Good morning, ladies and gentlemen. My name is Jan Egberts. I'm the chairman of the board of Nordic Nanovector. Together with me here are Peter Braun, our new CEO, as well as Malene Brondberg, our CFO, and Marco Renoldi, our chief operating officer. First of all, I'd like to emphasize the forward-looking statement. We're obviously a public traded company, so please read this carefully when you're considering investing in our company. Today, I'm going to cover a couple of the highlights prior to Peter joining us, and then I will introduce Peter, and then I will hand over to him. Shortly before Peter joined us, we had a very successful private placement in February, and in addition, an oversubscribed PP offering in April, which is a very good indication. Which raised about NOK 422 million or about $48 million in proceeds.
It really helped our runway all the way through into the second half of 2022. As you're aware, we made some very significant protocol changes to the PARADIGME study, which really helped us improve our execution and the recruitment last year. We released earlier this week some very promising phase I-B data from the ARCHER-1 study, where we evaluated Betalutin together with rituximab in second-line follicular. We had some changes on the board, as you're aware. Hilde, after a number of years, unfortunately, was not able to stand for re-election at the AGM. She has left our board. Solveig Hellebust was appointed as a new non-executive director at our most recent AGM on April 28th of this year. Some changes on the board.
Finally, obviously, you have read the announcement, and some of you have seen Peter in some presentations, but now I'd like to introduce Peter to you and hand over the presentation from here onwards to Peter. As you know, Peter has over 30 years of experience with Roche, including launching a number of very important products like Herceptin and Tarceva. In addition to some of these marketing roles, he also had some general management roles and some other commercial roles and being involved in launch activities. Very relevant experience for our company as an oncology company, and we're very pleased that Peter has decided to join us. With having said that, finally, I'd like to thank Lars Nieba for his energy over the last year, where we really made a major change and a major improvement to the company.
Now I'd like to hand over to Peter, who will take you through the rest of the presentation. Thank you.
Great. Thank you, Jan, for the kind introduction. I'm excited to be here on my first quarterly call with Nordic Nanovector, and I'm even more excited to be leading this organization to the next stage in our journey. Prior to going into the quarterly update, I'd like to take just a couple of minutes to briefly introduce myself and highlight some of the elements that I think are relevant to Nordic Nanovector. As you can see, a large part of my career has been at Roche, where I rose within the leadership ranks and had the opportunity actually to learn from the best on various dimensions in oncology, ranging from commercial to development and into access. I had the opportunity to lead a variety of country organizations, both in developed as well as developing countries, as well as at the global level.
I also directly led and indirectly drove multiple launches of brands such as Herceptin, MabThera, Avastin, and numerous other oncology and non-oncology products. Many of these are actually monoclonal antibodies, which are now indeed standards of care in the clinic. Possibly the most relevant part of my career that is relevant to Nordic Nanovector was when I was leading the Herceptin project during what was possibly the most exciting period of its life cycle, and certainly a product that I think everyone can agree changed medical textbooks and changed the lives of countless patients suffering from not only breast cancer but also gastric cancer. I had the privilege of leading a cross-functional team, which stretched from commercial to medical to clinical science, clinical operations, manufacturing, regulatory, and even into diagnostics.
Additionally, as lifecycle leader of Herceptin, which was and still is the lead compound of the HER2 franchise, I was also deeply involved in the early clinical development of the HER2 sisters, those being Perjeta and Kadcyla. Of course, Kadcyla is the armed version of Herceptin. I'm also familiar with armed monoclonal antibodies. Since having left Roche, I dove straight into the exciting world of biotech, which is, of course, more resource constrained. Now since the 6th of April, less than two months, I have the privilege of leading Nordic Nanovector. I'll change gears now, and I'll share with you why I joined Nordic Nanovector, and I think this also serves as a nice summary of why I believe investors, other stakeholders, and then ultimately patients should also be excited.
First of all, at a high level, radiopharmaceuticals clearly have a key role to play in the treatment of cancer, it serves as an additional modality in attacking this disease. Radiopharmaceuticals have previously been underappreciated. The interest, however, has increased noticeably over the last couple of years. This increase is largely the result of the evolution that we've seen in the technology and the platform, which actually allows now for better targeting, better efficacy, and better safety profiles. Within this context, Nordic Nanovector and more specifically Betalutin is playing a key role. Within the radioimmunotherapy space, Betalutin is one of the most attractive and advanced in clinical development with compelling data in treating non-Hodgkin's lymphoma patients. The first step of this journey is in, as you know, third-line follicular lymphoma patients, particularly in the 70% of those patients who are elderly and frail and resistant or refractory to anti-CD20 immunotherapy.
We've made significant progress in executing PARADIGME. We'll be sharing more information on that shortly. This, of course, is the pivotal phase IIb trial. Lastly, Betalutin is but the first step of the portfolio, and we continue to explore how to best leverage the assets that we have in the company, as well as the deep heritage that we have in this space. Our mission is to develop innovative targeted therapies for hematological cancers where there is a high unmet medical need. As you know, non-Hodgkin's lymphoma is a common cancer, and approximately 150,000 new cases are diagnosed every year in the U.S. and the largest European markets. Despite the fact that there are multiple treatment options, there remains a high unmet medical need in both the aggressive and indolent subtypes, particularly in the relapse setting.
There's essentially two things that are driving this unmet medical need in this space. First of all, although rituximab-containing regimens have transformed the treatment of follicular lymphoma in the first-line setting, practically all patients will relapse, and in fact, 40%-60% will become refractory or develop resistance within five years. There's clearly a need for additional agents that can drive remission in later lines. Secondly, follicular lymphoma, as you know, is primarily diagnosed in older people. Simply due to age and associated comorbidities, compounded by cumulative toxicity and burden of multiple rounds of cancer treatments, many of these patients unfortunately fall into the elderly and frail category by the time they reach third line. The proportion of elderly and frail in this setting is approximately 70%.
This is where Betalutin, with its unique profile, can change the landscape for these patients, offering durable responses balanced with excellent tolerability and maintaining quality of life, all with one administration. Diving deeper into follicular lymphoma setting, I'd like to contextualize how Betalutin's unique product profile positions it for success. On this slide, we can see that the treatment landscape across multiple lines and across patient populations. I'd like to draw attention to several things on this slide. First of all, from left to right, we see that the patients in later lines of therapy tend to be quite elderly and progressively more frail. In the third-line setting, these patients, as mentioned previously, represent approximately 70% of the segment. If we look at the second-line setting, these patients represent approximately 50% of these patients.
In summary, between second and third line, a large proportion of these patients are indeed elderly and frail. Secondly, as you can see, there are multiple treatment modalities, lots of boxes, either available or under development, ranging from CAR-Ts to bispecifics to PI3 kinases. These treatment options, however, due to safety and tolerability profiles, are often limited to those patients who are still fit, and therefore, on the left-hand side of this graph. You will notice that EZH2 inhibitors are portrayed here as an option. It is important to note that they have their greatest effect in patients with the relevant mutation, meaning the EZH2 mutation, which actually, unfortunately, only represents 15% of the population. The other option that we see here in this setting is rituximab single agent, which is sometimes used simply because there are not many other options that the hematologist can offer.
Let's not forget, many of these patients have in fact already relapsed or are refractory to rituximab. There aren't many options, that's why physicians go with that option. This means that patients who are frail and have relapsed or are refractory to rituximab regimens do not have many options. This is exactly where Betalutin, with its unique profile, could have a very real impact for frail patients in the clinic. It offers durable responses in elderly patients who are heavily pretreated, a predictable and manageable side effect profile, all with a single dose administration. This positioning that I just shared with you clearly resonates with customers. The efficacy seen in LYMRIT 37-01 Part A was certainly seen as a strength. We saw approximately 70% overall response and median duration of response of about 13.6 months.
More specifically, we saw 32% achieve a complete response with a median duration of response of 32 months. This was seen as compelling by hem-oncs in the clinic. This is combined with a manageable safety profile, I'll be going into more details of that shortly, and the simplicity of a one-time treatment. In summary, the positioning as depicted in the previous slide clearly resonates with customers when they see the LYMRIT 37-01 Part A data. Over the next couple of slides, I'll provide a high-level view of the clinical data, so two slides on that. I'll go into a little bit more detail on the safety and tolerability. These are, in fact, the reason to believe for the potential for Betalutin. Here we see a waterfall chart which summarizes the data from LYMRIT 37-01 Part A with each bar representing a patient.
The Y-axis is the change in tumor size as a percent of baseline. Lines going down is good. The first conclusion we can draw is that there is a lot of surface area under the X-axis. In fact, 90% of evaluable patients had a reduction in tumor size and derived a clinical benefit from a single-dose administration. Secondly, Betalutin is clearly active, and we see that follicular lymphoma and marginal zone lymphoma are particularly radiosensitive. On this slide, we see another perspective of the efficacy seen in relapsed refractory patients. Here, I'd like to draw attention to the third line in bold, roughly in the middle of the slide, where we can see that follicular lymphoma patients with two or more prior therapies achieved an overall response rate of 70%.
Of the 32 who had a complete response, we saw that median duration of response was a remarkable 32 months, again with a one administration. That was on efficacy. Changing gears in terms of tolerability. The data from LYMRIT 37-01 Part A shows that the side effects were primarily hematological in nature. You can see this on the right-hand side of the slide. These are transient and reversible drops in lab results such as platelets and white blood cells, something hematologists are clearly comfortable managing. What's remarkable, and on the left-hand side of the slide, what is remarkable is that this is in a population that has a median age of 68 years and is heavily pretreated. This is certainly gentle when compared to the other clinical options available for later-line follicular lymphoma patients. Referring back to the landscape slide that I shared with you earlier.
In summary, what we saw over the last three slides is our reason to believe that Betalutin offers the potential for durable responses, particularly in relapsed refractory, elderly, and frail patients, a gentle side effect profile, all within a single administration. Now let's take a look at PARADIGME. As a reminder, as a result of the LYMRIT 37-01 Part A data that I just shared with you, PARADIGME, the phase IIb trial, was designed to determine the value of Betalutin in third-line follicular lymphoma patients. As previously communicated as well, the primary endpoint is overall response rates, with secondary endpoints being duration of response, progression-free survival, overall survival, and the quality of life. The original design was to randomize across two arms with differing doses. After the interim analysis last summer, the independent review committee recommended to continue only with the 40/15 arm.
As a result of this, of course in agreement with the FDA, the patient numbers were reduced from 130 to 120. Since our last quarterly call, we've added 10 fully enrolled patients. After we checked yesterday, we have four in screening, two of whom will be enrolled in the coming days. Given that in Q3 of last year, three patients were enrolled, and in Q4 we recruited 14, we now have a similar order of magnitude of patients compared to last quarter. This is despite the significant COVID restrictions seen, particularly in Europe. This slide, I'd like to provide a little bit more detail and context on the PARADIGME trial. What we've seen is that the clinical trial amendments as well as the improved trial execution are clearly delivering results.
As a reminder, the amendments to the protocol expanded the inclusion criteria to allow for two sets of patients. The first set of patients were those who had previously received autologous stem cell transplantation, and the second set of patients were those who had lower platelet counts at baseline. These two changes have allowed for a greater proportion of patients to be considered and is what brought us to this higher level of enrollment. Additionally, we of course continue to focus on a variety of initiatives that are designed to accelerate patient recruitment. This higher level of recruitment was despite the significant challenges that COVID restrictions have brought, especially in Q1 of this year in comparison to Q4 of last year, particularly in Europe.
As you're likely aware, follicular lymphoma is an indolent disease, meaning that even under normal circumstances, part of the clinical strategy of managing patients is to watch and wait. Now, as a result of COVID, ESMO last year issued guidelines which called upon clinicians to do more watching and waiting to prevent patients from having to come into the clinic. What we have seen, and has indeed been confirmed by Q1 calls with other companies that are active in the follicular lymphoma space, the number of patients suffering from follicular lymphoma coming through the clinic has dropped by about 20%-30%. As COVID restrictions are lifted, we expect this to have a positive effect on our continued recruitment of patients into PARADIGME. With all of the above considerations, we expect to complete enrollment, allowing for top-line results to be shared by the end of 2021.
Upon completion of PARADIGME, we have a clear regulatory strategy to gain rapid approval. Our BLA filing with the FDA for accelerated approval will be based on the PARADIGME data, as well as the initiation of a confirmatory phase III trial, which we intend to focus on second-line patients. Our plans would be to do this during the course of 2022. It is also worth noting that the Fast Track designation granted in the U.S. means that we have a stronger dialogue with the FDA, which we are certainly utilizing. Coming onto my last slide before handing over to Malene to cover the financials. As I'm sure you've seen in yesterday's press release, we now have additional reason to believe in the potential for Betalutin in addressing the unmet medical need in the follicular lymphoma setting.
Just as a reminder, Archer-1, a small phase I-B trial, was designed to evaluate the safety and tolerability of Betalutin when used in combination with the mainstay rituximab. The secondary objective was to evaluate the anti-tumor activity of this combination. The study population was in follicular lymphoma patients who had received one or more regimens. This is an earlier line of patients to those in the PARADIGME trial. What was seen was that the excellent safety and tolerability was similar to that observed in LYMRIT 37-01 Part A, also when used in combination with rituximab. What we also saw was that seven out of seven patients achieved a response, five of whom were complete responders. We now have another data point confirming the activity of Betalutin in patients suffering from follicular lymphoma.
The key insights derived from this trial are certainly hypothesis-generating and is, of course, being taken into consideration as we evaluate the design of the confirmatory phase III study that I mentioned earlier in second-line follicular lymphoma. The design will, of course, be finalized in collaboration with experts in the lymphoma space, as well as in consultation with the FDA. With that, I'll pause and hand over to you, Malene. Over to you.
Thank you very much. Good morning, everyone. On the next slide, you can see that we have kept the good cost control. If you look at the Q1 this year, we had NOK 101 million in spending, which is lower than last year of NOK 126 million. We kept, as I said, the cost control in place. We, of course, still continue to spend most of the money as we should on the CMC and clinical. You can also see here that with the cash flow, we had a minus NOK 134 million, which is a little bit more than last year, that's simply just due to the fact that we had more bills to pay in this quarter. On the next slide, you can see that the cash runway, which has now, as Jan also said, has extended into the second half 2022.
That's, of course, due to that we had the two placements, or the first one was the private placement in February, which gave us NOK 361 million, and another one, which was the repair, a very successful repair, which was NOK 61 million. In total, that's NOK 422 million in gross, which net is NOK 395 million. This means, as I said, that we have cash into the second half 2022. With that, I would like to hand it back to you, Peter.
Thank you, Malene. Onto our summary slide. In summary, we are well-positioned to win. Radiopharmaceuticals clearly have a key role to play in the future of cancer therapy, and we're well-positioned there. Betalutin is an important and exciting product opportunity, in fact, one of the most attractive and advanced in this radiopharmaceutical space. We're clearly focused on completing PARADIGME, and we target to have preliminary three-month top-line data by the end of this year. I hope that you agree that despite the COVID challenges that we've had, we've brought the recruitment levels to another order of magnitude. Lastly, beyond PARADIGME, multiple opportunities exist for us to go beyond Betalutin, and we would build then on the proprietary anti-CD37 franchise that we have and build upon the heritage that we have in radiopharmaceuticals.
With that, I'll stop presenting and open the floor to any questions that you may have.
Thank you, Peter. We do have quite some questions today, and I have tried to group them into some topics, and then we will collect the latest arrivals in the end. First of all, a lot of questions about the progress. First question is, what is the rationale for reiterating readout of top-line data second half of 2021 when patient recruitment is significantly lower than expectations communicated in Q4 presentation?
Okay. This is Peter. I'll address that one. Then I'll ask Marco if he has anything else to add. As was shared, if you look at the Q3 numbers that we had last year where recruitment was approximately 3%, the changes that were made, the amendments that were made, also all the efforts that went into the operational aspects of the trial last year, we have significantly improved the recruitment rate to another level. In Q4, we had 14 patients included. This quarter's numbers of 10. When you include as well the patients that are in late-stage screening, you can add another two because they will be included in the coming days, we're clearly at another level.
That's, of course, within the context of what has been, particularly in Europe, a very challenging environment to include patients that are in the non-Hodgkin's lymphoma space, particularly follicular lymphoma. What we saw, and as I shared in the presentation, what we and clinicians have seen is a significant drop of 20% to 30% of patients coming through the clinic. Within that context, the number of patients that were recruited and included in the trial is clearly at another level. We are at that higher level, and as particularly here in Europe, we pull out of the COVID situation, we do expect to see more patients coming through the clinic, and we do expect to be able to capture and benefit from that increased patient flow through the clinic. Marco, do you have anything else that you want to add to that?
I think you covered it very well, Peter. I would only emphasize that clearly the impact of COVID restrictions in Q1 in Europe were probably higher than we had anticipated. We see that the impact of vaccination program are changing the landscape in many countries, starting from the U.K., Germany, and Southern European countries. We see that the initiatives that we implemented are really bringing a different path, a different type of patient enrollment. With the support of the vaccination program and the lifting of COVID restrictions, we have great hopes that in the next few quarters, we will be able to achieve the desired level of enrollment that everybody expects.
Thank you, Marco and Peter. The next question is whether it is possible to do a top-line efficacy readout around New Year, even without 120 patients enrolled at that point.
Well, let me first of all reiterate that our intention is to complete recruitment within the timeframe foreseen. That's clear. The intention is to provide top-line data by the end of the year. I don't know, Marco, do you want to add anything else? No? Okay.
Thank you. How much time do you think you need from readout of top-line data from PARADIGME to a completed BLA for Betalutin to be sent to the FDA?
Marco, do you want to handle that one?
In order to have validated data, so clean data that you can use for the regulatory submission, you clearly need, and we mentioned this during the previous quarterly call, six-eight weeks, but this may not be required in terms of providing top-line data. I think you need to consider what is the reason why you are basically, for what scope you are communicating the data. It's about six-eight weeks to complete the cleaning all the data in order to be able to file them for your BLA package.
Thank you, Marco. Is there an increase in screening, and how many patients do you expect to recruit each month until readout?
As mentioned earlier, what we've seen as a result of COVID restrictions over the last quarter is that there was a pullback in the number of patients coming through the clinic. We pull out of the COVID restrictions, those numbers will indeed increase. Again, I would like to reiterate that we confirm our expectation to be able to complete recruitment and provide top-line data by the end of the year. Marco, I don't know if you want to add anything. No, we're good. Okay.
Okay. Can you say something about which countries show the best recruitment, and how was the distribution of recruitment for the past three months?
Yeah. As was previously communicated in previous quarterly calls, we don't comment on recruitment by country. What we can say is that there are additional countries that are coming online. We won't comment on specific country numbers and evolutions within countries. Marco, anything? No. Okay. We're good.
Good. The next question is whether you can say something about the proportion of trial sites in Europe, high level.
Marco, do you want to comment?
Yeah. We clearly have a higher number of sites in Europe compared to other regions in the world, whether it's the U.S. or Asia or other regions. This is quite normal. Most of hematology oncology trials with any type of drugs do have the majority of sites in the European region. This is quite aligned to certainly my experience with a series of other oncology companies.
Thank you. There's another question. In order to be able to read top-line data towards the end of the year, when must PARADIGME be completed by the latest? Another variation of the same question asked before.
Yep. Can you repeat the question? Sorry.
Yeah. In order to be able to read top-line data towards the end of the year, when must PARADIGME be completed by the latest?
Again, I'll just reiterate that we expect to complete recruitment in such a way that we can provide top-line data by the end of the year.
Thank you. We have a longer question that we have been asked to read out in its whole formulation, and it's about the guided three-month readout also. Can you elaborate on how the recruitment is going to increase, give some specific data, and build some confidence for the general investor, which countries are expected to increase and why, and is it just based on severity of corona?
Okay. Marco, can you handle that one?
Yeah, I think as I mentioned earlier, we clearly see the impact of vaccination program throughout key European countries, large European countries where we have a fairly high number of sites. I'm talking about the U.K., I'm talking about Germany, talking about Italy and Spain. We feel that with the softening of the COVID restrictions, these countries, which have a fairly high number of enrolling sites, will be able to go back to the full ability to enroll patients. We expect that with their strengthened contribution to enrollment and the impact of the amendment that we approved throughout the participating countries, we can go back to the expected rate of enrollment.
Thank you, Marco. With that, I think we have covered the questions that have come in relation to PARADIGME and the data readout. We will move to ARCHER. When do you expect data from cohort 2 in the ARCHER study?
Marco, can you handle that one?
The data that was communicated in the press release issued yesterday includes the data from both cohort 1 and cohort 2. If you recall, we had three patients in cohort 1 and four patients in cohort 2. We felt it was appropriate to provide a comprehensive summary of both efficacy and safety. As Peter highlighted in his presentation, we had seven responses out of seven patients. Both patients in cohort 1 and patients in cohort 2 responded. The responses are still ongoing in all of the patients. At least some of them, I think four or five of them, have already reached two years since the administration of rituximab, since the administration of Betalutin. Apologies.
Thank you. Is it possible that the two PRs in Archer-1 after time or over time, I guess, can become CRs, or is this very unlikely?
It's difficult to predict. Clearly, as you remember from the design of the study, these patients are on long-term maintenance with an anti-CD20 with rituximab, which is administered, again, for two years. It could be that, of course, with the impact of maintenance therapy, these patients could possibly evolve, but it's very difficult for me to address your question. I would need probably a crystal ball to address the question.
Will you actively seek a partner for the next phase of Archer?
Jan, do you want to handle the partner question?
Yeah. No, we're not going to make any specific statements regarding potential partnership discussions. That's really where I would like to leave it. For strategic reasons, we're not going to disclose that information at this stage.
Thank you, Jan . The last question about Archer would be, when do you expect to make a decision regarding the next step for Archer-1?
Yeah. Maybe just as a summary with Archer-1, what we saw was, again, excellent safety and tolerability that was similar to what we have seen. And this is within the context of combination with rituximab. Secondly, we saw excellent data confirming that Betalutin appears to have an effect. Sorry, there's a bit of noise in the background there, I'm not sure. Clearly, the key insights that we derive from this trial are certainly hypothesis generating. This is certainly being taken into consideration as we look at the phase III study that we're evaluating for second-line follicular lymphoma. This is going to be feeding and informing the step that we will be taking past PARADIGME. That design will, of course, be finalized together with experts in the field as well as in consultation with the FDA.
Thank you, Peter. We will move to partnerships and commercialization. The first question is, what is your strategy to get Betalutin approved in MZL the fastest way possible while retaining as much as possible of the upside to the company?
Okay. Marco, do you want to comment on MZL?
Yeah. As Peter highlighted in his presentation, we saw very promising data on marginal zone lymphoma patients. You recall both the waterfall and the actual response rates in the nine marginal zone lymphoma patients. We had considered last year, if you recall, the possibility to include an arm in the PARADIGME study to enroll enough marginal zone lymphoma patients to further understand the efficacy level and consider a potential development plan. In the end, we prefer to focus on timely completion of the trial. Clearly, marginal zone lymphoma represents an interesting opportunity. It is not as large an opportunity as follicular lymphoma, and therefore we are still considering how we can best maximize this option from a regulatory perspective. Peter alluded to the phase III, which we are currently planning to activate. It is a requirement to file for accelerated approval. Of course, we will focus on second-line follicular lymphoma.
We will explore options to consider how to best move forward marginal zone. At the time being, we have no clear plan, but bear with us, and we'll provide further details. We know marginal zone is a radiosensitive tumor, and we know that Betalutin can provide marginal zone lymphoma patients with a clear benefit. Of course, we need to maximize the path to approval, and therefore, we still have a lot of thought to be given to this topic.
Thank you, Marco. We have some questions about partnerships again and commercial strategy, and I think while they are a little bit similar, but I'll try to cover it all. One question is, the commercial strategy for Betalutin in Asia and Europe is to establish partnership. How is this work progressing? Same kind of question, are there any dialogues regarding a partnership? If Betalutin gets approval, would you prefer to sell the company or would you prefer to build a sales organization and sell by yourself?
Okay. Jan, do you want to?
Yeah. No, very similar to what I said before, for very obvious competitive reasons, we cannot disclose specifics regarding potential discussions we are having with one or more parties.
Thank you, Jan. We have one question about financing. Will there be another capital issue this year?
As I said, we have money now going into the second half of 2022. Of course, it always depends on the pipeline and whatever, but we have, as we said, we have money now to the completion of the PARADIGME, and that is of course where our focus is. Jan, I don't know whether you want to say more.
Thank you, Malene. We have a couple of questions about the same topic related to, and I think this goes to you, Marco. MEI Pharma recently received accelerated approval for their agents for 3L based on a sample of 91 patients. Their original population target was 130. Do you view it as possible to achieve AA based on less than 120 patients?
Can you please repeat? We know that MEI Pharma informed the street that the FDA accepted their application for marginal zone lymphoma. Can you please repeat the question because this is what was reported in the past few days.
Yeah. I'll try once again. It says, MEI Pharma recently received Accelerated Approval for their agent for 3L based on a sample of 91 patients with an original target of 130 patients. In light of that, do you see it possible to achieve AA based on less than 120 patients?
Maybe we'll leave the disconnect on the approval to another date. What I can tell you, and I'm speaking on behalf of my colleagues in the clinical and regulatory teams, we have had robust discussions with the FDA on several occasions during 2020 and 2021 when we discussed the different amendments related to new patients to be enrolled in the PARADIGME trial regarding the recommendation from the independent review committee to reduce the trial from two arms to one arm. On the occasion of these interactions, we also discussed quite at some level of detail what would be the required type of efficacy and safety information to file a BLA package amenable for receiving Accelerated Approval.
We believe that with the data that we have collected to date, once we have completed PARADIGME and pending data, and with the additional wealth of safety data collected in the other trials, we will be able to meet the expectations of the FDA. I hope that clarifies the question.
Thank you, Marco. With that, I believe we have covered all the questions that have been submitted. Thank you everyone for sending it.
Okay, good. I think there's only one slide left, and that's simply a reminder of the upcoming dates. Yeah, you can see them on the screen. Thank you very much. I think this was, I hope you agree, a nice quarterly summary and my first one for Nordic Nanovector. Looking forward to hearing you either later today, in the coming weeks, and certainly in approximately three months. Thank you.