SEATTLE, WA--(Marketwired - Feb 28, 2017) - CFN Media Group ("CannabisFN"), the leading creative agency and digital media network dedicated to legal cannabis, announces publication of an article discussing the initiation of Tetra Bio-Pharma Inc.'s (
Tetra Bio-Pharma recently announced that the Therapeutic Products Directorate ("TPD") of Health Canada approved its Phase I clinical study of PPP001 covering smoked cannabis for the management of uncontrolled pain in cancer and AIDS patients. The announcement was followed one week later by the beginning of the trial, as Tetra was clearly ready to get going. The trial is a first study approved that could eventually lead to approval of the product as a prescription drug. The study assesses single and 7-day multiple daily ascending doses of smoked cannabis on the cognitive function in healthy adults.
It is the first development program aiming to obtain prescription drug approval and government provided insurance coverage for medical marijuana patients. If successful, the approval would set Tetra apart from all other medical marijuana providers who cannot get government provided insurance coverage and reimbursement for their patients. This could prove to be a major value driver for the company, as the lack of reimbursement is a serious obstacle for many patients seeking treatment.
Tetra Bio-Pharma also recently completed a pre-IND meeting with the United States Food & Drug Administration ("FDA") Division of Anesthesia, Analgesia, and Addiction Products ("DAAAP") Center for Drug Evaluation and Research ("CDER") in late-January. During the meeting, the FDA provided guidance on the design of Phase I clinical trials and the overall program, while validating that the company was on the right track.
Last week, White House press secretary Sean Spicer indicated that the federal government could be expected to step up enforcement of federal recreational cannabis laws, presumably in the face of various state laws permitting recreational use. The comment caused widespread concern in the industry. Whether the comment results in action or not, investors should note that development of cannabinoid based drugs should not be affected as it has nothing to do with recreational legalization. Additionally, Mr. Spicer reinforced the idea that the current administration is supportive of medical marijuana use.
Please follow the link to read the full article: http://www.cannabisfn.com/tetra-bio-pharma-begins-clinical-trials/
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CFN Media (CannabisFN), the leading creative agency and media network dedicated to legal cannabis, helps marijuana businesses attract investors, customers (B2B, B2C), capital, and media visibility. Private and public marijuana companies and brands in the US and Canada rely on CFN Media to grow and succeed.
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Frank Lane
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