Tetra Bio Pharma Inc (OTCMKTS:TBPMF) has been working aggressively to accelerate its filing of a pre-marketing application for the enrolment of its cannabis drugs PPP005 and PPP001 under Directive-2001/83/EC of the European Parliament as well as of the Council. The company has completed numerous well-designed safety pharmacokinetic and pharmacodynamic trials in healthy subjects and has two current, well-designed clinical studies in patients. These studies are all double-blind, placebo controlled and randomized.
The upcoming plans
Tetra Bio Pharma reported that the Directive-2001/83/EC offers them with the regulatory and legal framework required for pre-marketing application filing of its cannabis drugs. Dr. Guy Chamberland, the Interim CEO and CSO, expressed that the company has conducted its own clinical studies and has impressive clinical study data to start the filing process for the registration of PPP005 and PPP001 under the Directive 2001/83/EC.
They plan to get a Full Market Authorisation since Tetra has a report supporting the therapeutic product’s safety, efficacy and quality. Tetra has performed all its clinical studies with the quality of evidence as mandated by the National Competent authorities approving drugs.
Earlier in this month, Tetra Bio-Pharma secured a CBD supply deal with True North Cannabis in Canada. The former firm will advance a cannabinoid derived topical cream and oral capsule for curing joint pain and inflammation. These products are expected to be commercialized under the earlier reported association with Genacol. As per the industry report, the industry of topical pain relief products is valued at over $2.5 billion. The new offerings are expected to be released in 2019.
Tetra Bio Pharma’s formulation and regulatory expertise along with clinical study data from its PPP005 studies will go a long way to advance these unique offerings for Genacol. It will work with the regulatory agencies to get marketing authority within Genacol’s global sales network where their brand offerings are available in over 40 nations, including Europe, Asia, Latin America, the Middle East, Africa and the U.S.