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Item: Tetra will be launching Rx Oil (or by another name) some time between March 1 and May 31, 2018, through Aphria, according to one source. 


Rundown of the News of 2018 for Tetra Bio-Pharma: PART 1: CLINICAL TRIALS PROGRESSION:
Tetra Bio-Pharma is doing a clinical study for cannabis oil capsules (chronic pain market) enrolling patients and to be completed in the next two quarters (Fall 2018). It also has a worldwide first Phase III clinical study on marijuana the form of which has this year just received orphan drug status for patients with severe cancer pain (regional pain syndrome). What that means is Tetra now has a late-stage clinical trial going with an orphan-drug status marijuana formulation that will meet a very great need of innumerable cancer patients. What's the big deal over orphan-drug status, you ask? Well, for one thing it provides for lucrative multi-year tax reductions for Tetra as an incentive toward success, and for another thing, it gives Tetra exclusive development rights for a specific condition and for seven years as a reward for tackling a condition that has heretofore been very resistant to current treatments. That's exclusivity with a capital 'E'. It will also set a good precedent with Health Canada and the FDA as Tetra moves to expand the number of conditions the formulation can be used for and it is a very good way to leverage their assets into further related clinical trials


Tetra continues to work with its clinical partners as it progresses along this road. Sante Cannabis is handling the cannabis oil Phase II trials, leveraging each partner's strengths with its own in order for each to get the most bang for their investment buck. Aprhia has been their go-to-guy for creating their PPP001, for example, which is "a unique blend of 3 strains of standardized dried cannabis, creating a drug substance with 9.5% THC and 2.5% CBD", according to Tetra's Anne Courtois, DVM. Plus, they have a distribution agreement with Aphria for it, as well. In their Phase 1 clinical trial they learned how "to avoid inappropriate use that could lead to accumulation of cannabinoids in the body," said Dr. Guy Chamberland, M.Sc., Ph.D and CSO of Tetra. 


The Phase 2 clinical trial "will be used to support Product License Applications post-legalization", said Tetra. "The launch of the Phase 3 clinical trial of Tetra's extremely high-quality marijuana under FDA and Health Canada oversight will be used to support the marketing application of PPP001", as well, and this Phase 3 is a worldwide first because it's the first Phase 3 that uses the basic dried marijuana plant as a drug. (Remember, Tetra and Aprhia have a way to make the exact same plant be reproduced as many times as they need it to be.) According to them, their "encapsulated cannabis oils (PPP005) ... [single and multiple dose of encapsulated cannabis oil (10 mg THC with 10 mg CBD)] products are ready to commercialize in the retail market post-legalization" in Canada.  Tetra has explicitly stated its clinical program is designed to create the intellectual property necessary to build a leading position in "the development and commercialization of cannabis-based natural health products". We currently know of plans to market various products in Portugal and in Israel, besides Canada, with major contracts for distribution made with several major pharmaceutical players, some not revealed as of this date to protect competitiveness and maintain the element of surprise


Furthermore, March 22, 2018, Santé Cannabis received authorization from the Office of Controlled Substances to use the cannabis oil capsules of PPP005 (a controlled substance) in Tetra's Phase 2 study. This allowed the Phase 2 clinical trial of PPP005 cannabis oil for use in chronic pain conditions to begin. This study and the Phase 3 study of PPP001 is being conducted by Dr. Antonio Vigano of Sante Cannabis. Through the exemption granted by the authorization, Santé Cannabis will actually be able to prescribe Tetra's cannabis oil medication and for Aphria to ship the products to the study's patient's homes. According to Tetra and Sante Cannabis, the screening and enrollment of study patients was faster than expected and allows Tetra to meet its corporate objectives in a speedier timeline


Another interesting part of these cannabis oil studies under Health Canada and FDA guidelines is that they have targeted the extremely large, chronic pain patient base. These include the many who are currently using dangerous and addictive opioids to control their pains. Dr. Guy Chamberland also stated that "many of these patients will also be taking opioids or other prescription medications. The capability of different doses and ratios of medical cannabis oil to change the amount and type of concomitant medications, such as opioids, used for pain, and the need for rescue pain medication to control chronic non-cancer and cancer pain is evaluated. The use of measures that quantify different pain drug regimens used by the patients will help us understand the potential of cannabis oils to be used for opioid sparing." They are targeting the exact contrasts that caregivers would want to know before trying to add a new drug into the mix with opioid drugs their patients use. This is clinical data that applies specificially to Tetra Bio-Pharma products alone and thus the physicians will be inclined to recommend and prescribe the various applicable Tetra medications. This study shows where they can take advantage of the benefits of cannabis oil to reduce and eliminate opioid and other dangerous medications from their patients' regimens and also to know how to avoid the dangers from combining too much or too often, cannabis oil products with opioid medications. Doctors are most concerned with how to reap the benefits of cannabis oil for patients while avoiding any dangers possibile from multiple drug interactions. Tetra is amassing a great array of data that is proving to be very helpful in this regard.


Breakdown and categorization of Tetra's 2018 news thus far:
1. Tetra Bio-Pharma CLINICAL STUDY 
  -- on CANNABIS OIL CAPSULES
  -- for CHRONIC PAIN PATIENTS
  -- Expecting COMPLETION DUE BY FALL 2018 
  -- 12 April, 2018 news release

2. NOW ENROLLING PATIENTS IN PHASE 3 CLINICAL TRIAL FOR MARIJUANA
  -- WORLDWIDE FIRST! -- for ongoing PPP001 SMOKABLE CANNABIS Pellet PRESCRIPTION DRUG Study  -- 04 April, 2018 news release

3. FDA ORPHAN DRUG DESIGNATION GRANTED FOR MARIJUANA!
  -- WORLDWIDE FIRST! -- FOR PPP001
  -- for TREATMENT OF COMPLEX REGIONAL PAIN SYNDROME
  -- 14 March, 2018 news release

4. HEALTH CANADA PHASE 3 CLINICAL TRIAL APPROVED!
  -- for PPP001 SMOKABLE DRIED CANNABIS as a PRESCRIPTION DRUG!
  -- 04 February, 2018 news release5. HEALTH CANADA PHASE 2 CLINICAL TRIAL APPROVED! 
  -- for CANNABIS OIL
  -- in PARTNERSHIP with SANTE CANNABIS
  -- 29 January, 2018 news release6. HEALTH CANADA PHASE 1 CLINICAL TRIAL APPROVED!
  -- for PPP005 (CANNABIS OIL)
  -- 16 January, 2018 news release

II. EXPANSION NEWS:
Term Sheet Signed for LANDMARK COMMERCIALIZATION IN ISRAEL
 -- OF LEAD PHARMACEUTICAL PRODUCT PPP001
 -- 24 April, 2018 

CO-DEVELOPMENT & DISTRIBUTION PARTNERSHIP Term Sheet
  -- 08 March, 2018

 FIRST STEPS INTO EUROPEAN CANNABIS MARKET
 -- 06 March, 2018 

NEPTUNE & TETRA BIO-PHARMA ENTER CO-DEVELOPMENT AGREEMENT
 -- for PURIFIED CANNABINOID OIL-BASED PRODUCTS
 -- for PAIN & INFLAMMATION
 -- 12 February, 2018 

III. DEALS WITH INSIDERS: 
ACQUISITION OF REMAINING 20% INTEREST IN PHYTOPAIN PHARMA INC. COMPLETED
 -- 19 March, 2018 GROWPROS SALE COMPLETED
 -- CASH & SHARES
 -- 22 February, 2018

AGREEMENT TO ACQUIRE REMAINING 20% INTEREST IN PHYTOPAIN PHARMA SUBSIDIARY
 -- 02 January, 2018 

IV. PPOs: 
$4,292,000 ON-BROKERED PRIVATE PLACEMENT CLOSED
 -- 27 March, 2018 

NON-BROKERED PRIVATE PLACEMENT ANNOUNCED
 -- 16 March, 2018 

BOUGHT DEAL FINANCING CLOSED
  -- 05 March, 2018 

OFFERING UPSIZED
 -- 08 February, 2018$8 million

BOUGHT DEAL OFFERING ANNOUNCED
 -- 08 February, 2018 

V. INTERNAL CHANGES:
Gregory Drohan APPOINTED TO BOARD OF DIRECTORS
 -- 10 April, 2018 

GUY CHAMBERLAND NAMED INTERIM CEO
  -- 03 April, 2018 

APHRIA CFO NAMED CHAIRMAN OF AUDIT COMMITTEE
 -- 26 February, 2018 

VI. STOCK MARKET NEWS:
ADDED TO HORIZONS MARIJUANA LIFE SCIENCES INDEX
 -- LEADING CANNABIS ETF
 -- 20 March, 2018 

Conclusion:
Very strong clinical and development program is opening worldwide opportunities with exclusvisity, upfront payments and royalty participation. A good royalty in pharmaceutical industry would be a minimum of 3% and up to 10%+-. It is very telling that they are already signing such agreements and have others in negotiations that they haven't announced and which are for multiple other territories worldwide. I am reminded of an old proverb: Cast your bread upon the waters and in many days it shall return unto you. Indeed, we now see that the investment in this clinical approach for Tetra is seeing these coming waves of return on its investment.

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