Portola Pharmaceuticals' (PTLA) CEO Bill Lis Hosts Portola APEX Topline Study Results Conference Call (Transcript)

| About: Portola Pharmaceuticals (PTLA)

Portola Pharmaceuticals Incorporated (NASDAQ:PTLA)

Portola APEX Topline Study Results Conference

March 24, 2016 08:30 AM ET

Executives

Ana Kapor - IR & Corporate Communication

Bill Lis - CEO

John Curnutte - EVP, R&D

Mardi Dier - EVP & CFO

Alex Gold - SVP, Clinical Development

Analysts

Matthew Harrison - Morgan Stanley

Vamil Divan - Credit Suisse

Jay Olson - Goldman Sachs

Phil Nadeau - Cowen & Company

Yigal Nochomovitz - Citigroup

Operator

Welcome to the Portola Pharmaceuticals Conference Call. This call is being recorded. At the end of the Company's prepared remarks, we will open the call for questions and will provide specific instructions.

I would now like to turn the call over to Ana Kapor, Investor Relations and Corporate Communication at Portola. Please go ahead.

Ana Kapor

Thank you, and welcome to Portola's conference call to discuss the top-line results of our APEX Study. Joining me on the call are Bill Lis, Chief Executive Officer, Dr. John Curnutte, Executive Vice President of Research, Mardi Dier, Chief Financial Officer and Dr. Alex Gold, Senior Vice President of Clinical Development. We issued the press release announcing the results for Portola's Phase 3 APEX trial earlier today, a copy of which can be found on portola.com in the Investor Relations section.

Before we begin, I would like to remind you the various remarks that we make on this call contain forward-looking statements, subject to risks, uncertainties and other factors that could cause actual results to differ materially from those expressed or implied. All forward-looking statements made on this call are made based on the beliefs of Portola as of this date only. Future events or simply the passage of time may cause these beliefs to change. For a more detailed description of the risks that impact these forward-looking statements, please refer to our annual reports on Form 10-K and our most recent quarterly report on Form 10-Q. Please be aware that you should not place undue reliance on the forward-looking statements made today.

Finally, this conference call is property of Portola Pharmaceuticals, Inc. and any recording, duplication or rebroadcast without the express written consent of Portola Pharmaceuticals is prohibited.

With that, I will turn the call over to Bill Lis, CEO of Portola.

Bill Lis

Thanks Ana. Good morning everybody and thanks for joining the call. I'm just going to make three quick points and then we're going to then open it up for questions. I think you all realize this is a really important day for Portola. Since its founding Portola has one path, one mission to make significant advance in the field. We firmly believe with the APEX data that we certainly made a significant advance in the field of thrombosis. On behalf of Portola, I'd like to thank our academic leaders, the patients, the investigators that participate in the APEX trial and then publicly thank those who helped us to fund the trial.

What's important is we put out the press release yesterday and because of the complexity and the uniqueness of the analysis plan for APEX, we decided to provide more data than usual, more data than we had planned, and this is really just to help you formulate an opinion. We understand the complexity of this, so hopefully we'll provide some clarity today but we're not going to provide -- to be able to provide a lot today, because just in about two months from now we're going to be presenting a lot more analysis from the clinical trial, the full data set, a lot of pre-specified analysis which are important to understand what we believe is a clear clinical benefit of this drug in this patient population.

We're also hoping to publish simultaneously. So, we're very limited in what we can say today and in addition we hope to have -- to be having discussions with the FDA in the very near future, so that limits to what we have to say today. With that said again hopefully, we have provided to you more data in the press release than you're used to, to again help you guys in some of the opinions that you’ll form and help you make some decisions. So, that's all I have to say.

And with that I'll open it up for questions.

Question-and-Answer Session

Operator

Thank you. [Operator Instructions] Our first question comes from Matthew Harrison from Morgan Stanley. Your line is now open.

Matthew Harrison

So if I can ask two, I'll ask the first one and then maybe can ask one after that, first, can you provide us any examples that you're aware of where companies have (a) either been able to file when you fail the sequential testing procedure, or have drugs that have been approved, and when you fail the sequential testing procedure and just how -- if you can give us any context for how Cardiorenal might deal with this kind of data set?

Bill Lis

So first, this is not going to Cardiorenal, this is going to the Hematology-Oncology Group as part of [SEDAR] [ph], so a point of clarification for folks, so this would be the groups that approve the Factor Xa inhibitors for the VTE indications not the atrial fibrillation or acute coronary syndrome indication, so really Matt it's a good question. It's just unprecedented territory. Historically when you do sequential testing procedures, usually you will start with the largest data set and you work your way down to smaller data set and enrich patient population. Remember we made the decision here to do something different based on the FDA guidance documents that was published which encouraged and recommended to companies to enrich patients in the form that we did and so after discussions with the FDA and EMA that's the decision that we made to identify these patients who are at higher risk and likely to have more benefit.

So, that's one of the things that we're anxious to speak to the FDA because we're at some level we’re in uncharted territory, especially in the field that we're in, we're really the first to do this. So that's why when we talk about, I mean people will have their opinions we understand that, that there's differing opinions, but as we look at it today with our -- as we look at our top-line results and then obviously the additional results that support when we look at it, we look at it through the lens of we think that the data stand on their own, there is a lot more analysis to come that are pre-specified but really the top-line data stand on their own and that we believe that even Cohort 1 is sufficiently strong for us to allow us to do a formal and proper analysis of Cohort 2 and Cohort 3, we believe that. And then as you work through and obviously if you see the P-values and robustness of the data, most importantly in the overall patient population for where the real power of the study the greatest power of the study I should say, then you see how we come to the conclusion that we really believe that we will be able to file this drug and we believe there's a good chance still we're confident that we can get approval based on the APEX clinical trial.

A lot of it's going to depend on the consistency of the data, remember whether the trial was -- the first cohort, we didn't hit P-value of 0.0 - 0.05 or not, the FDA was always going to look at the totality of the data because of the uniqueness of this, Cohort 1 was going to be looked at in a number of different ways, Cohort 2 was going to be looked at in a number of different ways, cohort 3, there are a number of sensitivity analyses that were set up because of the uniqueness of this, so it's really a totality of the data, remember you've seen the top-line data where we showed to you, there's a consistency, 20%-20%-24% we see that as the consistency of the data across the primary cohort in a [Indiscernible] size. And then you look at the flip side of it Matt, I mean this was unexpected, remember we got a little less efficacy than we thought, but we got a lot less bleeding than we thought. So, this was really surprising and as Ander Cohen our study Chairman said, this was the first time that has been seen, we have never seen a robust reduction in clinical benefit without a statistically significant increase in bleeding and so as we said in the press release, that's why it was interesting I think -- we get to the same net clinical benefit that we've planned, we just get to it with different paths I mean we're almost spot on.

So this is the lens we're looking at it. Now we know there is a differing opinion. We're not trying to bias too much. We understand how the [vesting] [ph] procedure was set up, we understand people may want to be a purist about the P-value of 0.0 - 0.05, we understand it, we're just looking at it through a different lens, and so hopefully that gives you some sense and back to your question, what is the precedent well, we really don't have any, but we sure hope the robustness and the consistency of the data if all of the other analysis show that, so symptomatic of that, the demographic data, the data according to the admission diagnosis, all of the supportive data around bleeding, we hope to support the package for a submission that is what we currently believe right now, and that's why we look forward to, we're not going to say too much today because we have got a presentation, we're hoping for a simultaneous publication at ISTH it's only two months away, we know people want to see the data, we've only seen it for the last two days or so, so we have a lot more to do.

So hopefully that gives you a sense of the lens of what we're looking through and those of us that are close to it so why we still have a confidence level with this, again hopefully we deserve a lot of credit. We've advanced this deal significantly, no one has been able to do what we did in this clinical trial. As a matter of fact most people said you have no chance. So clearly, the properties of Betrixaban stand clearly when you use it in enriched patient population and you combine those two together, there's something special that could be had from the results. Now we've got to get through the technicality, there's no doubt about it there's a headwind with it, we're not trying to deny that at all. It's not what we're trying to do here. We're just trying to say that the FDA from the start with this closed testing procedure of this new enrichment strategy for which we're the first company to do it that it is the totality of the data whether it was overwhelmingly positive and as we plan or positive as we see it today through a different lens.

Matthew Harrison

Thanks, Bill. And if I can just follow-up with one other question. Can you just, I mean you touched on this a little bit and I am not sure that if you can comment. But can you either, (a) comment on what you view is the sensitivity to this analysis? Obviously you [atypically] [ph] reclassified patients, moved some patients around and so one concern maybe that the initial p value you provide may look very different when the FDA reanalyzes the data. Any comments you can make about that or separately any comment…?

Bill Lis

So I am not going to make it long and I am going to let Alex, our Head of Clinical Development. Precisely, we know what those pre-specified analyses are. One of them we had discussed with you previously. If you remember last summer when we said look the FDA is looking through the primary analysis cohort through few different lenses, when the events occur we talked about these windows. Regardless of window, window of 35 to 42 days what is the appropriate way, so we’ve already built those sensitivity analysis in such as that; Alex do you want to comment further on those and then maybe the other ones that…?

Alex Gold

As Bill mentioned the full details will come through in the publication because we just started these analysis. But you’re asking a good question in any case as Bill said there will be a consideration of different sensitivity analysis, redefinitions to explore the robustness of the data and the overall theme is based on the more data you get in so if you remove your restrictions for example on the follow-up of the ultrasounds, if you substitute the analysis for D-dimer of the local lab with a central lab and a variety of different other approaches will all be important for us for the scientific community and for the FDA to assess the robustness so we cannot discuss the full extent of these results today. But as we start the -- as Bill mentioned the overall theme we’re seeing here there is a consistent result and the result across the groups that you have seen already gives you the sense of how consistent it is. And so that gives us a lot of optimism that this is something that we will submit to the agency, and we’ll be able to file, they’ll be considering the full extent of the data, the sensitivity analysis and that this was a positive theme and overall is a positive result for the trial.

Operator

And our next question comes from Vamil Divan from Credit Suisse. Your line is now open.

Vamil Divan

So just two if I could, one, and I'm not sure how much you can talk about this right now versus once all the data is out. But is there anything early on that you’re seeing that maybe explains why the results are so I think different from what you’re saying you’re getting to the net clinical benefit but in a very different way. Is there anything that you’ve seen in terms of the patients or the way the data is playing out that can maybe help explain some of that again I appreciate if you can’t share much on that point right now? And then my second one is I guess as you start having these discussions with the FDA, if there is a need to do another large Phase 3 study in order to show the benefit on the primary endpoint, is that something that you feel you’d be willing to do and are able to do that given your current financial position?

Bill Lis

Yes, so I’ll take the second one first, Vamil, I think again we have not looked at the second because we really believe that data is going to stand on its own in APEX. And again I think look at this through the lens of the significant unmet medical need and what we’ve accomplished compared to others that have tried. And again we look at it through the lens of its robustness. So we’re focused on this dataset it's a large dataset, we think there is sufficient power at least in the overall study population to come to some definitive conclusions. The question for the agency is from a technical standpoint can we get through and do those analyses in a formal way and present them along with the sensitivity analyses for completeness and whether that’s how the drug will be judged for approval. We believe if we get it through to that point then we have a very-very good short and so that's what we are focused on at this point.

With regard to the patients, I think we're going to -- well what we know is, we did what we planned and then it is we got the highest risk population in the rich population that's ever been studied. So I think that that's also important to keep in mind remember the frailty of these patients I think John you were telling -- John Curnutte was telling the other day we have patients over the age of 100, the average age is over 75, these are sick frail patients and the ability to show a clinical benefit without an increase in major bleeding I think is all that more important, given the risk I mean, we have got event rates that are very-very high, if you consider just within a 35 day period or a week or two thereafter on a very short period of time even given the standard of care, these patients are still suffering a high event rate, so that's the important part of it. I think that's what I can say from a patient standpoint and with respect to the D-dimer patients the age greater than 75 as we said before and we've published that, we know that there is an increasing enrichment for these patients and again we're hopeful that we've demonstrated some consistent benefit over these types of patients that we've studied.

Vamil Divan

Okay. Thank you.

Bill Lis

So I think, the important thing, a lot of the questions and what you're all going to ask, so Matt, Vamil I'm sure all of the questions you are going to ask, we're going to be able to answer to a very large extent in just a few minutes at the ISTH. So we wish we could do it sooner, it is really a shame if you got this data, right before ACC, we really wished we could have the ability to present it just next week at ACC, unfortunately we'd like to publish simultaneously as well, it's very important to us that we present and publish and so for that reason, we believe ISTH is the best time to do it and it's not too far from now.

Operator

And our next question comes from Jay Olson from Goldman Sachs. Your line is now open.

Jay Olson

I guess first of all, can you just talk about the -- how the magnitude of the net clinical benefit compared to your expectations? And then what you think the FDA's expectations are for an approval drug in this setting?

Bill Lis

Yes. So it's a good question, Jay. All I could tell you is what our expectations are, we never sit down with the FDA, we don't talk for example, do you need of P-value of 0.0-01 precisely from the overall study, we talk into the terms for net clinical benefit, never really discussed, we know it will be reviewed, we talked about the fact that it will be reviewed. So we put some parameters in place. Alex, maybe you want to comment, to how we do that and then we'll have that data at -- well we commented on a little bit so I will let Alex speak and then I'll comment further.

Alex Gold

Sure, yes it's a good question. There is no predefined threshold as you just heard from Bill, you can gleam at the trends obviously and see that we have a reduction that is in-line with what many trials have shown and have been considered significant from the clinical standpoint and that is reflected I think in the quote that you see from our Co-Chairmen of the trial, who is one of the world leading authorities on VTE, prevention and treatment. And so I think you can see there that this reduction in events is clinically meaningful and that's what we find certainly compelling on the background of the fact that there is no significant increase in major bleeding and that is unprecedented if you look at the prior trials in this space with Factor Xa inhibitors. So I think that short of what we will present when we complete the analysis, where you will see the actual calculations, I think what you can gleam is that there's an effect that is recognized as clinically meaningful and what's important is that the penalty is no significant increase in major bleeding which is really differentiating based on state of the art and in prior trials in this space.

Bill Lis

So then back to what our expectations were, so you know Jay we said what our expectations were. If you remember based on the beginning of the study actually you had been following us at that time but we were -- we said that we were expecting a somewhere around 2.5% absolute benefit and then we commented that we hope not to have more than 1% absolute net harm or something close to that. So we were hoping 0.7, 0.8, 0.9, going against you now it's not a precise math and that clinical benefit is calculated differently. But that gives you a sense if you take one minus the other where we were thinking the net clinical benefit was.

And in the overall population and even to some extent in each one of the cohorts we’re just almost spot-on. So that’s important. Again, as I said we got there through a little bit different path and that the efficacy was a little less than we had thought and that’s probably what you see in the P-value of cohort 1 for sure and maybe a little bit cohort 2. But the bleeding is absolutely a surprise to us that it formed that well, given the fact that we showed robustness of clinical benefit, so that’s the surprise. If the 5% or 10% and remember in the ADOPT trial the 13% relative risk reduction and they had a doubling of the bleeding, remember in the -- so we get through all the trials that has been done what it takes we have the most drug event and the least amount of bleeding. So I think betrixaban has earned a little bit credit here.

Jay Olson

Can you give us some idea of when you plan to meet with the FDA and how long it will take before you determine whether or not you can file an NDA based on APEX?

Bill Lis

I am sorry I think that -- can you repeat that to me?

Alex Gold

When you’ll meet with the FDA?

Bill Lis

We’re going to try to do it as soon as possible. We’re going to try to do it as soon as possible.

Jay Olson

When do you think a decision can be reached in terms of fileability of the APEX results?

Bill Lis

We hope soon, I can only use the word soon because -- but we have fast-track status, we hope that gives us the opportunity to speak to them soon and we’ll keep you posted. I think what you’re going to hear from us Jay over the next few months hopefully again at ISTH you’re going to see a lot of data. We’ll have a lot of meetings and opportunities for a robust discussion around that data. We’re looking forward to that and then hopefully in the very near future we’ll be speaking to the FDA and we’ll keep you full up-to-date on that, so this will probably be material meetings and we’ll communicate. We’re going to try to be as transparent as we can I mean we’ve always done that, done it that way.

Jay Olson

All right, thank you.

Operator

And our next [Multiple Speakers].

Bill Lis

And actually the important point is that hopefully the FDA again we -- they recognize the -- there is nothing available for patients that are medically ill at high risk for clots and are discharged from the hospital, so nothing available.

Alex Gold

Yes, and that is the reason why fast-track was granted for this drug in this study. So, the answer under the umbrella of this fast-track our plan is it really means fast we will get in touch with the FDA as soon as we can, which is almost immediate and we will plan to schedule the meeting and proceed through the procedure of submitting the data to them and have the conversations.

Operator

And our next question comes from Phil Nadeau from Cowen & Company. Your line is now open.

Phil Nadeau

I guess just first on the statistics. Bill I think you have made a case why this trial could be considered a positive study. But there is a separate issue of being able to file on a single study. And in the past you suggested that the statistics necessary for that would be somewhat higher or somewhat more rigorous than needed to consider a trial positive. So, what is your understanding for what the FDA looks for and as a single study filing and maybe can you just talk a little bit more about why you think this meets that even now that, there is only one P-value less than 0.01?

Bill Lis

Yes, I think it's all focused on the overall patient population, that's where the focus begun and as we've mentioned all along that our hope was to get a label for the overall patient population, our goal was to show, uniqueness and distinction of benefits for the D-dimer group and the D-dimer or age greater than 75, we had hoped that they could stand on their own, but I think now it comes down to the overall patient population and the efficacy, safety and net clinical benefit, so that's specifically how we feel.

Phil Nadeau

Okay, then secondarily on the dosing, it does seem like the relative risk reduction is maybe a bit less than we'd though on the VTE point and the bleeding is certainly less, would there be any benefit to dosing more aggressively to maybe get a larger magnitude of effect even if you do sacrifice a bit more bleed?

Bill Lis

Yes, I think it's a real good question, you think about that. You just don't know, and you are always trying thread this needle, what we believe again, if these data can't stand on their own, this is the best clinical profile that you can get, right because physicians, as you've seen in this field, physicians are becoming more and more concerned with bleeding especially in frail patients, so could you get more efficacy, we're going to wait to see and look at all the sensitivity analyses, again robustness of data, we are going to take a look at the -- as Alex described, some of the other ways in looking at the individual cohorts and also wait to look at the symptomatic events, but as we look at it, like this, if we could have thought, if we thought at the beginning of the trial, we could have got a 25% relative risk reduction with no increased bleeding, we would have probably powered and set up for that, just it is surprising, we just -- I'd have thought again we're looking through the lens of ADOPT 13% relative risk production, you're already getting an increase in major bleeding.

So we just didn’t think it was possible, so it's a great question, we have pondered it I think you've seen, we've presented the beta now in our concentration average and how it compares to the adopters of the VTE dose of Betrixaban and where it is for rivaroxaban and we kind of wanted to put ourselves right in the middle there and then we thought the properties of this half life and the renal would provide additional benefit, it appears that happened, so for us, we think, we threaded the needle we just didn’t hours of study for this bleeding and efficacy profile, so except in the overall population in cohort 2.

So hindsight it is always 20-20 that and again you learn a lot from these studies it is still total ground but from a clinical standpoint to be asked about the profile of the drug takeaway the statistics are important, we know they are important we know that ultimately that the statistics will judge the drug and the outcome of APEX. But as you look at the clinical profile of this, this is -- I mean asked -- you just ask physicians if they want a 35% of relative risk reduction and a 40% increase in major bleeding or a 25% relative risk reduction and no increase in major bleeding, I think you're going to get about 100% that want the latter, so that's different that is -- you would say could you really just -- because you want it back in time, because you really want what you asked for the first time I mean like that is what I am -- I think, right at now, I can talk -- I get though of the technical issue of the 0.054 and set it 0.05 on the first cohort and have further discussions with the totality of the data, so R&D for this drug, that's how I did -- I am more managing to that as clinicians and maybe others will differ, again we are not -- I'm not trying to bias people too much today, I think we want to let people make their own opinions, they can look at the data and you can judge so that's why I mean we'll answer questions but that's how [Multiple Speakers] I think.

Phil Nadeau

I guess just to push you on that point you just made, in some of our conversations with the physicians they did suggest they wanted to see like a 30% relative risk reduction in order to change standard of care or for the standard of care to change principally, is that not the same feedback you've gotten or do you think that those physicians were assuming that to be higher bleed risk than what we saw…?

Bill Lis

Well, I think that through the lens I think again it is unprecedented physicians are always seeing more bleeding right when you study versus placebo or active control you seek superiority, bleeding is always higher. So, Alex can make a comment. So I think they would look through the lens that we do and that’s why we went after the 30% to 40% because we felt we’re also going to be a 30%, 40%, 50% increase in major bleeding, all we were hoping for that is that if income was excess intracranial or fetal bleeding. In our case actually the directionally the intracranial bleeds they were betrixaban and noted that not --so anyway I think it's how you look through the lens you always when you ask a physician how much do you want to see the change in the standard of care, and the question is always is how much bleeding are you willing to accept as well this was the thread the needle that we always do.

Phil Nadeau

Great, thanks for taking my questions.

Bill Lis

So again we think we got there, we think we got to what is clinically meaningful we just think we got there through a different path. We were -- it was a little surprising result.

Alex Gold

Yes, I was just going to add that of course you know but remembering that this is a comparison against standard of care. So this is additional reduction beyond the current standard of care that is in the 20% to 25% range and of course if you ask physicians would 50% reduction be better, of course it would be. But if you look at all the previous recent trails that were reported all of them had a penalty of bleeding. And if you look at the actual reactions of physicians when there is the penalty of bleeding it's not a positive reaction, they always see it as a significant negative. And if you look at the precedent in this particular field and how people reacted to the imbalance and fatal bleeds experienced between the two arms, it was not a positive reaction. So here seeing this balance and actually numerically lower intracranial hemorrhages in betrixaban arm and no excess of fatal bleeds, that’s a significantly important background underlying this additional efficacy that potentially maybe seeing here with against the standard of care.

Operator

[Operator Instructions] Our next question comes from Yigal Nochomovitz from Citigroup. Your line is now open.

Yigal Nochomovitz

I just wanted to ask about cohort 3 it was interesting to me that you sort of saw the best risk reduction there with the lowest P-value. I mean obviously you had structured the study based on looking at the MAGELLAN subgroups to enrich in D-dimer in age over 75 though with the 0.76 risk reduction in the overall it would suggest that that 9% incremental patient population that’s non-D-dimer and under 75 is actually doing surprisingly well given the hypothesis around efficacy for APEX. So I was just wondering if you could comment on that, because that seems to [Multiple Speakers].

Bill Lis

Great question, when we do these large trials Yigal we’re always surprised by something and that so I think it speaks to the expertise we have on our academic leadership. They always were an important patient population because remember they are D-dimer negative, they’re under the age of 75, those are two independent risk factors in and of itself. But remember we put two additional risk factors on them so they are a very high risk patient population in and of itself they don’t have the highest event rate but certainly they respond to treatment. The question is then how are they different than the D-dimer, I think we’re going to find out a lot, it's interesting is when we went through this enrichment and you can look at the enrichment documents in Dr. Temple’s document, he talked about this -- sometimes you find out things about the enrichment during the study and we have to access that. And that’s why we did I think Alex mentioned some of the pre-specified additional analyses that we’ll do around the D-dimer patient population, it is our guess we’re going to find out a little bit about this biomarker and some of the noise. And then you’ll be able to get clarity as to where the robustness is I think again we’re the first study to do it from a prospective standpoint, the folks at J&J admires it from a retrospective.

I think at the end of the day you're probably going to see consistency of data as our guess, you're going to see more consistent, so at the end of the day, and my guess is because again this is the powering thing and then there's some sensitivity around how data is collected, at the end of the day my guess is you're going to see more, it will be more consistent, the APEX data will be more consistent with what we're seeing in MAGELLAN than not, I think it's just going to be, you can't see it in the top-line but we will see, we've to crunch through some of the data and it is going to be very interesting presentation at ISTH and I really hope we get a publication that is simultaneous because these are all really good questions and I think that the really answer the field is looking for, again I think as I said in my opening comments, this is a major advance to the field this study, this is a landmark study, and I think you'll start to see some of that come out when we of course start presenting at ISTH and publish.

Yigal Nochomovitz

And just a few other little questions here, can you just say at this point, what the baseline of VTE rates were in the three cohorts and can you say that whether the analyses from your CRO and Duke were basically in alignment on what you're representing today?

Bill Lis

Yes, those are two great questions and I think, those are questions that I can't answer today, but we'll be happy to share and we got ISTH, so it is hopefully it's not too far, it's just two months from now but those are all the question that would be answered specifically, very specifically.

Yigal Nochomovitz

And then just one quick thing [Multiple Speakers].

Bill Lis

Matching wise, that is matching wise we are good at it.

Alex Gold

One of the conditions for us to lock the data base was to ensure that this matching between the independent group and the CRO was performed and we received that confirmatory of the executive committee received a letter, so to answer that question, it was done, it was a precondition for locking it's a so [Multiple Speakers].

Bill Lis

But someone mentioned earlier, certainly the FDA is going to do some analyses as well of the beta I mean this a hairline the P-value of 0.054 is just right on the line, if you knew the forest clock you’d like right on the line of munity so I'm sure there is going to be additional analyses that will be done by the FDA as well.

Yigal Nochomovitz

Are you going to at ISTH, are you planning to show us both analyses from Duke and the CRO or are we just going to get one?

Bill Lis

It's one, it matches, so it's one.

Yigal Nochomovitz

Okay. And just one last thing [Multiple Speakers]. Okay.

Bill Lis

The other analysis will be done, other -- again in the future there might be something that the FDA does or something that we do, that the FDA requests of us slightly different way but no for the top-line results it is -- and the additional results that secondary analyses will come from what we call the collaboration of the two so.

Yigal Nochomovitz

Okay, and just to confirm to file, whatever you decide to file on, assuming it’s overall, the criterion was 0.01 or better is that correct?

Bill Lis

Well, it is -- we are going to talk about what -- we statistically and precedents have shown P-value at 0.01 or less allows for a single trial approval, that's what we have from precedent but there's never a discussion with the agency, they always want to look at the totality that is what they said, we will look at the totality of the data and its robustness and net clinical benefit so.

Yigal Nochomovitz

Okay, got it. Thank you very much.

Bill Lis

But that's why the P-value there in the overall population is important to us.

Operator

The Q&A portion of the call is now concluded. I would now like to turn the call back over Portola Pharmaceuticals for closing remarks.

Bill Lis

I just want to thank everybody, it's a important day for Portola as I said, we look forward to further discussions following the ISTH presentation and hopefully, publication and then if there is any updates on the FDA front to how -- we will keep people updated.

Operator

This concludes today’s conference call for Portola Pharmaceuticals. You may now disconnect.

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