Welcome to the Iovance Biotherapeutics third quarter and year-to-date 2021 financial results. My name is Andrew, and I'll be your operator for today's call. At this time, all participants are in a listen-only mode. Later, we'll conduct a question and answer session. During the question and answer session, if you have a question, please press star then one on your touchtone telephone. Please note that today's conference is being recorded. I will now turn the call over to Sara Pellegrino, Vice President, Investor Relations and Public Relations at Iovance. Sara, you may begin. Thank you, operator. Good afternoon, and thank you for joining us. Speaking on today's call, we have Fred Vogt, our Interim President and Chief Executive Officer, Igor Bilinsky, our Chief Operating Officer, Jim Ziegler, our Senior Vice President, Commercial, Dr. Friedrich Graf Finckenstein, our Chief Medical Officer, and Jean-Marc Bellemin, our Chief Financial Officer. Dr. Madan Jagasia, our Senior Vice President, Medical Affairs, and Laurel Todd, Vice President of Policy, are also on the call to participate in the Q&A session. This afternoon, we issued a press release that can be found on our website at iovance.com, which includes the financial results for the three and nine months ended on September 30th, 2021, as well as corporate updates. Before we start, I would like to remind everyone that statements made during this conference call will include forward-looking statements regarding Iovance's goals, business focus, business plans, pre-commercial activities, clinical trials, and regulatory plans and results, potential future applications of our technologies, manufacturing capabilities, regulatory feedback and guidance, payer interactions, collaborations, cash position and expense guidance, and future updates. Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond our control, including the risks and uncertainties described from time to time in our SEC filings. Our results may differ materially from those projected during today's call. We undertake no obligation to publicly update any forward-looking statement. With that, I will turn the call over to Fred. Thank you, Sara, and good afternoon, everyone. I am pleased to highlight our year-to-date progress at Iovance during today's conference call. We have continued to advance our tumor-infiltrating lymphocyte or TIL platform into new indications in earlier treatment settings throughout this year. For our lead TIL product candidate, lifileucel in metastatic melanoma, our top priority remains our ongoing work to address FDA feedback regarding the potency assays for lifileucel to support our planned BLA submission. We have continued our ongoing work developing and validating our potency assays and have engaged in discussions with FDA during the second half of 2021. The anticipated BLA submission for lifileucel continues to be planned for the first half of 2022. We remain confident in our current guidance and timelines. Resolution of the potency assays for lifileucel is also an important next regulatory step for our cervical and non-small cell lung clinical programs. Turning to our clinical pipeline, we now have clinical data showing the promise of TIL therapy in four different solid tumor types from first line to late-stage treatment settings, furthering our confidence in TIL as a broad platform that may shift the treatment paradigm for patients with cancer. We continue to be excited about three key initiatives that have the potential to meaningfully impact patients while creating shareholder value. First, lifileucel in post anti-PD-1 melanoma continues to show increasing long-term durability following one-time treatment, as demonstrated in our ASCO 2021 presentation, where we showed median duration of response was not reached at 33 months of median study follow-up. Second, we continue to build on the potential for the combination of TIL with pembrolizumab, which supports our strategy to broaden access to TIL therapy for more patients in earlier treatment settings. We're excited about presenting combination data in several advanced cancers at the upcoming SITC Annual Meeting. As noted in this afternoon's press release, the FDA granted Fast Track designation for lifileucel in combination with pembrolizumab for the treatment of metastatic melanoma based on the unmet medical need and potential advantages for this combination over available care. This Fast Track designation allows for potential accelerated approval and priority review, as well as more frequent interactions with FDA. Finally, our initial clinical data in metastatic non-small cell lung cancer demonstrated a 21.4% overall response rate in heavily pretreated patients, all of whom have progressed on prior immune checkpoint inhibitor therapy. This population represents a significant unmet need in non-small cell lung cancer. We provided a top-line corporate announcement of the initial data earlier in the second quarter and look forward to presenting these data to a physician audience for the first time during this, the upcoming SITC meeting. On the research side, we are bringing the next generation of TIL products and supporting therapies into the clinic. We are advancing a TIL product that is genetically modified to inactivate PD-1, which we have designated IOV-4001, as well as our novel IL-2 analog, IOV-3001. Both IOV-4001 and 3001 are progressing through IND-enabling studies and are moving towards the clinic. In summary, we continue to execute all development, manufacturing, and pre-commercial activities in furthering our commitment to address the critical needs of patients with cancer in multiple solid tumor cancers and treatment settings. I'm confident in the quality of our senior leadership as well as our full internal organization to deliver towards this mission. Today, we have more than 300 employees who on average have more than 3.5 years of cell therapy experience. Members of our executive leadership team will now provide updates for their respective departments, beginning with our Chief Operating Officer, Igor Bilinsky. Thank you, Fred. I'm pleased to speak today about our new manufacturing facility, the Iovance Cell Therapy Center, or iCTC, at the Philadelphia Navy Yard. The iCTC is a 136,000 sq ft state-of-the-art LEED Gold-certified cell therapy manufacturing facility. In the third quarter at iCTC, we initiated manufacturing of investigational TIL therapies for patients enrolled in Iovance clinical trials, followed by an official opening ceremony at the end of September. To date, more than 500 patients have received Iovance TIL with a continuing manufacturing success rate above 90%. Iovance has transformed TIL manufacturing from a lengthy single-center academic process to a shorter, scalable, centralized GMP process that yields a cryopreserved product for shipment back to clinical sites where the patients are treated. Our current Gen 2 process is 22 days. We're also continuing to advance our TIL leadership position through our ongoing clinical studies to investigate a 16-day third generation, or Gen 3, process. Gen 3 may further improve Iovance TIL manufacturing efficiencies and deliver Iovance TIL to patients even sooner. We also believe that 16 days for TIL manufacturing is the fastest in the industry at this time. In addition to commencing clinical manufacturing to supply investigational Iovance TIL therapies to patients with cancer enrolled in our clinical trials, we are advancing commercial manufacturing readiness activities for Iovance TIL at iCTC. Commercial supply remains on track for 2022, pending regulatory approval, with ultimate capacity to meet the demand for up to thousands of patients in multiple indications. In support of Iovance TIL manufacturing capabilities and pipelines, we have been sharply focused on building our robust and growing intellectual property, or IP, portfolio. Today, we have more than 30 granted and allowed U.S. and international patents and more than 700 patents and patent applications filed globally across major pharmaceutical markets and other key geographies. In the past quarter, expansion to our patent portfolio includes 2 new patents covering TIL compositions prepared from tumor digests and methods of treating HPV-positive cancers, including cervical and head and neck cancers. We believe that our internal manufacturing and IP position have firmly established our leadership in developing and delivering TIL therapies for unmet need patient populations with cancer. I would now like to hand the call to Jim Ziegler, our Senior Vice President, Commercial, to highlight our commercial launch preparations. Jim? Thanks, Igor. Throughout this year, including earlier this quarter at our ribbon-cutting event, we have been fortunate to meet several key opinion leaders, investigators, patients, and family members who all understand the challenges of metastatic melanoma. The opportunities to hear their stories reinforce our commitment and our sense of urgency to bring lifileucel to market. At Iovance, we have a mission to be the global leader in innovating, developing, and delivering TIL cell therapy for patients with cancer. This is an obligation we all take personally. Our commercial team remains focused on customer and patient centricity to ensure a positive experience with lifileucel in three areas of operational excellence. First, we continue to enhance our partnership with the leading U.S. cancer centers to build their Iovance TIL service line capabilities. We are pleased with the partnership and engagement with these centers around a shared goal to ensure timely and appropriate access to lifileucel upon approval. Our customer-centric onboarding program includes a training curriculum that ensures cross-disciplinary teams at each authorized treatment center can administer the lifileucel treatment regimen upon FDA approval. The planned timing and execution of key onboarding and training is also aligned to our BLA submission to ensure just-in-time training and readiness. Second, our market access team continues to engage commercial, Medicare, and Medicaid payers to ensure patients have appropriate and timely access to lifileucel. We believe payers appreciate the unmet need and the clinical value of lifileucel. Third, the development of IovanceCares, our own cell ordering and patient support platform, is on track for launch. IovanceCares is designed to be customer-centric in planning and coordinating patient care throughout the lifileucel journey. We have incorporated customer feedback in the design of IovanceCares throughout the process. The platform includes our proprietary chain of identity and chain of custody system, our fully integrated patient management approach, and our integrated approach to quality. IovanceCares is patient-centric with dedicated Iovance case managers to handle the needs of HCPs and patients. The case managers will also provide reimbursement support for sites and patients at every step of the journey. Demonstrating operational excellence across these three areas is expected to ensure patients have timely access to lifileucel upon approval. With a gated approach to commercial readiness, the commercial organization is well-positioned to scale our efforts based upon internal milestones and timelines. I will now pass the call to Frederick to highlight our upcoming clinical presentations. Thank you, Jim. I am pleased to highlight upcoming clinical data updates as well as the status of our four ongoing clinical studies. Our drug development strategy focuses on cancer populations with high unmet need with substantial opportunity for TIL to make a meaningful impact. Since we have upcoming presentations as well as a conference call and webcast during SITC, I will briefly touch upon the highlights. As Fred mentioned, we are excited about the combination of TIL with pembrolizumab as an approach for earlier-line treatment settings. Primary resistance to immune checkpoint inhibitors is frequently observed in multiple tumor types. There's a need to increase overall response rate and deepen responses with more complete responses in anti-PD-1 naive patients. Previous results presented in head and neck cancer and melanoma patients demonstrated overall response rates that are significantly higher than pembrolizumab alone in patients who are naive to immune checkpoint inhibitors. Moving to our non-small cell lung cancer program, SITC will be the first medical meeting for us to share clinical data for our TIL therapy, LN-145, in patients with metastatic non-small cell lung cancer who enrolled in cohort 3B of the ongoing basket study IOV-COM-202. As a reminder, cohort 3B enrolled 28 patients that had progressed from prior immune checkpoint inhibitor therapy. This was a heavily pretreated population for which there is a significant unmet need to increase response rate and prolong survival. As previously reported in our top line corporate announcement, we were very pleased to see an overall response rate of 21.4%, and we look forward to providing additional details at SITC. Turning to our ongoing clinical studies, we have four active clinical studies with Iovance TIL as follows. In our IOV-LUN-202 study in second-line lung cancer, which has more than 20 active sites in the U.S. and Canada. In our IOV-COM-202 basket study of Iovance TIL and TIL plus immune checkpoint inhibitor combinations, we have completed enrollment in the relapsed refractory non-small cell lung cancer and head and neck cohort. Recruitment continues in melanoma and with TIL combinations in non-small cell lung cancer. In our C-145-04 clinical study in advanced cervical cancer, we continue to recruit a cohort of patients not previously treated with systemic therapy or anti-PD-1 to receive Iovance TIL plus pembrolizumab. We are also actively enrolling in our IOV-CLL-01 study in CLL/SLL patients, which is our first hematologic indication. I will now hand the call over to Jean-Marc to discuss our third quarter 2021 financial results. Thank you, Fred. My comments will reflect the high-level financial results from our third quarter and year to date 2021. Additional details can be found in this afternoon's press release as well as in our SEC filings. I will begin with our cash position. As of September 30, 2021, Iovance held $660.8 million in cash equivalents, investments and restricted cash compared to $635 million on December 31, 2020. Our strong cash position is expected to be sufficient well into 2023 to advance our operating plan, including pipeline development, commercial manufacturing readiness, and launch preparation with no immediate need to raise dilutive capital. Moving on to the income statement. Our net loss for the third quarter ended September 30, 2021 was $86.1 million or $0.55 per share, compared to a net loss of $58.6 million or $0.40 per share for the third quarter ended September 30, 2020. Net loss for the nine months ended September 30, 2021 was $242.9 million or $1.60 per share, compared to a net loss of $191.2 million or $1.41 per share for the same period ended September 30, 2020. Research and development expenses were $65.4 million for the third quarter ended September 30, 2021, an increase of $22.3 million compared to $43.1 million for the third quarter ended September 30, 2020. Research and development expenses were $183.4 million for the nine months ended September 30, 2021, an increase of $34.1 million compared to $149.3 million for the same period ended September 30, 2020. The increase in research and development expenses in the third quarter 2021 over the prior year period was primarily attributable to an increase in cost associated with growth of the internal research and development team, an increase in clinical trial costs, and ICTC facility related costs. The increase in research and development expenses in the first nine months of 2021 over the prior year period was primarily attributable to growth of the internal research and development team and an increase in ICTC facility related costs. Following completion of the iCTC, we have concluded our initial $85 million investment in constructing the facility. General and administrative expenses were $20.9 million for the third quarter ended September 30, 2021, an increase of $5 million compared to $15.9 million for the third quarter ended September 30, 2020. General and administrative expenses were $59.8 million for the nine months ended September 30, 2021, an increase of $15.7 million compared to $44.1 million for the same period ended September 30, 2020. The increase in general and administrative expenses in the third quarter and first nine months of 2021 compared to the prior year periods were primarily attributable to growth of the internal general and administrative team and higher stock-based compensation expenses. As of September 30, 2021, there were approximately 156.7 million common shares outstanding. We continue to focus on investment in four key areas as outlined previously to ensure the growth and strength of our value creation. This includes advancement and expansion of our clinical pipeline, launch readiness, a strong cash position, and manufacturing at iCTC, which will provide new cost efficiencies as we are able to shift work currently being done through contract manufacturers to iCTC. I remain confident that by managing our investment across these priorities, we will continue to stay focused and align our spending with our corporate priorities. I will now hand the call back to the operator to kick off the Q&A session. Thank you. As a reminder, to ask a question, you will need to press star one on your telephone. To withdraw your question, press the pound key. We ask that you please limit yourself to one question, and then you may reenter the queue. If time permits, we will take any additional questions. Our first question comes from the line of Mara Goldstein with Mizuho. Thanks very much for taking the question. I just wanted to go back for a second to the question of the discussion with FDA, and I respect that there's very little that you can say about it. You know, the press release makes reference to still being able to come up with a solution that will satisfy the agency. I'm wondering if you can maybe share with us, you know, where you are in the process in terms of the discussion level with them. You know, the original plan had been that you had some assays already on hand, and that you also were pursuing a development track for new assays and would present those to the agency. Maybe, you know, 'cause we're just about anniversarying this, maybe you can kind of walk us through exactly where things are at. Sure, Mara. That was the plan, as we discussed back in June, and that's still the plan. We're just right now in the middle of a path when we're having those FDA and those regulatory discussions. Is it? Go ahead. Sorry, I didn't mean to interrupt you. I was gonna say, is it fair to characterize that you're still in a back and forth with the agency? Yeah, I mean, we would describe it as engagement. Yes, we're in discussions and having that kind of level with them. The anticipated BLA filing timeline is still first half of 2022. I know I appreciate the discussion around the activities this company's undertaking in advance of being able to submit, and I'm speaking, you know, from a commercial perspective. Relative to the capital that the company raised ahead of launching and where you are now, I'm just curious about, you know, how much capital is being deployed while you are waiting that you would have otherwise not spent. Well, we're continuing to run our research and development program as we would normally have spent it, so we have all the clinical assets still progressing. We're just running this in parallel, so I wouldn't characterize it that way. I would basically say we're continuing the development of the TIL platform as we intended, and at the same time we're working with FDA on moving forward on the potency assay situation, which is something that we think is a gating item across the- Mm-hmm. the TIL platform right now. Okay. I really appreciate. I'll hop off and let others ask questions. No problem. Thank you, Mara. Thank you. Our next question comes from the line of Michael Yee with Jefferies. Hi, Fred. Thanks and appreciate the question. My question is, if you feel that you can reiterate the filing guidance today, what are you specifically waiting for? Is it an official sign-off on the assay? Is it meeting minutes? Do you have a good sense of what actually is going to be measured? Can you just give us a sense of the fact that you feel very good about that and perhaps you're just waiting for meeting minutes? I guess that's question one. Question two is, would you press release this announcement? Tell us what would happen, what would need to then happen after that to actually file. Thank you. Sure. Thanks, Michael. Well, let me take them in reverse order. On the press release, when material information is available to us, for example, responses from the FDA that are clear that we could put a press release out on the basis of, I think we would try to do that. We would very much like to update the market as soon as we can about the situation with FDA and our potency assays, of course. Turning to your first question, it's a very detailed, long engagement that we're engaged in. You know, it's a six-month process here, and it could go beyond that, of course, into 2022. We never said we might, you know, we might have continuing stuff spill over in the early 2022 as we sort this out. Nevertheless, in the sort of the blow-by-blow of things with the FDA, yes, there are things like minutes. Yes, there are, you know, responses from the FDA and that sort of thing. We're not, you know, we're not particularly waiting on anything right now. You know, we'll update when we can based on the disclosures that we have available to us at the time. Thank you. Thank you. Our next question comes from the line of Mark Breidenbach with Oppenheimer. Hey, guys. It's not on for Mark. Thanks for the question. Apologies if this has been asked before, but I'm just trying to think of worst case scenarios here on the potency assay and path. Have we ruled out FDA asking you for a randomized trial in order to support initial approval? Is that something that's been discussed or is that completely out of the question in your view? Thanks. Yeah, thanks. While we can never say what FDA truly might want at the end, right now FDA is not asking for that. The way we've been treating this entire interaction with FDA is on the basis that we would be able to use the cohort 4 pivotal study data that we've already generated. Great. Thanks. Thank you. Our next question comes from the line of Asthika Goonewardene with Truist Securities. Hi, this is Bill on for Asthika. I just had a couple questions. We heard from some comments from another TIL company that the FDA has accepted their proposed potency assays, and we were wondering if the FDA has given you any guidance as to what components of their assays were viewed favorably or any suggestions, and how does what you have in development compare to that, in case you do have any guidance? Yeah, good question. Yes, there's been some comments by a competitor about this regarding a pre, you know, pre-IND meeting and I believe a pre-IND meeting and then definitely an IND. At that stage of development, things are much more lightweight in terms of what you have with FDA. We've been engaged with FDA for a long time on these things, and we've got a lot of detail from them about this. We don't really think there's crossover between the two. FDA is not really supposed to tell you what other sponsors are doing anyway. We think our assay technology, the most recent assay technology that we've developed, does answer the question of how to show potency of TIL therapy consistent with the mechanism of action of that therapy. Great. Thanks. I guess just one more on the IOV-LUN-202 study. Would you be able to contrast both the enrollment rate and the number of patients you have recruited so far, based on PD-L1 expression level, so below 1% and above 1% to 49%, the two cohorts? Frederick, do you wanna answer that one? Sure. This is Frederick. Thanks for the question. I don't think that at this time we would be commenting on the number of enrolled patients. Remember the study is designed to enroll patients who have failed one line of prior chemo-immunotherapy combination, in two different cohorts one and cohort two. I would expect, since the available care for these patients is similar, that the distribution across the two cohorts would be reflective of the distribution of the PD-L1 status in the population, which you can assume is about one-third and two-third. Again, I don't think that we're gonna comment on the exact enrollment number or distribution at this time. Thank you. Appreciate it. Thank you. Our next question comes from the line of Madhu Kumar with Goldman Sachs. Yeah, thanks for taking our question. As we think about kind of the potency assay situation, to what extent is this kind of a process of negotiation of kind of like sorting out your views on what are kind of relevant potency assays versus kind of the regulators take as compared to kind of just really testing hypotheses and really kind of sorting out, what is a real metric of TIL cell potency? I think it includes both of those components, Madhu. It's a discussion about the mechanism of action of TILs and how potency assays can reflect that, and then specifically how assays that we've developed work and how they assess, we think accurately the potency of TIL therapy. FDA has issued guidance in 2011 on this, as you guys know, and a lot of the detail of that guidance is wrapped up in these sort of discussions. We are at a pretty advanced state in the sense that we've got these methods and we've got data and we've got things we can talk about with FDA, so a lot of that's part of the discussion as well. Okay. How much lead time do you think you would need to, like, actually get resolution of the potency assay before you could feel confident maintaining this first half 2022 guidance? Like, if it's March of next year and you guys haven't reached resolution, would that be kind of like what's the bound in which you would try to push back the timing potentially of a BLA from first half 2022? We don't know exactly. We are able because a lot of the things we're doing right now are enabling us to file a BLA to sort of do two things at once. We can engage with FDA on the potency assay and prepare everything for the BLA. At some point, obviously, you know, that could slip it, but it's not something that I would worry about, at least not initially in the half of next year. Okay, great. Thank you. Thank you. Our next question comes from the line of Colleen Kusy with Baird. Great. Thanks so much for taking our question. Is it fair to assume that the third more novel potency assay is really the lead at this point that you're discussing with the FDA? And when might we get more information on what that is? Yeah, Colleen, we haven't disclosed the detail yet, although obviously, when we talk about the potency assays, we talk often about the most recent assay or set of assay technologies that we've developed. I really can't say what the lead is at this point. Again, the new assay technology is something that we think is the right answer to FDA's questions alone or perhaps in combination with other assessments that we're already making. I don't know when we can disclose it. Remember that all these discussions are in confidence with FDA, and the technology itself is proprietary. Immediately, we won't be able to disclose it. I hope that we can disclose it sometime in the near, you know, near to mid-future. Certainly we would wanna put it out there so that we're more aware of how it works. Great. Thanks. One more quick one. On the upcoming presentation at SITC, just what tumor types will be included in that frontline pembro combo? Yeah, we haven't disclosed that yet. The abstracts, we're under embargo right now, so that should be available on November ninth in the morning. When the abstracts come out, you'll be able to see more about that. Great. Thank you. Thank you. Our next question comes from the line of Ben Burnett with Stifel. Hi, this is Kelly Breese on for Ben Burnett. Thanks for taking our question. I just had one quick one. We were just wondering if you could give us any guidance or any details about when we might see some data for TILs using the Gen 3 manufacturing process for any of the indications that it's being explored in. Thank you. That's something we're looking at as soon as we can. Right now, I can't say anything about that, but, stay tuned on that. We are interested in trying to get that data out, when we have something meaningful to report. Okay. Thank you so much. Thank you. Our next question comes from the line of Nick Abbate with Wells Fargo. Pardon me, Nick. Please check your mute button. Sorry about that. Yes, thank you. Can you talk about the ongoing patient assessment for melanoma cohort 2, and specifically will patients be called in for last scan to ensure inclusion of contemporary data with the BLA? How does the timing for collection of that clinical data relate to resolution of this potency issue? You know, given that we often hear it takes three months to read and clean clinical data through under central review. Yeah. Nick, I think you're referring to cohort 4, right? Oh, sorry. The melanoma BLA cohort. Melanoma cohort. 4. Yes. Apologies. Friedrich, could you answer that one, please? I completely heard the question. Can you repeat that? Yeah, sure. You know, it's about the ongoing patient assessment, efficacy assessment in melanoma cohort 4, and specifically, you know, will patients be called in for a last scan to ensure inclusion of contemporary data in the BLA? How does the timing for collection of clinical data relate to resolution of potency, given that we often hear it takes, you know, 3 months to read and clean data through central review? Yeah, understood. Thanks. Yeah. This is going a little bit into the inner workings of preparing a data cut for a single-arm response rate endpoint trial. We would not call patients in specifically for an assessment. This is not an overall survival trial where oftentimes you do an overall survival call as you're getting closer to the data cut. We are continuing to assess patients that are ongoing in the predefined assessment schedule for the CT scans, and then we're defining a data cutoff date, and everything up to that data cutoff date would be included in the analysis. You usually choose that data cutoff date to allow for sufficient time that would allow you to clean the data prior to what we call the database lock. That is still about 2-3 x a month timeframe that you mentioned. That can be shorter, it can be longer, depending on what you think you need. That can be done without calling patients in specifically for an assessment, which would probably not be appropriate because it would be asking for additional scans more frequently than predefined and what they agreed to in their consent. Did that answer your question? Yeah. It does. I guess the question is, you know, the timing of that, defining the cutoff date versus, you know, where you are in the potency issue, resolution of potency issue. You know, something has to be rate limiting. I guess you don't want the clinical data to be rate limiting. Yeah. Although they can run in parallel to some extent, because we could be doing IRC work while we're resolving the potency assay issue and then sort of at the end of that process, as we've discussed on a lot of our calls, then go back and revisit the full analysis set with the potency assay information in hand. Okay. Does that make- Great. Thank you. Thank you. Before we continue, if you have any additional questions, please press star one. Our next question comes from the line of Peter Lawson with Barclays. Great. Thanks for taking my questions. Just on the potency assays. Just, I guess, how many potency assays do you think you need and do you have? How many of those do you think you could essentially have patent protection around that could create, could preclude other users? Yeah, good question, Peter. We have a lot of them. I don't have an actual final number on them because there's so many variations. It's really a rather complicated environment. We've shown multiple assays to the FDA and as most of you know, we're on our third assay or set of assays that we're showing them right now. Some of them, like the newer ones, do have IP associated with them that might create some barriers to entry for others, which I think is valuable. Others are more generic assays that have been out there for a while that may not provide as much protection, if you know what I mean. Got you. You talk about three sets of assays. Is this refinement as you go from, you know, step one to step two to step three, or as they've kind of rejected all of them in step one, and you've had to kinda come back with a step two and then a step three? How does that work? I wouldn't treat them as refinements. Some of them are completely new approaches. One of the ones that we're most focused on right now is what we were just talking about earlier with the question or really new technologies or new ways of looking at how TILs work, how the mechanism of action of TIL can be reflected into a potency assay. That's more of the you know, I wouldn't treat them as refinements at all, really, when you're doing something like that. There are some of the earlier assays might be viewed as sort of variations of each other, but the new stuff that we're doing is really fundamentally new. Got you. You feel like kind of each step is gonna kinda getting you closer with the FDA, or has it accelerated recently or any kind of sense of speed of progress would be great. Yeah, we feel like we're making progress and it's good enough that we can continue to guide towards a first half of 2022 BLA filing, which is coming up fairly soon here. We're comfortable with where we are right now with FDA. There's work to be done and we're still working. That's, you know, as things stand today, we're standing by that guidance. Great. Thank you so much. Thanks for the detail. Thank you. I'm showing no further questions. With that, I'll turn the call back over to Fred for any closing remarks. Thank you again for joining the Iovance Biotherapeutics third quarter 2021 financial results conference call. I'd like to thank our investors, analysts, patients, collaborators, and employees for their support. Please feel free to reach out to our investor relations team if you wish to follow up. Thanks everyone. This concludes today's meeting. Thank you for participating, and you may now disconnect.