MMJ International Holdings - Duane Boise
MMJ International Holdings
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Duane Boise: [00:00:24] In short we're taking the FDA approach and we're creating a whole plant natural extract medicine to go at multiple sclerosis and Huntington's disease.
Dan Humiston: [00:00:42] From MJBulls media it's the raising cannabis capital show. I'm Dan Humiston and on today's show how this company is using cannabis to formulate an FDA approved drug for M.S. and Huntington disease.
Dan Humiston: [00:01:07] Today the raising cannabis capital series we are joined by Duane Boise the CEO of M MJ International Holdings Duane welcome to the show.
Duane Boise: [00:01:16] Thanks Sam. Thanks for having me today.
Dan Humiston: [00:01:19] Well MJ international holding companies is a pharmaceutical company and you're in the process of creating some cannabis based medicine to help people with some really serious diseases and we're going to get into all that but before we do I thought we'd take a minute to talk about what I think is a kind of a confusing topic or it's confusing to a lot of people but I'm afraid is going to have a gigantic impact on our industry and its drugs versus supplements. I mean the FDA and the FTC clearly define the difference and they clearly define what you can and cannot say about each of them. A lot of people will be listening this show and they'll say and I saw this on a Web site. If I take this CBD it'll help with this or if I take this it will help with this across the line and explain why that's so dangerous.
Duane Boise: [00:02:07] Well it's very dangerous and I think it's evidenced by the most recent actions of the FDA because the state to stay federally illegal business is really out of control. Last year in November the FDA issued this cease and desist order against the Stanley Brothers that was making fraudulent medical claims on Charlotte's Web. Now don't take me out of context here. I mean I'm all for having something help a person that's chronically ill and in need of something but did it work for Charlotte on that Sanjay Gupta special once. Yes. Did it work for 30 days. Probably. Did it work for 180 days. Who knows. Did it work for a thousand starlets. I don't know. So you can't come out and make medical claims CVD when you don't know really what it does efficacy of it and you can't reproduce the same thing a second time. But consumer falls into this fantasy a really false information.
Dan Humiston: [00:03:02] You know we go back to supplements you go to the GNC and you buy supplements and when you buy them they don't say this cures this they can't do that. It's against the law as a supplement manufacturer to say that this cures whatever. So as it stands right now a lot of the companies have kind of ventured off the ranch and have started making medical claims it doesn't matter whether there's evidence support it. It hasn't gone through the proper channels it is not recognized by the FDA as being medicine and they're going to get in trouble and that's why you know what you're doing is going to take more time. It's going to take a lot more money. But when you're finished you will be able to do a lot of things legally that companies right now are doing illegally is that correct.
Duane Boise: [00:03:50] That is correct. You know I'm aware that there's going to be more enforcement actions coming down from the FDA and the DEA. And we want to be on the right side of that. There indeed is a outlined approach by the federal government to create medicine and prove to the FDA that we can do it consistently. Give or take 3 to 5 percent variance each time and that we align the production of that medicine to a chronic disease that we know all the antidotes all evidence we're seeing on the street in the different states that have approved it that it works. In short we're taking the FDA approach and we're creating a whole plant natural extract medicine to go at multiple sclerosis and Huntington's disease and the FDA is very constrained in protocols on us on the development process. We are delivering that medicine in a gel cap form similar to an ad Bill we are going through all the necessary clinical trials and research and analytics and we have everything teed up basically to start moving it into our Phase 2 clinical trials on both M.S. and Huntington's.
Dan Humiston: [00:04:59] When I think of a drug going through the FDA process you hear how many years it takes and how many POPs starts that goes through this process. But you just recently had some really exciting news that may speed that up. Me talk to everybody about that.
Duane Boise: [00:05:17] So I think it was about two months ago the FDA had awarded us orphan status an orphan is not the age of the patient population but it's the size of the population think back in the 70s. They put this legislation in place that if you have a small population meaning 200000 patients or less that you could apply for an orphan designation which gives you several benefits. One of it is that it speeds up the process and gives your priority review. The outcomes from your clinical trials. The second most important aspect is that we're creating protection for our medicine for a period of seven years. I say it's a de facto patent on a schedule one substance which otherwise can't be patent. Defend the patent in a federal patent case and the federal government actually comes in and defends the exclusivity of that drug again for the labeling. And we will get a reimbursement back from the federal government potentially up to two million dollars to offset the cost of the clinical trials. So that is a very significant benefit. And our strategy early on was plan to target the populations that would meet you know 200000 patients or less Huntington's disease in the United States serves 40000 or less patients which is why we were awarded that as far as your channels.
Dan Humiston: [00:06:42] What if you've done so far and to secure all of the products that you need to do the testing all that stuff. Is it that all ready to go.
Duane Boise: [00:06:49] We've identified the specific plant genetics we've gone through all the required FDA extractions and analytics. We have stability done the extracts both for the THC and the CBD. Hopefully within the next 30 days I'll have a DEA permit to ship from our analytical lab in Canada into the United States.
Duane Boise: [00:07:13] I believe that's the first to a schedule one facility that will start to manufacture our gel cap and do the very specific analytic requirements that the FDA has to ask us to perform on stability.
Dan Humiston: [00:07:28] Just a quick reminder that you can view each of the company's confidential pitch decks including how much they're raising and the terms of their deals on the MJ BLS web site. Go to MJ bulls dot com to find the cannabis investment opportunity that's right for you.
Dan Humiston: [00:07:46] You've raised some seed money to get to this point but now this next phase is going to be really expensive. What's your plan for covering the cost. Can you tell us a little bit about your capital raise.
Duane Boise: [00:08:00] So we've raised approximately three million dollars to date. Spent most of it getting to where we're at. All our filings with the FDA are are in order. I expect to get one more word within the next two weeks from me from the FDA and that's a fast track designation for the Multiple Sclerosis clinical trials. So we have everything teed up ready to go both in and the multiple sclerosis I have physicians ready the universities the hospitals and the patients assembled. And this next raise will be to actually offset the cost of the clinical trials. And how much of you raising the Huntington say Sue we anticipate to be around 4 million. If we receive breakthrough status which we anticipate again that will shorten the timeline that we'll have to operate under the FDA guidance ideally to do both studies and get them both completed through phase 3 we'll need 15 million dollars in rehab budgets and everything outlining the finite detail of those.
Dan Humiston: [00:09:01] There's a couple of things about this deal that are unique to it and also very attractive. One is this is in cannabis investment opportunity but it's not going to be affected by cannabis laws. If they change because you know this is about creating a drug that can be impacted by it if the last change is the other one I love about it is the barriers to entry in this. I mean once you get this drug and if you have a seven year then I hear you say that you have a seven year monopoly on this once you get it.
Duane Boise: [00:09:29] Absolutely yes. Once the FDA approval for the labeling we have seven years on that drug that nobody can come behind us so gotten and obtained this orphan drug status the trip actually created that de facto patent for your medicine.
Dan Humiston: [00:09:41] Yeah well I know a lot of people would have loved to been in Pfizer one of these companies when they were just getting started.
Dan Humiston: [00:09:49] I mean to get the pharmaceutical returns would be a dream come true. So I have a feeling that this won't be long before you. This opportunity is off the table because you fill it out quick.
Duane Boise: [00:09:59] We're well down the road.
Dan Humiston: [00:10:01] Well we've been speaking with Duane Boise from MJ international holdings and I have all their information including their third investment deck and the MJ pls Web site Duane this is very important work that you're doing and I appreciate you sharing it with us today.
Duane Boise: [00:10:17] Well we're working hard at it and we do have an experienced team from Big Pharma that's done this before. So we're knowledgeable on the process and we're moving the ball down the road. I really appreciate the opportunity to talk to you today Dan and look forward to your reaching out of choice again and getting an update in any investors that may seek further information to be happy to speak to you.
Dan Humiston: [00:10:40] Definitely want you back on the show. Good luck with this.
Duane Boise: [00:10:43] Thanks so much. Dan you have a great day now.
Dan Humiston: [00:10:47] Thanks for listening to raising cannabis capital to learn more about today's guests or to become a guest. Visit our Web site at MBulls dot com. Today's show is produced by MJ bulls media with original music produced by Jamie Humiston I'm Dan Humiston and you've been listening to the raising cannabis capital podcast.
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