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spk01: Good day and thank you for standing by. Welcome to the Spectrum Pharmaceuticals 2Q 2022 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1-1 on your telephone. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Michael Grabo, Senior Vice President of Corporate Strategy and Operations. Please go ahead.
spk05: Thank you, operator. Good morning to everyone. Thank you for joining us today for Section Pharmaceutical's second quarter 2022 financial results conference call. Our second quarter financial results press release was sent out earlier this morning and is available on our website at www.sppirx.com. Joining me in the call today from Spectrum Pharmaceuticals will be Tom Riga, President and CEO, Dr. Francois Lebel, Chief Medical Officer, and Nora Brennan, Chief Financial Officer. Before we get started, I would like to reference the notice regarding forward-looking statements included in today's press release. This notice emphasizes the major uncertainties and risks inherent in the forward-looking statements they will make this morning. These statements are not guarantees of future performance, and undue reliance should not be placed on them. Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such forward-looking statements. With that, let me hand the call over to Tom Riga, CEO of Spectrum.
spk07: Good morning, and thank you for joining us on the call today. This is a pivotal time for Spectrum as we work toward FDA approvals in the coming months for our late-stage assets, posiotinib and eflipagrastim, both of which are under active review at the agency. Since the beginning of the year, we have continued to focus on the following three key business objectives. One, gaining FDA approvals and further advancing our two late-stage assets. Two, reducing our operating cash burn. And three, ensuring we are prepared to successfully launch both products. Let me provide highlights, starting with epilipidrastim. Our BLA is under active review with the FDA with a PDUFA date of September 9th, less than a month from today. The pre-approval inspection of HOMNE's drug substance manufacturing facility in South Korea has been conducted by the FDA. As I've stated previously, this inspection was a critical step for an approval. The pre-approval inspection was completed in early July with a comprehensive examination of GMP practices, quality management system, manufacturing processes, and overall state of process control. The inspection resulted with two observations, which were resolved. We have subsequently had labeling discussions with the FDA and await the final regulatory actions. We appreciate the diligent effort that the FDA is making in their review process, and we look forward to their final decision. Let me shift to POSIOTMIP. Our NDA is under active review, and the agency has set a PDUFA date of November 24, 2022, with an initial indication for the treatment of patients with previously treated, locally advanced, or metastatic non-small cell lung cancer harboring HER2 exon 20 insertion mutations. This product has a fast-track designation and is on an accelerated approval pathway. In the second quarter, we advanced the global confirmatory study in support of our application. This is an important and required step in the approval process. We are actively preparing for the upcoming ODAC meeting that will include a discussion of the Poseidon data package that supports the NDA. We anticipate that the ODAC discussion will be centered around the overall risk benefit, dosing, the clinical relevance of the data in the NDA package, and the context in the current treatment landscape. We look forward to the opportunity to highlight the role that posiotinib can play in addressing an important unmet medical need. The ODAC meeting is scheduled for September 22nd and we will share additional information regarding the Poseidon discussion when it becomes available. In anticipation of two FDA approvals later this year, we have kicked off our commercial readiness efforts and our enthusiasm to enter these markets is high. Our commercial leadership infrastructure is in place and we are ready to engage key customers, group purchasing organizations, specialty pharmacies, and third-party payers to ensure we optimize the launch trajectory. We are ready to launch both epilipagrastim and posiotinib upon their respective approvals with a fully integrated commercial infrastructure. This includes sales, access and reimbursement, marketing, commercial operations, and medical affairs. We will launch both products with one sales force and believe we have the resources needed to successfully achieve our goals. we have been strategic in our approach with FTEs and have built a scalable infrastructure that is now in the process of expanding to support our commercialization efforts. Moving to our operations, we have made a concerted effort to minimize our operating cash burn while optimizing our investments in our late-days assets. As you will see in the second quarter financials, we are holding ourselves accountable to reducing the cash burn of the organization. While there will be an increase in SG&A expenses post-product approvals, you can expect to continue to see financial discipline as we become a lean, effective, and successful company. In May, we announced the appointment of Ms. Nora Brennan as the new CFO of Spectrum. This is Nora's first time on our call, and she will be reviewing the financial highlights after Dr. LaBelle's prepared remarks. In a short period of time, Nora's impact to the organization is already being felt. Her deep knowledge of the company as the previous audit chair to the board of directors and her familiarity with the team has allowed her to hit the ground running in her new role. With that, I will now turn the call over to Dr. LaBelle for a more detailed update on our clinical development progress.
spk06: Good morning, everyone. I'm glad to be with you on today's call and pleased to report on our latest achievements. The post-diagnostic NDA is currently under active review at the FDA. There is a This is a major step toward advancing treatment of non-small cell lung cancer patients with HER2 exon 20 mutations. The filing is based on our positive data from Core 2 of the Zena 20 clinical trial. The R&D team is actively supporting the FDA review, preparing for the ODAC meeting and advancing the PMR. These are major undertakings and we have strong internal and external teams that are fully engaged to bringing a successful outcome. We intend to confirm that POSI is a safe and effective treatment for a patient population with a clear unmet medical need. We have generated extensive exposure response data that confirms our dosing at 16 milligrams per day as an effective starting dose. The adverse event profile is familiar to lung cancer specialists who have extensive experience with TKI-class cytokines. Lung cancer patient arboreum, virtuous SON20 insertion, has limited treatment options, and POSI would be a welcome addition to the treatment landscape. Our randomized confirmatory study is underway. We have leveraged our team with the extensive experience of PPD, one of the largest international CROs, to conduct the study in as many as 20 countries, targeting up to 150 sites. I just returned from the World Lung Cancer Meeting, where we had multiple interaction with highly interested international investigators. We look forward to continuing our active engagement with investigators at the ESMO upcoming meeting. Study 301, or Pinnacle, is designed to enroll 268 patients with previously treated non-small cell lung cancer harboring HER2 exon 20 mutations. Patients are being randomized two to one into this global multicenter study to receive 8 mg of POSI-administered BIV versus 75 mg per meter square of Dusty Taxol-administered IV every three weeks. The patient will be evaluated at week six and every six weeks thereafter. Following progression on Dusty Taxol, the patient will be allowed to cross over to the POSI arm. The primary endpoint is progression-free survival with OS, ORR, duration of response and disease control rate, and safety as secondary objectives. This design will provide a power of 95% to test the hypothesis that COSI is superior to DOS-B taxol for either a ratio of equal or smaller than 0.58 using two-sided log-ranked tests. Separately, I would like to highlight that our Closiocinib clinical program has now achieved two positive cores in first-line and second-line HER2 exon 20 mutated lung cancer, a rare disease. We now have the largest data set for HER2 exon 20 insertion mutations and have well-characterized the safety profile of Closiocinib. We will be presenting new data at ESMO 2022, being held in September in Paris. The data shows a high level of activity for POSI in patients with a G778-P780 duplication mutation, the second most prevalent mutation in ER2 exon 20 non-small cell lung cancer. More to come on this so stay tuned. As you can see, we continue to make solid progress on our too-late stage development program and regulatory strategy. We will keep you posted as we achieve additional key milestones. I will now turn the call to Nora to review our financials for the board.
spk02: Thank you, Francois, and thank you, Tom, for your kind introduction. I'm truly excited to be a member of Spectrum's leadership team. For the second quarter of 2022, total research and development expenses were $16 million, as compared to $29.1 million in the same period in 2021. A decrease of $13.1 million is primarily related to deprioritized programs, streamlined spend on both EFLA and POSI, and a decrease in personnel expenses due to the strategic restructuring. Selling general and administrative expenses were $9.4 million in the quarter, compared to $15 million in the same period in 2021. The decrease of $5.6 million was primarily due to decreased employee compensation, benefits, and other headcount related expenses. The net loss for the quarter was $29 million from continuing operations, or $0.17 per share, compared to a net loss of $49.9 million, or $0.32 per share, in the comparable period in 2021. Operating cash burn was approximately $23.4 million in Q2 as compared to $29.7 million in the same period last year. The decrease was due to reduced overall expenses. This is part of our ongoing strategic effort to reduce the overall cash burn of the company while optimizing our investments in the late-stage assets. We ended the second quarter with approximately $68 million in cash plus marketable securities, which extends the company's runway into 2023. That concludes our prepared remarks, and I'd like to open a call for questions. Operator?
spk01: As a reminder, to ask a question, you will need to press star 11 on your telephone. Please stand by while we compile the Q&A roster. Our first question comes from Maury Raycroft with Jefferies. Your line is now open.
spk03: Hi, this is Kevin. Hi, it's actually, it's Kevin on for Maury. But yeah, congrats on the update today, and thanks for taking our questions. So just with starting with POSI, you said the ADCOM would focus on a number of topics, including dosing. I guess just for the eight-milligram BID dosing, can you speak to the totality of data you've gathered there in cohort five, and are you proactively sharing that with the FDA, or have they requested it?
spk07: Yeah, thanks, Kevin, for the question. Francois, you want to handle that one?
spk06: Sure. So as a reminder, we did file on the basis of E-Core 2, which was 16-milligram 2D. Having said that, though, We have shared all the data that we had essentially up to May of this year with the agency and have had a number of discussions as to the attributes of the BID dosing versus QD. So I think the FDA has a full view of what we have. We have conducted also extensive modeling of exposure response, which the FDA also has. And that discussion continues. We suspect that, we don't know for sure, but we expect that, you know, that topic will come up during ODAC and we're fully prepared to address any further questions.
spk03: Okay. Thank you, Francois. And then just for the confirmatory phase three, can you just talk about what your latest thoughts are on what the docetaxel arm might do? I know there are some other phase threes. set to read out soon using this as a control arm in lung cancer. And then, you know, what sort of PFS difference with POSI would you consider to be a success in this trial?
spk06: So, I'm not sure the first part of your question was what regarding the control arm?
spk03: Just what the control arm might do in terms of PFS. What are your expectations, I guess, based on recent or historical data?
spk06: Right. So, I mean, the largest study randomized in wild-type, I think, talks about a PFS of the order of three months, three to 3.5 months. And we expect the PFS with our dosing to, you know, potentially nearly double that. But obviously, you have to do the study with fully randomized to see the results, but that's the expectation.
spk03: Okay, great. Thanks. And sorry, just last one on EFLA. Congrats on getting the reinspection done. Could you just say if there's any other gating factors that remain prior to the PDUFA date next month?
spk07: Yeah, Kevin, obviously the last gating factor is FDA holds the final decision, but from our perspective, The inspection has been closed. All documentation has been provided. We've had subsequent and active discussions on labeling, and there are no outstanding issues from our standpoint that we know today, and we're looking forward to the action date on September 9th.
spk03: Great. Thanks, Tom. I'll hop back in the queue. Thank you. Appreciate it.
spk01: Please stand by for the next question. The next question comes from Ed White with HC Wainwright. Your line is now open.
spk06: Hey, Ed. Hey, Tom. Good morning. Good morning. So just a couple of questions perhaps on the two potential launches that you have upcoming. You gave us a little comment on the Salesforce leadership going in. I just wanted to ask about how we should be thinking about the ramp up for sgna expenses into the second half of the year as you build up the field salesforce team um well maybe i'll just stop there and ask my next question later yeah so ed we're uh we're actually here in boston and the commercial leadership team has spent their time
spk07: deep in preparation and the enthusiasm was really, really excellent. And our expectation is day one, the commercial leadership team is in place. They're strategically located around the country. Their day one plan has been set. We've also begun the expansion of the frontline salespeople. The plan there would be an incremental 25 FTEs, so taking the total commercial infrastructure to 40. That obviously won't happen overnight, but we've had time and have done a lot of extensive work in strategic geographies around the country to identify those folks. So as it relates to your question of SG&A and overall cash burn, I think the way I'd be thinking about this is if you look at our historical performance, I think it's in line with what we've guided toward. We had a strategic focus to reduce the operating cash burn of the company by 20% to 25% is what we said in January. I think you see this quarter we have delivered on that. If you look at the line items for R&D, I would expect that to be pretty stable moving forward. I think you'd see a modest increase in SG&A, especially during that launch timeframe, but I fully anticipate our mantra is going to be a disciplined and lean organization that enables us to achieve our goals. I would look at this quarter and I would put some modest increases for SG&A during the launch period.
spk06: Okay. Thanks, Tom. And then perhaps if you can just give us your thoughts on the GCSF market. I know it's been changing since you first filed for approval. So what are your thoughts on the market as we head into launch?
spk07: We're thrilled to enter this market. We still see it as a $2 billion market. We have no delusions of how competitive it will be, and we think we're uniquely qualified to do it both based on FTE know-how, experience, as well as we have a novel asset that we think will bring a unique proposition to the market. I think to your question, the most recent data actually increases our enthusiasm because the share of the Oncro device, which is a bit different in its delivery mechanism, has come down over 20% over the last three quarters. And I look at that as opportunities for the pre-filled syringe business, which we will have. And I think having a unique product will enable us to compete with the innovator, with the on-pro, with the biosimilars, and we will go at this market assertively in each of the core segments. We've taken the time to study the real drivers of the business in each of the key segments, as well as the key stakeholders. And after spending time with our commercial leadership team, I think I'm more confident than ever in their ability to execute.
spk06: Thanks, Tom. And now if I can move over to a couple of POSI questions. If you get approval by the PDUFA date, you'll be launching into a holiday season. How should we be thinking about 2022 sales versus 2023? Are you expecting a sort of slow ramp as you launch into the holiday season and then expect an uptick in the beginning of 2023? Just how should we be thinking about that? And then the other question is just your thoughts on the European outlook for POSI, you know, what's the potential there in your strategy? Yeah.
spk07: So let me take those one at a time. So the holiday outlook for launching, I think your question was with POSI, you know, that's a small molecule, so getting drug and channel is much faster than that of a biologic. We will be out in force, but inevitably the time between Thanksgiving and Christmas is always It's always a difficult time. And I think the ramp of a rare mutated lung cancer product, there is a slower ramp with a therapeutic that's focused on a very niche population. So I would anticipate that ramp to be slower, especially during the down period of the holiday season. But we will be out in force in launching that product if it gets approved on the 24th. As it relates to EFLA, I think that one, assuming an approval or an action date that's positive on the 9th of September, then you would have the cycle time of call it five to eight weeks for a drug to get in channel. We would be out day one with our team working with key stakeholders, working with contracts, and engaging key customers. but the actual launch of the product would be aimed in the October timeframe, and that would be a bit more clear of a situation, depending on when the product becomes available to the channel. I think your other question, Ed, is around Europe. So Europe for Poseyotinib, just by way of reminder, we have rights, worldwide rights, less China and Korea for the asset. We've had initial discussions outside the U.S., specifically in Japan, given the prevalence of the mutation in that particular population. Our focus today is about ODAC PrEP and gaining the initial approval in the U.S. as a primary strategy, but we do see a vehicle for areas outside the U.S. that would become more of a business development opportunity. If you're asking about EMA specifically, I think that conversation post-approval would need to be had, assuming it's an accelerated approval in the U.S. to see what the receptivity is there for Europe. And we largely think that it's an opportunity for licensing post-approval. So our first mission here is prepare for ODAC, gain the U.S. approval, and then capitalize on the other territories through the lens of business development.
spk06: Okay, thanks, Tom, for taking my questions. Anytime.
spk01: Please stand by for the next question. Our next question comes from Rennie Benjamin with JMP Securities. Your line is now open.
spk08: Hey, Tom and gang. Hey, Rennie. And congrats on the completion of the FDA inspections. I'd love to get, you know, maybe just some more color on that inspection. You know, I know you mentioned that there were two observations. They're now solved or, you know, they're no longer issues. Can you, you know, just give us a sense, like, have you gotten, you know, since you've already gotten into labeling discussions, it seems like that is the last step. Seems like all the boxes have been checked and almost, I hate to say it, a formality, but it My sense is that it almost seems like it's a foregone conclusion that an approval is coming. Is there anything that's remaining with the review outside of continued labeling discussions? And did you get feedback that the inspection is 100% done, like that's it, all the issues have been resolved?
spk07: Yeah, so let me address these one at a time. I'm much more conservative. I don't think anything's a formality, although I appreciate your confidence. I think ultimately the 9th is the key date. But as it relates to the inspection, there were two observations that were addressed with the inspector on site. The examples of those observations, there was one of temperature mapping that needed to be done in one of the storage areas. There was an in-process labeling procedure that needed to be updated. So from our perspective, relatively minor after a full comprehensive inspection, we provided the data both at the end of the inspection and then subsequently in writing to FDA. So from that standpoint, there's been no additional conversation. FDA always has the right to come back and ask questions should they want. I don't think there's going to be something that says, absolutely final until you gain the approval. The labeling discussions, from our perspective, we believe have been both comprehensive, but the agency can come back and have discussions if they'd like. So we're obviously optimistic, but I call it cautiously optimistic right up until the point I see that approval in hand. Got it. All right.
spk08: Thanks for that call. And then just kind of building on Ed's question regarding kind of the current market dynamics. You know, you're about a month away. You're going to hit the ground running, you know, pretty much on day one. Can you just review for us kind of what does this current $2 billion market look like, and where do you initially start to gain market share? And then ultimately, let's just say a year or three years from now, you know, where do you continue to gain market share? And I guess where, you know, internally, how are you viewing like your peak opportunity?
spk07: Yeah, so let me try, let me see if I can offer some assistance and you tell me if you need more. So the way we think about this is there's about 1.1 million units of long-acting GCSF that is administered in the United States every year. We break that out into three specific classes of trade. There's clinics, there's non-340B and 340B hospitals. So we've spent a lot of time both intro experience and customer know-how from the leadership team that we've got, but equally as important, spending time qualitatively and quantitatively to really understand what drives the decision. Because any time you enter a competitive market and things are relatively equal on the surface, you ask yourself what ultimately drives the decision. And as it turns out, there are differences of what ultimately drive decisions in each of those classes of trade. So we've spent time to understand where our product offering in totality, it resonates with the decision drivers of each of those classes of trade, and that's going to ultimately garner the beginnings of our strategy. So as it relates to share and how we calculate peak, we haven't really gotten into that publicly, and I won't here today, but when we take a look at what's ultimately driving decisions in this marketplace today, There's a lot of stakeholders, and it's relatively complex. Anytime you have a market of this size with this number of competitors, I think details matter, and I think the team has done a thorough job in their assessment. So what I've reviewed this week is both the specific, not only the specific doors that we're going to walk in, the specific customers that ultimately drive those decisions and how we intend to engage them, And I think the team has put together a pretty comprehensive plan that we look forward to competing with. Got it. Hope that's helpful. I know I didn't answer your question on peak share and peak sales, but hopefully that gives you some insight.
spk08: No, no, it definitely does. Just maybe some housekeeping ones. Can you just remind us, what's the patent expiration for AFLA? How are you thinking about pricing? And how should we be about any sort of gross net, you know, sort of adjustments?
spk07: So the patent for EFLA goes well into the 30s. So that's, I think it's north of 35 is where that goes. And there's some extensions that are available to us. So the way we think about this is there is the initial approval phase. that we will launch the product. And I think the pricing dynamics in the market, I think that's public. We have not made public our strategy. We'll do that upon approval if we're so fortunate. But as we think about the trajectory and lifecycle of the asset, we are going to develop and try to find ultimately the clinical answer around same-day dosing because we do see, you know, we saw the initial signal in a relatively small number of patients. We intend to expand that cohort and see if that signal remains, and we think that could be a long-term differentiating attribute of the asset that will certainly help through the balance of the IP. So we have both a near-term plan that I think is very specific at this point to commercialize out of the gate with the non-inferiority label that we expect if we should be approved, and then a lifecycle management plan that will put us in position to optimize the duration and lifecycle of the asset. Got it.
spk08: Okay. And then another one, just a clarifying point, again, off of Ed's question regarding the x us kind of opportunity and you know of course the funding uh of the of the company going forward can you you know kind of give us an update as to how um or if like bd discussions are are ongoing and you know how you're thinking about monetizing um you know the the opportunity for both asla or and or posy
spk07: you know in regions where you know what you just you're not interested in and and don't have the bandwidth for yeah so business development is you know that's that's in our fabric so it's always a topic in our company and I think there's a number of there's a number of areas where those conversations are active and ongoing today but as it relates to licensing of non-us territories I think the answer is different depending on the asset so Ed had asked a question earlier about POSI-HOTLIB, and I think there is, you know, with an assumption of an approval, which I think has got our focus today, there is absolutely discussions to be had, and we will continue to have for business development for the rights outside the United States. I think when you look at EFMA, just as a reminder, we have worldwide rights, less China, Korea, and Japan. So Japan is the difference. We have rights with POSI. We don't have rights with EFLA. But I think the conclusion is the same for EFLA as we look at the ex-US dynamic as it relates to growth factor. It's a very different world in terms of how those products are brought to market, how they're reimbursed. It's just an entirely different business, and we don't believe that that business is in our interest to bring forward. So, our business development efforts for non-U.S. territories with these assets will be focused on Poseidon.
spk08: Excellent. Thank you very much for the caller and obviously good luck going forward. Always appreciate it, Russ.
spk01: Please stand by for your next question. The next question is from William Wood with VRS. Your line is now open.
spk04: Hi, this is William Wood. I'm from . I appreciate you taking our questions and congratulations on the very nice progression that you've had this quarter. We're just curious specifically on how you're preparing for the ODAC meeting and maybe, what might be the key topics that you're expecting the FDA to bring up given that they're, given their cautious commentary on granting accelerated approvals. And then maybe also how much you think the split data, those data gets reviewed by the committee members.
spk07: Yeah, so I think you're, Good question. I think we're spending a good bit of time on preparation because I think it's warranted. I think the FDA, you know, we are about, we're aware of the kind of macro environment of FDA comments on accelerated approvals. But we believe that posiotinib has addressed a real unmet medical need. I think kind of macro environment of FDA comments on accelerated approvals. But we believe that posiotinib has addressed a real unmet medical need. I think it's got a well-characterized profile as it relates to safety. It's been demonstrated in its effectiveness. And today, we have the largest database in the world of this particular mutated cancer. We look forward to representing that, but, you know, we are looking at the macro environment here, so your point's well taken, and we are preparing as such, and the team is spending a great deal of time to make sure that this gets the attention that it deserves.
spk04: Thank you. That was very helpful. And then additionally, you've mentioned that you're going to have additional, you've got your abstract coming at ESMO. Just curious if we could get a little extra color on what we might be expecting and then how that might be incorporated into the approval process, if at all.
spk07: I'll let Francois comment on the ESMO data, but I think the The approval process, I don't know that that data has anything to do with it. This is about cohort two in this population. So our NDA has been filed, is under review, which will be the topic of the NDA. I think this data that Francois will speak about here will be interesting, but as it relates to approval process, it's not part of that topic, although it's in the data set. Francois, do you have a comment?
spk06: Yeah, sure. That's correct. The ESMO data shows high activity against a second most common mutation in the exon 20 world. So that's of interest when you have high activity. But that is not in itself, as Thomas just said, is not subject to the discussion for the NDA. I mean, that data is in the NDA. But, you know, there was a lot of investigators who were interested in understanding the activity of POSI against various mutations, and that's what we're going to be showcasing at ESMO on one particular common mutation. As to, I think you've asked a little bit about, a little more about the ODAC and what we are expecting. We don't know for sure what the FDA will have a specific question or what the ODAC members will ask us, but obviously we are preparing for, you know, a high number of different questions. We suspect that, you know, the overall risk benefit of the drug will be a subject of discussion. As you pointed out, dosing, You know, the filing is done on QD. We have provided extensive data on DID dosing. So we suspect that that will be also a subject of discussion. And obviously we monitor carefully the treatment landscape as it is evolving. And we think we're in a good position. And patient, let's face it, need options and we seriously believe that POSI would present a very attractive option.
spk04: Excellent. Thank you very much. I think I'll leave it there. I appreciate your answering our questions and congratulations again. Thanks, William.
spk01: Please stand by for the next question. Our next question comes from Pekar Agarwal with Cantor Fitzgerald. Your line is now open.
spk00: Hi, good morning, Tom and team. Congrats on the quarter and congrats, Nora. So first question is on Rollantis. So it seems that the manufacturing issues have been resolved, so I have a follow-up on commercialization here. Pricing in GCFF market is more or less in a free fall right now with net pricing declining 30% plus year on year and will probably continue to decline for the foreseeable future based on commentary from other players in this market. So maybe what's your strategy on pricing and how it may evolve in this market? Is there a scenario where you can keep pricing stable? And then I had a follow-up on both of you. Thank you.
spk07: Hey, Picard. Nice to chat with you. So we have not given our final price, but the comment that I would make on this particular issue is today's dynamic is a situation where there's one innovator product and all biosimilars that have gone through the 351k pathway. So inevitably, they're reimbursement and the dynamics that they are trying to compete with is subject to the behavior of each other. We will be bringing the first novel asset to the market in over 20 years and that will offer some distinct advantages and opportunities to have an offering that provides a bit more stability and predictability, and we think that is advantageous to the end user, and we will operate that way. So we are tracking that very closely, but we see the behavior within the market as an opportunity because we don't need to enter as one of the players that ultimately is competing with each other whose reimbursement is inevitably tied to one another. Hope that makes sense.
spk00: No, that's really helpful, John. And a follow-up on POSI. So maybe on the confirmatory phase three, how many sites are active right now? What percentage of your target patients have been enrolled in phase three? And where do you need to be on enrollment to satisfy FDA's focus on substantial enrollment by 3.8? Thank you.
spk06: Sure, so we're very active in opening sites, but as I'm sure you know, it takes a long time to open sites. We have some sites open. I'm not going to give you numbers today. I'm not going to speak directly to enrollment today. And so we're moving as fast as we can internationally, as well as in North America. So I can't remember. The second part of your question was what?
spk00: Where do you need to be on enrollment to satisfy on FDA's substantial enrollment for PDUFA?
spk06: Right. So we have discussed directly with the agency if there was a particular threshold that we had to achieve by PDUFA date. And the information we got from the agencies that this would be a multifactorial judgment, that there's not a single number that one has to achieve, and that, you know, we believe that on the basis of that discussion is that we have to demonstrate a true active program here that, you know, as you know, over the years, the last few years, a number of companies maybe were not quite as serious as they probably had to be. And we believe that we will be able to show unequivocally that we are taking this commitment very seriously and are moving forward as fast as we can.
spk00: Got it. Thank you, Francois. And maybe just lastly on POSI, Any updates on plans for moving into earlier lines, first line setting? Have you had any discussions with the regulators on what might be required? Thank you.
spk07: Yeah, so thanks for the question. We have a lot of aspiration for the asset of what it could potentially be beyond the initial indication, but we are really taking a disciplined approach here to focus on gaining the initial approval. we see the unmet need and patients need and physicians need therapeutic options for this particular population. So right now, focus of the company is to make sure we're optimally prepared for our ODAC meeting and gaining a positive nod here in November. And once we get to that point, then we will look to share in advance our Development efforts both to what you mentioned because of the positive cohort for data, but in other Interesting areas of medical need that we believe would advance the program as well Thanks for doing my questions and looking forward to the next update we should At this time I am showing there are no more questions and
spk01: I would now like to turn the conference back to Tom Riga for closing remarks.
spk07: Thank you, everybody, for your active participation and all your questions on today's call and for your interest in Spectrum. If you have additional questions, as always, feel free to contact us anytime. Have a great day.
spk01: This concludes today's conference call. Thank you for participating. You may now disconnect.
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