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Episode 8: Putting pharmacogenomics to the test...

Episode 8: And now for something completely indifferent
In episode 8 of GSC’s podcast, we talk to pharmacist and researcher John Papastergiou, as well as Ned Pojskic, our pharmacy strategy leader, about the research project GSC is currently sponsoring, looking at pharmacogenomics testing and patient outcomes in a community pharmacy.
And now for something completely indifferent

And now for something completely indifferent

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Episode 8 Transcript

[INTRODUCTION]

[0:00:15.1] SM: Hello and welcome to another episode of GSCs podcast; And Now For Something Completely Indifferent, where we will be discussing the hottest topics and trends in Canadian health benefits. I am one of your hosts; Sarah Murphy.

Before we get started with today’s episode, we would like to remind our listeners that the views expressed in this podcast are those of the individuals speaking and not necessarily the views of GSC. We will sometimes talk about sensitive and even possibly controversial subjects and we therefore reserve the right to potentially offend and are apologizing for it upfront. You can download this podcast from our website at greenshield.ca/podcast or subscribe to it from wherever you get your podcasts. We also encourage you to read our publications, the inside story and follow the script which you can also download from our website, and please be sure to follow the conversation on Twitter and LinkedIn.

[INTRO]

[0:01:08.7] SM: And now let’s get started. Today’s episode is hosted by David Willows, GSCs chief innovation and marketing officer.

Hello, David.

[0:01:17.0] DW: Good afternoon, Sarah. Thanks for doing that intro. We have with us today our colleague, Ned Pojskic.

[0:01:22.7] SM: Not Peter?

[0:01:23.8] DW: Not Peter Gove, and you’re trying to draw me into something. I can tell, and we’re all thankful for that. Well, let’s get right to it then. A couple of podcasts ago our colleague, Peter Gove, came in for his third podcast, something he’s very proud of. At that point, he was ahead of Ned by two. Ned has closely quick the gap and Ned is in here for his third podcast, something that will undoubtedly upset Peter Gove.

Ned, it’s no secret now that we’ve put it on the airwaves, you and Peter have a bit of a rivalry going on. Sarah described sitting in the office between you two and the tension that exist between your office and Peter’s office, and he had some rather unkind words for you. Do you have any message to Peter Gove here for your third podcast?

[0:02:09.6] SM: Did you hear what he said about you?

[0:02:10.4] NP: He did today. I mean, you could cut the tension with a knife. It’s there. Yeah, I didn’t appreciate the comments, definitely the part about the Ph.D. part. My response back to Peter was the sort of the full Ph.D. is better than the half one. That was my first one. He said public policy. It was actually in pharmaceutical policy. I had to clarify that one.

[0:02:32.6] DW: Okay. Your Ph.D. is in pharmaceutical policy. He questions whether that was

“a real Ph.D.”

[0:02:38.2] SM: Like legit?

[0:02:39.5] NP: Yes. Following the recording, I actually send them a link to the UoT website where we can all kind of verify.

[0:02:45.7] DW: Okay. Today, we’re going to talk about pharmacogenomics, and Ned’s very real Ph.D. will come into play because we’re going to talk about a randomized control trial that GSC is launching with a renowned pharmacist in Toronto, and Ned will certainly be talking about the lengths that we’re going to make sure that research is deep and real. Peter Gove may want to sort of zip it around this one, because Ned’s Ph.D. is going to be flying in full glory through this podcast. So let’s get to that.

[INTERVIEW]

[0:03:21.3] DW: Okay. So in the podcast studio today and as our guest, John, has already noticed, it really is a wellness room. There’s a bed in here. We have an old friend and colleague, Ned Pojskic, our leader of pharmacy and health provider relationships and our new guest for the

next half hour or so, John Papastergiou, a pharmacist from Toronto who’s going to talk to us about pharmacogenomics. Welcome, John.

[0:03:45.1] JP: Thanks. Good to be here. [0:03:45.8] DW: Welcome back, Ned. [0:03:46.9] NP: Thank you.

[0:03:48.2] JP: I love the room, by the way. Nice room. [0:03:50.5] DW: You’re comfortable. Your coat is on the bed. [0:03:52.6] JP: I see there’s a defib —

[0:03:54.7] DW: I can’t say the word. Defibrillator is a very hard word, but know you’re safe.

[0:03:57.6] JP: It’s a wellness room. Yeah, it’s very exciting to be here.

[0:04:00.0] DW: None of us are trained to use it though. Just for the record. So we’re here to talk about pharmacogenomics, and it’s a very trendy topic certainly in our industry and in the broader healthcare world. Ned, I’m going to start with you and I’m going to ask you one to define it. I gave you about a 15-minute lead time to tell you I was going to ask you to define it. I know you’ve got Google open on your laptop in front of you, so you’re just going to read it.

[0:04:26.0] NP: I don’t want to mess this up.

[0:04:27.1] DW: Then I’m also going to ask you for the GSC perspective on this topic, because I know over the last few years there’s been a lot of talk about pharmacogenomics, and as our want, I think that maybe we have taken a bit of a different position/tact in how we talk about this. So I’m going to ask you to sort of explain where we’re at in our thinking about it.

[0:04:49.5] NP: Yeah, I’m going to read the Google definition. Fundamentally, the relationship between one’s genetic makeup and a patient’s response to drugs. The idea there ultimately is

that patients respond to drugs differently based on their inherent generic makeup. This concept of pharmacogenomics is an interesting one and it’s one that’s sort of have some kind of intrinsic natural value to most people, because when you start talking about DNA, you start about genomics, you automatically think that there’s a sort of a definitive answer there to everything that has to do with disease and health. There’s something very rewarding about the concept, like the DNA must be the answer to everything that we sort of question around health. I think what’s interesting about that, it’s probably true to some degree, but certainly not to the degree to which I think has been made out to be popularly true and also in our industry specifically.

[0:05:35.7] DW: I think there’s a globe a mail, a very long form article just in the last month or so which said we’re just starting to understand the science.

[0:05:44.0] NP: Absolutely, and I think we’re starting to understand the limitations to genes being the predictors of disease. There’s a very strong understanding now that genes are basically a potential. All they are is a potential, but it’s the expression of those genes that ultimately influences what will happen in terms of disease or health for that matter.

[0:06:00.2] DW: What has been our take in terms of this topic coming in to our arena in benefits and certainly the discussion around whether this is useful in the work we do, whether it’s in pharmacy benefit management or disability management.

[0:06:16.7] NP: This has sort of taken off like a storm in our industry. There’s just sort of, as I said, intrinsic affiliation to this concept. So a lot of topic, every conference in our space talks about this particular aspect, and there is — And much of that is quite favorable position sort of as the future of benefits and future benefits management and all those aspects. There is a less sort of rational thought around it I think. There’s sort of a lot of hype, but no one delves deeper beyond the potential, because the potential is there and everybody understands the potential and all we hear about at various events is the potential. We understand it and we agree the potential is there. But sort of where are we today and are we going to realize that potential now? Maybe in 15 years, maybe never. That’s really the fundamental question, and then that naturally leads itself to the next topic of this question, which is does the type of role to play in benefits plan specifically?

[0:07:06.7] DW: Yeah. Ned is going to come back and talk to us a bit about how we’re trying to fill in the gaps on some of those questions, but first I want to welcome John again and ask John to tell us a bit about himself. He’s a pharmacist, and not only a pharmacist [inaudible 0:07:20.7] too humble to say this. I believe you are the pharmacist of the year. You won an award.

[0:07:25.5] JP: I was back in 2004 Canadian Pharmacist of the Year, which was that was a great honor and I think it speaks to the fact that I’m first and foremost a frontline community pharmacist, but I do do other things and part of that is a practice research. I’m very interested in kind of expanding the scope of pharmacy practice. I’m looking for new areas where pharmacist could potentially play a bigger role, and pharmacogenomics obviously is an exciting new are and it caught my interest about probably three years ago when I first heard about the technology being made available and cheap enough for possibly used in community pharmacy.

Yeah, with respect to my background, I own and operate two pharmacies here in the city in Toronto, busy kind of urban stores, but I am faculty of both the University of Toronto and Waterloo and a lot of my time is spent doing this type of research in different areas. I’m very interested in point of care testing as well and immunization. I’ve dabbled in a little bit of everything.

[0:08:21.9] DW: What are some of the research projects you’ve already taken part in before we talk about the one that we’re kicking off right now?

[0:08:27.5] JP: We just published something in maybe two issues ago of the Journal of the American Pharmacist Association. It was a big strep paper where we looked at point of care strep testing in the community pharmacy. I’ve done work with A1C screening for diabetes patients. A lot of research early work around immunization and what was the pharmacist’s impact on immunization rates and what was the perceived value for both patients and what were some of the challenges that pharmacists had experienced. So we’ve done work in those areas as well. We’ve already published a paper in pharmacogenomics also.

So what started as kind of a side hobby for me has become almost a second career where we

— Because not many community pharmacists are involved in this area. It seems that our work gets quite a bit of interest. It’s great to be here to talk about this and potentially a much larger study, and I think our study now will fill a gap that’s out there in the literature.

[0:09:24.7] DW: Okay. That’s why you’re here today and that’s why you’re our partner on the research initiative that we’re going to talk a bit more about now. Ned, in our discussions internally about pharmacogenomics over the last couple of years, I think you’ve distilled sort of our perspective quite well that we see promise in the science, but haven’t seen really the research to tell us when and how to use this now and in the future.

As we’ve done in the past, we are looking at putting some dollars really in play to do some research on this front. Can you first tell us what an RCT is and why a carrier/PBM is doing what we’re doing and what it is exactly we’re asking John to do with us?

[0:10:06.3] NP: Yeah. When we refer to an RCT, we’re talking about a randomized control trial, which is considered to be the sort of highest form of scientific evidence, because there’s all kinds of different evidence you can generate, anything from an opinion to an observational study. Ultimately at the upper end of that hierarchy is the notion of a randomized control trial.

[0:10:24.2] DW: This is not a pilot.

[0:10:25.0] NP: No.

[0:10:25.3] DW: No, and our industry loves pilots. I’m not putting down pilots, because we’ve done pilots too. We all do that, but this is sort of another level.

[0:10:32.9] NP: Absolutely. I think that’s a key distinction, because when you’re doing a pilot, you’re testing something on a small scale that you want to see rolled out on a bigger scale, but a pilot doesn’t always — Or most of the time doesn’t have the necessary components to truly evaluate what it is that you’re trying to assess, and RCT does that. It answers questions unequivocally. It says either it has value, it doesn’t have value, depending what your research question is. Ultimately, it’s much harder to criticize a randomized control trial if properly conducted, because it has the necessarily safeguards to answer truly definitively answer questions around value of something, impact of something, etc.

[0:11:09.4] DW: Okay. So we’re doing one of these with John. One, why are we doing it? Specifically, what are we trying to find out with this trial?

[0:11:18.3] NP: Yeah. So I mean I think we’re very much agnostic to the concept of pharmacogenomics in a sense of whether it’s valuable or not from a clinical outcome-based perspective. What we’re saying is that there is a limited amount of research out there in terms of quality and quantity and potential bias. We’re saying there needs to be more and there needs to be more high quality evidence, and so this aiming to fill that gap with a very, very defined and focused research question that basically says, “If we employ this technology, if we put it in practice, in a clinical practice, in a community pharmacy,” which is what John does, “are we going to see impacts on patient outcomes?” and that’s essential, right? Are patients actually going to get better, because we can answer all kinds of proxy questions around what happened because of this, but we need to know does it actually do something at the patient level, because that’s what we’re all chasing at the end of the day, better patient outcomes. We have to answer that definitive question.

Tons of research out there on the topic, some preliminary research, some basic scientific research, some proxy research, a very little on this ultimate question. We’re focusing on mental health specifically because this is an area that has been shown or potentially argued has the greatest amount of promise for the technology. We’re starting there and we’re saying, “Let’s see whether these patients actually indeed improve in their outcomes as the result of having John and his team access the pharmacogenomics testing information.”

[0:12:39.9] DW: Okay. Great. John, I’m going to ask you some very specific questions about how we translate this into your store, because you’re running a business there and yet somehow you’re going to bring in your patients and get them involved in this. What is the process for getting your just regular customers into a research project like this?

[0:12:57.9] JP: It’s good questioning. We’re fortunate enough that my team is used to doing this, because we’ve done it actually numerous times in the past and this is actually a follow up or kind of a second larger study to an initial preliminary study that we published about a half a year ago. What we tried to do in that study specifically was see, “Hey, can pharmacists embrace pharmacogenomics? Could they get patients to do it in the pharmacy? What were they doing with the results?”

We weren’t really looking at clinical outcomes there, but we were offering a service to patients. We were taking cheek swabs, and then we wanted to really see were the pharmacists recruiting the right patients, because it’s very easy to offer a $500 test to everyone. The challenge is are you going to offer to the patients that really need it? I think we were able to show that in the pilot study that, “Hey, pharmacists do a good job selecting the right patients. They understand who would potentially benefit and who wouldn’t.”

[0:13:51.6] DW: So who are the right patients in your mind?

[0:13:53.7] JP: Well, for starters, you have to be on a medication and having a challenge with the medication that has a potential drug gene interaction. When we get these reports back, and really the tools that the vendors offer us when we send in a genetic test is an evidence-based report that tells us, “Hey, for these 120 medications, there’s guidelines that suggest it could be a potential drug gene interaction,” and for our patient we have a fast, slow intermediate metabolizer, and that will make clinical decisions based on the guidance. It’s not the pharmacists kind of pulling things out of their own head. It’s really using what’s there in the evidence to try and make better patient decisions, I guess.

The first study, we didn’t look at outcomes, and that’s very important. We just wanted to see, “Hey, could pharmacists do this? What did patients think and were we actually intervening? What did physicians think?” I think those were the kind of three or four things we wanted to focus on, and now we’re at the point of where we want to look at the outcome specifically.

[0:14:49.3] DW: But the good news for this trial is you’ve actually got a team there that’s worked in this before.

[0:14:55.5] JP: Absolutely, 350 patients that what we call a genomics clinic. We’re very used to doing that. Patients in the community are kind of — I know we offer the service. Now physicians are like referring patients to us. Within the confines of a study though, there are certain things you have to, the consent process and everything else, and that’s where I think we’ve trained our team specifically to be able to say, “Hey, it’s not just offering a service to a patient. This is a randomized trial, so we have to have people blinded. We have to make sure the patients sign informed consents so they know what they’re getting into,” and everything else, because we want to make sure we’re following the scientific process, because if we find some real positive

outcomes, obviously we’re going to try to publish this in a high impact journal. That’s important also.

[0:15:40.9] DW: Can you explain the concept of blinded?

[0:15:43.6] JP: Yeah, it’s a good question. We want to eliminate as much bias as we can in the study, and there’s always a bias whenever a healthcare professional was talking to you about something. So we wanted to — For as long as we could, keep both the patients and the pharmacist unaware of what test they were actually going to get or what arm they were going to go into. There’s going to be two arms obviously, the control arm, and that’s really just going to be standard of care. What you would get in a typical community pharmacy.

In our pharmacy, we have a little bit more than a typical pharmacy. Our pharmacists are kind of used to offering these enhanced services, and the other arm is going to be standard of care plus a genetic test. So the pharmacist will be armed with the results of the genomic test, but we didn’t want to tell the patients or the pharmacists at the beginning when they’re recruiting of patients which arm they would go into. So the patient will be randomized. Everyone is going to get swabbed, so the patient won’t know if the pharmacist is going to have access to the results or not, and actually the pharmacists won’t know which group that patient falls into until the results come back usually about 7 or 8 days later. That’s as far along as we could blind the pharmacists, because at some point they’re going to know they have access to some result and they’re going to be unblinded. But for the purposes of that initial kind of conversation with the patient, it should be completely unbiased.

[0:16:57.2] NP: So if I can add, that’s a key point that John made, because what we’ve seen in the past research on pharmacogenomics especially in the mental health space, is when you do not blind patients, you tend to see sometimes positive outcomes. When you blind them, some of those positive outcomes disappear, and that’s just because if you think about the human makeup, placebo effect is incredibly powerful. You’d take a patient who has mental health issues and you start doing a cheek swab and things like that, things that are not usually part of standard of care. They’ll start thinking, “This is something new and interesting.

I’m going to get better,” and they get better. You have to remove that bias. If everybody is cheeked swab, we remove that potential bias difference, and the only difference between two groups is access to pharmacogenetic testings amnesia.

[0:17:34.9] NP: That’s right. We’ve seen that in practice in other studies. Simply sitting with a pharmacists and talking to them. So that process of if we didn’t have the cheek swab being done in both groups, the intervention group would have spent more time with the pharmacist and that alone sometimes can make that difference. The patients feel like, “Hey, they’re spending more time with me. I have access to this healthcare provider. Maybe I’m going to feel better.”

We want to eliminate as much of those differences between the two groups as we can, at the same time, this is the real world trait. Although it’s going to be a very controlled trial setting, it’s patients that are wandering in to your community pharmacy at the same time. So it’s going to be interesting to see how these all plays out.

[0:18:14.5] DW: Okay. I think people might be interested in — So these people are wandering in. Ned has said that we’re looking at people with mental health conditions. So I presume they’re taking an antidepressant or antianxiety medication. So what is that patient experience in the trial? What step-by-step do they go through?

[0:18:29.3] JP: Yeah. The first thing is they’ll have to qualify. We have a screening question here that essentially is going to access how happy they are with their medication. Are they experiencing any side effects? Do they feel there’s opportunity for them to be even better? Once we have those scores, we can have a threshold cutoff. We’ll essentially determine that, “Hey, this patient is having some challenges. Maybe we’ll offer them access to the study.” Right?

At that point, the research pharmacists will try to get consent from the patient, explain what we’re going to try to do with this study, explain that it will be randomized blinded. They may not get access to their genomic results at the beginning. The great thing about this study is everyone will have access at the end.

[0:19:09.7] JP: Yeah. I think that’s going to help us recruit patients, because there’s enough kind of information out there that I think there’s already some perceived value from the patients around getting some type of genetic testing. We’ll see how that all works out, but the reality is

they are going to get access to the test in both arms, and then at that point we’re going to do a medication review with the patients, go through kind of the study process, take a swab, and then there’ll be a series of follow ups. Throughout that time, the pharmacists will be making interventions, right? Because by the nature of being recruited, you have some type of problem with your medication.

During the control arm, the pharmacist will try to intervene, maybe switch the medication, change a dose. Some of these stuff we’re allowed to do even within our own scope in Ontario, right? Try to get them optimized. On the flipside, in those patients that are in the intervention kind of group, we’re going to wait for the results of the genomic test and see if that will help guide our decision making.

[0:20:05.1] DW: Okay. What, at the end of all of that, are the health outcomes that could be evident that are positive?

[0:20:12.5] JP: Yeah. We’re going to use a bunch of scales and we’re going to see, “Hey, are the patients feeling better? Do they have fewer side effects? Their perceptions are very important to us, but there are a number of skills that will help us measure kind of these changes overtime and we’re planning to assess them at one month, three month and six months. I think given the size of our sample, which is going to be over 200 patients. So we should be able to detect the difference.

[0:20:36.8] DW: Okay. Terrific. So I think we understand the mechanics of what we’re about to embark on. Let me ask both of you sort of like trying to project ahead, and I don’t want to get predictions necessarily of what the outcome is going to be. But, Ned, I’ll ask you first, and then John. What’s the best case scenario that would come out of this in terms of a positive read on what pharmacogenomics could do and what do you fear are some of the barriers or the roadblocks that could stop this science from being truly meaningful to [inaudible 0:21:07.0] members in the end?

[0:21:08.3] NP: Yeah. A best possible scenario, I think if you think about it from the impact or the testing would be that at the end of the day, we see these patients improve in the intervention group and improve also in the control group. They’re very likely to improve, because as John said, pharmacists are intervening and working with the patients. But the delta, the difference

between those two groups will be the sort of net value of the testing, and that net value should presumably reach statistical significance which means that at the end of the day, the testing does improve outcomes beyond standard care, beyond standard pharmacist care.

So that will be the best outcome, then we can conclusively say that adding this on top of standard care will make an impact, patients will get better. They will improve. Roadblocks, I mean, I think that the potential as I said at the beginning is there. The roadblock is sort of, “Does this testing actually have clinical significance?” Because that’s sort of the true thing.

At the end of the day, there’s a lot of technologies and things that have maybe — They can potentially have an impact, but clinically, as we look at these patients, as we look at their clinical journey, will it actually make that difference is the sort of key variable here. I don’t know the answer to that, right? Or maybe there’s a subset of clinical scenarios, only a subset that might merit these patients being tested for different [inaudible 0:22:19.2] makeup. We don’t know what those scenarios are, but perhaps this will uncover some of that. Lots of potential roadblocks along the way, but I think this will help us lead us to address some of those.

[0:22:29.4] DW: John, do you have a same or a different answer to that?

[0:22:32.2] JP: Yeah. I think so. I think I also have the ability to comment on what we saw on the original study, right? There was about 16% of the patient population there. They were enrolled because of some type of psychiatric medication, and what I could say definitely is the pharmacists were intervening based on the results. Usually on average, something like 1.5 times per patient. So they were making interventions. What we didn’t assess was, “Hey, were these interventions clinically significant? That’s what we’re going to do here.”

Anecdotally, speaking of the patients and seeing them coming back, they seem to have improved now with that same thing have happened if we didn’t have the genetic test spent all these time with them. I’m not so sure yet, but the testing did — The arm pharmacist with some additional information that I think gave them more confidence to make these clinical interventions and go back to the physician and say, “Hey, I have this genomic test result. I think we’re better suited taking this patient from drug A and putting them on drug B.” They were doing that for sure.

What we’re going to see here is that’s still going to happen in the control group and is there going to be a difference or no difference, and that’s going to be the interesting aspect. So we know I think patients benefited, but with just the genomics that was driving that, and that’s what we’re trying to elucidate here.

[0:23:48.5] NP: The other thing I wanted to add was that the literature is quite clear. The pharmacists intervening the care of patients outside of what the doctor provides can have a huge impact. We see it with diabetes. We see it with hypertension. We see it with asthma, and in some cases in mental health as well. Maybe at the end of the day, that’s all that we need, is intensive pharmacist intervention with patients who are mental health, and that then leads us to another area where we can maybe invest and maybe they invest in mental health services provided by pharmacists, right? This is sort of a natural offshoot of this research.

[0:24:17.8] JP: Ned and I have talked about this both arms, so the control and treatment arm are going to be followed pretty closely with a series of scales. Pharmacists generally in practice don’t use assessment skills. I know I’ve sat on advisory boards with psychiatrists where they’ve tried to encourage us to do more of that. If we see both groups improve and both groups improve on about the same rate, it could simply be us doing those reassessments at 1, 3, 6 months, getting them on therapies quicker and following up with them. That maybe driving a difference, and that will still be a good finding if both groups improve. I don’t think they’ll be disappointed with that.

[0:24:53.1] DW: Okay. That scenario right there, you’ve got psychiatrists encouraging pharmacists to sort of expand their scope in some way and provide these mental health services in the community. Are physicians in any way a barrier to this whole process?

[0:25:08.7] JP: You can get some, right? I mean we saw that in our pilot study as well. There’s always that group that’s very engaged, used to working with pharmacists and they’re very supportive of programs like this. There’s other and maybe don’t believe in pharmacogenomics. Maybe they don’t know a lot about it. Maybe they’re not used to pharmacists doing as much as we’re doing, that sometimes it can be a little apprehensive.

What I found in my local community there, we got about 8 or 10 docs we work very closely with. They’re very used to kind of the services that we offer, and we already have them referring

patients to us for these type of services. So I’m not really worried about that. When you talk about a broader kind of expansion of a program like this, that’s one of the things I think pharmacists that are contemplating offering more and more enhanced scope type services, they have to develop those relationships with the physicians, because you can’t do it unfortunately on Ontario on your own. You need to collaborate with the docs, the psychiatrists and that’s an important part of health care also. So building those relationships is very key.

[0:26:04.9] DW: Okay. We could probably do another show on that topic. We don’t have time to do that, so I want to thank both Ned and John for laying out the adventure we’re about to start on, the RCT is starting right now, and we hope to have it completed by the fall. I’m hoping both of you will come back at the end of it and tell us what we found and share that with our listeners. Thank you.

[0:26:26.0] NP: Thank you. [END OF INTERVIEW]

[0:26:31.3] SM: Thank you to our listeners for tuning in to another episode of And Now For Something Completely Indifferent, a Canadian health benefits industry podcast. To make sure to get future episodes, please subscribe to this podcast wherever you get your podcasts or visit our website at greenshield.ca/podcast to download.

As a reminder, we talk about these issues consistently in our publications, which are available on our website. Specifically for today’s episode, you can check out our April 2018 edition of The Inside Story. Thanks for listening, and we’ll talk about soon.

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