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ARIAD Pharmaceuticals, Inc. (NASDAQ:ARIA)

38th Annual Deutsche Bank Health Care Conference

May 30, 2013 10:00 am ET

Executives

Harvey J. Berger - Principal Founder, Chairman of the Board, Chief Executive Officer, President and Chairman of Executive Committee

Analysts

Robyn Karnauskas - Deutsche Bank AG, Research Division

Robyn Karnauskas - Deutsche Bank AG, Research Division

Good morning, or good afternoon or good evening, I don't know what time it is. Next, we have ARIAD Pharmaceuticals. My name is Robyn Karnauskas. I'm the Deutsche biotechnology analyst. And I'd encourage any of you listening to the webcast, I win an award if someone on the webcast asks a question via yorn, this is www.yorn.com, and you can actually ask a question anonymously or post feedback. Any questions, Harvey will answer these questions except about ASCO data. So with that, I'd like to turn it over to Harvey. Thanks.

Harvey J. Berger

Thanks, Robyn. So I'm looking forward to seeing what somebody will send us in on e-mail. So good morning. It's a great time for us as we head into ASCO this weekend. One of the 3 really important meetings for the company ASCO, ESMO and ASH. This will be an important time as I'll talk about briefly this morning, as well as you'll hear over the weekend and early into early next week where we update the story and update clinical information on our 2 lead cancer medicines, Iclusig and 26113.

Before I get started, let me just mention that I'll be making forward-looking statements under the Private Securities Litigation Reform Act, and I encourage everybody to read our periodic filings with the SEC.

Well, 2013 has been off to a very strong start. We're already almost to the mid-point of the year, but so I look back to this year, we've reported first quarter sales, first time sales for ARIAD of almost $6.5 million based on a launch in beginning of January, a positive opinion from the CHMP, our European team in place ready to go, transitioning into Phase II in Japan as we continue our global move on Iclusig, and importantly, a move of 113 plan to go into Phase II very shortly. So quite a lot has been done.

Let's start with the U.S. launch update. As I mentioned, first quarter sales of $6.4 million with $3.3 million in deferred revenue, namely inventory on top of that. The uptake of Iclusig in the U.S. marketplace has been strong and fast, with over 400 patients now on Iclusig through the end of April, over 300 unique physician prescribers, and very importantly, 70/30 split between community and academic physicians. Quite honestly, that's probably the reverse of what we would have expected this early in the year, although that's what where we expected to get to. But it tells us that the adoption and uptake of Iclusig in this very important group of physicians is fast and early.

We're also seeing uptake of Iclusig in all lines of resistant/intolerant treatment, with about a quarter of the patients in the second line. That also is very early and a strong indicator of the success of the launch of Iclusig in the U.S. market.

And lastly, less than 10% of patients have the otherwise untreatable T315I mutation. So that makes a very small part of the overall utilization of Iclusig.

And lastly, strong payer support with about 95% of patients in -- with respect to the payers providing full coverage exactly as anticipated.

As well Iclusig is getting ready for launch in Europe. We are very close with a positive CHMP opinion in hand. We expect the European Commission approval shortly this quarter with a broad label, including second line use of Iclusig. We see the market opportunity in Europe for patients who are going through switch TKIs to be substantial and larger than in the U.S. anticipated to be about 3,800 patients with CML and Philadelphia-positive ALL, that's patients we anticipate will switch TKIs over this year. We'll begin our launch in the countries where we can commercialize most rapidly, namely France, Germany and the U.K. We already have an ATU program in place in France with $3.2 million of Iclusig sales at the tail end of last year and through the first quarter of this year. We expect that program to continue and to be broadly adopted in France. I can't stress enough the strength of our exceptional management team that is in place in Europe. Our European corporate headquarters are in Lausanne, Switzerland. The team is leading the commercialization efforts throughout Europe.

So beyond our first approval, it's important to put this into perspective that our basic strategy for the company continues strong and unequivocal with internal discovery driving innovation and driving new products, global capabilities from commercial to clinical development, medical affairs, regulatory approvals and global manufacturing. So in place, all of the capabilities necessary to be one of the leaders in the global oncology business. And importantly, this strategic approach is driven by the key issue of full global integration that we will discover, develop and deliver innovative new cancer medicines to patients worldwide on our own.

That leads to what we think is the key differentiation for ARIAD, which is the long-term value proposition, a sustainable fully integrated, global oncology business that defines who we are, what we build and the value proposition for investors.

113, you'll hear a lot about that this weekend. Another one of our internally discovered cancer medicines. APG 6113 is a triple inhibitor, if you will. It's a strong inhibitor of ALK, anaplastic lymphoma kinase. We have already resented compelling clinical proof of concept data at last year's ESMO. You will hear more about that and the clinical data in the coming days. EGFR and ROS1, 2 additional promising opportunities, more data to come both at ASCO as well as most importantly on EGFR at the ESMO meeting in the fall in Europe.

So 113 is moving into Phase II and into the pivotal trials. We expect the transition to the Phase II cohorts to occur within a matter of days by ASCO. I can't say that very much longer since ASCO starts tomorrow. The pivotal trial in ALK-positive non-small cell lung cancer patient to start in the third quarter, so on track, on plan. We have disclosed some of the details based on the abstract that's been published on 113 that we've done to a 300 milligram daily dose in Phase I. And you will hear more about this where we'll provide complete details of the selection of our going forward Phase II and other -- and going forward dose. The dose for the ALK and EGFR cohorts and for the EGFR and for the ALK pivotal trial all well-defined, and again, we'll provide complete details of that at the presentation. And importantly, we have -- we expect that the third cohort in the Phase II trial, the one that focuses on T790M EGFRm patients will be very well-defined. It will be an appropriate, well-defined population that provides the basis for assessing the efficacy of 113 in EGFR resistant patients. And again, there will be more data on our Phase II plans over the weekend.

So as we look to the remainder of 2013, I can't stress enough how pleased we are with the strong and ongoing launch of Iclusig in the U.S., the anticipated approval, pricing and reimbursement and promotional activities of Iclusig in Europe, that's going to be a steady flow of progress over the coming months, leading to a global, global presence not only in the U.S. and Europe, as well in Japan and Asia. As we also go forward, we'll be expanding the Iclusig opportunity, not only in CML and Philadelphia-positive ALL path, the resistant/intolerant population, but as well developing Iclusig in other solid tumors and hematologic malignancy such as GIST. As I mentioned a moment ago, we'll be initiating the 113 pivotal trial in the third quarter, and expect important presentations later this year at ESMO, which takes place in Europe in the end of September.

So as we head into ASCO 2013, I'm very pleased to look at ARIAD as a sustainable, fully integrated, global cancer company now with a strong presence in the growing global marketplace defined by being able to discover, develop and deliver innovative medicines to patients with cancer, patients with the most aggressive and difficult to treat malignancies. Thank you.

Robyn Karnauskas - Deutsche Bank AG, Research Division

Thank you. Any questions from the audience? Maybe first, we can start with the Stanley Cup, who do you think the 2 players in the Stanley Cup are going to be? And I hope one is Black Hawk.

Harvey J. Berger

I think I'll pass on that.

Robyn Karnauskas - Deutsche Bank AG, Research Division

You'll pass. You're already passing it's not even ASCO question. All right so Iclusig, so there's been a lot of talk about the launch. And I think one of the metrics that you guys have been giving on your calls I think is really interesting and really important that you're really growing faster than other drugs that launched that are now billion-dollar blockbuster drugs and that's a metric I think the street missed, or they didn't pick up on that early on. So I thought just to go to a little deeper into that comparison. How is your launch trajectory as far as the EPIC study ultimately, if you look over a longer period of time? How will that compare to these drugs as they came on over a long period of time as their indications expanded to get to the billion dollars?

Harvey J. Berger

Well, I think that a couple of questions wrapped up in one. What we've looked at is the -- are the number of prescriptions, number of bottles that have been sold in the first 4 months, and we continue to do this, comparing the Iclusig launch with the same first 4 months say up in the nilotinib launch. It's clear that the nilotinib is the leading medicine in the space both for resistant/intolerant patients, as well as for the newly diagnosed patient, certainly of the second-generation medicines. And so it's a very appropriate comparison. When nilotinib launched 5 years ago, nilotinib launched into a marketplace that had one other drug, dasatinib, which it was launched before it in the resistant/intolerant patient population. So we launched Iclusig into a market that has at least 2, 3 if you include BOSULIF medicines for physicians to choose from, and in the first 4 months, Iclusig is tracking at 40% above nilotinib. Nilotinib today is a billion-dollar annual medicine in terms of revenues. So, I mean it's a very good metric. We think it's a very good way to measure the uptake and the success of the launch at a comparable point in time, not using price because revenues are going to depend on what the -- what reimbursement is and what the policies are and, of course, cost. But number of bottles is a direct -- 30-day supply, is a direct measure of the demand for the drug. And we are, quite honestly, struck that at 40% above nilotinib, that's a very, very strong initial launch. So, both nilotinib and dasatinib got approval in the frontline about 3 years into their life cycle. So we expect to have data on Iclusig -- initial data on Iclusig based on the interim analysis by third quarter next year and the final analysis of the primary endpoint by early into 2014. So that is ahead, time-wise relative to when nilotinib and dasatinib got into the frontline. How big the ultimate market is going to be? I think it's driven by one and only one factor, which is how much better the efficacy of Iclusig is relative to Gleevec? We know how nilotinib and dasatinib compare to Gleevec. So we have a good comparator. If Iclusig does much better than that, then the market is going to be potentially much bigger. And I think it's really efficacy driven. The drug appears to be very well tolerated, and what we're seeing in the field is it's very well tolerated in the resistant/intolerant population. Once we have those data in the frontline, it will be driven by the efficacy results.

Robyn Karnauskas - Deutsche Bank AG, Research Division

Okay, that's very helpful. And then you also broke out that a lot more community-based physicians are prescribing versus the academics. And again, that's also very unusual in oncology. I usually see like more academic being a dominant prescriber. Why do you think that is? So I understand -- why you think that is -- is that the marketing strategy? And what does that mean for the launch going forward? What does that mean for uptake amongst these patients in different lines?

Harvey J. Berger

CML is different than most cancers in terms of their treatment. CML, by virtue, the availability of Gleevec has become a disease that is treated routinely by well-trained, board-certified hematologists and oncologists who may practice in a community setting, either in a large practice group or in a community cancer center or large community hospital, but have all the capabilities and expertise to be able to give a once a day oral medicine for a disease like CML. So community physician uptake for CML drugs in general is greater than, say, somebody who has advanced ovarian cancer where that's usually much more than in the academic center. So I think it's very important because the earlier -- in terms of lines of treatment you go to second line and frontline, the more of that care is handled in the community setting. And so in order to be well-positioned not only to capture the largest share possible of the second line, but as well to be well-positioned once we have the EPIC data and are able to promote in the frontline, you want to already be a known commodity to the community physicians because they write most of the prescriptions for frontline CML, and many of the prescriptions for second line CML. So I think what's driving it is not so much our marketing strategy, but rather that we identify who the high prescribers are, whether they're in the community or the academic center, it shouldn't make any difference. High prescribers for second-generation TKIs in CML or high prescribers in general, and they are driven just like the academic physicians, by data and the publication in the New England journal of the frontline of the Phase I trial and the presentation at ASH and ASCO of essentially all of the data on Iclusig, I think is well known to them as the academic physicians who are the investigators and it's data that's driving the uptake.

Robyn Karnauskas - Deutsche Bank AG, Research Division

That's helpful. And for duration of therapy, at what point do you think you'll be able to give us color or feel comfortable giving color as far as how long some of these patients are staying on drug in the real world?

Harvey J. Berger

Well, it's impossible to give much color because we've only been in the market for 4 months, and you'll see presented over the weekend at ASCO an abstract on the long-term follow-up of the data from the Phase I trial, and that will be very informative. What we've said is that the discontinuation rate in the real world of the community of the commercial utilization of Iclusig is well under 10% and that even includes all the advanced phase patients that came on early. So with a less than 10% discontinuation rate and 4 months of follow-up, most patients who went on drug are still on drug and I expect they're going to be on drug for years and years to come. There's nothing to suggest that those patients are going to come off drug and if the Phase I data that will be presented this weekend are indicative, it's very clear that once you respond, you have a likelihood you can be on therapy for years.

Robyn Karnauskas - Deutsche Bank AG, Research Division

And as far as internal expectations, are you outperforming or in line with internal expectations for the launch?

Harvey J. Berger

Well, the guidance or the insights that we gave last October at our Analyst Day, we're very consistent with our internal projections and those are the projections that we use to guide the ramp-up of staff, the ramp-up of organization, so we are exceeding internal expectations.

Robyn Karnauskas - Deutsche Bank AG, Research Division

Great. And as far as the EPIC trial, so a lot of studies right now are being used when they hit they're already allowing for reimbursement right away. Like what are your thoughts on compendia listing for EPIC? We're seeing this across the board that clinical trials are allowing reimbursement well ahead of improved label.

Harvey J. Berger

If it can be done, we'll do it. I mean, I'm not 100% sure that's as widespread as you suggest. But I mean, for as big an indication as frontline CML, I think there's going to be a lot of hesitation to reimburse based on data as opposed to approval, because it means accepting a very large market, because there's a lot of frontline patients, that's what's driven Gleevec to $4 billion or $5 billion a year. But if it can be done, we'll certainly -- you won't see us sit on the sidelines and not try to get it done.

Robyn Karnauskas - Deutsche Bank AG, Research Division

Is there a threshold in your mind that this would become the standard of care -- threshold for data at the interim, which would make it easier for reimbursement on a compendia basis?

Harvey J. Berger

Well, I think the question -- I wouldn't put too much focus on the interim analysis to -- when at the interim analysis for efficacy, it has to be a very, very, very dramatic difference. Because remember, it's getting to the primary endpoint with half the number of patients we think is needed. It's purely patient number-driven. So to get there at the time of the interim analysis would be pretty remarkable. We'll certainly have safety data, whether we meet the predefined efficacy endpoint based upon half the number of patients is absolutely impossible to predict. It would be pretty extraordinary. So your question applies I think equally to the interim analysis or to presentation of the full trial, full patient group trial. And those are about 6 months apart, and approval is probably 6 months after that. So you're talking about a window from up to a year from the interim analysis to full approval, assuming it's all positive. So you've got a window in there that I think we would look at the data, and I think depending upon how significant it is, how clear the difference is, how big the magnitude of difference is, where Gleevec actually comes out, I mean is a huge -- all of these is very dependent upon where Gleevec's numbers turn out. We've made some assumptions, but there's variation. Does it come out roughly where it is done? And where does it come out in the past than a 12-month MMR of about 20%, 25% being the range or does it come out higher or lower? It could be either. It's impossible to set an arbitrary number today.

Robyn Karnauskas - Deutsche Bank AG, Research Division

Okay. As far as the switch market opportunity like you were talking about that market and you've talked about the resistant patients in that bucket, but the intolerant patients, how much uptake are you seeing in the intolerant patients?

Harvey J. Berger

Substantial. It's a mix between intolerant and resistant, and many of the patients who are resistant never have mutations documented. They're clinically resistant, mutational testing is few and far between. PCR testing of MR, molecular response, is much more common than mutational testing in the real-world, both in the U.S. and Europe. So the resistant population or the clinical failure population and the intolerant population are overlapping. Many patients who are intolerant are also getting suboptimal or inadequate clinical responses because if a patient has side effects that are significant enough to consider they are becoming intolerant, they tend not to take the medicine or take only some of it. In turn, nothing breeds resistance better than a suboptimal treatment. So they then overlap. And in the PACE trial, for example, we had to work very hard to find the 10% of the population that were pure, absolute intolerant, because many patients have aspects above. So we're seeing -- I mean in the community, there's a routine practice that's probably higher than 10%, it's probably 25% they're intolerant in one way or another, but we're seeing uptake in both groups and it's really -- it's very much physician specific.

Robyn Karnauskas - Deutsche Bank AG, Research Division

Okay. And as far as European launch, right now there's a lot of companies having -- launching in Europe, it's been a more challenging environment, it's taking longer. What is your philosophy on price versus the United States? Are you going to hold out for similar pricing? Or do you feel like you'll have more flexibility?

Harvey J. Berger

There's no conceivable way you get the same pricing in Europe as you get in the U.S. for a drug like Iclusig or any other of these drugs. It's absolutely flat-out, not possible because -- because, just the price standards are lower. And what we expect is that we will get a premium to nilotinib or dasatinib, the second-generation medicines, a comparable type of premium percentage wise to what we have in the U.S., but the actual price will definitely be less than in the U.S. because it's impossible to get U.S. pricing in Europe.

Robyn Karnauskas - Deutsche Bank AG, Research Division

How do you model duration though? So if you -- like a -- if European country sort of want to have said how much they're going to be paying, you don't really know duration yet, duration maybe very long, maybe you can look to nilotinib a little bit, but how do you help these countries get comfortable with the price point?

Harvey J. Berger

We'll provide all that to them. I mean we -- all of our modeling has been built around sort of a mean median duration of 3 years. Obviously, we're not just saying it's 3 years for everybody. There are the way we've really done the modeling and the overall models for the drug, our patients with second line chronic phase disease are going to be on drug way longer. Patients who have blast phase disease aren't going to be on for 6 months. So you have to really take into account the various categories of disease when you model duration, and that's the way we would do it with any of the countries that want that type of information. As if you want one number for -- fits all, it's probably 3 years, but you'll see data at ASCO imminently that really speaks to the long-term deep responses that are being seen with Iclusig in the very sick patients.

Robyn Karnauskas - Deutsche Bank AG, Research Division

Any questions? I'm not going to win an award if no one's put anything on the yorn. Oh, yes?

Unknown Analyst

In terms of the 2,500 patients that you talked about for annual switching. Can you help us characterize how many of them are from nearly diagnosis and they got initiated on either the first-generation or second-generation drug and then in the same calendar year switched to ponatinib? And what percentage of those switched patients are from sort of the large prevalence pool that's out there who's been either first or second generation drugs for years? Can you help us to parse that out?

Harvey J. Berger

I'm sorry, I'm not sure I understood -- heard all of it, but of the 2,500 patients that we estimate or that we estimated end of last year would be switch patients during this year. Those 2,500 -- that assumption is around 2,500 over 12 months. So that's -- divide the 2,500 by 12, which gives you a little over 200 patients per month being the pool of available patients who will switch from 1 TKI to another. We've also estimated that a bit over half of those patients, I think about 60% of them, are second lines which is in the remaining 40% round numbers are third line or greater switches. So that's the population that we've modeled around with 400 patients. With 400 patients on Iclusig at the end of 4 months, that's about 1,200 patients over the year if you just multiply it by 3. And obviously the number of patients on Iclusig goes up every month, not stays flat. So we're at a what could be a very high penetration number relative to the 2,500. That among other things has led us to believe that the 2,500 may be a bit on the low side based on now that there's a much better switch option available, namely Iclusig. So Iclusig, we see, is driving physicians to make decisions about switching, because they now have something materially, significantly better and different than what they had until beginning of this year. So the likelihood -- and it's too early to know exactly and we won't really update that number until much later into the year, the likelihood is that the 2,500 number may be low and may actually turn out to be higher, relative to the realities of what we're seeing in the marketplace. So Iclusig availability may well, in part, be changing the total number of available patients, because you now have a new option that when we did the market research last year was only investigational drug not available yet even though you try to encourage physicians to avail those in the market research to take that into account. Obviously, you can't get that sort of traction until it's actually in the market and used. So that's where we see this evolving the same in Europe. In Europe, we think the number is about 3,800. That's the comparable number to the 2,500, and we'll see where it ends up as we go forward.

Robyn Karnauskas - Deutsche Bank AG, Research Division

A question from the yorn, I actually thank whoever it was, I appreciate it. So please discuss how the company approaches U.K. nice cost benefit and how they would pitch for premium pricing above nilotinib.

Harvey J. Berger

I'm not going to disclose or go through what our exact strategy is and how to position Iclusig benefit in any country, including in the U.K., but I think the data speak for themselves in terms of the strength of the efficacy and the well -- the great tolerability of Iclusig in practice to date. I think both of them will provide us with a strong basis for demonstrating superiority to the available medicines. Every country is different. Every country's reimbursement processes and metrics for pharmaco economics are different. We have -- I think probably the most important answer is, 2 of the people we've hired in Europe, our general manager, Jonathan Dickinson, and our head of market access or pricing and reimbursement, are just extraordinarily experienced with 2 of the major experienced successful oncology businesses in the world, having between the 2 of them, got the pricing approval and launch of essentially 50% of the major new drugs -- cancer drugs in Europe in the last several years. So we've got the expertise and the talent. To answer the question, I think it's too early for us to sort of lay out how we're going to get there, but we will.

Robyn Karnauskas - Deutsche Bank AG, Research Division

Two questions on 113. I guess, first, just on the brain met reduction that you're seeing, which is pretty impressive. Have we seen brain met reduction with other targeted therapies, like, I don't know how often they get to the brain, like how unique is this and how does this help as far as you think differentiating the product or even pricing?

Harvey J. Berger

Great question. So as best as we know, 50% of the patients who failed crizotinib, failed with brain mets. If you don't have a treatment for brain mets, you're not going to live very long. It doesn't matter what else you do. It's not a good thing. And so half of the failures by all the statistics that are available are patients with lung cancer that has spread to the brain. The ability of 113 to rather dramatically diminish brain metastases is a huge benefit for the medicine and for patients who will be taking it. We've seen one case on LVK, the Novartis drug, that's an ALK inhibitor that was presented at ESMO last year, so 1 case of an effect on brain metastases. More than that, no data had been presented, so I have no way to understand or know what the other agents have seen or what the other agents -- what you can expect from them, but we've seen one case. The abstract that was published on 113, I think have 4 out of 5 patients that had brain metastases, showing document CT responses. That's rather remarkably high, whether it was a brain met or whether it's a primary brain tumor. And we've -- to sort of speak to our confidence in 113's ability to affect ALK-driven brain mets, we have added a fifth cohort to the Phase II trial, which will start during the third quarter. The rest will start before, but the fifth extra cohort will focus on patients with brain metastases who have failed crizotinib, so that we can do detailed brain imaging, detailed brain assessment of those patients, not to complement the response rate, but rather to more deeply understand the metabolic impacts with PET scanning potentially, the MR and CT configuration, how effective are you, which locations, so that will be -- allow us to study that in greater depth, because we feel that's one of the important differentiators of 113 relative to any drug in this class.

Robyn Karnauskas - Deutsche Bank AG, Research Division

Was there anything about these patients if you look at the 5 patients, were they on healthier side within the population? Is there anything unique about them?

Harvey J. Berger

Well unfortunately, what's unique about them is that they have brain mets and the other patients didn't. Early in the trial, the Phase I trial, we excluded patients with active brain metastases because the clinical course of the patient with lung cancer that spread to the brain is different than the clinical course of somebody who just has low non-CNS brain metastases. Given -- really it's encouragement of the investigators, we amended the trial about halfway through to allow patients with brain metastases in recognizing that it confuses -- resist determination of PRs, confuses some of the outcomes, but the advantages of having data of patients with brain mets outweighs the complexities in the trial. So it's a -- the investigators have particularly looked to try to get those patients now in so that we could get this information and it will be a critical part of the fifth cohort and they obviously will be allowed into the pivotal trial that will start in the third quarter.

Robyn Karnauskas - Deutsche Bank AG, Research Division

Okay. Last question, and probably this is a question you get the most, I'm guessing, is regarding the EGFR activity of the drug and the abstract, you're not seeing out a lot of responses in these EGFR patients. I've heard some of your comments as to why that would be, but maybe give me your best guess and why proceed in this population? What's going to give you confidence that if you proceed forward in this population, that you're going to see responses?

Harvey J. Berger

So far, we've seen 1 partial response and several patients with stable disease, that's not good enough to make a drug. So we believe and we'll present data this weekend that we can achieve sufficient blood levels of 113 so that at the chosen dose based on the TK as we now understand it, that there's a high likelihood that almost all patients that goes will have more than enough exposure to 113. In addition, the population that we're going to study in Phase II is the population that you should study for this, which is patients who recently failed an EGFR inhibitor, have a documented T790M mutation as EGFRm and in turn get started on 113 promptly without intervening chemotherapy, bevacizumab and other targeted agents. So if your tumor isn't driven by T790M and EGFR, there's no way the drug can work. Most of the -- as you'll see, most of the patients who were studied in the Phase I trial were really Phase I patients who were enrolled so that we could study PK and safety way more than efficacy in EGFR. The EGFR population and the ALK positive population are just totally different. ALK patients, you fail one drug, crizotinib, you go on the trial, period. This is because crizotinib became available only over the last few years while the EGFR inhibitors have been around for 8 to 10 years. So you have way more complex, long-term, different therapies, different -- just different courses of treatment. And so the Phase II cohort, the third cohort, will be unambiguous, every patient will be T790M positive, will be well-defined at all at the dose we think is the right dose, and we believe there's a good chance of highly likely the drugs is going to work there. If it works, we'll see it. If it doesn't, we'll know the answer. But we think we're very well-positioned now for the Phase II study to get the data that we need.

Robyn Karnauskas - Deutsche Bank AG, Research Division

Well, great. Thank you very much.

Harvey J. Berger

Thanks, Robyn.

Robyn Karnauskas - Deutsche Bank AG, Research Division

Thank you.

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