Cannabinoid-based drug developer Tetra Bio-Pharma (Tetra Bio-Pharma Stock Quote, Chart TSXV:TBP) is one step closer to reaching the US market for its cannabinoid-based drugs, says analyst Rahul Sarugaser of Paradigm Capital who on Thursday reiterated his “Buy” rating and $1.75 price target for
Tetra Bio-Pharma, which has a number of Health Canada-approved clinical trials underway, announced that it has met with the US FDA concerning the application for its dronabinol-containing pure synthetic THC product, PPP002, under the FDA’s accelerated 505(b)(2) pathway, clearing the company to conduct its clinical program. The move effectively puts PPP002 in position for FDA marketing approval by the first quarter of 2019 and, subsequently, US commercialization by early 2020, says Sarugaser, who applauds TBP’s “expert navigation of the US regulatory architecture.”
“This is the first tangible interaction we have between TBP and the FDA—providing the Street its first real visibility on a potential TBP-developed, FDA-approved product on the U.S. market,” says the analyst in a client update on Thursday. “This also puts TBP at the vanguard of Canadian companies actively advancing products through the FDA’s regulatory infrastructure, seeking FDA drug approvals in the near term.”
Tetra Bio-Pharma intends to undertake a Phase 2 clinical trial of PPP002 to evaluate its efficacy in dealing with chronic pain, says Sarugaser, potentially pitting it against standard-of-care opioid medication.
“This clinical direction aligns TBP, once again, with today’s political and social impetus to reduce North America’s consumption and abuse of opioids—a cause supported in the US as vehemently as it is in Canada,” he says.
Sarugaser’s $1.75 target represents a projected 12-month return of 43 per cent at the time of publication.