Another Needle-Free Epi Option?: An Update on Nasdepi

In this episode, I'm joined by Scott Lyman, CEO and Co-Founder of Belhaven BioPharma, to discuss Nasdepi®, an investigational dry powder epinephrine nasal spray currently in development for the treatment of anaphylaxis.

Nasdepi® is designed as a needle-free alternative to traditional auto-injectors, with early clinical data suggesting rapid absorption and strong temperature stability.

We talk about:

• Why alternative delivery systems matter
• Needle fears and other real-world barriers to carrying epinephrine
• Human factor studies and ease of use in high-stress situations
• What “investigational” means and where the product stands in development

This episode is part of a broader series exploring epinephrine options beginning with episode 67. As always, this podcast does not promote any specific product, just information and education. 

Episode links:
-Nasdepi: https://belhavenbio.com/nasdepi-progress/

Special thanks to Kyle Dine for permission to use his song The Doghouse for the podcast theme!
www.kyledine.com

Find Dr. Whitehouse:
-thefoodallergypsychologist.com
-Instagram: @thefoodallergypsychologist
-Facebook: Dr. Amanda Whitehouse, Food Allergy Anxiety Psychologist
-welcome@dramandawhitehouse.com

Transcript

Scott Lyman 0:00

we're happy to be one of many that are in this space. We'll all take pride in getting a product to market. I wanna keep people's mind focused on the emergency. I don't want them having to worry about the medicine, and did it get in and am I getting better, did I leave it in the heat, is it expired? None of that.

Speaker 0:19

Welcome to the Don't Feed the Fear podcast, where we dive into the complex world of food allergy anxiety. I'm your host, Dr. Amanda Whitehouse, food allergy anxiety psychologist and food allergy mom. Whether you're dealing with allergies yourself or supporting someone who is, join us for an empathetic and informative journey toward food allergy calm and confidence.

0:41

This season on the podcast, we have been exploring the expanding landscape of allergy management. We have more options than ever before. This space feels exciting and at times overwhelming. So I'm working on helping to bring you information to navigate that. Today's episode is the next in a series specifically on epinephrine, because when it comes to food allergies and anaphylaxis, there is nothing more important than our epinephrine and clarity and confidence about it matter. My guest today is Scott Lyman, CEO, and co-founder of Bellhaven Biopharma, the company that is developing Nasdepi a needle free dry powder intranasal epinephrine. I want to be clear that this is different from Neffy the intranasal spray epinephrine, which is already on the market and they're working hard to bring an exciting and more convenient new option of epinephrine to all of us. Scott taught me so much in this conversation about his experience in spray dried powder technologies. He comes from a deep background in drug development and commercialization. Over his career, he has contributed to multiple FDA approvals across immunology, infectious disease, neurology, and HIV medicine. In this conversation, he shares the science behind nasal epinephrine delivery, the rationale for the dry powder formulation, what data suggest about absorption and stability, and where Nasdepi currently stands in the regulatory process. As always, my goal in this series is not to promote any one product. I've invited representatives from across the epinephrine landscape to join me on the show. Some declined, others have joined, and I appreciate their input. My hope is that all of this information leads to more informed conversations with your own medical team.

Amanda Whitehouse, PhD 2:18

thank you so much for being on the show, Scott. I'm excited to have you here because there's so much excitement in the world of food allergies right now, and you are right on the cusp of it from what I'm learning about you and your work.

Scott Lyman 2:28

That's right. I appreciate you having me.

Amanda Whitehouse, PhD 2:30

Yeah. Would you start by just telling us a little bit about you professionally and how you got into what you're doing now?

Scott Lyman 2:36

Sure. So I'm a chemical engineer by training, and my first role out of graduate school was at Amgen, where I was spray drying some antibodies and making powders. And we were testing them in animals to see if there was a better way to deliver drugs. We worked on that for a little while. And then we acquired a product called Enbrel, which is for rheumatoid arthritis. Big drug. But at the time it was a very clunky administration. You'd get these vials full of powder, you'd have to, mm-hmm. Fill from a syringe, diluent into the vial, shake it up, draw the liquid back into the syringe, and then inject yourself. Not once, but twice. And so I led a team that took two lyo vials where you had to do the reconstitution and turned it into one lyo vial. And that's called a bioequivalency regulatory pathway. And then we went from one lyo vial to a prefilled syringe, which was better. And then we did a prefilled syringe to an autoinjector. So my experience started spray drying powders taking liquid drugs and turning them into powders, and then also doing route of administration changes. So that was 25 years ago, and I went off and did a lot of different roles at a. Various companies and did some startups, worked at big companies like at GSK and and places like that, and. All of a sudden I got connected with somebody whose brother was an allergist who thought that a dry powder nasal approach would be the next wave for emergency or rescue medications. And so, sort of brought me full circle from where I started my career. And I liked the idea of working on drugs that have already been approved so you don't have to worry about whether they work or they're efficacious. You don't have to worry about that they're safe. You just have to. Transition them from an autoinjector in the case of epinephrine to a dry powder nasal administration. So it's not the most cutting edge science, but it's definitely something where there's a light at the end of the tunnel. We just have to make sure that from an engineering and and medical perspective, that we can deliver the same amount of drug just a different way.

Amanda Whitehouse, PhD 4:56

And obviously most of my audience we're probably not familiar with the process of how do you move that into an actual product that that can be on the market?

Scott Lyman 5:05

Yeah, so we spent a lot of time trying to understand the need. So this was 2020 when we started Bellhaven, and we knew at that time that there was a couple companies that were looking at doing a liquid nasal administration. We said, well, that's interesting. That's a step in the right direction. You get rid of the needle, but there's still an issue with a liquid drug. So especially epinephrine. Epinephrine is susceptible to heat degradation, humidity. It doesn't like to be at low pH, even in the light it can go bad. And so we said, well, that's great, but if you're gonna do a nasal administration, why don't you fix all the problems associated with the EpiPen? So that's what, even though we knew that there was other people working on something slightly better, we thought we could fix, fix everything. So we put together sort of a business plan and looked at the landscape. We are drug developers, we're not device developers. So we've partnered with a device company that already had a device made. So all we had to do was formulate the dry powder and use a existing device. So we put this plan together. I went out pitched it to sort of my Rolodex of people I know. So this is pharma, med tech physicians, people that understand the need, and it's a pretty easy sell. The EpiPen is a, it's a great villain in the story. It's got a short shelf life. It's big, it's clunky. You really need to be trained in order to administer it properly. It goes bad. It's had its own share of publicity around cost and stockouts when kids are going back to school. So, I didn't have to sell it very hard for people to understand the need. So so that's what we did. We just decided, we're gonna do this. We're gonna raise this money. I'm gonna get a team together. It's a virtual team, not expansive by any means, and we're gonna do the formulation work. And then we're gonna do, we do a small amount of animal work. Luckily epinephrine is a pretty understood drug. So when you do a dog study, you just give the dogs their doggy Gatorade and, and snacks and they're ready to go again. You just give them two days and they're ready to be administered another time. So it was great from that perspective. It's great because, because it's an approved drug, the timeline is short. So normally when angel investors hear about pharma, they wanna run away. It's too long. I'm not gonna get anything out of it'cause it takes too much money. But with something like this, we've come up with a way where we can get approval in four years. We don't need massive amounts of capital. We don't need venture capital to come in and, and provide the funding to get this done. So it's just been a, an easy story to tell. I think we've got a very differentiated product. We don't oversell what we think we can do. We think beyond making the goal of this whole thing is to make epinephrine protection easy. I want everything to be easy. It's half the size. It's about the size of a car key. We've even, you know, developed a key chain that you can put on, and so you can carry it with you on your keys. It's intuitive, right? It's super simple. I don't want a bystander to be handed this device and put a needle through their thumb like you do with an EpiPen. I want them to be able to pull this out, put it in a nose, single use, done. And you don't have to be an active participant either. So you don't have to suck anything in, like with a liquid. You don't even need to be conscious. So the great thing about the nose is it's a natural filter. So it wants to filter things. So it brings a drug on board very rapidly. We get drug on board much faster than a traditional route of administration. And then you don't have to think about it. This is heat resistant, so you can bring it to the beach, bring it to a baseball game where it's a hundred degrees. It's not gonna go bad, it's not gonna freeze. Shelf life is at least three years. We just wanted to check all the boxes around simplicity and not having anybody be nervous. We have we talk to patients that, will go out and they'll say, now I don't trust my EpiPen. I'm gonna call the doc and get a new script because I don't trust cloudy.

Amanda Whitehouse, PhD 9:41

They're

Scott Lyman 9:41

staring at

Amanda Whitehouse, PhD 9:42

the window there. Do I get it too hot or too cold? I live in Buffalo. We've had so many EpiPens ruined because they got left in the car, in the garage in the winter.

Scott Lyman 9:49

Exactly, exactly. So Simplicity was the name of the game. I think we're well on our way. We really are driven by trying to make this a global product. So by making the shelf life. Long, three times as long having it be heat resistant. We're trying to make the cost of goods as low as possible so that whoever commercializes it probably won't be Bellhaven. We need a partner that has the breadth and reach to get it out to patients globally,

Amanda Whitehouse, PhD 10:17

absolutely. Can we describe what it looks like? I know everybody will be curious.

Scott Lyman 10:21

Yeah, it, there's a couple things I compare it to. The device itself sits in a tube that is actually the people that make this tube are the ones that make the mini m and m tubes. That's how we started, started, I was gonna say,

Amanda Whitehouse, PhD 10:33

looks like a candy tube or maybe

Scott Lyman 10:35

like

Amanda Whitehouse, PhD 10:35

a bottle the size of an average pharmacy pill bottle.

Scott Lyman 10:38

Exactly. Or a 35 if you're old enough, 35 millimeter film case.

Amanda Whitehouse, PhD 10:42

Yeah.

Scott Lyman 10:43

It's really great technology. It's a plastic container. It's very sturdy. You could drop the device. It's not gonna actuate. You could put it in a bag and beat it up pretty hard. And the, the interesting part is it's actually got a desiccant polymer inside of it that helps protect the device from moisture or heat. So even though the powder itself is very, very stable it's just another level of protection. So

Amanda Whitehouse, PhD 11:10

yeah. And it

11:10

looks

Scott Lyman 11:10

and it's about half the size.

Amanda Whitehouse, PhD 11:12

Yeah. And it's got an easy open lid, like with a little lift there to grab the lid is attached. You can hear it clicking open, so you know it's open and closed. It looks pretty.

Scott Lyman 11:21

Very intuitive device, single use, and you don't have to worry about which nostril you put it in. We've had two clinical trials both of which have shown rapid onset of action and then sustained drug levels for the first 45, 60 minutes.

Amanda Whitehouse, PhD 11:36

Okay.

Scott Lyman 11:36

And like I said, it's pretty intuitive. We've done what they call human factor studies where we've given the instructions for use to parents and patients and caregivers and bystanders, and you give'em a device that they haven't seen before and they just kind of walk through it and we haven't seen any, any real issues.

Amanda Whitehouse, PhD 11:57

Yeah. Yeah. And I can see when you open that vial and pull it out, it's just, it very clearly looks just like a nose spray that someone would use. And when you demonstrate, I hear it, you can, it clicks so you know that it's fully administered.

Scott Lyman 12:07

That's right. The actual product will have a little blue line around the outside of the, and so that once that blue line, once you actuate the device, that blue line disappears. So you know that it's, that it's been, actuated.

Amanda Whitehouse, PhD 12:20

I'm in good company. As soon as you started talking, you held up your EpiPen and I sit here at my desk all day. I've got EPIs, I've got generic epinephrine, I've got ques, I've got Neffy. So in that one, I think a lot of people are hearing about nasal delivery. And I think you touched on, but explain to us in more detail how this is different from Neffy, which we're all glad now that we have this option, but not exactly the same as your product, right?

Scott Lyman 12:42

No. So, what we're trying to do with the dry powder administration, there's a few things, is the liquid epinephrine in general is susceptible to degradation. It just, it just is. And so we want to take that out of the equation. The other thing is a liquid product needs preservatives. Preservative in and of itself can cause a reaction, so you don't want to do that. And then the other piece is, what we've seen is liquid nasal administrated drugs can sometimes be susceptible to half a dose when you have rhinitis, so allergic rhinitis, runny nose et cetera. What we've seen is

Amanda Whitehouse, PhD 13:24

people with allergies are more likely

Scott Lyman 13:25

to have, of course. Exactly. Well, you may come into an event. With, with it from a cold or asthma symptoms or something like that. And then the event itself may cause allergic rhinitis. And so you wanna know that you're still gonna get the dose on board. I think that's one of the things with the liquid products is sometimes if you have rhinitis, you're supposed to give two doses, so you're supposed to give one dose five minutes after the first dose in the same nostril, which comes back to my whole theme around simple. If I'm having a anaphylactic event, the last thing I wanna do is have to think about much of anything. Right? Has it been

Amanda Whitehouse, PhD 14:04

five minutes? And where's the other dose?

Scott Lyman 14:05

Which, which side did I do the first one in? Which nostril did I do it in? I do. I have a second dose. I know we're supposed to. We sell, Nasdepi is, was what we call it, na nasal dry powder epi. It's nothing.

Amanda Whitehouse, PhD 14:18

Oh, I get it. I didn't connect that. Thank you. Yeah. Yeah. You laying that out for me?

Scott Lyman 14:22

Yeah. And so, you know, the product comes as a two pack, right? That's how all, all emergencies products typically come. And you are supposed to have those with you at all times. But then, real world rears its ugly head and sometimes you don't have a a second dose. And so what we completed was a study where we induced allergic rhinitis. So with an allergen challenge and tested NASDAQ to see if you would need a second dose. Based on the data, looks like, in fact in the presence of rhinitis, the drug actually gets on board slightly faster and there's actually more uptake of drug. In that arm. So we feel very good that you wouldn't need a second dose in that situation, which once again comes back to the theme of, of simplicity. I know your audience is a lot of parents. What we hear is you, we don't want kids to not be invited to birthday parties because the parents that are hosting don't feel comfortable administering an EpiPen or play dates or you name it, right? So if you show up at somebody's house and say, Hey, here, I'm gonna give you this. It's very simple. You just administer this into the nose. That's probably a little more palatable to some hosts than others. And that's the last thing we want is a kid to miss out on activities because the current standard of care is, is clunky and hard and scares people.

Amanda Whitehouse, PhD 15:49

It scares people and it scares not just others. It scares people with allergies. I mean, as a psychologist, the folks that I work with, there's so much fear. A big chunk of it is around the needles. And I just think this wave of needle free options is gonna change what allergy management looks like. It's so exciting.

Scott Lyman 16:05

Yeah, absolutely. Absolutely. So that's our goal is to make it super simple. We're hoping we can drive the cost down to the point where instead of getting two of these, maybe you're getting six of'em. Or multiple packs so that you have the protection, the web of protection everywhere you have one in your purse, in the car,'cause now you can leave it in the car. Right? Right. You can take it to the office, at home, you name it. And so you're never in a situation where something happens and you can't find it.

Amanda Whitehouse, PhD 16:37

Definitely right, if we could toss it in, all those places have one in every purse, every gym bag, every sports team bag that our kids are running off with. Me as a parent just thinking, I'm just stashing these babies everywhere.

Scott Lyman 16:48

Mm-hmm.

Amanda Whitehouse, PhD 16:49

Obviously, we still want our kids to learn and remember to carry them and adults too. If we can take the remembering out of it and just have them in all the places, that's another layer of protection.

Scott Lyman 16:59

Yep.

Amanda Whitehouse, PhD 16:59

Agreed. Great.

Scott Lyman 17:00

We've just completed, the big milestone is getting what they call registration batches. So this is actually making the powder, filling it into the devices packaging them, labeling them, and then putting them up on stability. So you need to have 12 months of stability to be able to file for approval, and then you'll add that stability as you get approved. And so that's what's really driving everything. We've got a couple clinical trials what we call a comparability study just to make sure we are as good as the EpiPen and as good as the manual intramuscular injection. The FDA has already asked us to do a repeat dose study just in case something would happen or you've got a breakthrough event, we'll do a repeat dosing in the same nostril, repeat dosing in the opposite nostril. And then a self-administration study. So most of these clinical trials, it's healthy volunteers. We don't do, we don't induce anaphylaxis in patients. That's just too concerning mm-hmm. Of a, of an endeavor. But, most of the time it's a healthcare practitioner that administers the dose. And this is another thing that we think we simplify, is when you see EpiPen data, depending on if how the healthcare practitioner administers it, it can be widely variable. I think we've seen that in some of the data with even the liquid nasal administration. It was very different when the patients did it versus the healthcare practitioners. So we, we have to do that same study to show that when a patient administers it, it's gonna be the same as if a doctor, nurse would administer it. So we'll do that, and then we are gonna repeat the rhinitis. Because the liquid nasal product had a little bit of an issue with rhinitis. We need to run that study and show that we hopefully don't have any problems with rhinitis. And then, as you know, anybody that's over 30 kilos gets the EpiPen currently. So that happens when you're around eight years old. So. Because the physiology of eight to 17 year olds in general is a little different. We need to go study it just a few adolescents to make sure that,'cause the, the volume of blood is a little different. The nose size might be slightly different that we're not seeing anything unusual. And then we are developing an EpiPen, junior equivalent Nasdepi. And we've, we've got. All of our data modeled, so we know exactly what that dose should look like. This is about four to seven year olds in order to get that Junior approval as well.

Amanda Whitehouse, PhD 19:36

All right. There's a couple things in there I wanna clarify, just because I know people. Yep. We we're an anxious bunch. That's why I have this show. Yep. So I know there's a couple things in there that if people aren't clear on what you're saying, they might have hesitation and I don't wanna create that. You mentioned about that you don't induce anaphylaxis. In the study of the medication. But that's not just for your medication, it's my understanding that that's any new device, like with Neffy, that was the same development, right? Because we just measure the level in the blood, we wouldn't

Scott Lyman 20:02

Yeah, that's right. So there's two ways to make sure that the drug is doing what you need it to. So there's first the level of drug in the blood, that's number one. But then there's the pharmacodynamic markers that you can test. So this is heart rate. The heart rate should go up, the blood pressure should go up. And so when you measure those things, you know that you're getting not only the drug on board, but the body is reacting the way we want. So when we run the studies, we never wanna give anyone the actual allergen itself and then have to bring them back from a serious situation. So we only test this in healthy volunteers and we know that it's, the drug is working based on the pD markers, the blood pressure and the heart rate.

Amanda Whitehouse, PhD 20:51

Okay, good. Thank you for clarifying that. One thing that I know people are going to be curious about, are there any other nasal dry powder medications that would be familiar? We wanna know what it would feel like. We know what a nose spray feels like often, but not a dry powder.

Scott Lyman 21:03

Yeah, and you know, it's funny when you say powder. We have blank devices that have powder in it. If I sprayed one for you right here, I don't even know if you would see it. The particles are about 25 microns, which sound might sound big, but they're not very big at all. I think you would know that it'd been administered because you would look at the desk and you could sort of write your name in the powder. Right. Okay. So it's not like salt, it's more like talcum powder or something.

Amanda Whitehouse, PhD 21:36

Okay.

Scott Lyman 21:36

Hitting the nasal mucosa. There is one dry powder nasal product out on the market. It's called Baqsimi. It's for hypoglycemia, it's a glucagon. Oh,

Amanda Whitehouse, PhD 21:47

okay.

Scott Lyman 21:48

And that was launched in 2019 by Eli Lilly. And so same device is what we're using. The powders made a different way, but about the same amount of powder and it's just for basically diabetic shock. And they haven't had any issues. So that's, that's really our game plan is we just, we follow what Neffy did to get their approval. We follow what Baqsimi did with this device to get the get approval.

Amanda Whitehouse, PhD 22:15

Great. After the approval is there, you mentioned having a company that is capable of Mark selling it worldwide, right?

Scott Lyman 22:22

Yeah, yeah, yeah. We know what we do Good. We we're good at developing drugs and getting them approved, and following quality management systems and making sure all the regulatory requirements are being addressed. What we don't wanna do is, is build a commercial organization, right? I'm not a marketing person, I'm not a salesperson. We wanna get it in the hands of somebody that's got the reach and the breadth to make it a success. We want this to get to the, get to the people that need it most. And so that's what we're planning to do is, is essentially find a partner that wants to, wants to have a great product and get it supplied to people throughout the world.

Amanda Whitehouse, PhD 23:02

Yeah, I can't wait. I'm curious about your insights. I know nothing about your field. Epinephrine has been around for years and people have had allergies for years, they're increasing, but it's been EpiPen only for years and years. Why all of a sudden now are all of these alternatives being created and explored?

Scott Lyman 23:20

That's a good question. I mean, I think dry powder nasal for in particular is gonna revolutionize sort of rescue meds and and emergency use meds. One of the things we don't talk about is the powder gets on board through the nose so fast. I mean, when you have maximum drug concentrations within five minutes in some cases. It's basically hitting the nasal mucosa, getting to the end of the bloodstream, going straight to the heart and out. It really makes a good case for if you're having an emergency or you're trying to rescue somebody outside of an iv, which takes time, IV is by far the fastest, right? You push that in and you're gonna get drug. Really fast. But this might be the second best way to get drugs on board. So I just think from a dry powder nasal perspective, I think we're sort of entering a new area. I don't know why epinephrine itself was ignored for so long. Mm-hmm. I'm glad people are starting to pay attention. I've worked on a lot of very tough new areas of pharma. And finally this I idea came along, I said, let's just, let's start fixing some of the things that we shouldn't be having to deal with in the 21st century. So

Amanda Whitehouse, PhD 24:39

yeah. I'm so glad that you are, it is exciting. I can't wait. I mean, we, we've, we've been excited to have options and choices and that's what this season of my podcast is all about. So I think giving us power and control and having more of a choice in how we. Live our lives and manage our, our medical needs addresses our anxiety so effectively in terms of having a choice.

Scott Lyman 24:58

Yeah. And all these products has a different place. Different preferences for different people. I mean, we're happy to be one of many that are in this space. We'll all take pride in getting a product to market and if people choose Neffy over Nasdepi. Okay. I wanna keep people's mind focused on the emergency. I don't want them having to worry about the medicine, and did it get in and am I getting better, did I leave it in the heat, is it expired? None of that.

Amanda Whitehouse, PhD 25:29

Yeah. So the idea to have something like this that's so easily administered and effective and pain free and, it's just, I, I'm so excited to like, lay the options out in front of my teenager, you know? Yeah. Which ones do you want? And which ones where, like you said, different, maybe different things for different people and circumstances.

Scott Lyman 25:44

And I think you said it too, about getting people used to it. So I'm, I'm happy that Neffy is out there and getting people to understand the nasal route of administration. Go for it. Right. Get people on board for that. But I think there is a, a little bit of a, education piece around administration of these things. We've even seen it in our clinical trials. We'll take patients and they'll get three different doses of the product a week apart, let's say. And the first dose, they'll say, oh, that felt weird or they'll mark things down that they weren't quite ready for, but by the time the second dose comes they hardly even notice it. And the third dose. And you know, it's funny because we're actually administering more drug in the last administration and people aren't even talking about any, they're

Amanda Whitehouse, PhD 26:38

not noticing that.

Scott Lyman 26:39

No, no. Which'cause they're so

Amanda Whitehouse, PhD 26:41

familiar with the product.

Scott Lyman 26:42

They're familiar with it. Like you said, you hear the click and you might jump a little bit, but that's just air pressure pushing the powder. Which is a really small amount of powder out the end, and you don't even, you don't even notice it. Um, right.

Amanda Whitehouse, PhD 26:56

Well, and I would argue that that's a little bit of all of our trauma from, from needles and the click that we hear in those needles that hurt. Oh, yeah. You know, so I think that people will probably notice that when they are becoming familiar with your product. It's really exciting.

Scott Lyman 27:09

We hope so.

Amanda Whitehouse, PhD 27:09

Yeah. Well, you reminded me something I've been saying over and over, I'm sure you would agree, that we need to stop saying EpiPen. We need to call it

Scott Lyman 27:16

Oh yeah.

Amanda Whitehouse, PhD 27:16

Epinephrine, right? Mm-hmm. It's, it's hard. It's like Kleenex. We just say it, but I, I think it's important for, for kids to understand any epinephrine is the medication that they need or adults for other adults to understand. There's no difference if someone has an emergency epinephrine, not a particular product. It's all the same medication.

Scott Lyman 27:34

Yeah. We hope to put EpiPen in the same bucket as TiVo someday. Right. Even though you call it your TiVo, it's not really

Amanda Whitehouse, PhD 27:42

Right.

Scott Lyman 27:42

That company doesn't exist anymore.

Amanda Whitehouse, PhD 27:45

Well said. Is there anything that we didn't touch on that you wanna make sure people know?

Scott Lyman 27:48

Like I said, we were eyes wide open when we started Bellhaven, that there was liquid nasal options that were tracking ahead of us. And we just said, why would you half fix a problem when you can fix it all the way? So from an engineer's perspective. It's just seemed like a, an easy thing to, to do. And based on our investor base and their willingness to push this forward I feel pretty good about it.

Amanda Whitehouse, PhD 28:17

Wonderful. Yeah. Well, thank you for all of the really complicated time and work. Even though you said it's already an approved medication, it's a simpler process. It still sounds quite complex.

Scott Lyman 28:27

It is it, I actually thought it would be easier, because we have a huge quality management system and the regulatory piece in the, in the clinical and the medical. It's not as straightforward as people think.

Amanda Whitehouse, PhD 28:40

Yeah. Well thank you for helping us understand that. I think we'll appreciate it more.

Scott Lyman 28:44

That's right. Well, I appreciate it. Thanks for having me.

28:46

as we wrap up our episode, here are your three next steps. First, if you want to learn more about nasda and Follow its development, you can visit Bellhaven Biopharma's website: bellhaven bio.com/nasdepi-progress and Nasdepi is spelled N-A-S-D-E-P-I. Continue to follow guidance from your own healthcare provider regarding currently approved treatments. And remember, this is something that we're looking ahead to as an option, hopefully in the near future. Second. If you haven't listened to any other episodes in this epinephrine series, I encourage you to go back and hear those conversations, starting with the episode from March 17th, episode number 67, with Dr. Farah Khan, simplifying epinephrine. She does a great job in that episode of reminding us what really matters when we are considering epinephrine. And third, as allergy management becomes more complex and rich with more options, give yourself permission to feel both hopeful and overwhelmed, or any other combination of emotions that you might be experiencing. Remember to continue asking questions, listen to the information that your emotions are telling you, there might be something important that they're trying to bring your attention to, and then seek clarity and use credible sources to guide you in navigating that. I hope that these episodes will be one important part of those resources. Thank you Scott Lyman on behalf of Nasdepi. Thank you all for listening, for your likes, your shares, your ratings and reviews. All of those are continuing to help me connect and expand this resource within our community. the content of this podcast is for informational and educational purposes only, and is not a substitute for professional medical or mental health advice, diagnosis, or treatment. If you have any questions about your own medical experience or mental health needs, please consult a professional. I'm Dr. Amanda Whitehouse. Thanks for joining me. And until we chat again, remember don't feed the fear.