a rare disease with a limited number of patients for uveal melanoma. When we look at 10 accounts or 10 hospitals that we wanted to enroll the EAP, we estimate that -- and those are world-renowned centers on top of that, so those are going to be the larger hospitals that we are covering or treating most of the patients with uveal melanoma. But we would estimate that that would represent roughly half of the hospitals in the United States that are treating uveal melanoma. Does that answer your question?

That does.

If we do the 80-20 rule, I think it would be something along the lines of 20 centers probably account for about 80% of the treatments. The data is never totally clear. What we'll end up doing is trying to steer patients to our initial 10 centers. And this is a fairly tight well-informed patient community, as is often the case with these ultra-ultra-orphan diseases, and we'll make sure that it's well known where our centers are. And we're going to try to offer, what I'll call, white-glove service. So patients know how to get to where we are and know how to get a hotel booked, et cetera, so they can get at A to B, and they're not feeling like they're lost to figure out on their own.

Okay, great. Thank you for the color. And then Gerard, you gave us a lot of data in the prepared remarks. Just for clarity, is there any new data or perhaps any data sliced in a different way that you would highlight, or should we think about this is similar to the recent presentation?

I think it just was -- it was reprisal of the data we've already gone through with in the past. And then, plus I added some of the Southampton publication data that recently came out.

Okay, great. Thanks for clarifying that. And then I guess the other question, as we start to see investigators publish data, we start to see other areas where this could be used, HEPZATO, how do you think about off-label usage upon approval?

Obviously, it's not something you market, but just how should we think about that? Do you expect it to happen in isolated situations and to what magnitude?

That's a good question. And also a very difficult one to -- one that one must answer carefully. We -- obviously, we will not promote this. The doctors also are free to read case study reports or alternative cohort reports and such. Probably, there is a modest amount of data out there in ICC, and we expect there may very well likely be case studies published in other tumor types. So I expect doctors will try this, it really is going to be to the extent to which they wish to push on the interested payers, or alternatively, the extent to which patients are willing to pay out of pocket. But there is a modest amount of data, expect there will be more data coming out of Europe in the coming year or two in other indications.

And I think in very difficult three diseases, where importantly, there are really well-established guidelines. I think ICC fits into that category, which is about two to three times the size of ocular melanoma. I think that's one where we might pick up some off-label usage.

Okay, great. And finally, just shifting to the income statement. A couple of things jumped out at me in fourth quarter. First, you've got this big bolus of other revenue in fourth quarter '21, what exactly was that and how should we think about that line, going forward?

Tony?

Yes, we had a prepaid amount that we had with medac, it was being amortized over, I think, seven years. And as a result of the termination, we accelerated some of that deferred revenue in the fourth quarter. So it was something that was prepaid that we were deferring.

Okay. And that's a one-time event?

It will be a one-time event, yes.

Okay, perfect. And then also SG&A, around $4 million in Q3, around $3 million in Q4, which quarter do you think is more reflective of what we should think about for SG&A?

I think probably the higher quarter going forward, given increased hires and increased activity getting ready for commercialization.

Okay, great. Thank you for taking all the questions.

Swayampakula Ramakanth.

Thank you. And this is RK from H.C. Wainwright. Good morning, Gerard and Tony. Most of my questions have been asked, but in general, I'm just trying to understand what's the market for CHEMOSAT in Europe? And how are you trying to ensure better market penetration than what medac had done in the last few years?

Yeah, I think the potential for Europe, given its much larger population offset by a lower price point, is probably about, let's call it, $100 million in all of Europe for ocular melanoma. To increase penetration, we need to do really three things. One is for the markets we are in, start getting patients referred to those treating sites. So that means that we need to find out where those patients are diagnosed, who are going in on a regular basis, getting CAT scans or MRIs, looking for liver [meds]. We need to make sure the physician who're surveilling them know about these treatment settings, know about the data, and get them referred to those sites.

The second thing is opening new sites, whether or not it's -- for example, in Germany, we probably could use more sites, I think in the south part of Germany. But as importantly or more importantly, opening sites in other markets. France and Italy obviously are two large markets in Spain that jumped to mind. So we need to garner interest with medical oncologists in those sites and interventional oncologists in open sites.

And then the third thing after that would obviously be getting national coverage. That in itself takes some time, and it's difficult to do that in every -- in any market, unless you have real support from the treating physicians. So you need to get in there prior to national coverage, build support, and then putting your submission.

So those are the kind of -- those are the necessary steps and kind of in that order that we'll take on. It will be a multi-year effort. But I think by the time we starting to see it for meaningful revenue uptake in the US, I think Europe is probably going to lag a bit, again just the national reimbursement requirements to really get revenue going, but we will definitely get there.

I think the other point that no one's mentioned that I think it's important to keep in mind is having European rights from a strategic perspective, I think, is very valuable as this company evolves and grows. But I think it will be a lot more attractive from other dimensions, if we do maintain global rights, or at least importantly, rights in the Europe and the US. So we're glad to have that all back in our camp.

Yes, that's for sure, Gerard. In terms of national coverage, probably you said this, but I didn't catch it, is there any coverage at all in any geography? I know you're -- you said you're looking into UK in the immediate future.

There is coverage in Germany under a process called (inaudible). What happens there is the hospital every year has to actually request funding for approved products that don't have national coverage. They can make a special request. And they do that, sort of, in a basket every year. That definitely is a bit of a cap on how much business you can get. Just not only do you need to get a new hospital up and interested in it, you'll also need to get their financial office onboard to actually put in the requests every year before they use the product.

There are ways to simplify that, for example, getting a set price would be the next step. We're working on that right now. So if we have a set price that removes one negotiating knob that have to deal with, but it makes it a bit easier for them. But yeah, there is some coverage right now in Germany. It's not a kind of write it down and you get paid type coverage, but it is coverage. And we're going to push hard. Germany is one place where we trying to open up additional sites as well as try to get more referring patients because there is some coverage there now.

Thank you, Gerard. Talk to you soon.

Thank you, RK. Thank you.

Arlinda Lee.

Hey, good morning, everybody. It's Ben Shim calling on for Arlinda Lee of Canaccord Genuity. Congrats on all the progress, gents. I got a question for Gerard. Perhaps on CHEMOSAT, can you remind us what the legal intellectual property protection runway is? And how does that compare to the practical competitive barriers to entry? And I got a couple of follow-ups.

Sure, Ben. Good to hear your voice. There is IP still on various components of the product, but I'll be blunt and say, look, I think anybody can engineer around that IP over the course of a year, year and a half. There's no way to get the type of filter we use. There's no way to get a 100% air-tight set of IP around carbon adsorption of small molecules. We do have patents, in terms of the specific design. And what that would do, we require someone to find a way to come up with a filter that does the same thing, which they could do, but they have -- it would have to be by definition different than our system.

To get different than our system, they're going to have to run preclinical -- in-vitro and in-vivo preclinical studies, they're going to need to do Phase 1, 2s, then they're going to have to rerun everything, a pivotal trial in whatever patient population they choose. Let's say, ocular melanoma, they're going to have to run that all over again. They're going to have to run that trial when we're out there already treating patients. So that's a seven year plus process to go from zero to on the market. And that essentially the IP protection we have, which ironically is very similar to the IP protection occurred at my last company that's Vericel, where they had old-school 1980s cell therapy technology growing by leaps and bounds.

And what keeps competitors out of the market there is you can't do exactly what they do. You'd have to re-create it. You'd have to prove the FDA that is the same. So similar to that company, there is no of [505B2], there's no 510K. It is a drug-device combination, ANDA type process to get a me too on the market. You'd have to start from ground zero and replicate everything. And while replicating it makes sure you don't do anything that we have IP on.

Wow, great. That's great, thanks. Switching to the NDA refiling, given a six-month review time, given that we're going to have a bunch of holidays within the second half, how soon will you know if there is going to be an AdCom, if any?

John, when will we know if there's going to be an AdCom or not? We have talked about this, but John, why don't you handle that?

Well, sure, Gerard. With a six-month review clock from the PDUFA requirements, one would anticipate an AdCom in month five. So that we give them the opportunity to get everything complete. You would know FDA would tell us probably within a month or two of their receipt of the resubmission, if in fact an AdCom was on the -- in the offering. So to get that and then plan for it in month five is probably reasonable. I mean, six-month review clock is short. And if we did have one, it would probably be in month five. And we hear you about the holidays sprinkled amongst the out months there, it's going to be interesting.

Knock on wood. Hopefully, everything goes to plan here. My last question is regarding the European experience, and you've got quite a bit of, I guess, experience in data there and number of patients. How helpful will that be for the FDA in support of this NDA refiling?

John, what's your perspective on that?

So when you say a real-world experience, Ben, is that your --?

Yes.

The point about real-world experience that, of course, it's not contributing to the meaningful safety dataset. We do have reported evidence from various European [countries] either through a registry or other single center institution work that we'll use as supportive evidence for the NDA, but it wouldn't be part of what FDA would consider part of the safety database. So while it's important and it's supportive, it wouldn't be considered as part of the FOCUS trial data. It's a different quality of data.

Yeah, I think another way to look at this is if there was a strong theme through the published literature that there were significant safety issues with the current product with the gen-2 filter, it would be problematic. The FDA would read that. They will read these papers. The theme is not such. The theme is one of a safe product for a devastating disease.

So I think technically, it's not part of the safety database publications, but I'd be hard-pressed to think that they will take note of it on. So I think it's very helpful. It's there, but we can't pound the table and point to it. We have to just make sure they're aware of them and let them read it without us making too much noise about it.

Sure. That's very helpful color. Thank you very much for taking my questions.

All right. Thank you, Ben.

There are no further questions in queue, I would like to turn the floor back over to Gerard for any closing comments.

Yeah. I just wanted to say that I appreciate everyone taking the time and your support. This is a very exciting time for us here at the company. And we very much look forward to giving you further updates as the year progresses. And everyone, have a great day. Thank you.

Thank you. Ladies and gentlemen, this does conclude today's event. You may disconnect your phone lines at this time and have a wonderful day. Thank you for your participation.