Q1 2020 Earnings Call

Thank you for standing by and welcome to the system Bio May 2020 business update conference call. At this time all participants are in listen only mode. After the speakers presentation. There will be a question answer session.

To ask your question during the session you wanted to press Star one on your telephone if you require any further systems. Please press star Zero I would now like turn the conference over to your speaker today.

Eric part B piece.

Strategy in Investor Relations. Thank you. Please go ahead.

Thank you and good morning, everyone. We hope you and your family there seems despite these challenging circumstances.

On today's call, who will discuss our first quarter 2020 financial results I'd Love an update on the regulatory progress in commercial opportunity for Disodium.

Joining me on today's call are Dr., Thomas panel, President and Chief Executive Officer, Dr. Chan skew strategic planning and CMC and Monaco for our Chief Financial Officer.

Earlier. This morning, we issued a press release outlining some of the highlights that will be covered on the call today, the press release and the flights to which we will look for our available in the Investor section of the company's website at <unk> Dot com.

I would like to remind you that today's discussion will include forward looking statements related to the company's current plans and expectations, which are subject to risks and uncertainties.

Actual results may differ materially due to various factors, including those described in second by his most recent annual report on form 10-K, and other FTC filings.

These statements represent threatened by his views as of this call and should not be relied upon as with any future date testing bio undertakes no obligation to publicly update these forward looking statement.

Now before I hand, the call to Dr. candle to take us through the agenda I would like to provide an update on the critical business area that second as it relates to the cobot 19 pandemic.

First and foremost our primary concern remains the health and wellbeing of our employees.

All 28 employees are in good health and Weve instituted a number of new policies to ensure their ongoing safety and wellbeing.

Turning to slide three as you can see we've had no business disruption from cobot 19 to date.

That being said there are four critical areas of the business that we are continually monitoring.

First is clinical second just regulatory 30, CMC and for his operation.

And I will take a minute to review a couple key points for each area.

Regarding clinical all patients and the visitor I went through the 12 month Mark as of May 29, 2019 at which point, we did our last data cut.

This data cut was the basis for the initiation of our BLE submission in the fourth quarter of 29 team. There was no risk for us in terms of critical processes, such as patient enrollment.

Looking at regulatory we remain on track with our original plans to complete the olay submission in the second half of 2020.

As you May recall, we had four face to face meetings with the FDA and 29 team and we do not expect any additional safety. These meetings TV needed prior to the anticipated completion of our BLE condition, and we expect to maintain our regular correspondence with the FDA via teleconference is an email.

Additionally, we're going through the M&A scientific advice process, which we've been able to do through a <unk> be a written correspondents and teleconference, and Chad will take us through the outcome and a little more detail later.

Next in terms of CMC. The team has been in close contact with our CMO is Fujian Baxter as well as our distributors that distribute the consumable and the input into the manufacturing process.

Overall, they remain confident and their ability to remain fully operational in terms of the P.P. coupons and to maintain business continuity.

Finally, looking at operation, we've instituted a flexible work from home policy for all employees in Canada, and the U.S. and all internal operations are continuing at normal levels.

So again at this time there'd been no disruptions to our business as a result, a code at 19.

We continue to monitor the rapidly evolving environment regarding the potential impacts of the pandemic and we remain committed to the health and safety of patients caregivers and employees.

With that I will turn call over to Tom.

Thanks, Aaron and good morning, everyone. Thanks, so much for calling in and I Hope you and your family's roll healthy unsafe.

Please turn to slide for our agenda slide there are four important topics, we would like to talk to you about today.

First we believe that seen him has a highly differentiated mechanism of action versus available and pipeline any trends that helps explain the favorable axiom safety profile.

Second we're confident in the strong commercial opportunity supported by our recent market research results.

Third in the first quarter 2020, we successfully completed the manufacturing of the pre PQ batch Fuji demonstrating meaningful progress for CMC comparability and finally, we have a clear regulatory path forward in both the U.S. and Europe.

Please turn to slide five which shows the long arduous challenging journey, a patient with bladder cancer is forced to travel the average patient diagnosis bladder cancers and their seventies and so the pandemic has resulted in even more frightening patient experience, we know what a huge difference the saying im could make in saving in improving the lives of these patients and we are mark.

Motivated than ever to bring our product to market.

And I can assure you that despite the current challenges the FDA and yeah may remain as committed as ever to help find new M life saving solutions for patients with bladder cancer.

Please turn to slide six which is a very important description of how Vicinium works first of all the same attaches to Abcam, which was expressed by bladder cancer cells. This was the same to selectively kill bladder cancer cells, well generally leaping healthy cells alone.

But even more interesting is the fact that vicinium peers also activate the patients T cell mediated immune response.

Those activated T cells are able to identify the neoantigens being expressed by bladder cancer cells and that's there also able to attack the tumor while leaving healthy cells alone.

What is striking about both mechanisms is reflectivity, which differentiates us from BCG and other chemotherapeutic agents such as might've My sense, Jim said of being involved star.

All of these agents indiscriminately attack healthy and cancer cells, which results in a very different safety and tolerability profile.

So please turn to slide seven in the first quarter. This year, we conducted in depth interviews with physicians were the highest prescribers for the treatment of non muscle invasive bladder cancer. The physicians, we spoke to had not been involved in any non muscle invasive bladder cancer clinical trials and had no relationship with industry, allowing us to collect unbiased market.

Search results.

On slide eight you can see that we show these positions the clinical profiles of Keytruda, which is currently the most commonly prescribed oncology product in the world and Vicinium based on data submitted by Merck incessant bound to the left in the fourth quarter of 2019.

You can see that the CNN keytruda bolt had very similar in very compelling efficacy data, which demonstrate a strong complete response in duration of response.

You can also see that the Sam has an advantage in a very important efficacy measure time to suspect to me our data show that 76% of patients who received the city I'm are able to avoid radical cystectomy for at least three years.

But the biggest difference between Vicinium Keytruda is safety and Tolerability therapy with Vicinium results in roughly one third the rate of treatment related grade three to five adverse events and one third the need to discontinue therapy. We believe this maybe due to the fact that keytruda is given intravenously and cousins a higher rate of immune mediated safety issues.

Slide nine shows position reaction to the product profiles of the salmon Keytruda physicians report that went prescribing a branded agent they would use the stadium over 80% of the time.

You can also see on the right hand side that physicians report that while the two products have comfortable oxy data. The seen him has a clear advantage in terms of safety and ease of integration.

On Slide 10, we then ask physicians why they prefer vicinium over Keytruda and they offered for explanations first you're all just prefer to retain ownership of the patient journey, rather than referring patients to the medical oncologists given that the same name is administered intervest sickly, they're able to keep treating the patient and keep conducting follow up diagnose.

Castex, which is an important part of the urology clinic business model.

Physicians told us they preferred the clinical profile vicinium over keytruda and that they valued the fact that the treatment protocol of what's your name is identical to that of BCG along for seamless patient continuity.

Finally, there are a number of important cycle logic reasons that patients prefer to stay with the urologist as opposed to being referred to a new physician in a new hospital or medical center.

So to summarize we think that Keytruda is a very important invaluable product for patients across a wide variety of indications, having said that in non muscle invasive bladder cancer. It appears that the profile and vicinium, it's highly differentiated and more compelling which speaks to the significant commercial opportunities that exist for vicinium once were able to go.

And regulatory approval.

With that I'll turn it over to Chad Chad.

Thanks, Tom on Slide 11, we have an update on manufacturing activities related to demonstrating analytical compare ability.

Just want to provide some background on our decision to outsource manufacturing of Vicinium to contract manufacturers in 2018. After we conducted several rounds of market research related to the size of the global therapeutic market in non muscle invasive bladder cancer. We determined that are manufacturing facility would not be capable of meeting the anticipated long term demand.

So we made the decision to outsource manufacturing for commercial supply Vicinium to Fujian Baxter, we did this to leverage not only their considerable manufacturing expertise unrelated regulatory experience, but also to capitalize on their larger scale, which will allow us to produce enough supply to meet the anticipated significant demand in this market.

Returning to today's update we recently completed manufacturing and release testing of the pre PDQ batches, Suji importantly, and similar to our first commercial scale GMP batch of Fuji the pre PDQ batch met all quality acceptance criteria. This continues a long history assessing miles manufacturing vicinium that consistently meeting.

Quality standards, all the way from phase one two and three clinical development through to our transfer the process to Fuji.

We believe this provides a positive read through on our ability to demonstrate analytical comparability during the process performance qualification or PPP CPQ campaign at Fujian Baxter.

Turning to slide 12, we've captured the key reasons why we are confident in the Tbtu campaign, and our ability to demonstrate analytical comparability.

First we have clear requirements from the FDA on the campaign, which will consist of three consecutive manufacturing runs for drug substance and drug product.

Second we have a considerable amount of experience with the Vicinium manufacturing process within the company from our history of producing clinical batches and this helps us to support our CMO is an increase the likelihood of success.

Third you've already manufactured to commercial scale batches that Fuji and one at Baxter and each of those met all the required quality standards. In addition, we've done extensive bio physical testing of the drug substance from the first GMP batch it Fuji to assess the primary secondary and tertiary structure of the protein and based on those results. We believe the materials compare.

Joel meeting highly similar to the material manufactured by Stephan previously for the phase three clinical trial.

Building on what Aaron said earlier, we also feel confident that based on our discussions with their Cmos to date, we will not experience major supply chain disruptions due to covert 19 and in fact, we already have all the raw materials and consumables required for manufacturing the P. PQ batches in place that are Cmos.

Turning to slide 13, you'll see a timeline of the CMC activities in 2020 that are required for us to finalize module three and complete the BLE submission. We successfully manufactured the pre CPQ drug substance batches Suji, which has also been used to produce the first drug products P. PQ Badgett Baxter an approach that was developed during discussion with the FDA NRC.

MC previously meeting.

In the middle part of the year, we expect to complete the PQ campaign, and then finalized module three and the BLA submission in the second half of 2020.

Working forward from that date, we anticipate potentially U.S. approval in the first half of 2021.

Finally, turning to slide 14, we recently received official scientific advice from the committee for medicinal products for human use no. One is the CH MP of the European Medicines Agency. This advice specifically relates to the company's approach to submitting a marketing authorization application for regulatory approval of Vicinium in Europe.

Very pleased with the response from the C. H MP and importantly, they did not request additional clinical trials in support of the submission of the marketing authorization application.

They also agreed that the Nonclinical pharmacology and safety data that we provided you never meeting package with sufficient for the purposes of the submission.

It was also acknowledged that due to the considerable burden of radical suspected mi on the lives of patients with non muscle invasive bladder cancer. The development of Terry therapies that would help patients avoid suspect to me would be welcomed.

Also received some helpful guidance on additional data analyses that should be included in the marketing authorization application. We believe that we'll be able to perform these analyses with her phase three data.

Based on this C.H.M.T. guidance, we expect to submit the marketing authorization application for Vicinium to the M&A in early 2021, which could lead to potential approval in early 2022.

With that I'll turn the call over to Monica Monica.

Thank you Chad.

We continue to build the foundation for our go to market strategy with stage gate in commercial spend in the U.S.

On the next few flies I will walk you through an update on our progress across key areas and how we're thinking about them in terms of inputs and assumptions in our financial model.

So please turn to slide 15.

We know there are approximately 1500 or roughly 30% of urologists, who treat about 75% of non muscle invasive bladder cancer patients most of which are co located in large urology group practices.

We believe this will allow us to have a very focused and efficient salesforce of roughly 40 to 50 sales representative via a contract sales organization, which we plan to deploy shortly before lunch.

This assumption translate to an estimated 10 to 15 million dollar investment on an annualized basis, while achieving the reach and frequency levels necessary for a successful watch.

Turning to slide 16 fewer research we have gained a meaningful understanding of the doctor patient interaction.

We have learned that the average patient usually a mail in their seventies goes to their urologists office on their own during a regular course of treatment or diagnostics.

However at times of pivotal treatment decisions, such as starting on a new drug therapy, a family member or caregiver will play a prominent role in the interaction with the urologist.

Our research shows at a high percentage of the time. This caregiver is a spouse daughter or granddaughter and we know they are more likely to engage in digital and social media, such as Google Facebook and Twitter for medical information.

It is for this reason that we believe we can reach caregivers and family members, who we know our highly influential in the treatment decision, making process through digital and social channels to educate them on the value of the send him.

This strategy will not only help to inform and provide the right tools for these important caregivers, but will also be an efficient and scalable commercial approach since digital and social spend it's usually a fraction of the investments versus traditional channels like television direct to consumer advertising.

On slide 17, you can see the pricing benchmarks and associated reimbursement research results, we have seen during our rounds of payer market research.

We are encouraged by the level of advocacy from payers. We think we can expect for the appropriate use of Vicinium and our research suggests there will not be significant barriers in the form of prior authorizations or stuff at it.

Our view is that this will be a critical driver of rapid uptake of Vicinium at launch.

We believe the customer insights we have learned to date in combination with our thoughtful and stage needed approach to commercial spending will help us realize the full market opportunity for vicinium, while paving the way for profitability.

Finally, please turn to slide 18 for an overview of our first quarter 2020 financial results.

We finished the first quarter of 2020 with approximately $42.5 million in cash and cash equivalents, which we believe is sufficient to fund our strategic priorities into 2021.

Yeah.

It's an ATM program in the fourth quarter of last year, and we're very pleased with how it has operated thus far.

We run our ATM at a low level and take down less than 10% of average trading volume and on most days b cell above the average daily price.

This allows us to strategically easy ATM, when demand outweighs supply, which minimizes the market impact while strengthening our balance sheet.

We ended the year with 110 million shares of common stock outstanding or 143 million on a fully diluted basis and as we have highlighted before the company carries no debt, which is obviously, an even greater strength in the current environment.

With that I will turn the call back to Tom Tom.

Thanks Monica.

So please turn to slide 19, I just want to summarize what I think the four key takeaways are from this call.

We believe the stadium has a highly differentiated clinical profile based on its unique mechanism of action. We believe the market research I presented earlier shows the substantial commercial opportunity.

I'm very pleased by the progress the team has made demonstrating analytical comparability between our clinical and commercial drug product and we believe we have a very clear regulatory path forward in Europe, and the United States.

With that I'll open up the line to questions operator.

As a reminder to ask your question you would need to press star one on your telephone to withdraw your question press the pound or hash key.

Please stand by all the compiled the queuing day roster.

Your first question comes on a John Newman with Canaccord.

[noise] you guys. Good morning, Congrats on all the progress, especially with the manufacturing of the Mi. My question is just a regarding the manufacturing Tom.

Because you just walk us through maybe the next few steps sounds like you PPG run is going well I'm. Just wondering if you could sort of take us through the next couple stuff to get she's through to the end of easily submission. Thanks.

Yeah sure all I'll make a few comments and then all on check and see if Chad would like to add anything. So we've completed the pre pick your run it through June as well as the first CPQ run at Baxter. So we're ready to go with the Pp Q campaign, which as you know is three consecutive run that'll happen this summer it Fuji and.

And we'll ship ship supply to Baxter to complete the fill and finish and the drug products steps of the P.P. Q, we're hoping that that assuming all of those go well that will wrap up module three which is the CMC module for the BLM submission and we'll build to finalize completion of our be away by the end of.

The year.

So that's kind of the next process going forward, Chad anything that you'd like to add to that.

No Tom I think you covered that really well.

Great. Thanks.

John right.

If I could it said one additional question regarding Europe.

Just curious if if you're able to talk at all about some of the.

Analyses that you may looks like you to run and then also just wondering if you could talk a bit about the opportunity for non muscle invasive bladder cancer in Europe in terms of the commercial size of that market. Thank you.

Yeah. So in terms of the additional guidance I mean, just just to the high level. What I can say is that the the yeah me orientation to non muscle invasive bladder cancer is a bit different than that of the yeah. The FDA put out guidance in February 2018, they're very clear on single arm trial with prime.

Endpoints of complete response and duration of response.

The European approach is more I'm looking at they like to see controlled clinical trials relative to standard of care looking at survival endpoints. As you know we do have three survival endpoints that are secondary endpoint progression free survival event free survival in overall survival. So it's a matter of making sure.

That all of those data are are fully analyzed and aligned with the way that Europe likes to see the data.

Regarding the market opportunity it it's its a very interesting analysis of Europe as you know the the primary risk factor for bladder cancer is cigarette smoking and if you look at the most recent data from the World Health organization in the United States the rate of smoking spot.

17% in Europe, it's about 28%.

So you take a larger population what the demographics that are that are at risk for bladder cancer you add the additional smoking and what you see when you look at the full European opportunity is that there are two to three times.

The number of patients that have bladder cancer I'm again into U.S. Each year 80000 patients are diagnosed with bladder cancer in Europe, It's two to three times that amount and so on so that the incidence is very significant the other thing we see is that when we look at benchmark data for advance you're a field carcinoma you know.

For muscle invasive or metastatic bladder cancer for like the checkpoint inhibitors that available in both the U.S. and and Europe, we see that the price is about 60% to 65% in Europe of the U.S. price, which is quite a bit higher than other benchmark. So it's a very good and fair price that is being reimbursed currently.

In Europe. So when you put those two things together, we estimate that the peak sales in Europe will actually be higher than the United States, which as you know and you can find all the data on the market dynamics in our backup the U.S. to the substantial opportunity, but Europe is an even larger opportunities. So you know we had not.

Previously guided on M.A. process because of the different standards for non muscle invasive bladder cancer, but we're very pleased to have the successful scientific opinion and very pleased with the opportunity going forward does did you have a follow up question John.

No. That's all thank you Tom.

Thank you John.

Your next question comes a lot of Chris.

Howerton with Jefferies.

Great. Thanks for taking the questions and good morning, good morning town.

A great. So I think you know maybe my first question, perhaps is directed towards Monika.

Maybe interested in understanding a little bit more in terms of what the perception is of the prior authorizations in the step edits that you saw.

And some of that payers you know what exactly are they expecting you to step that it through and what do you think would be the constitution of the prior authorization and.

Then I have this you follow up questions.

Great well all all on take a crack at that and then because I've been talking a lot of those pairs. My Monica will ask you to add onto it. So I mean as as everybody well knows there's there's such significant cost restraints right now that we see through managed care, just giving the escalating costs of pharmaceuticals, and so two of the more common it.

Well just managed care organizations take is.

Yeah, that's to make sure that everything that should have been tried has been previously tried men prior authorizations, where doctors can document where the patient ism therapy.

What we see and bladder cancer is quite you need so bladder cancers, the most expensive Catherine treating the United States. It it will be $6 billion in cost maybe more now with everything going on for on the treatment of bladder cancer and and most of that has taken on by Medicare as well as the.

Commercial payers and so they're very anxious to find pharmaceutical interventions that can help treat this disease help avoid radical steps to me and potentially help lower overall cost. So when we go to them and we talk about.

You know that the price benchmarks that exist and we obviously a lot of them are interested in value based contracting. So we talk about how we could arrange that based on the actual outcomes of of therapy relative to the benchmarks that you see in our back up.

What we hear from them.

Is that there would be minimal step outs at its a prior off so to answer your question about what they're looking for you as they definitely would like to see either the lack of availability of BCG or BCG and responsiveness and they also wouldn't like to see that that its demonstrated high.

Grade non muscle invasive bladder cancer, not low grade and as you know about.

40% to 50% of non muscle invasive bladder cancer is high grade. So so that the step outs Edison the prior off they're doing will be around making sure its high risk disease, and making sure that patient has failed on B.C.G.. Let me just stop modic anything you'd like to add to that.

No Tom Thanks, I think you covered it well.

Great. Thanks Green, Chris did you have a follow up.

Hi, Yes, a couple of follow up questions. If it's okay sector I guess I'm do we have any additional or perhaps insights from keytruda in terms of what the.

Market access and perhaps initial penetration that we've seen in that indication because I suspect they probably had a couple of months of marketing in that indication today to any visibility in terms of axis and penetration with that and keytruda. So far.

Yeah. Thanks, I don't because of the data like I don't have any quantitative data, but we've obviously been talking to lots of.

Physician, so what I can tell you is that they're using mostly its medical oncologists, obviously in the academic medical centers or the you know teaching hospitals, they're using yet you know in their Ivy infusion rooms, and so far from a reimbursement perspective, what we hear as they're really.

Not consistent with what I was just talking about they're not really getting any significant pushback from payers in terms of process or stuff at it so payers seem to be reimbursing. It much the same way that they are reimbursing.

The advanced do you feel carcinoma.

Okay excellent.

Okay, and then I'm curious I guess two parts with respect to the confirmatory trial first and foremost just wanted to see if there's any updates in terms of your thinking or timelines.

Given the decoded 19 pandemic and how we should be thinking about that if at all and then secondly, I'd be curious to do you think about what your views are with respect to market access both in the U.S. and in the U.S., if that confirmatory trial, where proven to be successful.

Yeah, great. Thank you. So in terms of timing, we're we're planning on initiating the timing right around the right around the time of approval in the U.S., so that would be roughly the second quarter of 2021.

We also we'll find out as we submit the M.A., whether we have a conditional approval pathway, which is the European equivalent of accelerate pathway, which would require then a confirmatory trial as well as we've said before we picture that being a global trial.

US Europe, and Japan, and the confirmatory trial. The general design has to come air versus standard of care on Chemotherapeutics agents, such as Jim said of being and might have my son and to set up a study show. We so we can show statistical superiority. So we're still going down that path, we still like we.

Still expect the conditional pathway in Europe, and then again that arm of the trial would actually start in early 2022 right around the time of European approval, so it'll be a little bit phase and then your question on on reimbursement Yeah, you know we.

I think a trial of 130 140 patients will allow us to show superiority because our data show that those chemotherapeutics agents have about a 20% complete response at three months of we have 40% maybe more in this patient population because it's less BCG exposure showing statistical superiority versus standard of care really.

As.

Improve global access so it would help us in the U.S. in Europe, but quite frankly would help us and all of the other big countries around the world because you'd be able to show those same those same data and those same price benchmarks. So I think we expect good reimbursement, but definitely a positive confirmatory trial natalee expand.

On the market opportunity for us, but could even further strengthened reimbursement.

Okay.

Thank you. Thank you, Tom and I'll hop back into queue. Thanks, Okay. Thanks, Chris.

Your last question, Sean Lee with H.C. Wainwright.

Good morning, guys and thanks for taking my question.

Sure. So just two quick ones. So you commented on the differences between calls.

Yeah, maybe use bladder cancer could you comment on whether there any significant differences in how bladder cancers tribute to the two different regions.

And secondly.

Could you comment a little bit on.

The company's potential commercial strategy for Europe, and if that's through a partnership with it.

The timeline when you start discussions on thanks.

Great. Thanks, Sean and good morning, So first of all just kind of talking about the difference between Europe, and and the U.S. and terms with the treatment of bladder cancer I mean in general I'd say, they're quite similar whereas I think there's significant differences in like China, and Japan in other parts of the world, but but Europe and.

And the U.S. are pretty similar they both use BCG as the workforce agent. They both you know think of that is kind of the snap first line standard of care. They both think of radical cystectomy as the the second line standard of care in.

In Europe, they especially some countries like the UK and Germany, they might do even more radical cystectomy. It's I think the health systems push a little harder and Europe, probably doesn't uses a little less chemotherapy. They.

Like unlike the U.S., even valves star is not approved in Europe. So they they tend to go a little lighter on the the chemotherapy, but in general and as I mentioned earlier, obviously, the European market appears to be a much bigger market and then the prices that in the 60% to 65%.

Benchmark versus the U.S., but but I'd say in general when we talk to key opinion leaders in U.S. in the U.S. and Europe, we see a lot of similarity in terms of treatment practices and then regarding partnerships. I mean, you know things are are moving very nicely for us as we've said before in terms of our partnership.

Discussions in both Asia as well as Europe. This European scientific opinion definitely will help accelerate you know the process and increase our probability of success of a really good partnership and in Europe and as we've said we picture. These partnerships being you know 50 50 values.

Sure agreements the partner with the marketing authorization hold that they would take responsibility for clinical regulatory and commercial so we still are picturing six to 10 partnerships outside the U.S. covering 60, 80 countries, which means we'll we'll have kind of minimal investor meant in terms of infrastructure.

Her head count outside the U.S. and let's just keep a very efficient model. So there's there's no doubt that this positive European opinion will help accelerate that process.

Did you have a follow up Sean.

No. That's all thank you for any additional color.

Okay, great. Thank you.

You have a follow up questions one of Chris Howerton with Jefferies.

Hey, there thanks for taking that followed by I forgot to ask agreement to ask or perhaps I was hoping somebody else would ask a in terms of the interpretation of the times is said to me data within that you seem to be prominently kind of mentioned within those commentary I believe that Chad was saying so.

It seems to at least a perception here in the U.S. that somewhat of a soft endpoint. So just wanted to see maybe is there you thought about that in a different way.

If it's a really good question, we wondered that because the f. day as sole explicit in their guidance. They say the whole point a pharmaceutical intervention is to help to avoid radical cystectomy. So the uptake has been crystal clear they really value. The data like we have the show 76% of patients delays and secondly by at least three year.

Sure.

We were pleased and Chad spoke to it that in Europe. They agreed that there's a significant unmet need especially for products that are able to delay radical stack to me why that is meaningful to us is by defining that unmet need we think it could provide the basis for accelerated assessment I think as you.

No in Europe, there was too assessment process. There was accelerated assessment, which is 150 days and regular assessment, which is 210 days and so based on that positive reaction. We it is our plan consistent with M. a protocol to request the accelerated assessment three months before we submit our EM.

Hey, I'm based on that unmet needs. So we were we were pleased to see they considered as much of an unmet need as the FDA does.

Did you ever Follicular.

No I don't think so thank you.

Great. Thank you.

I'm showing no further questions at this time I would now like to turn the conference back to Dr., Tom Cannell, President and CEO.

Thank you operator, and thanks again to everyone for your active engagement and great questions. This morning before we go I'd like to thank the brave patients as well as their families and caregivers and I'd like to thank our 28 employees assessment buyer, who have been working tirelessly. Despite the pandemic to help save and improve the lives of the patients we serve.

Sure I couldn't be more appreciate if we're proud of assessment team. So that concludes our call for today I Hope you all have a safe and healthy week and we look forward to talking Yeltsin. Thank you operator.

Ladies and gentlemen, this concludes today's conference call. Thank you for participating you may now disconnect.

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