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Aphria has been a long term shareholder of Tetra Bio-Pharma since 2016, now owning a large stake in the bio-pharmaceutical enterprise and partnering with them on a pipeline product marketwatch.com/press-release/aphria-makes-1000000-investmen.... Canopy Growth also is tied to Tetra Bio-Pharma though Canopy's subsidiary in the vaping market that they recently acquired, Storz & Bickel: marketwatch.com/press-release/tetra-bio-pharma-targets-multi.... "The Mighty Medic is a portable herbal vaporizer for cannabis use approved by Health Canada as a Class 11 medical device and as such, is eligible for reimbursement. The agreement allows Tetra to effectively bring PPP001 (Tetra's CAUMZ drug) to patients suffering from fibromyalgia and other chronic pain conditions, significantly expanding the market potential for PPP001." "The clinical use of medical cannabis in the management of fibromyalgia suggests these patients obtain significant relief. Moreover, the potential to reduce opioid use for these patients is a foremost consideration of using the Mighty Medic to deliver the cannabinoids and terpenes contained in PPP001 (CAUMZ) by inhalation." Dr. Ko, Medical Director, Fibromyalgia Clinics and Adjunct Lecturer at The Canadian Centre for Integrative Medicine, (Markham, Ontario) and Sunnybrook Health Sciences Centre, University of Toronto. Current treatments for fibromyalgia are expensive and include Lyrica, Cymbalta, Xyrem and Vimpat, along with opioids.

Tetra is running an advanced Phase 3 pivotal clinical trial on CAUMZ and under the FDA's authority and regulations is expanding the clinical trials from the one clinic in Canada to 10 clinical sites in the United States and over ten sites in Canada, for a total of over 20 clinical sites for the study. It is called the Serenity clinical trial. News flash, this is a first for Tetra and a first in the USA for advanced cancer pain and chronic pain as well. As a result, Tetra has been working with these major clinical sites to obtain their DEA licensing to work with cannabinoids, so that's also a first. In response to the author, Dr. Guy Chamberland, CEO of Tetra, graciously responded by email: "Tetra has been working with the sites in the USA to get them the DEA licenses needed. It does not take two days. The more prestigious the site is, the longer and more complex it is. There is DEA licenses, there is a scientific review committe, and then there is the ethics committee. Had you read the MD&A, AIF and short form prospectus you would have known that Tetra has been at this since June. So yes, the Serenity trial has been moving like we announced."

The combination product is what is being tested, eg., an exactly produced cannabinoid drug made of synthetic THC and CBD and the Mighty Medic. In a major news announcement released across North America, Tetra revealed that with good speed, "the US FDA granted a drug-device combination product jurisdiction for its Caumz®-kit; this is a Caumz® drug combined with the Mighty Medic® medical device. This decision was the first step in Tetra’s strategy to bring this innovative and first in class drug to the market. According to Dr. Chamberland, "Tetra is executing the regulatory strategy it has described in its AIF (filed on June 18, 2019 with SEDAR) and MD&A (filed on October 18, 2019 with SEDAR) and in a relatively timely fashion." Dr. Chamberland also continued to me on their work creating the drug synthetically and the FDA's approval of their vaporizer: "Did you ever think what it takes to re-create a synthetic version of a dried bud drug? Seriously, not a tremendous progress! (He means, tongue in cheek, this has progressed tremendously! This combination is propriety IP technology, by the way.) The FDA is hammering down on vaping yet Tetra obtains a positive outcome with a jurisdiction (approval) for a vaped drug. Guess the science was not that bad." No sir! Not bad, indeed!

"We are in active discussions with several North American pharmaceutical firms for the sale and distribution of Caumz® across North, Central and South America. We are evaluating the best path forward for Tetra and will update shareholders once we have a definite agreement with any potential partner. We believe this is the best path forward for us, as launching a commercial product in the U.S. requires the significant financial support.

Strategic partnering will be key to a successful launch of an approved Caumz®-kit. OUR PLAN IS TO MAXIMIZE SHAREHOLDER VALUE as we move forward.

[As we continue to move forward, we will continue] developing our programs, evaluating potential partnerships, and seeking institutional support of our company,” commented Guy Chamberland, CEO of Tetra Bio-Pharma.
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I will add two cents here. Any time you take on a partner and you do a 50/50 deal with them, you are giving a form of dilution. But it's generally not seen as a dilution. Your revenue will now be half what the partnership brings in, not 100%. BUT what you look for in a partnership is one where your 50% of the take will be 2, 3, 4 times or more than the 100% you would have made without them. So in one part of such a deal, the percentage take of each, you dilute your per share earnings but in the actual dollars amounts you earn, then, you of course make it up through the synergies created by the addition of the partner, thereby gaining a multiple of your original 100% take. It's the old 1 + 1 = 3 maxim created by synergies. As they say, the sum of the parts is greater than the parts! Another time-tested maxim. This is why partnerships are so popular, effective and lucrative! Two can often do ten times the output than one by himself. In fact, there's even an old proverb that says, One can put to flight 1000, but two can put to flight 10,000. That's the power of partnership that they are talking about.

The same thing can happen when you take a financier onboard. You can often make more with a 50% stake with them than a 100% stake without them. (But Tetra has explained in the news October 21st, that they have no desire to do one of their traditional (dilutive) financings they have done before:) According to Tetra, "Becoming a pharmaceutical company requires the support of Institutional investors and this cannot be achieved without strategic investment. Tetra is studying how it will make this transition with minimal impact on dilution. We have no desire to continue to initiate financing the traditional way to bring Caumz® to market. Selah: (Think about it!) For several months we have been studying various strategic investment formats and will continue to do so over the coming months as we try to find the best scenario for CURRENT share holders." Current share holders includes Aprhia, certain members of management and the board, officers, including Dr. Chamberland, executives, staff and previous investors in their early funding private placements. The company is currently fully funded, so it appears to this writer it is the opportunity being presented to them by these several large pharmaceutical companies seeking to obtain from Tetra sales, marketing and distribution rights to CAUMZ that had led Tetra Bio-Pharma to consider what's the best way to increase shareholder value through their commercialization of CAUMZ as they implement their manufacturing stage. With the passage of the SAFE Banking Act in the USA, with FDA and Health Canada approval for CAUMZ, and with major pharmaceutical contracts in hand, this would likely enable Tetra to receiving bank financing at favorable terms in the US and in Canada. Many firsts are happening. Keep your eyes on Tetra Bio-Pharma because they are definitely going places … literally!!
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