Delcath Systems, Inc. Q4 FY2021 Earnings Call

Good day ladies and gentlemen, and welcome to the Delcath fourth quarter 2021 earnings call. At this time, all participants have been placed on a listen-only mode. The floor will be open for questions and comments after the presentation. It is now my pleasure to turn the floor over to your host, David Hoffman, Delcath’s 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 Section 27(a) of the Securities Act of 1933 and Section 21(e) 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 III 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 with 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 used 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 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 to published studies in metastatic ocular melanoma. As we have previously reported, supportive predefined exploratory analyses were conducted comparing patients in the Hepzato arm versus a best alternative care or BAC arm. As a reminder, the BAC arm was comprised of 42 patients originally randomized in the FOCUS trial prior to its amendment in consultation with the FDA to a single-arm pivotal study in 2018. These predefined exploratory analyses between the BAC arm and Hepzato show statistically significant treatment advantages in 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 at 73.6% versus 37.5%, and almost triple the progression-free survival at nine months versus 3.1 months. Furthermore, 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. Per the statistical plan, a predefined exploratory survival analysis versus BAC will be conducted at 24 months after last patient last treatment, which occurred 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% of patients, and neutropenia, 19.8% of patients, which were 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 am glad to be able to announce that we are 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 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 U.K., 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 U.K., 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 submission 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 U.S. and European physicians who discussed their respective experiences 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, demonstrating 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 KOLs, last month we were pleased to see results from a single-institution retrospective study published in the Journal of Melanoma Research. The study was conducted by University Hospital Southampton and HS Foundation Trust in England on the use of Chemosat for the treatment of patients with liver dominant metastatic uveal melanoma and was authored by Dr. Sachin Modi and his colleagues. The study evaluated the safety and efficacy of Chemosat in 81 patients treated with Chemosat between 2012 and 2020. Approximately half of the patients had received other treatments, either systemic or liver-directed, before Chemosat treatment, similar to the FOCUS trial that included first-line patients and patients who had failed prior lines of therapy. 250 PHP procedures were performed in 81 patients with a median of three per patient. The analysis demonstrated a 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 median follow-up at 12.9 months, median overall progression-free survival and median overall survival were 8.4 and 14.9 months respectively. Treatment-emergent adverse events of grade 3 or 4 occurred in 27.7% of the patients. The most common grade 3 or 4 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 documenting 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 of Finance. Tony brings over 20 years of experience leading finance and operational teams at 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 in support of the launch and growth of products in advanced cell therapy and biologics. 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 U.S. and resume direct commercial operations in the EU. Regarding U.S. commercialization, a key goal is to have 10 expanded access sites open by the time of launch and 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 input from both medical oncologists and interventional oncologists to ensure that there is broad interest in sites and participant recruitment. As hopefully was evident from the virtual investor update presentation, there was real interest in investigating the use of the 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 U.S., 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, in 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 III results and the study at Southampton. Ahead of re-filing our NDA plan for mid-2022, we are excited to conduct a pre-NDA meeting in the 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 revenues for the three months ended December 31, 2021 were 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 the increase primarily due to the acceleration of deferred revenue caused by the termination of the medac license agreement. Research and development expenses for the quarter were $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 in the prior year quarter. Total operating expenses for the quarter were $6.6 million compared with $7.3 million in the prior year quarter. Expenses for the quarter included approximately $1.6 million of stock option expense compared to $3.5 million in the prior year quarter. The company recorded a net loss for the 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’d ask the operator to open the phone lines for Q&A. Can you please check for questions?

Your first question for today is coming from Marie Thibault. Please announce your affiliation and then pose your question.

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 what way would you like to see the data. John, do you want to chime in a bit? Certainly there won’t be any surprises, but do you 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. 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. This is really the first display of our data set in totality along with our complete response letter responses that the FDA will see all in one place, so we’re asking for their guidance on how they would like to see all of that compiled into the NDA resubmission, plus as Gerard said, asking some technical questions about the presentation of those data.

Okay, 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 effort there. I know that you mentioned you expect to submit for some national coverage by the end of the year. Thanks for taking the questions.

The transition has been relatively smooth for two main reasons. Firstly, both parties, medac and ourselves, were committed to ensuring there was no disruption in product supply to institutions and patients, and I want to commend medac for their professionalism during this transition. Secondly, we realized there wasn’t much ongoing promotion that we were aware of. Given our ongoing role in medical affairs, we have good insight into where treating physicians are located and in some cases when patients are being scheduled, making it easy for us to pick things up. When it comes to increasing our customer-facing team in Europe, once a site is operational, there isn’t much support needed. We prefer to check in occasionally to ensure that procedures are being followed according to the best protocols for patient care, so we like to be accessible, but there isn't a lot to manage. New representatives will primarily focus on identifying sites that are monitoring patients and directing them to treatment locations, as well as establishing new sites. I don’t anticipate significant disruption to the existing base business. As we establish our presence, I believe it will take some time, but we should eventually see a return to the growth we experienced until the end of 2018, after which the business plateaued. Regarding national coverage submissions, we aim to submit for Chemosat in the U.K. this year. We are relying on much of the work we have done in the U.S. for the value dossier that is also necessary or beneficial in the U.S. but is not as mandatory in Europe. A lot of the work regarding alternative treatment regimes and literature reviews is similar between European and U.S. submissions, so we will capitalize on that. I am mostly confident that we will make our submission in the U.K. We will also look into submissions for other countries, keeping in mind that each has its own calendar and process. We are working diligently to meet the submission deadline in the fall for the U.K.

All right, good luck with it. Thanks for taking my questions.

Thank you.

Your next question for today is coming from Yale Jen. Please announce your affiliation, then pose your question.

Good morning, this is Yale from Laidlaw & Company. I wanted to follow up on the earlier question regarding Europe. What should we expect in terms of revenue compared to last year and previous years? If we are successful, can we anticipate a more significant increase, or will there be a learning period before growth accelerates?

I believe it will take several quarters, specifically for the remainder of this year, before we observe a significant change. I hope to see some differences by the fourth quarter. As you may know, there are three main drivers for increasing revenue. The first is boosting patient referrals, which requires additional resources to find and engage with those patients. The second driver is the establishment of new sites, both domestically and internationally, which will naturally take time. The third involves reimbursement submissions for national coverage, which follow their own timeline. Although it will take time, I am optimistic that if we execute well and maintain focus—especially as a single product company—we will see an increase in revenue even prior to national reimbursement. However, I anticipate that the fourth quarter will be when we start noticing a substantial rise in both volume and revenue.

Okay, that’s very helpful. Are you guys going to build a head office in Europe, or those sales will be dispersed in their respective territories?

We currently have an office in Galway that handles some packaging in Ireland, which is technically our head office on paper. However, we do not plan to establish a head office with a significant number of employees. Instead, we envision a virtual business model in Europe apart from the manufacturing facility, as that seems to be the current trend.

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

I think it really is the medical writing that is really the gating factor, hands down. It’s a tremendous amount of information to 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. John, anything else you want to add to that, or do you agree it’s pretty much the medical writing?

Yes, it’s 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 analysis of that data set in the NDA, so it’s a huge amount of data and medical writing is quite challenging, yes.

There is some clean-up and monitoring happening at the sites, but it's minimal and not a significant barrier anymore. It's mainly about moving forward with submission, which typically takes about four months for most companies after data lock. We don't have the final data lock yet because we are still monitoring a few additional patients. However, we aim to expedite the process and submit in about two months.

Okay, so therefore no data remains to be collected or unclear at this point, is that right?

Yes, there’s nothing to be collected. We’re shooting for 100% monitoring. If monitoring ends up becoming gating again and we’re at 99.2, we’ll go with 99.2, which per the industry that’s just fine. 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.

Your next question is coming from Scott Henry. Please announce your affiliation, then pose your question.

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 U.S. launch. What is the total number of U.S. centers we should think about that account for the bulk of procedures here?

Kevin, you want to handle that?

Sure Gerard. I don’t want to provide a specific number, but it's not very large. This is a rare disease with a limited number of patients for uveal melanoma. When we consider 10 accounts or hospitals we aim to enroll in the expanded access program, we estimate that these are world-renowned centers, which means they are among the larger hospitals treating most uveal melanoma patients. We would estimate that this represents roughly half of the hospitals in the United States that treat uveal melanoma. Does that address your question?

That does.

Yes, if we apply the 80/20 rule, around 20 centers likely account for about 80% of the treatments. The data is never completely clear. Our goal is to guide patients to our initial 10 centers, which are fairly centralized, so they don’t feel lost trying to navigate on their own.

Okay, great. Thank you for the color. 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 as similar to the recent presentation?

Yes, I think it was a reprisal of the data we’ve already gone through in the past, plus I added some of the Southampton publication data that recently came out.

Okay, great. Thanks for clarifying that. Then I guess the other question, as we start to see investigators publish data and 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?

Yes, that’s a good question and also a very difficult one to answer carefully. We will not promote this, but doctors are free to read case study reports or alternative cohort reports. There is a modest amount of data available in ICC, and we anticipate there may be case studies published in other tumor types, so I expect doctors will consider this. It will depend on how much pressure they want to put on payors or how willing patients are to pay out of pocket. There is a modest amount of data and I expect more information will emerge from Europe in the next year or two concerning other indications. In particularly challenging diseases that lack well-established guidelines, ICC fits into that category, which is two to three times the size of ocular melanoma. That’s a situation where we might see some off-label usage.

Okay, great. Finally just shifting to the income statement, a couple 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 that 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. 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. 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 of the questions.

Your next question is coming from Swayampakula Ramakanth. Your line is live.

Thank you, this is RK from HC 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?

Yes, I think the potential for Europe, given it’s 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. The increased penetration, you know, 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 being diagnosed, who are going in on a regular basis, getting CAT scans or MRIs, looking for liver mets. We need to make sure the physicians who are 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, and Spain, that jump to mind, so we need to garner interest with medical oncologists in those sites and interventional oncologists and open sites. Then the third thing after that would be obviously getting national coverage. That in itself takes some time and it’s difficult to do that in any market unless you have real support from the treating physicians, so you need to try to get in there prior to national coverage, build support, and then put in your submission. 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’re starting to see some meaningful revenue uptake in the U.S., 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, I think it’ll be a lot more attractive from other dimensions if we do maintain global rights, or at least importantly rights in Europe and the U.S., so we’re glad to have all that 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 said you’re looking into U.K. in the immediate future.

Yes, there is coverage in Germany through a process where hospitals request funding for approved products that lack national coverage. Each year, they can submit a special request in a collective manner. This does limit the business potential since it requires not only engaging a new hospital but also securing approval from their financial office to make the annual request before using the product. There are ways to make this easier; for instance, establishing a set price would simplify negotiations for them, and we are currently working on that. While the coverage in Germany isn't straightforward, we do have some existing coverage, and we are committed to making further efforts to expand our presence and patient referrals in that market.

Thank you Gerard, talk to you soon.

Take care, RK. Thank you.

Your next question is coming from Arlinda Lee. Please announce your affiliation, then pose your question.

Hey everyone, it’s Ben Shim calling in for Arlinda Lee of Canaccord Genuity. Congrats on all the progress, gents. I’ve 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? Then I have a couple follow-ups.

Sure Ben, it's great to hear from you. We still hold intellectual property on various parts of the product, but to be straightforward, I believe that anyone could design around that IP in a year to a year and a half. There's no way to establish a completely airtight intellectual property barrier around the carbon absorption of small molecules using our type of filter. We do have patents on the specific design, which means that anyone trying to replicate our results would need to develop a filter that functions differently from ours. This would require them to redo preclinical studies, both in vitro and in vivo, conduct Phase I and II trials, and then execute a pivotal trial in the chosen patient population, such as ocular melanoma. They would have to complete that while we are already treating patients, which makes for a process of over seven years to reach the market. This is essentially the protection our IP offers, much like the situation at my previous company, Vericel, where competitors are kept out of the market due to the difficulty of replicating their 1980s cell therapy technology. There’s no 505(b)(2) process, no 510(k) for drug-device combinations, or an ANDA process to introduce a similar product into the market. Starting from scratch and replicating our work would necessitate careful consideration to avoid infringing on our IP.

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

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

Sure Gerard. With a six-month review period under the PDUFA requirements, one would expect the advisory committee meeting to occur around the fifth month. This would provide time to complete everything. The FDA will likely inform us within a month or two after receiving the re-submission if an advisory committee meeting is anticipated. Planning for it in the fifth month seems reasonable, as a six-month review period is brief, and if there is one, it would likely take place then. We understand your concerns regarding the holidays that are scattered in the upcoming months; it will 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 re-filing?

John, what’s your perspective on that?

When you refer to real-world experience, Ben, is that your perspective?

Yes.

The point about real-world experience is that, of course, it’s not contributing to the meaningful safety data set. We do have supported evidence from various European studies 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. 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.

Yes, I think another way to look at this is if there was a strong theme through the published literature that there was significant safety issues with the current product, with the gen-2 filter, it would be problematic. The FDA would read that, and 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, the publications, but I’d be hard pressed to think that they wouldn’t take note of it. 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.

Got you, 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.

Yes, I just want 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. 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.