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Aphria (APHA) Partner Tetra Bio-Pharma (TBP) To Begin Dronabinol Soft Gel Sales 2nd Half 2021

With the acquisition of GW Pharma by Jazz Pharmaceuticals for $7.2 Billion USD, investor activity has begun a new focus on cannabis pharmaceutical stocks. Aphria has been ahead of the game in this space, investing in it when pharmaceutical cannabis wasn't considered in vogue or cool. Indeed, Aphria twice bought shares of Tetra in a PPO and now holds near 10% of outstanding shares. Companies in this biopharmaceutical cannabinoid space had to grind it out with Research & Development, paying the price to achieve advances in clinical trial data and research studies as they longingly watched sales of LP cannabis products soar. But sooner or later, like a good education, the payoff starts to happen as such new niche markets create IP property and the companies invent themselves into the market through their scientific advancements.

Very few cannabis pharmaceuticals can claim the achievements of Tetra Bio-Pharma, publicly traded on the TSX exchange. Sound incredible? Let me highlight some supporting facts that are not well-known until now to 99% of investors. It's early-, mid- and late-stage pipeline is the stuff dreams are made of. They currently have a cannabinoid-based synthetic CBD, HU-308, aka ARDS-003, https://en.wikipedia.org/wiki/HU308, that's so potent, (5,000 times more selective for the CB2 receptor than for CB1), George Mason University and their biocontainment lab, along with Targeted Pharmaceuticals, the National Institute of Health (NIH), and an unnamed fund are partnering together with Tetra under the direction of none other than the imminent Dr. Lance Liotta, https://science.gmu.edu/directory/lance-liotta, to take ARDS-003 rapidly through COVID clinical trials in humans versus COVID-19, Acute Respiratory Distress Syndrome (ARDS) and Sepsis. All three conditions will benefit.

In fact, just months ago Tetra took a 20% stake in Targeted Pharmaceuticals, which is headed by Dr. Liotta, as the FDA has put Tetra's drug on the Covid Fast Track to do simultaneous Phased clinical trials. This ARDS-003 is no beginner drug, mind you. HU-308 has been included in over 350 peer-reviewed research studies documented on the NIH website, https://www.ncbi.nlm.nih.gov/pmc/?term=hu308, starting as early as 1990, https://doi.org/10.1016/S0957-4166(00)86322-3, in dozens of diseases and conditions, including the immune system and inflammation from the brain and major organs to viral infections. Note that among some of the NIH-sourced research authors for HU-308 is Dr. Melanie Kelly, PhD and Professor at Dalhousie University. She's Chief Science Officer at Tetra. 👉She's worked closely with Dr. Raphael Mechoulam, "the father of the endocannabinoid system", for some twenty years and on HU-308 specifically for over ten years that I know of. More about this drug in a coming article on this work at GMU!

👉Yesterday the company announced through social media that they expect sales of their ENJOUCA drug product, an inhaled cannabis made of three strains with Phase 1, 2 and a lot of Phase 3 safety and dosage available for doctors, to be almost a big as their dronabinol soft get sales.? REDUVO is Tetra's dronabinol soft gel product they own exclusive marketing rights to that's been filed with a New Drug Submission already and expected to debut in Canadian pharmacies in the 2nd half of 2021, which for Tetra their fiscal 2nd half starts June 1 (https://ir.tetrabiopharma.com/newsroom/press-releases/news-d...). ENJOUCA is Tetra's brand name for Qixleef in the non-prescription medical cannabis marketplace. Dania Scott, Sr. VP, Marketing Strategy, formerly with Canopy Growth, under Steeve Neron, Chief Marketing Officer, (https://ir.tetrabiopharma.com/newsroom/press-releases/news-d...), is spearheading the launch of QIXLEEF™ under the trademark, ENJOUCA™, as a non-prescription medical cannabis product in Canadian territories, and they are using its robust clinical data package to do so, to distribute their ENJOUCA™ branded products through the existing medical cannabis channels already in place. Ms. Scott also was named ENJOUCA™ Managing Director.

This is what Mr. Neron had to say about sales of Reduvo dronabinol soft gels and QIXLEEF (ENJOUCA) yesterday, February 9, 2021, on Facebook:
Steeve Neron, CMO, Tetra Bio-Pharma 2-9-21
Reduvo sales will materialize before Qixleef sales👈
Enjouca sales may be quite close to Reduvo👈
~ Reduvo is indicated for reducing CINV cancer-induced nausea & vomiting. Hence, the name Reduvo.
~ Reduvo, Adversa and Inhaled Dronabinol by Tetra are designed to meet a critical unmet medical need in cancer patient caregiving.

These are Tetra Bio-Pharma's three, yes, three, dronabinol products. Let me close with a brief explanation of the dronabinol picture at Tetra:
1. Dronabinol soft gels? Tetra Acquires Patented Dronabinol Commercial Rights https://ir.tetrabiopharma.com/newsroom/press-releases/news-d...
2. Dronabinol Adversa(R)? Patented mucoadhesive dronabinol that's better & safer than regular dronabinol
~ limit the first-pass metabolism, improve bioavailability, reduce gastro-intestinal exposure and side-effects, and finally enhance product stability
3. Dronabinol Inhaled? Patented inhaled dronabinol; it's better, safer & even faster than regular dronabinol
Remember that the most severe side effects of dronabinol are due to its first pass through the liver. But Tetra's Adversa and Inhaled forms don't have this issue.

A key way Adversa and Inhaled are safer for patients is because they bypass the liver and "first-pass liver metabolism", avoiding the toxicity issues seen with all the other dronabinol products. The Inhaled version is as rapid as a matter of five minutes, also avoiding first-pass liver metabolism and its associated issues. 👉Accordingly, Tetra has acquired the rights to the dronabinol supply of one of the U.S. makers of dronabinol?, who wishes to remain unnamed at this time and it will likely be announced later, something we may look forward to. My opinion is they want to be part of the Tetra story because Adversa and Inhaled are going to be even more liked by patients and doctors than regular dronabinol, due to the dramatic difference from the major side-effects of regular dronabinol. I think it's a brilliant plan for Tetra and its partner companies involved with this. According to Tetra, the market for dronabinol in Canada is expected to be $80 million CAD by 2022. So Tetra is poised to be the first entry into that marketplace with the soft gels, and the Adversa and Inhaled dronabinol drugs are also expected to be worldwide marketed (https://ir.tetrabiopharma.com/newsroom/press-releases/news-d...).

With Steeve Neron overseeing the sales launch with his strong sales & marketing team, I expect to see Tetra begin to capture a respectable market share of that $80 million. I like this three-pronged approached and their international marketing plans for their three dronabinols after opening up Canada. Today Mr. Neron commented to me that "I am simply obsessive at posting revenue ASAP". He's getting excited, folks. I'm looking forward to their weekly, monthly, quarterly and milestone revenue results and increases, once those start, remembering when the first sales by Aphria and Aurora were announced sometimes weekly! I was there through all of that and it was a good obsession for me. I feel the same about this. Me, too, Steeve. Me, too. Good luck! And congratulations also to Dr. Guy Chamberland, CEO and Dr. Bill Cheliak, Chairman.

Proof of the Canadian Opportunity?:
"Dronabinol is no longer being manufactured for sale in Canada👈 and is no longer available under any brand names.👈This article is being kept available for reference purposes only. If you are using this medication, speak with your doctor or pharmacist for information about your treatment options." https://www.rexall.ca/articles/view/1125/Marinol

Keep an eye out for my coming article on Tetra's ARDS-003 and the work at GMU's biocontainment lab. Be sure to upvote my article and share its link in your favorite social medias, and think about joining Motley Fool as a member. They do offer a free plan as well as paid subscriptions, and there are a lot of good MF journalists to discover. Thanks for reading my work. I always try to bring well-researched information to Motley Fool readers.
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Dr. Guy Chamberland tweets breaking news on patents👈 @DrGChamberland
1/4 I’m paying attention. Several people have asked about @tetrabiopharma’s #patents after I posted about our ODDs earlier today. [ODD = Orphan Drug Designation]
Here’s a list with many more filed & pending.👈👈
8:18 PM · Feb 7, 2021
2/4 ARDS-003 related patents👈; 1 #USA, 1 #EU, 1 #AUS granted, several pending per region, others filed.
3/4 PPP-003 related composition, method & use patents👈 for inflammatory pain indications of eye; #USA, #EU, #AUS granted patents & others pending.
4/4 Two USA granted patents👈 topical anti-inflammatory formulations; 1 allowed USA other inflammatory conditions👈; patents pending & filed.

Looks like official news releases will be forthcoming. This is a new development nobody mentioned to me. I like a company that keeps good secrets. GN

PS: The ARDS-003 patents cover Tetra's HU-308 which is in the major GMU research phases now. Remember, for the study at GMU, it's being called ARDS-003. That's what he's talking about. They also call HU-308 the PPP003 for eyes and ocular inflammation. Same drug, different condition. Super CBD, really. ARDS-003 is the injectable form. PPP-003 is not injectable. Got it? They all have their own paths to FDA approval, although all the separate studies do have various overlaps.
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