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MightyMaven (< 20)

MightyMaven beat the market on Thursday

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All-Time Best: APHQF +169.05
All-Time Worst: GSB -66.09

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Aphria Partner Tetra Bio-Pharma OK'd For Major Cannabis Oil Clinical Trials

January 16, 2018 – Comments (0) | RELATED TICKERS: APHQF

Health Canada Approves Start of Tetra Bio-Pharma Phase I Clinical Trial on Their Cannabis Oil:
Aphria partner Tetra Bio-Pharma Inc. today announced news that they received a No Objection Letter (NOL) from the Therapeutic Products Directorate (TPD), Health Canada, to conduct their phase I clinical trial to evaluate the safety, pharmacokinetics and pharmacodynamics of their cannabis oil PPP005 on January 12th, 2017. The cannabis oil is manufactured by Tetra's partner, Aphria Inc. Tetra's clinical research partner, Altasciences Clinical Research, will be initiating the clinical trial activities in the coming weeks. It will be a double-blind phase 1 study done in accordance with Health Canada, FDA and EMA standards. The companies plan to penetrate international markets with the product. Per statement by Bernard Fortier, CEO of Tetra, "this clinical trial is part of the sales and marketing strategy required to effectively penetrate the lucrative Pharmacy and Health Stores retail markets". 

Cannabis Oil Clinical Trials Signal Timely Launch of Tetra & Partners' Natural Health Products:
With this new clinical trial, the partnership states this is the launch of the first stage of Tetra's "plans to commercialize natural health products with its Partners". In this stage Tetra will "develop cannabis-based Supplements for commercialization under the Natural Health Product regulations in Canada and in other countries" and they highlighted as well that these are countries whose "regulatory authorities have a recognized pathway for approval and commercialization of such products", which will serve to accelerate the process for Tetra product sales in these markets. This is the right time and right place, and looking at the latest quarter of data available, Health Canada statistics show that the cannabis oil market grew 24% quarter to quarter from Q2 2017 to Q3 2017. A number of large producers, including Aphria Inc., are expecting their own cannabis oil products to grow to approximately 50% of their product lines. It is the author's belief that the PPP005 cannabis oil is the Rx Princeps/PPP001 blend because this means that medical practitioners and pharmacists will have additional, synergistic clinically-derived information about the same blend in a different form, which will allow them to make an even more informed decision about the Aphria-Tetra blend in the two products, dried and oil cannabis. That would be very smart! But if somehow it were not how it is, then the author would expect another news item before long to announce that exact thing, as a second oil being studied. But my opinion is that they are doing it now.

Further Developments Include Health Canada Registering Some of Tetra's Formulations as Drugs:
The company also noted that some of their formulations will also be registered as drugs through Health Canada's Therapeutic Products Directorate. Their pipeline of drugs, that is moving into and through various stages of clinical trials, is allowing them to become one of the important players in the post-legalization retail market. They are indeed the first company in the world to enter clinical trials for smokable cannabis as a drug. That's for Phase I, II and III. For example, the company's Rx Princeps dried smokable cannabis is already available through Aphria customer service throughout Canada according to my call to that department, and this product is also entering Phase III clinical trials with the regulatory agencies. When dealing with doctors, pharamacists and health food retailers, such credentials as seen with Tetra create open doors because there is tangible, quality research done on the specific products at the level of HC, FDA and EMA regulatory agencies and this is key information medical practicioners and pharmacists really want to see and study so that they can make the best, most informed decisions for their patients, naturally.  [more]

MightyMaven's Stock Picks

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Date
TickerCAPS RatingCallTime FrameStart PriceToday (Change)Stock
Gain
Index
Gain
ScorePitch
11/16/17 APHQF Outperform 1Y $6.36 $17.62
( 0%)
+177.04%+8.00%+169.05 Toggle the visibility of 60-Second Pitch and replies
07/14/17 GSB Outperform 5Y $5.27 $3.60
( 0%)
-31.68%+13.66%-45.33 Toggle the visibility of 60-Second Pitch and replies
07/06/17 XXII Outperform 5Y $1.69 $3.82
( 0%)
+126.17%+15.39%+110.78 Toggle the visibility of 60-Second Pitch and replies

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