Tetra Bio-Pharma Moves Closer to Clinical Trials


Ryan Allway

February 14th, 2017

News, Top News


Medical marijuana may be legal for roughly 60% of the U.S. population, but the cost of the drug remains prohibitive for many patients in need. Tetra Bio-Pharma Inc. (CSE: TBP) (OTC: GRPOF) aims to undergo FDA-sanctioned clinical trials for dried medical marijuana to secure prescription drug coverage from insurance companies. If successful, the company could potentially reach a large patient population with a unique option.

In this article, we will take a closer look at some of the company’s recent milestones and why investors may want to consider the stock for their portfolios.

FDA Clears Way for Phase I Trials

Tetra Bio-Pharma held a pre-Investigational New Drug (“IND”) meeting with the U.S. Food and Drug Administration (“FDA”) in late January to advance its PPP001 clinical trial. During the meeting, the FDA provided all the necessary guidance on the design of a Phase I clinical trial on healthy volunteers and its overall development program. The meeting further demonstrates the agency’s willingness to continue the clinical trial to develop a dried marijuana prescription drug.

“We could not be more pleased, as the FDA guidance gave us a clear path to progress from early to late phase clinical development,” said Dr. Chamberland, M.Sc., Ph.D., Chief Scientific Officer and Regulatory Affairs. “Adhering to the U.S. FDA regulations is part of Tetra Bio-Pharma’s dedication to the commercialization of cannabis as a prescription controlled drug and the corporation’s plan to seek reimbursement by insurers for patients.”

CFN Media recently caught up with Tetra’s CSO, Dr. Guy Chamberland. In this interview he discusses the meeting with the FDA, the company’s recent partnership with Sante Cannabis, and the pending PPP001 clinical trial.

 

PPP001 is a dried cannabis product with 9.5% tetrahydrocannabinol (“THC”) and 2% cannabidiol (“CBD”) that is being developed as a prescription drug that will meet the FDA’s high bar for quality and manufacturing. The company’s goal is to be the first to achieve reimbursement from insurance companies for the cost of the prescription, which could prove to be a game-changer for would-be medical marijuana patients that cannot afford the drug.

Enhancing the Odds of Success

Tetra Bio-Pharma recently partnered with Sante Cannabis in Montreal to assist in developing its clinical trials. As a leading private medical marijuana clinic, the organization has years of experience in educating patients and ensuring the optimal benefits. The company aims to leverage this expertise to ensure that its clinical trials are properly designed to achieve desired outcomes while helping achieve the organization’s goal of lowering costs for patients.

“Our clinic has provided services to almost 2,000 patients referred by over 1,500 physicians across Québec,” said Erin Prosk, Director of Santé Cannabis. “It is clear that both the medical community and the Quebec patient population are in desperate need of information about the potential benefits and risks of medical cannabis treatments … Of the 2,000 patients that we have seen, there is not one who is not burdened by [the cost of medical marijuana].”

These efforts are supported by an exceptional Scientific Advisory Board comprised of experts in clinical research, pain management, cancer, and neurological product drug development. Recently, the company expanded the board to include Dr. Gilles Chamberland, MD,FRCPC (no relation to Dr. Guy Chamberland) who will provide critical guidance on PPP’s clinical development program with regards to the safety of cannabis drug products and the potential mental health risks associated with marijuana.

Looking Ahead

Tetra Bio-Pharma Inc. (CSE: TBP) (OTC: GRPOF) continues to advance towards clinical trials for its PPP001, which aims to become the first dried marijuana prescription drug. After a successful pre-IND meeting and new partnership with the Sante Cannabis clinic, the company has assembled the right conditions to properly execute a clinical trial, significantly lower the cost of medical marijuana for patients, and unlock significant value for shareholders.

For more information, visit the company’s website or CannabisFN’s company profile.

This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.

About Ryan Allway

Mr. Allway has over a decade of experience in the financial markets as both a private investor and financial journalist. He has been actively involved in the cannabis industry since its inception, covering public and private companies.


Network Partners

Follow Us on Social Media

About CFN Media Group

CFN Enterprises Inc. (OTCQB: CNFN) owns and operates CFN Media Group, the premier agency and financial media network reaching executives, entrepreneurs and consumers worldwide. Through its proprietary content creation, video library, and distribution via www.CannabisFN.com, CFN has built an extensive database of cannabis interest, assisting many of the world’s largest cannabis firms and CBD brands to build awareness and thrive. For more information, please visit www.cfnenterprisesinc.com.

Disclaimer: Matters discussed on this website contain forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. CFN Media Group, which owns CannabisFN, is not registered with any financial or securities regulatory authority and does not provide nor claims to provide investment advice or recommendations to readers of this release. CFN Media Group, which owns CannabisFN, may from time-to-time have a position in the securities mentioned herein and will increase or decrease such positions without notice. The Information contains forward-looking statements, i.e. statements or discussions that constitute predictions, expectations, beliefs, plans, estimates, or projections as indicated by such words as "expects", "will", "anticipates", and "estimates"; therefore, you should proceed with extreme caution in relying upon such statements and conduct a full investigation of the Information and the Profiled Issuer as well as any such forward-looking statements. Any forward looking statements we make in the Information are limited to the time period in which they are made, and we do not undertake to update forward looking statements that may change at any time; The Information is presented only as a brief "snapshot" of the Profiled Issuer and should only be used, at most, and if at all, as a starting point for you to conduct a thorough investigation of the Profiled Issuer and its securities and to consult your financial, legal or other adviser(s) and avail yourself of the filings and information that may be accessed at www.sec.gov, www.pinksheets.com, www.otcmarkets.com or other electronic sources, including: (a) reviewing SEC periodic reports (Forms 10-Q and 10-K), reports of material events (Form 8-K), insider reports (Forms 3, 4, 5 and Schedule 13D); (b) reviewing Information and Disclosure Statements and unaudited financial reports filed with the Pink Sheets or www.otcmarkets.com; (c) obtaining and reviewing publicly available information contained in commonlyknown search engines such as Google; and (d) consulting investment guides at www.sec.gov and www.finra.com. You should always be cognizant that the Profiled Issuers may not be current in their reporting obligations with the SEC and OTCMarkets and/or have negative signs at www.otcmarkets.com (See section below titled "Risks Related to the Profiled Issuers, which provides additional information pertaining thereto). For making specific investment decisions, readers should seek their own advice and that of their own professional advisers. CFN Media Group, which owns CannabisFN, may be compensated for its Services in the form of cash-based and/or equity-based compensation in the companies it writes about, or a combination of the two. For full disclosure, please visit: https://www.cannabisfn.com/legal-disclaimer/. A short time after we acquire the securities of the foregoing company, we may publish the (favorable) information about the issuer referenced above advising others, including you, to purchase; and while doing so, we may sell the securities we acquired. In addition, a third-party shareholder compensating us may sell his or her shares of the issuer while we are publishing favorable information about the issuer. Except for the historical information presented herein, matters discussed in this article contain forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. CFN Media Group, which owns CannabisFN, is not registered with any financial or securities regulatory authority, and does not provide nor claims to provide investment advice or recommendations to readers of this release. CFN Media Group, which owns CannabisFN, may from time to time have a position in the securities mentioned herein and will increase or decrease such positions without notice. For making specific investment decisions, readers should seek their own advice and that of their own professional advisers. CFN Media Group, which owns CannabisFN, may be compensated for its Services in the form of cash-based and/or equity- based compensation in the companies it writes about, or a combination of the two. For full disclosure please visit: https://www.cannabisfn.com/legal-disclaimer/.

Copyright © Accelerize Inc. · All Rights Reserved · Privacy Policy · Legal Disclaimer

loading