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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.

Please be advised that this transcription was done from an audio recording. As such, the accuracy of the transcript may be

impacted by the quality of the recording (speaker cross‑talk, etc) and should be read as such. This transcription should be

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clarification is required. Please remember that Slingshot policies prohibit members from contacting the aforementioned expert

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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.




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?




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.




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.




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.




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.




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.




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.




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‑




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?




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.




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?




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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