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Tim Coughlin - VP & CFO

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Robyn Karnauskas - Deutsche Bank

Neurocrine Biosciences (NBIX) Deutsche Bank's 2012 dbAccess BioFEST December 4, 2012 10:45 AM ET

Robyn Karnauskas - Deutsche Bank

Great, thank you very much. My name is Robyn Karnauskas for those of you listening to the webcast. I am DB technology analyst at Deutsche Bank. I am very excited, next we have Neurocrine Biosciences and Tim Coughlin is here from Ukraine and the Vice President and Chief Financial Officer. For those of you who are listening to the webcast, feel free to email me with any questions you have at robyn.karnauskas@db.com or if anyone is brave enough, feel free to ask the question here in the room.

So thank you very much, thanks for coming.

Tim Coughlin

Wells thanks for the invite Robyn. We have a long relationship with Deutsche Bank. I am glad to be here. It is always a great meeting, always a great line up of one-on-one investor meetings. So we’re really happy to make a trip also. Before I go on, I have to remind you of our safe harbor. Our latest 10-Q was filed about a month ago with the SEC. I am going to be making forward-looking statements here.

So just a quick overview of Neurocrine Biosciences. We’re a drug discovery company focused on neurological and endocrine based disease sate. We develop drugs for proven biological targets, diseases with high end medical needs through a discipline but entreprenual approach. Our two lead programs are elagolix and our VMAT2 inhibitor and the NBI-98854. Elagolix is partnered with Abbott right now since Phase III studies for endometriosis and Phase II studies uterine fibroids to generate antagonists to basically work to kind of dampen the hormonal reproductive cascade lowering estrogen and progesterone levels in women which (inaudible) a disease endometriosis uterine fibroids. VMAT2 inhibitor works presynaptically to lower the levels of dopamine and that drug right now is in study for a Phase IIb studies for tardive dyskinesia.

So with that, I'll turn it over to Robyn to start the questions.

Robyn Karnauskas

Right so, I mean if I look at it from my perspective, I am still surprise how many people either ask me when I talk about Neurocrine, either ask me about the Abbott program and they don’t even know about the VMAT2 or are not even that familiar or they really are down forward about VMAT2 program following some of the confusion around the Phase II. So thought it may be good first of all to talk a little bit about, just remind investors about some of the controversy around the Phase II programs. Just help us understand better, how there can be variability around it and then after that we can talk about the checks you put in to place and how comfortable you are.

Tim Coughlin

Sure, so I think you’re right. I think the investment community looks at Neurocrine, places a value essentially on the cash on the balance sheet as well as elagolix maybe a little bit for VMAT2 but not as much as we would have hoped by now had that Phase II right out completely positive. One comment I guess I'll make before I go further is that we spend a lot of time looking at the data for VMAT2 after we got the readout of the 1101 study and a lot of hard work went into designing the controls that we put in place for the new 1201 study to prevent this from happening again. So in the 1101 study, there was 32 patient study, the crossover design looking at 12.5 milligrams and 50 milligrams of 98854 VMAT2 inhibitor against placebo into each group, each subject in the trial was their own control fluids. There is placebo arm for placebo period for two weeks and an active period for two weeks for every individual in a trial. So 32 placebo read out essentially. And then 16 and 16 in the 12.5 and 50 milligrams dosing.

The primary endpoint was the AIMS comparison at the end of the placebo period to the end of the active period. The AIMS assessment of the seven, you look at seven body regions, the arms, the legs, the chest and four positions on the face, the jaw, the tongue, facial expression and each of those is given a zero to four scale rating. So zero means there is no evidence of tardive dyskinesia or irregular movements. One is minimal, two is mild, three is moderate, four is severe. And you take those seven different rating areas and add them up and you come up with average score. I think in this study, the baseline score is 14 which is what you would expect in a tardive dyskinesia study. Now you wouldn’t expect anybody to go up to 28, anybody in the low single digits is mild, we’re looking at moderate to severe patients.

So the eight scale has a lot of judgment in it, its historically been used more as a safety scale and when people and physicians use it as a safety scale and this is investigating anti-psychotic drug, when they use it as a safety scale to more of an on-off switch. And do they have 2D or don’t they have 2D and the nuances of this scale really don’t get worn out. We’re using it as the FDA recommended an efficacy (ph) scale and as these patients came through the trial, we had eight sites in this study. Seven of the sites performed fairly well. There was one site where the AIMS was just completely misapplied. And that one site had scores that were inflated and also scores that didn’t correlate with the video evidence because we had all the AIMS assessment video tapped.

So when the (inaudible) originally read out, we sat down as a team, Chris O'Brien our Chief Medical Officer brought in the results and what we expected to see out of the trials, the 12.5 milligram would be minimally effective and not really separate from placebo. Show a little signal but not much. We expected the 50 milligram based on our PK modeling and our previous Phase I studies and our early open label Phase II study that’s a 50 milligram is going to work spectacularly. When it came in, the 50 milligram works slightly better than 12.5. so the first thing we thought is, okay, well maybe we don’t have the PK exposure, we don’t have drug on board, so we immediately looked and Haig Bozigian, our Chief Development Officer went, looked at all the PK records and we found that yes, we do have drug on board, then we moved next to okay, what's going on with the individual plot to the AIMS, we brought in, all 32 patients scores and plotted them on a graph. And when you look there is a clear separation between those who are in the other seven sites and this one outlier site. And all of the patients are coded so you don’t know who they are but the first three digits of each patient determines what site it was, when you looked at the graph you could see that this site 00X was out of whack.

So what we did that night is we put people on a plane to fly to that site to look at the video tape. Before we released all this information to Wall Street, we wanted to make sure we understood everything. So we put on a plane to fly there, they went and looked at those videos and determine if these things do not match up with what the scores were. We also went to sites that we thought performed well and looked at their videos and they did correspond to the scores we were given.

So we looked at approximately half the sites before release the data. We took that data, compiled it, pulled out the one site and released that to the street and showed street essentially here all the sites together and no we did not hit significant but if you pulled out this one site where we have a problem, that site, it shows significant and separation of placebo. After we finished that, we then set around the one individual who is one of the worldwide experts, who looked at every single video in a blinded fashion at every single site, rescored them and that again showed a significance in the separation placebo and release that data I think in June of this year.

So that’s kind of the history and there is some variability among raters but it shouldn’t be to this level. Because you are going to have some variability but not to this extent that we had. We people in this at this site who are rolling the trial, it shouldn’t even be qualified for the trial. That’s how we agreed to see how this work.

Robyn Karnauskas

Talk to us a little bit about variability with AIMS, like so when you are looking at each of these different I guess body regions and you are scaling there for awareness that variability comes, is it telling who is more, I am just trying to understand where that variability…

Tim Coughlin

So the variability comes from really looking at it and there is nuances you can tell a zero and you can tell a four. It’s the one, two and three where it kinds of gets the nuances and it’s more obviously art than science. And the variability comes with experience and the variability is reduced with experience and training. And so what we've done in this current trial is we've put in a mandatory training program, we had on before we actually ramped it up this time. So every person who is doing (inaudible) in this current trial and our future trials has been trained and we've really shrunk down the error margin. So they have to pass a test to be able to be an (inaudible) in our trial and we shrunk down our error margin to deal with the variability in the trial.

Robyn Karnauskas

Is the real test just figuring out whether someone is a moderate too severe patient or a mild to moderate or is it really within, or is it what we’re talking about before on offline (inaudible).

Tim Coughlin

So what happens is some people mistake and this depends on the level of experience, any sort of movement to sort of tardive dyskinesia. So someone with a Parkinson moving so that’s rhythmic where a tardive dyskinesia is more erratic movement. So that’s a small piece of the challenge because you can keep those people out of your trial. I think where you are getting (inaudible) is that the nuance between a minimal and moderate, there is some there and that’s probably why we put it in the sector training trying to shrink that down and make sure we don’t have minimal folks in there. We’re also putting controls that we’ll talk to a little bit later to keep those folks out from a third party basis as well.

Robyn Karnauskas

And when you said that there are people that should have been in the trial where you really just to clarify there was more mild patients with a moderate…

Tim Coughlin

They were mild patients. These are people that rank as probably four overall when they were given a ranking by the site out of 15. So clear differential there.

Robyn Karnauskas

And some people look to the placebo, they are like well, but the placebo seems fine. Why were the placebo fine versus like the active was not, it was a little off. Can you help us get comfortable there? That seems to be one question I get a lot.

Tim Coughlin

So if you remember, everybody has their own placebo. So what we did is, in this site they had five people out of the 15 in the 50 milligram to taking the third of the patients out. In the placebo arm, we’re taking seven out of 32, so we are taking 20% out. So that’s a reason we see it already, the question we get often is why did the placebo not change as much as the 50 milligram and that’s because there is a larger percentage in there. Additionally this site had a couple in the 12.5, you pull those out, it didn’t drop out numbers less than 20% to 12.5 as well.

Robyn Karnauskas

And then another question, I know the answer, another question I get a lot is, Robyn does it make sense to you that it would be the one site that has so many of the height of patients.

Tim Coughlin

So we get that questions Robyn and the interesting thing is, we have nothing to do with the randomization, that’s all handled by a third party and its just by chance that they ended up with five of the 50 milligram. We’d like to have it spread where each site got 2 of the 50 and its (inaudible) 2 of the 12.5, yes that will be ideal. We have no control over who gets what doses.

Robyn Karnauskas

Now have you told the site that they have a problem?

Tim Coughlin

No.

Robyn Karnauskas

You haven't told them. They figured it out?

Tim Coughlin

I don’t know.

Robyn Karnauskas

Okay.

Tim Coughlin

We aren't using them in the future though.

Robyn Karnauskas

Got it, they might figure it out. All right so when I think about the checks that you’ve put in place for the new trials, it will be good just to outline those?

Tim Coughlin

Sure, so I think the best way to do it is to put in to kind of three groups, the first is which I've already spoke to is, kind of the things that happened before the targets initiated and that’s a train and so for each site what we've required is that you have a treating physician who interacts with the patient and let`s say the visit of three hours because by the time they do all the blood draws, the assessment etcetera, it’s about a three hour visit. Well that physician, the treating physician stays at the patient for two hours and fifty minutes of the assessment, the five weekly visit.

We have a separate person at each site, independent person who is the AIMS assessor and they come in for the 10 minute AIMS assessment, and that’s the only time they see the patient. And that helps because there is a level of comfort to get still between the patient and the physician during those 2.5 hours rather than just having an independent person come and do the AIMS assessment. That person who is doing the AIMS assessment as I mentioned before has to be pretty qualified to do that and meet our strict criteria to come in. so once we got that established, when a subject shows up at the site for a screening visit, so now we’re going to talk about the screening visit, the screening visit and the AIMS assessment is done and video tapped and the independent AIMS assessor at the site does that video tape assessment is then uploaded into a file and that file is reviewed by an independent group that we've hired, the same individual that went around the country and looked at all the AIMS scores. They look at every single AIMS assessment and for AIMS only, they give a thumbs up or thumbs down, whether or not that person gets into the trial. So we've now eliminated the issue of enrolling people that are minimal or mild tardive dyskinesia. This person will make sure that only folks that moderate to severe tardive dyskinesia can get into the trial.

As an aside, Chris O'Brien our Chief Medical Officer also has access to look at these videos and he will use them as well just to kind of a third check, he doesn’t have to override anybody but he looks at it just to make sure things are going along the way they should. So now the patient has cleared both the hurdle to get into the trial per site at the independent reviewer now they are in doing visits and they come in for the first AIMS assessment after two weeks of dosing. But AIMS assessment again is, all the AIMS assessments are videotaped, uploaded, that AIMS assessments is then reviewed again by these QC folks who make sure that the AIMS is being applied properly. If for some reason we find that the AIMS isn't be applied properly, we then call that site and instruct them, hey this isn't working the way it should. We provide them with education again, get them up to speed, requalify them et cetera.

The next time that site has the same issue, that site is then prohibited from enrolling any more patients into the study. So two strikes and they are out. They can’t enroll anymore patients. Anybody that’s in the study at that site continues on and the important thing is that the scores given out to site stay. So no independent third party can get rid of those scores. These scores are given to the AIMS assessment, even if it’s wrong, we believe it’s wrong, that score stands for the primary endpoint assessment at week six.

Robyn Karnauskas

So I only have few key questions about that, I guess so first you have an independent assessor at baseline to determine comes in, he does the AIMS score, that independent assessor. Is that the score that sticks?

Tim Coughlin

No, so that’s only for screening.

Robyn Karnauskas

Just for screening.

Tim Coughlin

So after they are done screening and this person all they are saying is yes or no. it doesn't say in the trial…

Robyn Karnauskas

And they have the video and then someone says yes or no.

Tim Coughlin

Yes, okay so the independent person at the site does the scoring and to guess meet the criteria and that video goes up, let`s call the QC person. The QC person looks at the video says yes or no, they are in the study based solely on they could not qualify to the study for the CMI because the labs come back irregularly, whatever other reasons. But that person is in the video, the independent video viewer says yes or no in their study. The (inaudible) they have is the base line. That base line is a score that’s driven to determine, your baseline score and that compared with the week six AIMS for the response.

Robyn Karnauskas

And as a trained person again, it’s not the physician treating the patient?

Tim Coughlin

Correct.

Robyn Karnauskas

The training person at that site that does the impact. So one question I get, so if there is a site that’s not doing it, I mean their numbers really stick, how concerned are you that like a site that, I mean what if they really do something really wrong or they are really not…

Tim Coughlin

So, here is a couple of things to mitigate that. One, there is patients, this study is a 120 patient study and so with a correct scoring of just 32 subjects study we had values of p .0002. so if you have, if you just taking an equal distribution, so that will be three subjects per site and one site is really not doing well, I am not concerned about that. I am not concerned if two sites are not doing well.

The other thing is that, these subjects don’t all come in at once. So we’re reviewing all these video tapes and basically 24 hours then being uploaded and they are uploaded 24 hours within the visit. So I am not concerned about building a big backlog of problem assessment that can’t be overcome by the power to study up to or by correcting and advising the site that hey, there’s a problem here.

Robyn Karnauskas

And what percentage of patients are being excluded from participating in this trial?

Tim Coughlin

Okay, so that’s a good question. In the previous trial 1101, our screen fail rate I guess is what you’re getting at, was about 33%. So out of every, we had one out of three failed that either failed because of BMI, lab issues, not unstable drugs or didn’t have TD. And that assessment or the reason the screen fail rates of that is because people get referred into this trial by outside physicians, the psychiatrists may make them aware of it or if they have a care giver they bring them in, or the person comes in on their own. And everybody who shows up at the door and says wondering the trials is counted in the denominator, except for the screen fail rate. In this trial we expect the screen fail rate to go up to about 50% and the reason for that is we have more sites. We've had tighter controls and we think that part of that increase is going to be due to the more tight controls around the AIMS assessment. We don’t think a lot of these subjects is going to make it through to the video assessor saying no, this person doesn’t qualify. There will be some and there have been some but we don’t think that’s going to be a major driver in the increase any more so than we have more sites and more people involved in the trial. But right now as of today, we are running just shy of 50% fill rate. And that’s the way the site was designed.

Robyn Karnauskas

Okay. Have you had any sites yet that has been given a check?

Tim Coughlin

No, we have had people that come in don’t have TD, that aren't (inaudible) to moderate to severe category and so the video person has said no. not many, but one or two.

Robyn Karnauskas

And what happens to the independent assessor?

Tim Coughlin

They get a little nudge. That doesn't count as a check against them because (inaudible) but it will count against someone who scored because…

Robyn Karnauskas

Because of warning letter.

Tim Coughlin

Yes, exactly.

Robyn Karnauskas

Okay. What is the interest sending rolling in the study?

Tim Coughlin

Its rolling on target right now. We expect to have data in Q2 and the study should read out in Q2 and study design, I think we've already spoken on this but I will touch on it in conferences we talked about it, but its 50 milligrams of 98854 for six weeks in one arm, another arm, active arm, the study is 100 milligrams for two weeks and then four weeks of six, 50 milligrams. So a total six weeks of dosing in placebo and the placebo is sixty subjects and the other two arms are 30, so one to one randomization placebo versus active and all the patients roll on to six weeks of open label extension for safety. So the reason we pick the 100 milligram for two weeks is we've got data at 12.5 milligrams which we think is a minimally effective dose, we have data at 25 milligrams for two weeks data, 50 milligrams for two weeks and now to fill out the whole dose response curve will have data for two weeks at 100 milligrams. So we go to the FDA and say, here is where 12.5 looks like, here is what 100 looks like and here is why we chose our dose in between.

Robyn Karnauskas

Okay, question from an investor, so are you using the other six sites in the future, I guess the other sites in…

Tim Coughlin

Yes, we’ll be using them. I can’t say they are all in the study but we’ll be using them in the future.

Robyn Karnauskas

And I guess one other questions I have then is, I guess I have some personal experiences, I have friend who’s been on Zenotin (ph) which is the other, it’s not proof of targeted dyskinesia that’s given sometimes off label, could a patient have been that drug in the past? Could they have been on Zenotin (ph) in the past?

Tim Coughlin

That I honestly don’t know the answer to. I don’t think its excluded but I am sure there's got to be a period of time between when they were last dose on it usually, there is six months to a year, but I don’t specifically recall that. I'll have to get back to you on that.

Robyn Karnauskas

And then when I think about some of the safety, and this is really a question regarding if you look at Zenotin (ph), I know its approved for hunting in Korea, it’s in the site (inaudible) this drug, this is sort of one of the isomers that would be in Zenotin (ph) that should have a more clean profile, sort of the way.

Tim Coughlin

Although 98854 is not one of the isomers in Zenotin (ph).

Robyn Karnauskas

How would you sort of describe it?

Tim Coughlin

So what we did is we, and I can talk about a broader, is we approach drug development. When we look at different targets and what to do with, where to go with our research effort, we look at underserved markets to be able to make the pharmacoeconomic arguments. We look at known proven biological targets because we afford to blaze trails. We look for fast decision points, we don’t want to have to wait two and phase three depending on whether or not we have a drug and we also look for backup potential so we have things we could as backups to the compound and we look that we have expertise in house and at any time we have eight different molecules or targets in drug development within in the research group. So regarding VMAT2, Chris O'Brien our Chief Medical Officer came to the company I think in 2005, if I remember right and he worked with Prestwick before who developed tetrabenazine in the United States for (inaudible) Korea. And he put forth saying, you know what, this drug there is some work that by (inaudible) University showing that tetrabenazine and the VMAT2 inhibitor could work in tardive dyskinesia and he put forth the proposal if we could develop a VMAT2 inhibitor that has an extended half-life, a (inaudible) like tetrabenazine has a high affinity selectivity and various routes of metabolism because most of these folks are polypharmacy. And so our research group went to work for a period of three or so years and they come with three different chemotypes for VMAT2 inhibitor. Three of them we looked at, we picked 98854 to move forward and the other are waiting as backups for possible other indications for if something should happen to 98854.

The composition of matter on 98854 through 29 I believe and so it’s really a combination tenacity, a good science and obviously serendipity we were able to had a crack into this. But we've got two other ones back there to inhibitors as well behind that 98854. Yes, backup and follow on.

Robyn Karnauskas

So in addition, the drug should have potentially different safety profile because of (inaudible) of the more septicity on target versus benzene tetrabenazine has like four different items [Multiple Speakers] different receptors. The question I had was, do you have any updated thoughts given the Phase II as to what side affects you think are over the long haul going to be better with your products.

Tim Coughlin

The tetrabenazine has a black box warning for sucidality (ph). We hope we will avoid that one but that’s something that go in with tetrabenazine I think they had one suicide during a clinical trials and thus the black box. Tetrabenazine has a QTC prolongation warning. It has not a black box but say a warning. And we do 24 hour ultra-monitoring, we do EKGs when people come in for their visit to do EKGs and we haven't seen any signal that. Haig hasn’t shown that but you don’t know until you do your definitive QTC study and that won’t happen for another year or so, you have to have your dose down first before you can perform that study.

Other things that tetrabenazine has is three times a day dosing which is really a side effect, but you have to titrate up to side effects and then back off and we’re looking at a once a day dose here with our VMAT2 inhibitor. And what you will see though is side effects is the exacerbation of pharmacology. So you’ll see (inaudible) you’ll see some (inaudible) and you will see that as the doses get higher. That’s why we stopped at 100 milligrams because we don’t want to have a lot of those in our database. We did up to 150 milligrams in the safety portion in the Phase I safety trial and we think the 100 milligrams is going to be probably a little bit too much and that’s why we are keying on the 25575 range.

Robyn Karnauskas

Okay. That’s helpful. Quickly we can satisfy all the Abbott investors there, we probably should ask a little bit about Abbott. So first on uterine fibroids, so maybe give us a sense of now we have at the, how do you view the new slow uterine fibroids and give us some update on timelines for decisions as far as C2.

Tim Coughlin

Sure, (inaudible) is going to take us all a while to get used to them. So I'll use Abbott now to interchangeably as the new entity effective January 1st. Abbott’s been doing a tremendous job with uterine fibroids. They had a drug earlier, a couple of years ago asoprisnil which is a sperm creator in fibroids and they were doing really well. They’ve done a lot of work around the pharmacoeconomics, the market research, pay work, farm work and really has done a tremendous job in uterine fibroids. We couldn’t be happier with them relative to fibroids. Right now they are running a Phase IIa study to account for their proof of concept study. It’s in different cohorts. What I can tell you is that Abbott has told us that they are not going to say a lot about this study publicly because they don’t want to enable competition and because they are a $100 billion company which really doesn’t affect their, their shareholders aren't interested in this at this point. What they will say though is that, once they go into Phase IIb, that means they’ve got their proof of concepts in this Phase IIa study that’s ongoing right now. Clinical trials that does show this current study ending and I checked it yesterday in March of next year, Abbott also out there doing their spin roadshow for the spin out of (inaudible) and actually wrote this downtime, so I wouldn’t have misquoted that they expect to start Phase IIb in 2013 for uterine fibroids. So we don’t have any data as Neurocrine on what the trial looks like. I know they’ve got the cohorts, they’ve got three cohorts completed at least and we have no idea what that data looks like but we look at the disclosure they’ve made in this roadshow that is on right now, it’s a very positive for uterine fibroids and we’re excited about it and there is no reason why this drug should not work in uterine fibroids.

In our endometriosis trials, we saw a remarked reduction in bleeding in women. Granted these women were about a decade younger than those who at uterine fibroid trials but the mechanism should work. So we’re very happy with what we can read into their what they are saying in the slide deck out in the road right now.

Robyn Karnauskas

That’s helpful and when I think about the company as a whole, so I feel like a little bit there was some push out for the timeline for the Phase II trial just because you put on these section plays and uterine fibroids because Abby came into place, are you guys thinking forward as far as maybe giving yourself more wiggle room in case there are delays?

Tim Coughlin

You can always say that but you’re damned if you didn’t, damned you don’t. So we put a stake in the ground and most of the time we hit it, sometimes we don’t. for the VMAT2, part of that was because of the issue we came across, the other part of that which we haven't talked about a lot is that the FDA actually in their response kind of some communication we put in and we were waiting for that to start the next this current Phase II study that’s going on right now, that it’s just basically to say we have no objections to your trial design. And they also put in there though our roadmap for us to Phase III. And laying out, here is the things you should think about for in your Phase II meeting, here is your Phase III trials should like. So we took that as a very positive event and getting that extra language took a couple more weeks than what we were expecting and we’re expecting response and I believe it was sometime in late July, early August when we got in late August. And so it’s a tradeoff and you’ve got a little more comfort than the FDA and we started the trial a little later.

As far as the (inaudible), that whole program now is completely in their hands. One thing you realize going in with the a pharma as a partner, and every biotech will tell you this, is that, and every pharma will probably say this too, is that biotech thinks that pharma should move faster and pharma thinks biotech should disclose less and that’s where we always meet at loggerheads and we do think they should move faster but we think they are doing the right thing for the program. There is always a trend, when you sign a deal, you always know that you’re going to lose at least a year because of the whole transfer of data, getting all the rest of piece together and just getting them up to speed so they are comfortable. And we lost a little more time than that. It could have been due to (inaudible) in the split, I don’t know. But if the Phase III trials are running now, it’s pretty similar to what we had suggested back in when we did the deal.

Robyn Karnauskas

I guess and then just to follow up a little bit on that, so yes they gave you a roadmap, I guess first question, do you plan to share that design, I want to know what you expected.

Tim Coughlin

No I think what we’re going to do is get these Phase IIs right out so that we can give everybody a clean data set and say okay, we don’t have any post talk announces and here is what the drug does, here is how response, here it is in over 100 patients in these trials, actually it will be 120 under dosing in one and 45 in the next trial. Actually we've got another trial that’s going to be starting up probably it will be by the end of this month, this second Phase IIb study and that’s looking at patients with underlying type holder or maybe this type of disorder or who have been on (inaudible). So they are going to be in this next Phase IIb but we’d rather have that clean data set and then roll out once the entire Phase III, because you want to get to the end of Phase II when you have a discussion with the FDA then roll it all out at once.

Robyn Karnauskas

So why is there conductor on everything?

Tim Coughlin

I know they do.

Robyn Karnauskas

So on the second Phase II, I was wondering, now that you know all the checks in place for various scoring systems for tardive dyskinesia, I mean how quickly, do you see any potential glitches as far as running that program or…?

Tim Coughlin

So the second Phase II, the reason we are running the second one is to get experienced in folks with major depressed disorder and the metoclopramide. The FDA doesn’t care, the FDA says TD is TD is TD. We don’t care what the underlying disease state is. What we’re going to do is put in different safety assessments so that it’s going to be a gastrointestinal safety. There is going to be, obviously the pan score, you're going to have something, the matter score for MADRS score for maybe depressed disorder. So we’re going to put out another safety. So we want to see if there is any difference, there could be a difference in dosing. We don’t know. But we’re going to basically run this so we don’t get surprised with Phase III. We want our Phase III to be a recopulation of our Phase II program.

Robyn Karnauskas

And then maybe all in comfort things like TDs.

Tim Coughlin

Yes.

Robyn Karnauskas

Any additional thoughts on other indications outside of TD?

Tim Coughlin

So we are looking at turrets right now in the preclinical model. That as you can imagine going into a younger population, there is a lot higher safety hurdle. So we've done some of the preclinical tax work on that. The dosing part of that is done. The intellect portion is done and now we’re moving on to the assessment portion now.

Robyn Karnauskas

Thank you very much, I appreciate it.

Tim Coughlin

Thanks Robyn.

Question-and-Answer Session

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Source: Neurocrine Biosciences' Management Presents at Deutsche Bank's 2012 dbAccess BioFEST (Transcript)
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