rp‑g28. rp‑g28 is now in phase 3 trials with the foundation of ...€¦ · non‑public...
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Project Goal: Understanding the Unmet Medical Need in Lactose Intolerance Patients and the Potential of RP‑G28, Currently in a Phase 3 Trial
Project Date: 02/20/2019
Project Time: 1:00pm ET
Expert: Dr. William Chey ‑ MD Institution: University of Michigan
● Director of the Gastrointestinal Physiology Lab at Michigan Medicine. ● Member of the Board of Trustees of the American College of Gastroenterology, the Board of
Directors of the Rome Foundation, and a member of the Advisory Board of the International Foundation of Functional GI Disorder.
● Authored more than 300 manuscripts, reviews and book chapters, and was the Co‑Editor‑in‑Chief of the American Journal of Gastroenterology from 2010 to 2015.
● Member of the Company’s medical advisory board.
Call Sponsor: Ritter Pharmaceuticals Ritter Pharmaceuticals is an LA‑based, publicly traded company developing potentially the first FDA‑approved treatment for lactose intolerance, RP‑G28. RP‑G28 is now in Phase 3 trials with the first pivotal study underway. In December 2018, Ritter Pharmaceuticals announced that it had reached the halfway mark enrollment in this study, known as “Liberatus”, and expects data readout in h2 2019. Liberatus is a double‑blinded, placebo controlled, 525‑subject, multi‑centered U.S. only study.
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Call Leader: Hi, Doctor, are you there?
Doctor: Yeah.
Call Leader: Hi, great. So, Doctor, thank you very much for taking the time for this call
today. I'm looking forward to hearing your thoughts on this space. For
compliance purposes, I'd like to confirm a few points, which I'll read through
and you can grant your verbal consent at the end. Okay?
Doctor: Sure.
Call Leader: Great. So first, this call is being recorded and transcribed. Second, you the
expert, attest that you will not disclose any confidential or material
non‑public information. Finally, you attest that if you're a Physician
participating in a clinical trial, you will not discuss any information not yet in
the public domain. If you're a member of a Scientific Advisory Board, Clinical
Trial Steering Committee, and / or Data Safety Monitoring Board, you will
not disclose any information that is not publicly available or information that
will break any confidentiality agreements by which you were bound. Do you
agree to these terms, Doctor?
Doctor: Yes, I agree.
Call Leader: Great. Obviously, I’m serving as the Call Leader today, I too am required to
keep any material and non‑public information confidential. I attest that I will
not share any material, non‑public information, or information that will
break any confidentiality agreements by which I am bound. Additionally, I'd
just like to note that this call is intended for informational purposes only, not
investment advice. The contents of this call including any and all information
provided regarding individual securities or industries do not constitute
financial, legal, or tax advice.
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I'd just like to note this call is being sponsored by Ritter Pharmaceuticals
today. Ritter Pharmaceuticals is an LA based publicly traded company
developing, potentially, the first FDA approved treatment for lactose
intolerance, RP‑G28. RP‑G28 is now in Phase three trials with the first pivotal
study underway. In December 2018, Ritter Pharmaceuticals announced that
it had reached the halfway enrollment mark in this study, known as
“Liberatus”, and expects data readout in the second half of 2019.
So, Doctor, yeah. Great to have you on the phone. I think this conversation
should be pretty interesting. I know we've spoken years ago on other GI
things, so I'm looking forward to hearing you speak today. Maybe just to
start off, to give everyone kind of a little bit more familiarity with your
background, we have it posted on our site. But what's maybe your
experience and involvement with RP‑G28, and Ritter Pharmaceuticals, and
just a little bit about your background in GI?
Doctor: Sure. So I've been a Gastrologist, now, since 1993. I've been at the University
of Michigan where I'm a Professor of Medicine and Nutrition Sciences. I also
am the Director of the GI Physiology Laboratory, which is the laboratory that
conducts a lot of the physiologic and functional testing for patients with GI
disorders. So for example, as we'll talk about during this discussion, I
oversee all the breath testing that's done at University of Michigan. I've
been very involved in research around functional GI disorders. I've published
over 300 papers, and book chapters, and books. So I've been knocking
around academic GI for quite a long time.
I got involved with Ritter a number of years ago when Andrew contacted me
to help in the interpretation of data from the Phase two study. I've also
more recently helped in designing the Phase three studies, which are
ongoing in the United States.
Call Leader: Okay, great. Thank you. So it would be helpful for me to understand a little
bit more about LI in general. So maybe could you please just describe your
clinical practice and how, currently, patients are diagnosed with lactose
intolerance when they come to you?
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Doctor: So this is an incredibly common problem affecting literally tens of millions of
people in the United States. Anytime somebody comes in to my practice
with complaints of unexplained abdominal pain, cramping, discomfort,
bloating, gas, or diarrhea. Particularly, if they associate symptom onset with
eating a meal, I'm thinking about intolerances like lactose intolerance. So
particularly, if a patient is able to tell me that there's some association
between the onset of their symptoms and eating dairy products, I'm gonna
become even more suspicious about the possibility of lactose intolerance as
a cause for their symptoms.
It's important to realize that the likelihood of the diagnosis varies a lot based
upon the person that's sitting in front of you. So obviously, if I'm dealing
with a person of Asian descent or African descent, I'm gonna be thinking
very, very high on the list is gonna be lactose intolerance. The prevalence of
missing the enzyme lactase that's responsible for developing lactose
intolerance is present in 80 plus percent of Asians and Africans.
Call Leader: Wow. Okay, great. So it sounds like it is a pretty big issue in your practice.
How do patients go about treating it right now? How satisfied are these
patients with these treatments?
Doctor: Yeah, I think a lot of patients that come in will have a suspicion about this
possibility. I think what they don't realize is all the foods that contain lactose.
Like, I think when people think about lactose, they immediately associate
lactose with dairy products. Like milk, or some cheeses, ice cream, those
types of things, which are pretty obvious sources for lactose. The problem is
in the United States where we eat a lot of processed food, lactose is hidden
in a lot of foods.
So for example, I think people would be very surprised if you were to inspect
labels from many of the foods that you eat. That includes, by the way,
sauces and sweeteners of a variety of different types. You would be
surprised at, when you look at that package insert, that lactose is there.
Call Leader: Yeah, I grew up doing that for ... until I was about 12 years old. I grew up
looking at those labels and was always amazed by it, yeah.
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Doctor: Yeah. I think one of the problems for our patients is that unless somebody
has taught you to do that, you're not necessarily gonna be savvy enough to
figure that out. So a lot of times, people will come in and you'll say to them
... When you're concerned about the possibility of lactose intolerance, you'll
ask them, "Have you gone on a lactose reduced diet?" They'll say, "Oh, yes,
yes. I have." Then you'll speak to them and their idea of a lactose reduced
diet is avoiding milk and ice cream. What you come to realize when you've
done this for a while is that that's entirely inadequate if you're going to
really put somebody on a lactose reduced diet.
Call Leader: Yeah, I think that's helpful. Then, I'm aware of some OTC option and things
like that. Maybe talk about how effective they are and what some of the
strengths and weakness of those are with your patients. I guess, other
strategies besides avoidance.
Doctor: Yeah. So I've talked about some of the difficulties that surround going on an
elimination diet. Outside of figuring out everything that contains lactose,
obviously, another big issue is just ... it's inconvenient to have to restrict all
those different foods that people often times very much enjoy. There's
nothing worse than in the Summer and you can't have ice cream. But other
strategies are available for patients with lactose intolerance. The biggest one
are enzyme supplements.
So remember that lactose maldigestion, which is at the root cause of lactose
intolerance, which is ... Lactose intolerance refers to the patients that
develop symptoms. Lactose maldigestion are individuals that are missing the
enzyme that lead to lactose malabsorption. So given the fact that patients
are missing this enzyme from the lining of their small intestine, one strategy
is to actually provide the enzyme through the form of pills. So chewable
tablets or pills that you can take before a meal in the hopes of reducing the
frequency and severity of symptoms if you ingest dairy products.
One issue, just to recognize there, is that different people have different
levels of deficiency of the enzyme in the small intestine. Like, it would be
actually more convenient in many ways, if people all had just complete
deficiency of the enzyme. But it's important to recognize that. Some people
have complete deficiency of enzyme, many people have partial deficiency of
the enzyme. So the amount of enzyme that's appropriate for you may not be
the amount of enzyme that's appropriate for me.
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So when dealing with a patient in clinic, you have to go through the exercise
of dose titration in the hopes of identifying the right dose of that enzyme
replacement for the patient that you're caring for. That can take some work
and some effort and can be confusing as well for patients.
Call Leader: Yeah. I want to come back to your comments there on the enzyme and
what's going on in the mechanistic level. But before we do that, you
mentioned how some patients have complete depletion and others have
less. What's the breakdown of severe, moderate, and mild patients that you
see in your practice if you kind of put them into buckets for us?
Doctor: Well the thing is, for me as a Gastrologist, everybody that I see that has this
issue is moderate or severe or they wouldn't be seeing me. I think that there
are many more patients that have mild symptoms that just put up with it. Or
they've just figured out over time that if they avoid these things, they will do
okay. Many of these patients are managed in Primary Care, so my
population is very biased. All that being said, it's been estimated that
roughly 40 million people in the United States suffer with lactose intolerance
and that around nine million or so have moderate to severe symptoms. So
still a very common problem on the order of around five percent of the
population.
Call Leader: Got it. Interesting. Okay, so maybe moving into RP‑G28's profile, which has
been designed to selectively stimulate growth of lactose metabolizing
colonic bacteria in the gut. I kind of want to get a sense, before we move
into that, just kind of what role does the microbiome play in lactose
intolerance. You eluded to it a minute ago, but I'd like to hear a little bit
more about that.
Doctor: Yeah. So it's not a primary cause. The microbiome is not a cause for lactose
maldigestion or abnormal absorption. At the root cause of that is the lack of
that enzyme that I eluded to, lactase. But here's what happens when you
don't have lactase. For those of you on the call that don't know this, realize
that lactose is a disaccharide. It's actually two monosaccharides, two single
sugars that are hooked together by a bond. Lactase is the enzyme that
breaks down that bond and in that way cleaves the sugar into those
monosaccharides, which can easily be absorbed by the small intestine.
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When you don't have that enzyme and that sugar and lactose can't be
broken down into those monosaccharides, it is not absorbed by the human
small intestine. What happens is it traverses all the way through the human
small intestine, gets to the colon, where it's fermented by bacteria that live
in the colon. That fermentation of lactose leads to the production of gas and
chemicals, which can trigger the symptoms of lactose intolerance. Now, not
everybody gets symptoms when they maldigest and malabsorb lactose.
But for people with lactose intolerance, that sequence of events, and that
interaction between the lactose which isn't absorbed, and the microbiome
in the colon, and the production of those chemicals and gasses is what
triggers the typical symptoms of lactose intolerance.
Call Leader: Got it. So I guess one of the questions that comes to mind, then, is why not
just give a probiotic versus something like RP‑G28, which can be more
considered a prebiotic? What's the rationale to that and the trade offs?
Doctor: Yeah, you know one of the reasons I got interested in this project to begin
with is related to some of the problems that I see with probiotics. Okay, so if
you think about it from a pragmatic standpoint, consumers are in a tough
place that are buying probiotics. So let me explain to you what I mean by
that. Realize that probiotics are largely regulated in the United States as food
supplements. So there is no guarantee of quality control or viability of the
organism that a person might buy in a product from the store.
If fact, just impromptu studies, not formal studies. But that have been done
have demonstrated that some of the probiotic supplements that you buy on
the shelf in a typical drug store or a supermarket actually are inert. They
don't contain live bacteria. So and if you think about it from a
manufacturer's standpoint, it is ... It's gotta be very difficult to be able to
purify a certain set of strains of bacteria, put them into a pill or a tablet, put
food in there for those bacteria to be able to eat to stay alive. Keep them at
the right temperature so that they don't die. Have an appropriate shelf life
so that they're viable when the person buys it. Think about all those steps
that have to go just right for you to be able to get the product that you think
you're buying.
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Now contrast that with a prebiotic. So one of the reasons I got so interested
in this is because if you think about it, a prebiotic gets around a lot of those
practical problems that I've just laid out that are the case for probiotics.
Prebiotics are typically carbohydrates, very specific designer carbohydrates
that promote the growth of probiotic bacteria. So rather than giving the live
bacteria, you're giving the food that promotes the growth for that specific,
that official bacteria. In that way, you can avoid a lot of those practical
problems that I've laid out by just simply giving the food.
I liken it to thinking about it this way, if you think about your microbiome
and your GI tract as a garden. I think about probiotics as seed. Rather than
giving the seed, which can be good or bad seed, why not give the fertilizer
which is the prebiotic. Then the last thing, in terms of microbiome
strategies, are antibiotics, which I think of more as like weed killer. But in this
case, if you think about it from a pragmatic standpoint, I would actually
argue that the most practical strategy is the prebiotic strategy. We just have
to prove it works.
Call Leader: So I guess that kind of ties back in, now, to RP‑G28. What do you see as the
treatment benefit that RP‑G28 provides lactose intolerance patients?
Doctor: I think it dovetails on that answer‑
Call Leader: Right, exactly.
Doctor: ... that I just gave. But I think it's exciting because the preliminary data from
the Phase two study, I think, got all of our interests. The fact that for the
primary outcome, a composite score following a lactose challenge test
before and after RP‑G28 and comparing the placebo. I think the data is
compelling. Statistically significant increase in the likelihood of a four point
reduction in composite score with RP‑G28‑
Call Leader: Yep.
Doctor: ... compared to placebo.
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Call Leader: Yeah, I want to dig in a little bit on that symptom composite score and how
it's comprised of abdominal pain, bloating, gas, and cramping. I looked at
some other ones from like on the IBS side historically and things. But I know
that there are some specifics around getting the right primary endpoint. So
maybe could you just comment on how well that encapsulates it and
whether having more components is a benefit in lactose? Just kind of what
do you view that the primary endpoint itself has in terms of capturing really
what the patient's going through?
Doctor: I think that the primary endpoint, that composite score, it was created the
right way. Like so, the FDA has clearly moved towards patient reported
outcomes. Ritter went through the due diligence of doing qualitative work
with patients with lactose intolerance. What they quickly figured out, and I
think mirrors my clinical experience, is that patients with lactose intolerance
don't report one symptom. They report a set of different ... a range of
different types of symptoms, which I touched on before.
Things like abdominal pain, cramping, discomfort, gas, bloating. As well as,
changes in bowel habits, some patients get diarrhea. They picked the
symptoms that they identified as most commonly being reported by patients
with lactose intolerance. Abdominal pain, cramping, bloating, and gas
movement and made them into a composite score. So I think that this
composite score most accurately reflects what patients with lactose
intolerance actually report. Here's the great thing, is that they report the
data from the composite score, but also there's robust data from the
individual symptom endpoints, as well.
Call Leader: Yeah, I think we're gonna have to talk about that in a little bit more detail.
But the 30 day endpoint, I'm kind of curious what your take on that is and
how that relates to other things. My general understanding of kind of the
probiotic approach is that it's more on demand. So maybe just how can it be
differentiated as a symptom reduction after 30 days? Or out to 30 days?
How important do you think that is for patients and regulators when looking
at this approach verse [crosstalk]‑
Doctor: Yeah, I would challenge on the on‑demand. Actually, nobody should be
taking probiotics on demand. The probiotic studies that show benefit all
suggest continuous dosing is necessary to exert benefit for a symptom or set
of symptoms. So for example, if you look at the IBS data, the probiotic
studies that show a benefit are all continuous dosing studies. What's
interesting about them is that when you stop the probiotic, the benefits
almost universally go away very quickly. So there is continuous dosing that's
necessary to achieve a clinical benefit.
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As far as this particular 30 day endpoint, I think it's a very reasonable
endpoint because you would expect that it's going to take some time for the
prebiotic strategy to exert effect the microbiome for that to trickle down to
a point that you can see symptom benefit. So I think 30 days is a reasonable
stake to put in the ground, during which to have evaluated the primary
endpoint. Of course, at the end of the day, Ritter had to come to consensus
in regards to the primary endpoint, along with FDA. So this was a mutually
agreeable endpoint from the standpoint of the sponsor, as well as FDA.
Call Leader: Then just back kind of to the composite and all about trying to really
measure a patient's response. What's your view of this test’s ability to
measure a patient response to treatment? Is a four point or greater
reduction in a patient's LI composite score meaningful? I mean, just put a
little bit of context around that for yourself and for patients.
Doctor: Yeah. So just to give you some background, because I've looked at this data.
In terms of, just trying different ways to cut the data, in terms of trying to
understand what's clinically meaningful. This is derived from that qualitative
research done in patients that I referred to earlier, as responsible for leading
to the composite endpoint. As part of that same exercise, there was work
done to understand what is a clinically meaningful change in the symptom
scoring instrument. It turns out that a clinically meaningful change is in that
range of three to four. So certainly, a four point change in that composite
score can be held up as clinically meaningful.
Call Leader: Got it, okay. So this was a good segue here to actually dig into the specific
Phase two data. What is your overall assessment of the Phase 2b data that's
been released?
Doctor: Well, very promising. I think that the thing that really got my attention was
the fact that the data was looked at in three different ways. One, was the
composite symptom assessment along with individual symptom scores. So
just a general assessment of lactose intolerance symptoms. The second, was
dairy consumption, whether that increased after completion of the 30 day
course with RP‑G28. So a real world assessment of whether patients could
consume more dairy. Then the third, was global assessments. So more
general‑
Call Leader: Sorry, Doctor, sorry. On the milk or lactose consumption, that's going way
beyond the ... “it's in a package that we're not aware of it” or something like
that, right? We're actually looking at moving into a bowl of cereal, or ice
cream, or something like that? It's not just a trace amounts in a‑
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Doctor: Well, it was done by having patients complete diaries that recorded the
amount of dairy that they took in. So actually, as part of the study, the
sponsor was able to quantify the amount of milk and dairy that patients
were able to voluntarily consume while still being blinded as to whether
they received RP‑G28 or a placebo. So in a way, if you think about it, this is
the real world assessment of effectiveness of this particular prebiotic
strategy. At the end of the day, if the patient's symptoms got better but they
weren't necessarily feeling well enough to consume more dairy, you have to
ask yourself does that really matter.
I think the nice thing about this data set is that they've cut the data or
evaluated the data in a variety of different ways. The thing that's exciting
about it is the consistency of the response. Regardless of whether you're
looking at those composite or individual lactose intolerance symptoms, or
milk and dairy consumption, or a more global assessment. Like, adequate
relief, for example. Or satisfaction with the treatment. All of these different
sets of endpoints are going in the same direction, which to me is very
promising.
Call Leader: Yeah, I didn't mean to cut you off there before going on to the global
endpoint, the final thing that ... I stepped in on you to just focus on the milk
consumption for a second. Sorry, if you had a finishing comment there,
otherwise I think we can move on to the Phase three trial.
Doctor: Yeah, no, I really don't have anything else to add. I think the only thing I was
saying was that the third way to assess the symptoms was by looking at
global endpoints. Again, I already mentioned that those two ways in which
we do this, often in these types of trials, are by asking a patient if they
achieved adequate relief of their symptoms. Also, by assessing global
satisfaction of their experience with the treatment. On both accounts,
RP‑G28 did better than placebo.
Call Leader: Yeah. Then, in terms of just having a zero score in the number of patients
that were reporting out basically a complete resolution. Would that number
have surprised you? Or what did you make of the complete resolution
results?
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Doctor: Yeah, it's an important point that you raise. Because, a lot of times, people
are very critical of symptom scores and justifiably so. Obviously, it's in the
eye of the beholder, right? So the way I assess the severity of a symptom
may not be the same as the way you assess the severity of symptom.
But you know what? One endpoint that is assessed or judged the same way
by everybody is no symptoms. So as part of this study, one of things we did
was we ... an endpoint, one of the secondary endpoints, was complete
symptom response. That is complete resolution of symptoms after RP‑G28
or placebo. As you allude to, and I think importantly and really interestingly,
RP‑G28 led to a higher proportion of patients with complete resolution of
symptoms compared to placebo.
Call Leader: Great. So moving into the Phase three trial, which is gonna be reading out in
2019 here. Maybe I'd like to start the conversation or just start at a high
level, I like to ask: On a scale of one to ten, how optimistic about the Phase
three trial being positive are you? [crosstalk]‑
Doctor: Well, I think based‑
Call Leader: Just based on the things we've talked about so far.
Doctor: ... on the consistency of the results from Phase two, I'm quite optimistic. I
would say that if you were to hold my feet to the fire and ask for a rating, I'd
say on the order of seven to eight, which is probably about as high as I
would go for any of these. I've been involved with many drug development
programs, many Phase three drug development programs. Most of the time,
you don't have quite as consistent and strong a signal as you do for this one
going into Phase three. So I think this has a very good chance of succeeding
in Phase three.
I think that, to be frank with you, the thing that again as a scientist, the
much more interesting thing to me is the fact that if this works, it really
opens the door to the thought of creating prebiotic strategies for a wide
range of different disorders, not just lactose intolerance. If we can engineer
prebiotics in a way that promotes the growth or manipulate the microbiome
in a way that can affect lactose intolerance, it's entirely reasonable to
hypothesize that you could develop similar strategies to address a wide
range of diseases and disorders.
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By the way, not just GI diseases and disorders. So to me, that's the really
exciting part of this whole thing. To see if this strategy of manipulating the
microbiome to affect symptoms of lactose of tolerance holds true. Because
if it does, this could be the beginning of something really big.
Call Leader: Okay, great. You really kind of already alluded to it, but just how would you
perceive using this in your practice? In terms of, first line, second line? Is
there a subset of groups or a group of patients that you already can
imagine? Kind of maybe how big is that?
Doctor: Well, again for me‑
Call Leader: If the Phase three is positive and does get through the market.
Doctor: For me, as a Gastrologist, I'm gonna be thinking about using something like
this quite commonly. The reason why is because they're not going to be
seeing me if they've already gotten better on a lactose reduced diet or
enzyme supplements. So in my world, those things have already been tried.
Might have been tried poorly, and for that reason, sometimes we'll try it
again. But from my perspective, I would greatly welcome an alternative
strategy to the typical diet reduction.
The other thing that I think that's quite interesting to speculate about, which
is definitely a little bit off this beaten path. One other strategy that we're
starting to use a lot in patients with IBS, which is a different condition, is a
low FODMAP diet. One wonders about whether ... One of the parts of a low
FODMAP diet is to restrict the intake of dairy and lactose. One wonders
whether we might be able to make the low FODMAP diet less restrictive by
using this kind of strategy in patients with IBS. That's something down the
road, for sure. But it's something that I'm starting to think about based upon
the results of Phase two.
Call Leader: Yeah, so I think that this has really been helpful to me. I want to wrap up
with a review on the current regulatory environment. I think when I
mentioned this at the top of the call, we spoke on IBS and some of the
challenges that people were having just in terms of that whole process. I
know you were involved in that, so what's your view of the current
regulatory environment for GI product candidates in general? Where's the
agency's maybe thinking on lactose intolerance specifically?
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Doctor: Well, I'm bullish on the GI space, in general. There've been a lot of drugs
approved. Both, in regards to Luminal GI disease and liver disease.
Obviously, life changing drugs. But I'm also bullish in regards to FDA’s
renewed approach to symptom based disorders. I would say that in the last
10 years, we've seen a remarkable turnaround on the part of FDA in terms
of their acceptance and taking seriously symptom based disorders. Like,
irritable bowel syndrome and chronic constipation.
If you think about it, there have been a bunch of drugs that have been
approved in the last 10 years for those disorders. Including, IBS, chronic
idiopathic constipation, opioid induced constipation. If you think about it,
those are all symptom based disorders. Lactose is also a symptom based
disorder. I think that there's a very good chance ... and I think that without
going into details, I think it's fair to say that FDA has been very willing to
work with the sponsor in terms of helping to design their trials and also
choose their endpoints. So I'm quite optimistic about the possibility of this
getting approval if the trials are positive.
Call Leader: Okay, great. Well, Doctor, I think that's all the questions I had today. If you
had any other last closing comments, I'd be happy to hear them. But
otherwise, I really appreciate you making the time for this. This was very
helpful to me.
Doctor: Sure.
Call Leader: Okay, great. Have a good afternoon.
Doctor: Great.
Call Leader: Bye.
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