PINL:GRPOF - Post by User
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alphatradron Mar 27, 2019 8:37am
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Tetra Bio to File PPP001 With the European Medicines Agency
Tetra Bio to File PPP001 With the European Medicines Agency OTTAWA, March 27, 2019 (GLOBE NEWSWIRE) -- Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSX-V: TBP) (OTCQB: TBPMF), today announced it is ready to submit its PPP001 cannabinoid-derived drug as a herbal medicinal product to the European Medicines Agency. The pre-marketing application of PPP001 as a herbal medicinal product specifically for the European market in no way changes Tetra’s planned schedule to restart its Phase 3 Oncology Drug Development program for advanced cancer pain that was temporarily suspended in February 2019.
Tetra Bio-Pharma has gathered impressive scientific, clinical and safety data on PPP001, a dry pellet made of 3 strains of cannabis that generates a unique composition of medicinal products when administered to patients with Tetra’s class II medical devices and by smoking or vaporization.
“The European Union has shown an increased interest in the potential of both cannabinoid-derived drugs and medical cannabis as a means of alleviating a range of health conditions,” says Guy Chamberland, CEO and CSO of Tetra Bio-Pharma. “I am confident that our data on PPP001 gives us a unique and strong advantage that will result in marketing authorization in the European Economic Union with the current formulation. However, let me be clear that Tetra Bio-Pharma’s core strategy is about cannabinoid derived prescription medicines and we are working hard to restart our clinical trial as planned."