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MightyMaven (< 20)

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Time To Recap Tetra's Year of Strength & String of Successes

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August 09, 2018 – Comments (0) | RELATED TICKERS: APHQF , INSY

Aphria's investment in Tetra Bio Pharma continues to pay good dividends as the company continues to perform on its stated goals with some impressive achievements in 2018. In fact, if one takes the time to go back over the first half of 2018 (January thorugh June), it will likely be discovered that some of the key events that have been occurring have drifted back from the consciousness and need to be refreshed into current memory. Hard to believe one could forget some of the more dynamic news items, but it's a fast-paced world and sometimes that's just the way of things. As they say, Out of sight, out of mind, and it's really true especially for those who are following numerous investments in stocks and outside of stock. So important advice will include the maxim to always be sure you are on top of things and keep a detailed account of your flocks and stocks. People keep do lists for everyday things, and yet sometimes forget to make lists for their investments. Basically, if you can't remember your do list to have to write it down so you can more quickly order your day and week, you probably need to keep a written list of things on your investments for the same reason.

Tetra recently announced FDA meetings for new clinical trials on their Advanced Dronabinol, which allows far better performance of the underlying medication because of the way it is delivered into the body of the patient. It is revolutionary and disruptive to the market. By this method of drug delivery, the drug is able to perform its wonders without many of the major side effects, in general. This is currently unheard of. Seriously. Ask someone who has used dronabinol in conventional form if they have had or know other patients (they meet at their doctors' offices) that they have had problems with reactions, nausea, headaches and more to the point they may wonder if it was worth it. Sometimes the cure can be worse than the condition treated.

These type B and C meetings with the US FDA are to discuss requirements for obtaining marketing approval under the 505(b)(2) regulatory pathway for its dronabinol AdVersa mucoadhesive product, called PPP002 in the Tetra laboratory. So this is big news, and it's time to take notice, to wake up to where the company now is, or else. Tetra is developing this product in the USA under the accelerated 505(b)(2) pathway for chemotherapy-induced nausea and vomiting and anorexia and weight loss in people with AIDS (and note these are the same indications that have already been approved for Marinol, which is a form of dronabinol, if you weren't aware). So Aprhia's pharmaceutical investment has positioned itself to take considerable market share from the very large Marinol market out there. That is the goal and there appears little to do to stop it. The technology is for real. It works. It works consistently. They are applying it to a drug, made of cannabis, which is dronabinol (Marinol = MARIjuana + dronabiINOL).

Dronabinol works, for the most part, all things considered! But it has its flaws. And that is what the "Adversa" muco-adhesive technology is all about, removing the objectionable reactions and enabling patients to be free of the side effects. That the drug is already an approved drug and that it is going for terminally ill patients allows Tetra to bring their advanced version, the most advanced version on the market, to eagerly awaiting patients who are already hearing about it from their doctors. You have to think, which patient with an already big load from their illness would NOT want to switch to Tetra's Adversa dronabinol to at least try it. So this is majorly discounted news we didn't see a blip from. That can be our advantage. Keep your eyes on this so it doesn't get past your trigger finger, that's my thought. It looks very promising and not far off at all. The corporation is also developing PPP002 in Canada as an adjunct therapy for opioid reduction in patients with chronic pain. So ... Remember it's clinical trial applications are based on the FDA's Fast Track process toward gaining accelerated marketing approval in the USA, the largest pharmaceutical market in the world. Look for news on the clinical trial applications this Q3 2018. This is a wise investment of their time, money and effort. I would think most would agree.

You may ask are they going about it the right way, applying with the FDA for this product. Are they giving it the care and attention you want to give to a new paradigm in delivery of dronabinol that will disrupt that market. Yes is the answer if you believe the news about Camargo Pharmaceutical Services joining with Tetra to handle the FDA process for them. Tetra has found someone who has invented the wheel for 505b2 FDA processing; they have a clear and most importantly proven ability to help bring life-changing therapies to the market faster and more cost-effectively through the 505b2 process. Founded in 2003, "the company offers a full portfolio of pharmaceutical services from concept through commercialization" to improve medicines. The word from Tetra on its new partner is that "Camargo has emerged as one of the recognized experts and industry leaders utilizing the FDA 505(b)(2) approval pathway." So ... this is good. This is news we want to hear. We want top experts handling this, managing this, with the US FDA. We want proper care taken with baby. We want to see baby walk sooner than later. We don't want to see baby have misteps. We want to see baby with smiles and mama with smiles. Camargo will nurse this along very well, we have to think, from the sound of the news. The stakes are in the billions of dollars. Check out sales for Marinol to get an idea. Plus that into your favorite search engine. Marinol annual sales. The amount keeps growing as more indications are added. The market is now in the few hundred million a year area. On approval Adversa dronabinol will be a strong candidate for recommendations from doctors, in the writer's opinion.

How will Tetra penetrate the market? Even a good prodct has to introduce itself and that can take time, right? Well, actually, yes, unless you someone as a partner that knows that specific market and wants to bring you into it. Then you have someone with their foot already in the doors of the players. Here's an example of news I bet you forgot! I really think most Aphria and Tetra shareholders forgot this already. Tetra is working with a major US dronabinol distributor on their application to the FDA. The source for this is dated last year and the fact of this has fallen by the way side, although it is very important to those who are reminded of it. Especially so, it is important to reconsider and pin it to the recent FDA news announced this July 26, 2018. Nobody has talked about it for months and months on any message boards I am aware of. Yet this is a major distributor of dronabinol; it wants a piece of this pie, and it's a US distributor.

How do you forget this? But it has been forgotten. Let me wake us up. That was news from November 28, 2017. Here is the quote: Tetra "announced that it is partnering with a major manufacturer of controlled active pharmaceutical ingredients (APIs) in the USA for the manufacturing of Dronabinol XL AdVersa(R) as the Company accelerates its plans to submit a 505(b)(2) New Drug Application (NDA) for the treatment of chemotherapy-induced nausea and vomiting (CINV) and anorexia associated with weight loss in patients with AIDS."
 It was easy to assume they meant that by this they were accelerating their Adversa product line, but actually they were probably referring to the news of July 26, 2018 disclosing Camargo is handling the FDA submission through a 505(b)(2) new drug application (NDA).

"Camargo has emerged as one of the recognized experts and industry leaders utilizing the FDA 505(b)(2) approval pathway." A search of the word dronabinol on Carmargo's site gives just one result and that's on how to get dronabinol approved through the FDA's 505(b)(2) program, and it is worth a read for anyone who wants to know about the program Tetra is in with Camargo and it tells you a great deal of comparative literature on various cannabis products that were or were not approved and why they were or were not. There's a specific way to do it and specific reasons for success. If a company meets those requirements in what they do with the FDA, they will be approved.

The day this news came out, two weeks ago on July 26, 2018, I wrote in my notes, "Today's news may seem like a non-event to some investors, but they may be forgetting about the very large pharmaceutical manufacturing partner Tetra has signed an agreement with (referenced above). This partner has many years of involvement with dronabinol from a manufacturing and distribution aspect. This is really an incredibly important fact that you as an investor do not want to leave out." Now that we have stepped forward in time, the weight of this USA partner is bearing more on the minds of Tetra investors and it's front and center, not on the back shelf anymore.

Due to the high demand expected for this extended release form of dronabinol that Tetra is bringing out, there is going to be a big need for a way to meet the demand and produce huge quantities of Adversa dronabinol, XL for extended release. Reading today's news, there was no mention of this large US manufacturing partner, so it took a little while for me to reflect on these matters, and when I noted, that wait a minute, they already have a manufacturing and marketing plan in place, ready to go, then I realized how strong this bit of news is. Camargo does not manufacture or distribute dronabinol. As Tetra indicated, the dronabinol manufacturer they are talking about is very large and they are a distributor manufacturer. I don't have to say this, but I will ... this is the kind of partner you want to have and when you land a partnership like this, it's a powerful feeling, an awesome feeling. Now that we are closing in on key milestone and target dates, this news is fresher today than it ever was.

So what is critical to find out is how much time does it take to process and approve a 505b(2) accelerated drug application? Since Marinol has already been highly researched in phase trials, Tetra Bio-Pharma is able to piggy back on that success because it is the same drug, dronabinol, but it is delivered in another way, through the Adversa technology by Intelgenx, and doesn't go through the stomach for absorbtion like Marinol does, but goes through the mucous membranes. Tetra uses the term, mucosal. By this delivery method which you can read about here www.tetrabiopharma.com/etc etc, the drug is slowly released into the patient's system without flooding their body with the drug that would then dissipate over so many hours. Instead, the Tetra version is slowly absorbed into patients and that means they don't suffer the side effects like headaches, stomach aches, 

The company has their "Dronabinol XL buccal tablets" roadmapped for Accelerated Approval Phase II – Q3/18 trials; Phase III – Q1/19 trials. They are right on target with their planned FDA meetings. The outlook is very good for approval in this writer's opinion because the FDA has already approved dronabinol, which is a marijuana-based, THC drug, as well as just approved Epidiolex for epilepsy which is also a marijuana-based drug containing THC. Those approvals show the willingness of the FDA to be reasonable and scientific in their assessments of drugs. Another reason this writer has this belief it will be approved is because by using this method of delivery into the human body, it actually requires LESS of the drug because the Adversa invention increases the bioavailability of the drug to patients' bodies. That can mean many other good benefits as well since the kidneys and liver may have less waste products to work to discard from the medicine.

I'll leave you with this thought. Think about who is this very large manufacturer. Think about their role. Think about Tetra's partnering model where they find partners who already invented the wheel that Tetra needs, and create a synergistic relationship with that partner, saving both partners time, effort and money while enabling quicker speed to market and revenue growth and reduced expenses in the area of development and marketing. Think about how excited this large partner must be to take this role with Tetra. See if you can guess who it is. They are US based. They are very large. They are a dronabinol manufacturer. They are highly successful. It is likely that they suggested to Tetra that they should bring in the 505(b)(2) experts Camargo to move the FDA applications forward with the greatest speed. Camargo brings the top expertise found in dealing with 505(b)(2) applications at FDA. Again, we see the Tetra partnering model at work. And the same thing applies in that it saves Tetra and their large pharmaceutical manufacturing partner much, much time, energy, money and expands the speed of their opportunity to give the fastest entry of Tetra's product into the US market, the largest pharmaceutical market in the world.505(b)(2) 

The product is designed for chemotherapy-induced nausea & vomiting as well as for chronic pain symptoms.The 505(b)(2) speciality Contract Research Organization, Camargo, is guiding the regulatory submissions to the FDA. The corporation is also developing PPP002 in Canada as an adjunct therapy for opioid reduction in patients with chronic pain.

I'll leave you with some reading of just the news from this year so far and which I haven't covered suffiently well, but that you should know about. Most of this is a delay-effect news about the future, so the closer you get to the future, the more important it is to review that news. You want news that gets better over time, like fine wine. People tend to downplay future expectations in news, but someday, when that future arrives, they wake up. Best to be wide awake and prepared instead of letting the news rock you awake because that way you have time to start investing and build a position. Now, it's starting to get toward their first big approval. That's almost here.----

The Azevedos Partnership

The Landmark Commercialization Agreement in Israel

The Co-development and Distribution Partnership With Major Specialty Healthcare Distributor

The Namaste & RX Princeps Partnership

PS Innovations & Rx Princeps Partnership

The Neptune Co-development Partnership for Cannabis-oil Products

Approval for the Phase III Clinical Trial of their PPP001 Dried Cannabis Medicine
 -- the new investor presentation says on the roadmap page that they expect the results in Q4 2018 and that they will file the New Drug Application in the USA and Canada both the following quarter, Q1 2019. See how that old news gets better over time. You have to like it. Aphria picked a winner for us, those of us who came along for the ride.

Tetra Goes After Cannabis Oil Market Gaining Approval for Phase I Clinical Trial

Tetra Goes After Cannabis Oil Market Gaining Approval for Phase II Clinical Trial

Tetra Goes After Cannabis Oil Chronic Pain Market -- Clinical Study Completion by Fall

Here is the July presentation with roadmap that Tetra just put on their website

This is not an exhaustive list of all their 2018 news. For example, we expect to see North Bud Farms go public anyday this month as they work to close on the exchange listing. Tetra shareholders will be receiving shares in it.

At this point peoples' heads would be spinning with all the developments since the beginning of 2018. Easy to forget all these things. So ... WE NEED A LIST OF THESE ACHEIVEMENTS AND TRIALS AND TARGETS, A NUMBERED LIST. As a successful investor, it is very important to add these facts and expectations and news items to an expectations list as they come out in the press and not try to play catch up like people do with their bank books every month or two. Then review it regularly so that you are familiar with all the things, like the large dronabinol distributor manufacturer. This way you are either ahead of the game or right on it. The bottom line is the market has been woken up by the parade of good news.

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