Good morning, ladies and gentlemen, and welcome to the BioCryst 4th Quarter 2018 Earnings Conference Call. A listen only mode. Following management's prepared remarks, we will host a question and answer session and our instructions will be given at that time. As a reminder, this conference call is being recorded for replay purposes. It is now my pleasure to hand the conference over to John Blue.
Sir, you may begin.
Thanks, Brian. Good morning, and welcome to BioCryst's fourth quarter full year 2018 corporate update and financial results conference call. Today's press release and accompanying slides are available on our website. Participating on the call with me today are CEO, John Stonehouse CFO, Tom Stob, Chief Medical Officer, Doctor. Bill Sheridan and Chief Commercial Officer, Lynn Powell.
Following their remarks, we will answer your questions. Before we begin, I want to direct your attention Slide 2, which discusses our use of forward looking statements and potential risk factors regarding an investment in BioCryst. As detailed on the slide, today's conference call will contain forward looking statements including those statements regarding future results, unaudited and forward looking financial information, as well as the company's future performance and or achievements. These statements are subject to known and unknown risks and uncertainties, which may cause our actual results, performance or achievements to be materially different from any future results or performance expressed or implied in this presentation. You should not place undue reliance on these forward looking statements.
For additional information, including a detailed discussion of our risk factors, please refer to the company's documents filed with the Securities And Exchange Commission, which can be accessed on our website. I'd now like to turn the call over to John Stonehouse.
Thanks, John, and thanks to all of you for joining us this morning. BioCryst is off to a very exciting start in 2019 with some exceptional progress over the past few weeks Our number one priority is oral BCX7353 for the prevention of hereditary angioedema attacks. We remain on track to report 24 week safety and efficacy data in the second quarter from the APeX-two trial. We are now gearing up for our regulatory filing by year end and extensively planning and preparing for the launch of 7353 into the U. S marketplace next year.
Bill and I attended the recent AAAAI meeting, the largest allergy and immunology meeting in the U. S. In San Francisco and the excitement from patients and physicians around 7353 continues to build. Once again, we heard loudly and clearly that patients desperately want a once daily oral therapy to prevent HAE attacks and a single dose oral therapy to treat therapeutic attacks. We presented the full ZENITH-one clinical trial results at AAAAI.
Bill will share more with quickly ahead into the Phase III trial with the 750 milligram dose and we expect to begin the trial over the summer. We are also very excited to share with you the we prioritized 9930 to move into the clinic in the first half of the year. 9930 is an oral Factor D inhibitor for the treatment of complement mediated diseases. The beauty of having an oral Factor D inhibitor is that there are a number of these diseases already identified and the list is growing. You should think about this program like a pipeline in a molecule as there could be many indications to pursue with this one molecule.
Today patients with these devastating diseases either have nothing or IV infusion treatments 9930 would offer an oral option that could improve on existing therapies. Clinical development programs for these diseases can move quickly because the biomarkers are well established. So you can quickly understand whether your drug is working The opportunity here is bigger than HAE. The preclinical profile of 9930 we have thus far, which Bill will describe to you is fantastic. We expect to begin Bill and Lynn will provide more details around both the preclinical data profile and commercial opportunity with 9930.
And you'll get a better sense of why we're so excited. The BioCryst discovery team led by Doctor. Babu and our Birmingham, Alabama Research Headquarters has now successfully discovered where we plan to begin We are building a company that will soon have a highly differentiated marketed product and a growing clinical pipeline all focused on bringing We have also recently extended our cash runway further into 2020 with the addition of the 100,000,000 dollar debt facility we announced last month. This provides a company with additional financial flexibility to support these exciting programs. Now, I'd like to hand the call over to Bill for an update on the HAE program and more details about 9930.
Bill?
Thank you, John. I'll start with the HAE program and the data we just reported last week from the ZENITH-one trial at the AAAAI meeting. You'll recall that ZENITH-one was a phase 2 dose ranging proof of concept trial designed to estimate treatment effect, evaluate safety and tolerability, select clinically meaningful endpoints for a phase 3 registration trial, and identify the best dose to advance. We have thrilled that ZENITH-one so clearly achieved all its objectives. This trial also broke new ground as the first prospective randomized placebo controlled trial of acute HAE treatment administered at home by the patient early in the course of the attack, with a goal of stopping escalation of attack symptoms.
This aligns with modern treatment guidelines and is an important element of treatment that limits disease impact. We selected the 3 dose levels to test based on clinical PK profiles. As you can see on Slide 9, We had previously reported that all HAE subjects in a PK study dosed with 750 milligrams had drug levels more than 8 times EC50 within 30 minutes sustained through 24 hours post dose. This long duration of action is important given the recent evidence acute HAE treatments. With ZENITH-one completed, we now have real world controlled clinical trial results confirming its rapid onset of action and 24 hour duration of effect for single oral doses of 7353 and a clear dose response going 250 to 750 milligrams.
As John noted, in September, we reported results showing clinically meaningful and statistically significant treatment effects from our 750 milligram dose, together with a favorable safety and tolerability profile. Strongly supporting advancing the 750 milligram dose to Phase III. The most noteworthy additional data from the 25500 milligram cohorts reported last week at AAAAI was the clear dose response we observed across multiple endpoints. This is reflected on Slide 12 with the examples of improvements in visual analog scale scores and the proportion of subjects he used rescue medicine. As detailed on the safety summary slide 13, 7353 was generally safe and well tolerated with no notable differentiation from the adverse of profile of Placebo.
Our next step, the acute program for 7353 is to meet with regulators to discuss the Phase III trial with goal of starting patient enrollment over the summer. The prophylactic program also continues to make excellent progress. As John noted, The 24 week safety and efficacy readout from APeX-two is on schedule for the second quarter. As a reminder, the trial enrolled very quickly. In fact, over enroll with 121 subjects and is now powered at 99% to detect a 50% reduction in attack rate versus placebo.
We look forward to sharing the results with you in the second quarter. Both APeX-two and our safety trial APeXS continue to progress well. Patients have now started to enter an extension period beyond 48 weeks of dosing. The permits continued daily oral treatment through 96 weeks. In parallel, the team has made an excellent the FDA by the end of the year and to marketing authorization application with the EMA in the first half of twenty twenty.
We recently enrolled our first patients in the APAC J trial in Japan, which is being conducted to support the J NDA. This trial is a 24 subject, randomized, placebo controlled trial similar and designed to APeX-two using the same doses of 7353. Because there are no prophylactic treatments for HCA approved in Japan, the unmet need, therefore, HAE patients is high and clear. Now I am very excited to tell you more about 9930, our oral Factor D inhibitor for complement mediated diseases. Is advancing into Phase I clinical development.
Treatment options or must be treated with lifelong IV infusions. The only approved therapies in this field work to inhibit a terminal component of the complement cascade C5. Factor D is a critical enzyme in the alternative complement pathway that drives AMFA application of the entire complement system upstream to C5. With its mechanism of action as a Factor D inhibitor, We believe that 9930 is a potential treatment for a broader range of complement mediated disorders. Potential indications for 9930 include many rare disease with the kidney, blood, and nervous system.
Treatment with oral 9930 could fundamentally transform patients' lives and improve on existing therapy. The preclinical profile of oral 9930 is extremely attractive after oral dosing in non human primate complement activity was immediately and dramatically suppressed. In preclinical studies, this compound was potent, specific, and had a very wide safety margin.
Let me
now walk you through the data that has us so excited on Slide 18, the left hand table reports the consistent in vitro potency of 9930 across multiple complement assays. These include measurement of Factor D and Zimatic action, complement mediated destruction of red blood cells or hemolysis and deposition of complement enzyme C3 fragment on the surface of red cells from patients with PNH. The specificity values in the right hand table indicate a low likelihood of off target effects on other serine proteases. An important preclinical proof of concept test for 9930 was to dose animals orally and measure its effects on the complement cascade. This experiment answers the fundamental question, does enough drug get absorbed to work on the target?
We use the standard assay in this field, hemolysis of heterozygous red cells, On Slide 19, you can see that after dosing non human primates, 9930 rapidly suppressed complement activity with near complete suppression of complement mediated hemolysis by 24 hours, despite the 50% lower potency of 9930 on non human primate Factor D compared to human Factor D. Of note, the drug exposure needed was a fraction of the no observed adverse event level or no well exposure in preclinical safety study. The preclinical safety margin of 9930 that supports entry into clinical trials is also very encouraging On Slide 20, you can see first that we saw very high drug exposures proportional to dose and second that drug levels for the noes of 9930 were more than 500 times greater than the estimated therapeutic target level with an associated human equivalent dose of more than 5000 milligrams. This dose is so much higher than needed for target pharmacodynamic effects that it will never be necessary to study it in the clinic The preclinical safety and pharmacology profile of 9930 should provide us with tremendous dosing flexibility. Based on its preclinical PK, PD and safety profile, we expect that we will be able to safely dose oral 9913 people and achieve drug levels that block the complement cascade.
Proof of concept can be very efficient in this field, Conflement assays and many validated and highly predictive disease related biomarkers are already very well established. By using these tools in our clinical studies, we will be able to see proof of concept in a matter of days or weeks in most cases with very small patient numbers. We look forward to seeing the results from our single ascending dose and multiple ascending dose phase 1 trial when it reads out in the fourth quarter. In summary, the body of preclinical evidence for 9930 suggests that we have a great molecule here. We're driving hard to proof of concept in patients, and we can do this very quickly because complement assays of disease biomarkers are so good, needing very few patients to generate convincing evidence.
We believe oral 9930 could represent a pipeline and a product with the potential to address many different complement mediated disorders. Now I'd like to turn the call over to Lynn.
Thank you, Bill. I'm also very excited about the potential of 9930 from a commercial perspective. As you can see on slide 22, the single approved IV infusion therapy for complement mediated disorders already generated $3,600,000,000 in annual sales with just 3 approved indications. Interestingly, the majority of these sales come from outside the U. S, primarily from Europe.
We believe the future market for complement inhibitors could exceed 10,000,000,000 based on the range of potential indications An oral Factor D inhibitor like 9930 has the potential to capture a significant share of that opportunity because of its upstream inhibitory activity and of course the significant advantage of oral administration compared to lifelong infusions. With full global rights to 9930 and the relatively quick proof of concept, we look forward to seeing the data later this year. In the near term, next quarter. Our key focus is preparing the organization for launch of what will be the 1st once daily oral medicine to prevent HAE attacks. As you track the at a recent competitor launches, you can see on slide 23, the market mix continues to shift from acute only to prophylactic therapy as better prophylactic agents become available for patients.
Based on our recent conversations with physicians at AAAAI, and our own market research, we expect the availability of 7353 will further accelerate the movement of the market from acute of prophylaxis. Over the past several years, we have conducted market research with HAE patients and their physicians. Both prior and post the new therapies entering the market and the results have been remarkably consistent. On slide 2425, you can see some of our most recent round of research completed in late 2018. What is striking is that even with the new prophylactic treatment options that are available, patients continued to state their strong preference for an oral option with 89% of patients including 10 out of 14 TAKHZYRA patients saying that if an oral option were available, they would try it The allergists who treat HAE say the same with 97% expecting that patients would try an oral option.
Our focus will be to customer service. Now I'd like to turn the call over to Tom.
Thank you, Lynn. As John mentioned, we took an important step in the first quarter to further extend our cash runway and enhance our financial flexibility by closing $100,000,000 secured credit facility. This $100,000,000 facility represented a modification and an enhancement of our existing $30,000,000 secured credit facility outstanding at December 31. This new agreement provided $20,000,000 of immediate additional non dilutive capital to extend our cash runway. And provides flexibility for us to draw another In addition to the non dilutive cash added to the balance sheet in the first quarter, following positive APeX-two data, which is considered sufficient to file a new drug application.
We ended 2018 with $128,000,000 in cash and investments. Of course, this amount does not include the $20,000,000 we added upon the 1st quarter modification of our credit facility. With our existing cash as well as the contingent proceeds from the modified credit facility. We have a strong cash position that provides us the resources to fund our development programs and commercial preparations deeper into 2020 and well past the readout of APeX-two and the filing of our NDA application for prophylaxis Prophylaxis HAE indication. Our detailed 4th quarter and year end financial results can be found in the press release we issued this morning.
But I'd like to take some time to highlight some information for you given the many milestones we anticipate across our programs in 2019. As you see on Slide 27, revenue for the fourth quarter of 2018 decreased to $2,700,000. As compared to fiscal 2018 levels, we expect slightly more development activity and related revenue from Galidesivir in 2019 due to planned clinical activity. In addition, we expect to ship and record just under $7,000,000 of RAPAB product sales to the U. S.
Government under our procurement contract. With the expectation that this shipment increased to $23,400,000 from 16 point specifically the increase was due to the ongoing APeX-two APeXS APeX J trials and the completed ZENITH-one trial as well as wrapping up preclinical activities that allow us to conduct phase 1 trials in both our complement and FOP programs in 2019. Given the significant clinical development activities in our 4 rare disease programs and continued development activity with Galidesivir and Peramivir, we expect our 2019 R and D expenses will increase from 2018 levels. This increase is reflected in our 2019 guidance that I will discuss in a few moments. General and administrative expenses were creased slightly in the fourth quarter of 2018.
However, upon receiving positive APeX-two data in the second quarter of this year, we anticipate our G and A expenses will increase as we build out the necessary commercial and medical affairs infrastructure to successfully launch 7353 in 2020. Regarding operating guidance, We expect our 2019 cash utilization to be in the range of $105,000,000 to $130,000,000. And our 2019 operating expenses to be in the range of $120,000,000 to $145,000,000. This operating expense as in past years excludes equity based compensation due to difficulty in reliably projecting this expense as it is impacted by the volatility and price of our stock as well as by the vesting of outstanding performance based stock options. Furthermore, with the modification of our secured credit facility and looking below the operating 2019 is off to an outstanding start with strong clinical data from the full ZENITH-one data set advancement of a very exciting compound 9930 into the clinic and added financial flexibility for the company with our credit facility modification We look forward to sharing the Apex 2 results with you when the trial reads out next quarter.
This concludes our prepared remarks. And we would now like to take it to your questions or
you. And our first question will come from the line of Jessica Fye with JP Morgan. Your line is now open.
Thanks for taking our questions. This is Daniel for Jessica. Can you talk about the technique for confirming attacks in APeX-two and how this compares to FX 1? And I have a quick follow-up. Thanks.
Sure. Hi, Daniel. It's Bill. Yeah, the attacks in APeX-two are confirmed by the site investigator in a telephone call within approximately 2 business days of when they're notified the subject has had an attack, electronically, the subjects in the study carry an electronic diary each day they record whether or not they've had an attack. And that gives the site investigator the opportunity to go through a series of standardized questions about symptoms, treatment, follow-up and the like.
And make a judgment that's recorded then as investigator assessed attacks. And that becomes the primary analysis data set for efficacy for study. In contrast, in APeX-one, we had a remote expert panel of 3 expert physicians who received a spreadsheet with what was recorded in a diary from the patient, but they had no ability no facility to contact the patient or ask them questions. So that's a significant difference.
Got it. Thank you. And then for Zinnit-one for acute attacks, a number of endpoints were assessed. Can you maybe talk about what potential endpoints Phase 3 you're thinking, that would best highlight the product profile?
Well, we're very pleased that what we saw was a rapid onset of action and sustained duration. That's what patients need for acute treat for an acute treatment. We've got a number of endpoints to choose from. It's a highly competitive area. So at this stage, we're not going to disclose what we're advancing as primary endpoints of phase 3.
And as I mentioned on the call, the next step is to meet with regulators to discuss the design and then finalize the design and start the study in the summer. So we're looking forward to that.
Thank you. And our next question will come from the line of Maurice Raycroft with Jefferies. Your line is now open.
Everyone. Congrats on the progress and thanks for taking my questions. First question is for 9930 I'm wondering if you can comment on what the half life is and if you're not disclosing the half life, is there a strategy here to have a molecule with longer or shorter half life And then how does that play into the clinical indications that you're going to pursue?
Sure. Hi, Maury. We haven't disclosed the half life, but we'll out what it is in humans, which is what really matters. And we'll find that out pretty quickly, where we actively in all of our drug development programs, including 9930, we actively work on all of the traditional tactics for formulation development, but the first step here is to find out what its exposure profile is and its PD profile and safety profile is in people. So that'll be exciting.
You have an idea based on the non human primate data?
So we've got non clinical experience in several non clinical species. The predictability of human half life on the basis of non clinical findings is rather weak. It's so wide that people in the literature declare success if they get it within threefold by the way. So that's not particularly helpful. So I think we really need the human data.
Okay. And can you talk about which indications that you're considering?
All of them. So I think that what's fascinating here is that over the last, I'd say, 20 to 30 years, the explosion of understanding of how abnormal activation of the complement system or suppression of its inhibitors leads to disease outcomes that are really very, very significant across a broad range of diseases. And we've seen from initial indications of IV treatments, just what a striking difference adequate treatment can make. So we'll we'll pick things that are the most feasible with the medical needs high and it's very attractive.
Yes, this concept of pipeline in a molecule is really important for people to understand. You could build a whole company around an oral Factor D inhibitor because there's so much opportunity. So we're extremely excited with this program.
Great. And I'll ask one more question. Just based on the half life with 7353 for acute HAE. I guess how confident are are we that you can or how confident are you that you can and talk about the some of the supporting evidence that redosing particularly with peers here in mind? Is because of short half life or is it because of patients waiting too long to dose?
Yes, the half life, Bill, correct me if I'm wrong, is in the 50 to 70 hour rate So, and you saw from the clinical data that the Kaplan Meier Curve on reaching for rescue medicine got wider and wider as you went across 24 hour period. So, the likelihood that there's a redosing necessary appears to us to be low with 7353. And what's really interesting is now there are 2 sets of data showing real world experience with the short half life acute therapies. The first one was done by the group in Berlin. I think late last year that was published showed up 40% redose rate with fears here in the real world.
And then at the AAAAI meeting, the HAE Association had a poster and I think it was around 30% was the redose rate And so that's a problem. It's a problem from a payer perspective that you've got to pay for an additional dose. It's a problem from a patient perspective because the last thing you want to do is be questioning whether or not you're going to get full coverage with the dose you took. So For emotional reasons, financial reasons, having a long acting acute therapy is a must.
Got it. Okay. Thanks and congrats again.
Thanks.
Thank you. And our next question the line of Brian Abrahams with RBC Capital Markets. Your line is now open.
Hey guys, this is Owen on for Brian. Thanks for taking the questions and congrats on the recent progress. Just on the market research slide you presented in prophylactic, the question about switching from an injectable to an oral Did that include any explicit assumptions on efficacy? And along those lines, where are you viewing the bar for APeX-two given the the differentiation as an oral? And can you share any real any learnings on the real world use you have seen from following the continued TAKHZYRA launch?
Thank you.
Yes. So in terms of the market research data, we had seen that the we had seen that our product was preferred compared to the to other products. And if you look at Slide 24, this this situation had had the question asked within a period of showing profiles of drugs. So a profile of the phase 2 profile of 7353 and the market of profiles of TAKHZYRO and Hey Garda. And as you can see, very, very good interest in moving to an oral product.
And if we look similarly at the physician slide,
they really do show an interest in really recommending and allowing patients to move to an oral therapy. I think, Owen, one other really important piece that we're seeing both when we did this research a while back before the new therapies were on the market and now with the new therapies on the market, is a consistency that patients want to try an oral. And so I think our trial usage is going to be really high. That's that we see that consistently with all the market research we've done. And so then it's a matter of what experience do they have on the drug and will they stay on it.
And we think that just if you do the simple math of looking at injections with something like tax, Iro, where you have 2 or an injection every 2 weeks. That's many injections over the course of a year versus if you have a breakthrough attack on your oral therapy, it'll and you got to inject fears there, for example, it's way less. So we think that the usage The trial usage is going to be very high and we think many patients are going to stay on the therapy because they don't want an injection.
Got it. Thanks very much.
Thank you. And our next question will come from the line of Tyler Van Buren with Piper Jaffray. Your line is now open.
Hey, good morning guys. Congrats on the progress. I guess first question was on 99 30 as well. Can you speak a little bit more about the competitive landscape with respect to Factor D inhibitors? And specifically what makes you guys so excited?
And historically, has the difficulty been developing a molecule that's selective enough where it doesn't hit the other? Serine proteases or is a potency or all the above? Some additional thoughts would be helpful.
Yes. So it's I would say complement mediated diseases is crowded, but the vast majority dozens are injectable and there's only one other oral competitor. And in a market that's this big, we think that's a really nice opportunity for 9930 The second half of your question was all around specificity. This is a tough target. That's why there aren't a lot of oral Factor D inhibitors.
Like other targets we've gone after, our ability and the capability that we have with the group in Birmingham is to identify potent inhibitors, but also specific to that target. And so we can go after things like serine proteases and kinases and the like because we have both potency and specificity.
Yes. I think that we're thrilled with the data. We've got excellent potency specificity in a PKPD safety profile in the nonclinical body of evidence. So we're very much looking forward to getting our clinical data.
Based upon everything you're seeing clinically, does it, it compare fairly well to the injectables? Or how does it compare? And also, how do you think the mechanism compares to a C3 inhibitor?
So in conversations we've had with, expert advisors who we've been having conversations with about the program, As soon as we mentioned oral Factor D inhibitor, we get responses like wow, that's the holy grail of complement therapeutics. And the reason for that reaction, and I'm not kidding, that was a direct quote. The reason for that reaction is because the alternative pathway amplifies all of the different mechanisms of initiation of the complement cascade and Factor D is absolutely essential to do if you block Factor D and block amplification, no matter how complement got stimulated in the first place, and that opens up every disease. So for example, There are great reviews on kidney diseases that are driven by abnormalities of inhibitors of the alternative pathway and they're characterized by deposition of the the relevant fragments of complement, from that pathway, they have nothing to do pretty much with the terminal cascade which depends on C5 and C5 inhibitors can't address the fundamental pathology of the disease whereas a Factor D inhibitor could So I think there are 2 things here. One is you can address all of the current diseases because of the amplification loop, inhibitory aspects and you can address diseases that are too proximal for distal inhibitors to do anything for.
So that both of those aspects are very, very interesting and exciting.
Thank And our next question will come from the line of Sergey Belanger with Needham And Company. Your line is now open.
Hi, good morning. A couple of questions on 7353. Now that we're in March 2Q is just a few weeks away, any possibility that we can get more granularity on when in 2Q we'll see the Phase III data. And then on NDA filing plan for second half of twenty nineteen, what is the gating item for that? Is it the open label safety studies or a CMC component?
So it's 2nd quarter, full stop no more granularity than that and high degree of confidence that we'll hit that. With regard to the NDA, it is the safety study that the gating factor because we need and Bill's mentioned this numerous times, we need 100 patients for 48 weeks at each dose. That just takes a little bit longer time. CMC looks great. No issues there.
And so, in fact, we're starting to write certain sections of the NDA and CMC is one of them. So, yeah, you're right. It's the safety study. That's the gating factor for filing year end.
Okay. And then, now that you have proof of concept data and the acute treatment of HAE with 7353, coming out of a quad ai and the feedback you got there, where do you think in oral is more of a game changer that in the acute treatment or, prophylactic? I know your market research definitely supports an oral product for both, but where do you think the key game changer is here?
I think there is a lot of potential in both of those markets but I see the prophylactic market as being the biggest market and also the most rapidly growing market for an oral therapy, we believe that patients who have been on acute therapy because they didn't like to have an injection regularly may look an oral therapy for prophylaxis. So we believe that is growing fast.
Thank you.
You're welcome.
Thank you. Your final questions comes from Gena Wang with Barclays. Your line is now open.
Thank you for taking my questions. Just 2. First one is also regarding the 9930 Factor D inhibitors. Just wondering how do you see 930 compared to other Factor D inhibitors in the particularly Achilles the 1st generation and the 2nd generation assets.
Sure. Happy to take a stab at that. So we're very pleased with the profile we've seen. The history of the field indicates that it can be difficult to develop these types of drugs. And so that's why we're so excited by the in vivo proof of concept with the PD on complement mediated hemolysis, tremendous dose range we've been able to dose safely in animals, the very high safety margin, all those factors give us a lot of confidence that we should be able to see effects in humans.
We'll know that very soon. So, there's, as John mentioned before, this is a huge market, which is as Lynn pointed out, growing. So there's plenty of room for more than one player here. Yes.
And as a practice, we don't compare ourselves to other therapies other than the fact that there's a bunch of injectables in the clinic and on the market. And so an oral will be a game changer here. Your second question, Gina?
Follow-up on the 930 and if you can share any thoughts on the Phase 1 trial design, indication in trial design, anything you can share with us?
So in this circumstance, the first thing we need to understand is the drug levels that we get after oral dosing and less any dose and multiple ascending dose. So that's step 1. So that's what we'll be doing.
Okay. And the next question is just quick one on APACs too. I know you mentioned just wondering if you can remind us how would you define as a lung attack?
Would you define what? We couldn't hear that.
1 attack.
1 attack.
How do you define 1 attack? I think the question maybe getting at, if you hadn't attack recently and then you've symptoms continue, is that 2 attacks or 1 attack? So there is a time window element to it. So in the field, typically, experts feel that if symptoms happen on Tuesday, when they already happened on Monday, it's really just one continued attack. So that type of thing is taken into account.
In the adjudication of the attack by the investigators.
And that's where I think this investigator confirmed attack is more important than an adjudication panel because these docs know these patients and having a dialogue with the patient helps get clarity on that point.
Very helpful. Thank you.
You're welcome.
Thank you. This concludes our question and answer session for today. So now, I'd like to hand the conference back over to Mr. Stonehouse for any closing comments or remarks.
Yes, thank you. So as always, we appreciate your interest. We're off to a fantastic start in 2019. And clearly there are some very, very important milestones ahead. And you have our commitment to be on delivering those and keeping you
on today's conference. This does conclude our program and we may all disconnect. Everybody, have a good day.