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Darshan

Hey everyone, welcome to another episode of DarshanTalks. I'm your host Darshan Kulkarni. It's my mission to help patients trust the products they depend on. And today's guest is exactly the type of person we reach out to. And when I say we, I mean anyone who, who is trying to figure out what the right thing to do is you reach out to go, what do you think? And is this going to help enhance the issue of trust, and to help enhance the issue of how we get patients to trust the products? So as you know, I'm an attorney, I'm a pharmacist and advise companies with FDA regulated products. So if you think about drugs, wonder about medical devices, consider cannabis or or obsess over pharmacy, just the podcast for you. I'm a lawyer. So I do have to say this is not legal advice. And this is not going to be clinical advice. But these are podcasts I do because I find myself talking to very interesting people like our guests today, and they're a lot of fun, but I find myself learning something new each time but it'd be great if I knew someone else was listening as well. So if you like what you hear, please like leave a comment. Please subscribe. You can find me if you have questions on DarshanTalks on Twitter, or just go to our website at DarshanTalks calm. So our guest today is looks. That's beautiful is the Assistant Professor of medical ethics at the NYU Grossman School of Medicine. She is the purse she's a world renowned bioethicists and has spoken on a variety of issues. And we've actually had her as a guest previously. So our guest today Allison Bateman house, Elson, how are you? Hi, Dr.

Alison

Sean, thanks for inviting me back.

Darshan

Thanks for coming on. So so I get the good news of talking to you after after this, this FDA approval that has, for lack of a better term been been challenged by by a bunch of different people, and I've seen bioethicists come out. And I've seen non bioethicists come out on both sides of the story one, one set of groups coming out and saying, We want this drug. It's the Biogen Alzheimer's drug, I believe is is what it is. And we want this drug to be accessible. Because there's been no treatments out there no new treatments, since I think the 1980s, if I remember correctly, so something something new something that there's hope that comes with it. Other people are saying you lowered the standard you have is this drug? Does this drug even work? In fact, we had, I believe, three separate people who worked in the FDA Advisory Committee resigned because they weren't happy with the decision. But But let's sort of take that, take that spot and explore it. What is your take? Do you think this was a good decision? Was access more important than efficacy?

Alison

Well, FDA didn't ask me my opinion. So So um, you know, and I'll just say, who did FDA ask for their opinion, they asked for a bunch of independent experts their opinion, and then proceeded to rule in opposition to what those experts said. So I guess I'll say there was an independent panel of experts who recommended for this drug not to be approved. FDA approved it anyway. And the question now is, was that a was that approval, you know, in error, or was it appropriate. And this is where it really sort of the divide is the divide is people who really want to see evidence for approvals say, you know, evidence based approvals is what the FDA is known for. And we don't see evidence here, versus people who say, we may not see evidence here now. But as you pointed out, this is a devastating disease, there's been no therapeutic, you know, real sort of progress for a number of years, why not go ahead and try something if there's even, you know, a modicum of a chance it might work. And I have to say, I fall closer to the the side of people who want to see evidence base for approvals. But I also don't think that you necessarily want to ignore the fact that you know, this is a devastating disease, and sometimes it might make sense to lower the evidentiary bar for for a drug to be brought to market by FDA. So So I think this is a complicated area and happy to talk about it in depth, but I guess I'm not one of those people who would be resigning from an FDA Advisory Committee over this I see where they're coming from. But neither am I someone who is a static about this approval. I'm sort of like in the middle closer to those people who are upset about it then not but at the same time, you know, willing to at least countenance The idea that you might lower standards in certain circumstances.

Darshan

So that let's let's explore that a little bit, though, because when I when I think about that I think about, I believe it was yesterday that jack Woodcock came out, I think Zack Brennan was talking about it on Twitter. And she came out and said, We need to stop looking for this this higher standard prior to approval. And maybe we need to start looking at more clinical evidence, and I'm totally paraphrasing, so. So please take it for what that is, which is a total paraphrase. So feel free to look up the quote, and I'm happy to try to find it and send that out as well. But do you believe that's right, which is, we need to stop thinking about the FDA being a go no go decision as much as adding a additional proceed with caution, type of decision, which might be what they're doing here.

Alison

I'm sorry, that I'm gonna keep saying it's a complicated thing, because I just I don't think that there's one easy answer. So here, here's the situation, right? So a lot of people think that and I know you don't know this, but you don't think this, but I'm just I'm just laying it out there. A lot of people think FDA gets, you know, a bulk of data, and it looks at it, and it says yes or no, and that's just what happens. Where is FDA First off, is involved throughout the drug development process, they talk with companies before trials are started to talk about, you know, what is it we would really want to see from this drug? What's the best way to structure trials to try to get to that data, you know, looking at sort of data, you know, threw out the drug development process, right? Because there's normally multiple rounds of trials, saying, you know, what, this look more convincing, this look less convincing, what do we think would be, you know, really needed for the next time around, etc. So there's this iterative conversation going on. It's not just this one time decision. The other thing that I think is really important for people to understand is, there's this, you know, idea in the in the ethos that, you know, as you're saying, rather than having like this one point in time decision, maybe we should allow products to start being used, and then you can have actual, like, clinical, but non trial data that you could get, you know, quote, real world evidence from to be able to have an assessment of is this drug working or not. And that's already happening. So I, you know, there are people right now pushing for lack of sort of regulatory reform for that to happen, that's been happening, we have numerous types of approval pathways. So there is the sort of, you know, traditional approval where a drug goes through a phase one trial, a phase two trial, a phase three trial, the company hands over a bunch of data to FDA, FDA makes a decision. And if the decision is no, that's the end of the road. But that is not the only way things happen now, so FDA can say, hey, you've only gotten through phase two, but the data is looking really promising. And there's like a severe need for something. So we're going to allow you early access to a market, we're going to give you, you know, sort of accelerated approval, but what you have to do is you have to do a trial afterwards to confirm these findings. And if the findings are not confirmed, then we're going to take your marketing authorization away. So that's what happened in this case, this is not a typical, you know, post phase three approval in which we had a clinical trial that definitively said yes, or no, this product is safe and effective for this condition. This was an early approval based on data that the FDA found compelling that there might be benefit from this drug. And now we need to have the confirmatory trials to bear this out. And in theory, if the confirmatory trial doesn't bear that out, that accelerated approval will be withdrawn. So I think in theory, the idea that you should be able to allow early access in cases of unmet need, it's already there, we already have a regulatory framework that allows for that. So the real, you know, sort of tempest in a teapot at the moment is, is this a drug in which that should have happened? And I'll tell you that personally, the reason why I'm concerned about it is a, like I said, you know, we had a panel of experts who looked at the phase two data, and all of them except for one said, No, this drug should not be approved. And that one instead of saying yes, said I'm not voting. So not only was this not a, you know, unanimous endorsement of experts, it was pretty much a unit nanus bar one person who opted not to vote, you know, like refusal of the idea that this evidence was compelling enough for for an early authorization. So that's my my concern number one. My concern number two is the fact that I'm

Alison

It appears that the drug is safe. So I don't think we're really worried about, you know, bringing a drug to market that's going to hurt people. But we are potentially talking about bringing a drug to market that will not help people. And while that confirmatory trial is happening, it's going to be available for a profit. And it's an exceedingly expensive drug. And not only is an exceedingly expensive drug, it requires complex drug delivery. So, you know, there have to be imaging scans, you have to have, you know, the involvement of medical personnel, this is not an oral drug. And it's something that has to be reduced fairly frequently. So this is going to be a super expensive situation. And so I'm worried about the idea of, are we burdening individual patients, as well as the healthcare system with this enormous financial cost that doesn't actually get borne out by what comes of it. So that's, that's the other the other thing that I'm concerned about. And then the third thing I'm concerned about is I would be pretty much okay, except for the concern about, you know, the experts didn't like this data, but I'd be pretty much okay with the idea of bringing this drug to market through an accelerated approval, just given the severity of need, and the lack of other options, etc, if I knew that confirmatory trial was going to be robust, vigorous, done quickly, and let us know sooner than later whether all of this is worthwhile or not. And I don't have that confidence. So at this point in time, the estimate out there is that it's going to take nine years for this confirmatory trial. And I just mentioned, that's a super expensive drug that's going to have, you know, down system ramifications in terms of what healthcare systems choose to spend money on or not. And the idea that this is going to go on for up to nine years, without us having that data is super concerning to me, if you said that, you know, we're gonna put the pedal to the metal and in to two and a half, three years, we're gonna have definitive data, I would be much more comfortable. I'm not comfortable with this. So I think there's there's sort of three sets of concerns that I have about this approval, it's not that I'm opposed to accelerated approval in certain contexts. But there's three reasons or why I'm concerned about it in this context,

Darshan

I think I think they're all very valid reasons. But let's let's address I agree with you on the second one the most. But the first two, let's talk about those a little bit more. The first one, which is the experts voted one way and the FDA went the other. As you know, regulatorily, the FDA specifically comes out and says, We aren't bound by the decision of the experts. Additionally, there have been many situations, maybe not many, but several situations in which the FDA has done just this, which is they've gone against the opinion of the experts. And let's be honest, even in those cases, there was a little bit of a

Alison

mix of opinion. That's like saying that I bet that's the thing that I'm worried about. So right about 20% of the time, looking at historically, the FDA has chosen to do something other than what its expert advisory committee has recommended. But it is never not been a split decision. You know, so maybe out of the 11 person panel, six people voted for against and five people voted for, I'm not aware of any situation in which the vast majority of the panel voted against and then the FDA voted for. I think we think

Darshan

of the decision for the female sexual enhancement one I I remember that being particularly controversial as well, because the argument was that the data simply didn't support it. And it was going to be pretty expensive. I have no idea what actually happened with the drug and bn. But that was definitely in play.

Alison

I remember I remember that as a couple years ago. I don't remember the detail, but I I am willing to bet, although we should go back and look at the data and that it was a split decision on the part of the advisory board. Okay. Okay.

Darshan

So So you think that it was the is the fact that the decision went one way so heavily? That makes you now the

Alison

I mean, even with the COVID-19 vaccines, right? We have not had unanimous decisions by advisory boards. But you know, there's been a preponderance of votes one way or another. And people have sort of been comfortable with it. It's in this case, the preponderance, the overwhelming preponderance of votes were against, but eight and and and I think a lot of people were like, well, maybe, maybe, you know, the decision was not made at that the FDA decision was not made immediately pursuant to that advisory board. decision, right. There was some time lag there. So I think there there was this idea of maybe FDA saw something in the interim, maybe FDA had some data or something that the advisory board didn't have. And that's why they made this decision. So we were all waiting for the summary documentation to be released by FDA to see what exactly they based their decision on, it came out yesterday or maybe the day before, and there was nothing new in there, which sort of like, furthered the concern about, you know, using the exact same data, as your advisory board saw and found deeply unconvincing. What is it that you see here that that is convincing?

Darshan

What I think what I'm wondering is, and this is something I've been a proponent for, for a few years, and luckily, no one's picking me up on it. But I love the idea that when you're talking about court decisions, the judge looks at a bunch of different evidence and then says, This is what I base my decision on. Here's what I looked at, here. are the factors considered, here's the standard I use. And here's how I came out. Do you think that there's any sense in requiring the FDA to go down a similar process, don't just give me a checklist of things you saw? Give me a checklist of how you interpret that?

Alison

Well, that's basically what this summary document that just came out is, is it saying, you know, here's what we looked at. And then here's why we decided the way we did. So it's not just it's not just a checklist of you know, we've all this, it's actually saying, we found it convincing because of x. And and basically, it boiled down to you, he said, I guess the other thing we should say for your listeners is, when you have these accelerated approvals, the idea is to bring a product to market fast, because there's this unmet need. And so frequently, rather than looking at mortality outcomes, which are typically not fast, you're looking at some sort of surrogate outcome, whether that's, you know, something like, you know, for kidney disease, like you're creating them level or, or, you know, for cancer, you know, like tumor progression or, you know, lack of daily, you know, activity activities of daily living or something, there's something that can be measured in the shorter timeframe that we're using as a surrogate for this longer timeframe thing, which is typically mortality. And so the real sort of crux of the issue is, is this surrogate marker, which are called is it validated? And do we know that it is a good proxy for this thing we're actually trying to measure and in this case, the problem is we don't know that what they were looking at in this particular drug. We don't know that it's a validated surrogate markers. So what, what I think most people have Alzheimers, you've heard people talk about amyloid amyloid plaques, you know, amyloid buildup in your brain. That's been the prevailing hypothesis for decades that Alzheimers has something to do with these amyloid plaques. Hence, if you see a decrease in amyloid, that probably means that, you know, something beneficial is happening with regard to the Alzheimer's disease, because there's inferred this correlation. that's never been proven. So what we had is we had data that showed it affected amyloid. But the question is, is that marker, a validated surrogate marker? And that's what we don't know. So you know, it doesn't it doesn't do any good to affect amyloid if amyloid is not actually causative, or at least in route to the development or progression of Alzheimer's disease.

Darshan

Fair enough? I think that's that's a fair point to make. But as you pointed out, that's what the general the general thesis has been so far. You're right. It's not a validated market. But But alternatively, what was what was the alternative?

Alison

Well, I don't know for so you know, I'm an ethicist. I'm not a I'm not a drug developer. I'm not I'm not a clinical pathologist or anything. But but this is a thesis that has really come under fire in the last couple of years, simply because they're saying, you know, for quite some time now, everyone has been gunning for this amyloid hypothesis. And don't you think if it would actually, you know, a relationship between amyloid and Alzheimers at some point, one of these amyloid altering things would have panned out and since nothing's panning out, maybe the hypothesis is wrong. I have no idea. I have no idea what the hypothesis is going to be. But I share the concern about the fact that perhaps this surrogate marker is not strong enough to justify bringing this product to market on the basis of the evidence that it was brought to market given, as I said that concern about the length of time it's going to take to carry out those confirmatory trials, and the financial impact in the interim. And I just want to point out that the other thing that I think is really important to share with your audience is once a product is commercially available, it really becomes hard to actually do those confirmatory trials, right? Who's going to sign up to be in a clinical trial and to go through all the extra that is involved in in trials, you know, extra lab screening, extra visits to your doctor, you know, perhaps daily symptom logs or something who's going to do that when they could just take the drug You know, as a routine medicine that their doctor ordered for them. So we've seen this and COVID-19, that as soon as you know, these emergency use authorized vaccines are available for widespread use, who really has a sedative to join in clinical trials. And I think we're gonna see that same thing here now. So I said earlier, the estimate is going to take nine years to do this confirmatory trial, it may not even be possible to do it in nine years if people aren't, are signing up for the trial. And then I just have to mention as an ethicist, I think the people who are going to end up being in the trials are the people who cannot afford this drug. Because, you know, I don't have the money to pay for this expensive drug out of pocket. My insurance is not willing to pay for this drug because it doesn't have great evidence supporting it, and insurers have their prerogative to pick and choose what approved products they pay for. I'll just disclaim that, that it's different from Medicare. So anyone who is a Medicare expert, don't yell at me. I'm just setting that aside for a moment. But you know, most people who are in private insurance plans the insurance plan gets to decide for itself or not, are we going to pay for this new drug? Do we find it convincing? I would be really surprised if there's widespread acceptance of this drug by payers, which means people are going to have a financial gradients of ability to get access to this drug. And I think the people that you're going to end up seeing in trials are those who can't get access to it on the open market. And on one hand, you know, great that they have that opportunity to get access to it some way and and great that they're willing to participate in clinical trials, clinical trials benefit all of us. So everyone who participates in them should really be applauded and thanked. But at the same time, if you want to do a good clinical trial, you want to have a generalizable group of subjects. And by really having this economic gradient of you know, only the people who can't afford this drug commercially are the ones in our trials, that automatically starts to introduce bias, because what else is it that this person has not been able to afford? So

Darshan

so many points to get into there? Let's start with the first one, which is I'm actually agreeing with you that that cost is going to become a big issue, mostly because I think I read somewhere that this could bankrupt Medicare if but just based on the volume of patients in the light. So would you suggest from a bioethics standpoint, that in cases where you're bringing a product to market that has not been, quote unquote, confirmed to be as efficacious, that needs to be a downward pressure on the price until those confirmed confirmatory studies are done? Or is that not really something you're advocating for?

Alison

I hadn't really thought about it. I tend not to think about economics issues as much as I probably should. But yeah, I mean, I think I would agree with that. I think that there, I think, to the extent that a product is commercially available, but I'm weak evidence, I would be loath to let people charge, whatever they want for that product. You know, I think of like, truly life altering drugs, where we have evidence that, you know, this intervention saves lives, or this intervention reduces morbidity. I'm okay with us charging a lot for those. I mean, I'm not okay with the idea with the fact that, you know, just overall, our healthcare system is inequitable, and overly expensive, or whatever. But I really feel like this idea of sort of like value based pricing. Like if this is a transformative drug, that's going to actually save cost in the long run by PPV people alive or keeping them out of hospitals and keeping them employed and whatnot, then, yeah, let's pay for that drug as much as you know, the market can bear but I'm really concerned when, when it's a drug that we honestly don't even know if it works.

Darshan

So let's play that scenario out a little bit more. And I recognize

Alison

that and actually, can I can I just point out darsan. So right now, you know, I mentioned earlier, one of the other products that recently has been introduced into into populational use without, you know, pristine evidence, although much better evidence. There's like night and day difference are the COVID-19 vaccines. And of course, individuals are not paying for that, right? The government is paying for that because it sees it as a social good for us to get this, this, you know, product and try to increase herd immunity. So someone's still paying. It's not like, you know, companies are handing this out as as philanthropies. But it's different that asking an individual patient to pay for an exceedingly expensive product that doesn't have good evidence.

Darshan

So I think I'm agreeing with you, in many senses that there needs to be some kind of downward pressure on the price because of the contentious nature of the evidence. If that's true. Do you see that compromising whether whether drug companies even go and get approval because that would potentially affect their exclusivity and their ability to be in the market, because that means that they might be entering the market in this specific instance for up to nine years with a reduced price, and therefore they go, I'd rather not get on the market, because I bro I

Alison

mean, so but basically what would be happening by saying, you know, your ability to sell this product is going to be linked to its proof of efficacy and relate the value add of it, that makes us more like most other nations in the world, right, where there's regulatory approval of a product, but then before it's actually brought into use, there's a negotiation on the part of a national health care system of, you know, sure this products approved, but we actually think it's probably only the third best product out there for this indication. So we're not willing to pay as much as for those other first two drugs. And, you know, certainly people who live in the United Kingdom and other places that have this sort of, you know, intermediary of, you know, health economics assessment, they certainly complain because they don't have access to drugs to the same degree as people in the United States. But at the same time, you know, it is a very rational way to try to figure out how to use societal resources in a way that you know, really sort of up leverage is the benefit you get from it. So there's certainly pros and cons both ways.

Darshan

Absolutely. Let's, let's take a second the third point, I guess you had, which was on the confirmatory trials. And one of the things that really spoke out to me earlier was I read this article that the FDA does and with all due respect to the very, very hard working people at the FDA, they does they do a piss poor job with confirmatory studies after the fact that just not been great at postmarket, post marketing surveillance, that's just not where the efforts go. What worries me in a situation like this is you've got a drug whose entire efficacy is based on let's prove it in post marketing surveillance. And and we may not have the evidence to get that in the best case errors nine years after, and you're and Biogen is probably not going to care about that drug after past probably about seven or eight. So why are we even waiting? Like what what is the incentive advise you to continue doing the studies at that point? In fact, there have been situations I think it was, you know, even I could be wrong, where they just refused to do the study though postmarketing studies saying it's not profitable for us. And we'll just stop and be f8 and come back out to them for several years. So is that a worry? Or do you think I'm sort of overhyping that problem?

Alison

No, I think it's a huge worry. So I think the the post confirmatory, you know, sort of landscape is is actually slightly less dire, they new depict it to me, but but only slightly less, I think we are in a bad situation where companies are told you get this approval based on a confirmatory trial, and then the confirmatory trial either doesn't happen, or it doesn't happen within this time frame that was set, and there's not very much penalty for that happening. So I think that's a huge issue. And in fact, you know, out of all the things I'd like to see Congress intervene with, with regard to you know, drug development, or that that's the thing I would like to say, I would like to see there be like, literally a very high bar for excusing people to not meet these, you know, confirmatory trial obligations. Obviously, if you're something like COVID, that comes along, that disrupts the entire medical system, they need to be like, okay, we're going to have to give you an extra two years to finish that trial, because you just couldn't. But other than that, I really think whatever the upfront agreement is, needs to be honored, and there needs to be penalties for not meeting and, and, you know, just to tie it back to what you say, I completely agree that period of on patent, you know, ability to sell your drug for profit. That's the carrot that drives drug developers to do what it is they're being required to do. So by saying, you know, you get a carrot. And you know, you still don't really have to do what it is we demand you to do. It doesn't make a carrot anymore. It's just sort of like, you know, I guess it is it is a carrot with no stick. So, so I'm really concerned about that. Yeah. Oh, you're muted. You're muted. Sorry, thank

Darshan

you. No, not at all. I usually try to keep these 1520 minutes. We're already at double that time, because you're just a fascinating speaker. Do you mind if we have you back over and we have another discussion about this?

Alison

No, not at all. I think about this stuff way, way, way too much. So it's just nice to be able to like, share it with people.

Darshan

Wow. It's just super fun talking to you. But before we go, we have four questions we have to ask you. The first question based on what we discussed, what is the question you'd like to ask the audience

Alison

I guess, you know, do you feel strongly about the need to really have these confirmatory trials conducted in a timely manner as Darshan? And I do? Or are there reasons that you think that? You know? I don't know that it's okay for them to sort of get drawn out the way that they historically have been?

Darshan

So you answer, I usually try to answer the question, I would say, I think I share your view on this, which is, I think we need to, if we're going to focus more on a risk based approval, which is what we seem to be doing more and more, where we say that, you know, if we're willing to take on the risk that someone that the drug may not have all the efficacy in place, but we think that the, the evidence looks interesting, I think it's an interesting idea to say we'll approve it, but it'd be a semi, for lack of a better term conditional approval, which there's no such thing, but sort of, but if we're gonna do that, then we've got to require that someone actually spend the time and confirm that it's actually happening. So that's my position on it. Two other short questions for you. Well, before we go into this, what is what how can people reach you if they have questions?

Alison

I'm on Twitter at a Bateman house. I am available by email. If you just look at NYU Grossman School of Medicine under Allison Bateman house, you find my email address. And I think those are probably the best ways. Oh, no, no, I forgot I forgot. We're on clubhouse now. So some other ethicist and I now have a weekly one hour show on clubhouse called the ethics club. And we talk about it not only medical ethics, but other issues as well. So we actually just talked about this approval a couple of weeks ago. But we talked about all sorts of things. So next week, we're actually talking about engineering ethics with regard to, you know, sort of like safety code violations and whatnot with regard to, in this particular case, factories. So it's a very wide ranging show, and people can certainly reach me there as well.

Darshan

So go to clubhouse and talk to Allison. two last questions. Um, what was the one thing you learned in the last month

Alison

that people are endlessly creative, and I knew that but I continue to be amazed a new at how creative people are so ideal, a lot of time My specialty is access investigational medicines, I deal with lots of people who are very invested in trying to figure out how to optimize that either by speeding up the process or making it you know, easier to navigate or less expensive, or what have you. And, you know, I routinely get field that field proposals that sometimes I think, you know, are very promising that sometimes I think, have absolutely no chance to work, but are always endlessly creative. So that's, that's one thing that has been confirmed yet and new ever, ever. Just the last couple days.

Darshan

I'm gonna ask what might then be a duplicate question, which is what made you happy in the last week.

Alison

Ah, I just this morning went to a graduation of a family member. And that was super exciting. So it's graduation season. And you know, so many students and teachers have had just a really, really, really, really tough year, and to be able to celebrate in person with people who are all vaccinated. So we were able to be unmasked, you know, graduation, just really felt normal, and it felt exciting. So that's

Darshan

awesome. I'm gonna do a quick summary of our conversation, we actually ended up talking a little bit about just patient advocacy and how this actually tied into the Biogen Alzheimer's drug. We talked a little bit about confirmatory trials, we talked about your primary concerns in this specific instance, which included the experts were not fans for lack of a better term, the the limits their disposes to access because of costs and the like. And the fact that the confirmatory trials themselves may take up to nine years. So that's obviously going to be a potential concern. We talked about

Alison

that and have a skewed population in them, right? So it's going to be people in the United States, it's going to be people in the United States who can't afford the drug. And I imagine a lot of it's going to be ex United States, because they're going to be other countries that refuse to spend this money. So so a skewed population in those in those trials.

Darshan

100% agree. We also then talked about the concept of early approval, and what that actually could mean and the ramifications, whether it's patent, whether it's exclusivity or something else. He talked a little bit about the value of na or the lack of value of non validated surrogate markers, and what the implications of that are. Did I miss anything

Alison

No, I don't think so. But I need to put in there one disclaimer that I have consulted for Biogen in the past on access to investigational medicines, but I was in no way shape or form involved in this particular drugs path to FDA approval. So

Darshan

there you go. So I'm glad you mentioned that I have never thought to ask people about conflicts on this, but probably a good idea. So thank you for that. If you need to reach me, you can find me at DarshanTalks on Twitter or go to our website at DarshanTalks calm, but Alison, this was wonderful. So thank you so much for coming on. I'm looking forward to having you on again soon.

Alison

Thanks for the opportunity.

Alison

This is the DarshanTalks podcast, regulatory guy, irregular podcast with hosts Dr. Shaun Kulkarni. You can find the show on twitter at DarshanTalks or the show's website at DarshanTalks.com

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