Wednesday, March 14, 2018

Tetra Bio-Pharma Inc. - TBP.v

Tetra Bio-Pharma - TBP.v is a biopharmaceutical leader in cannabinoid-based drug discovery and development. The Company is engaged in the development of Bio Pharmaceuticals and Natural Health Products containing Cannabis and other medicinal plant based elements.


On March 14, 2018 the company released News
Tetra Bio-Pharma Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to the active ingredients of its PPP001 drug (delta-9-tetrahydrocannabinol 9.5% and cannabidiol 2.5%) for the treatment of complex regional pain syndrome (CRPS). The Orphan Drug Designation was granted for the active moiety of the drug PPP001 and not the formulation.

The FDA Orphan Drug Designation program provides orphan status to drugs intended to treat rare diseases or disorders that affect less than 200,000 people in the USA. This designation gives Tetra a seven-year marketing exclusivity, after drug approval by the FDA, and provides Tetra potential incentives such as access to federal grants and tax credits as well as a waiver of Prescription Drug User Fee Act filing fees. Tetra successfully completed a placebo-controlled Phase 1a and 1b study of PPP001 in healthy volunteers and demonstrated that PPP001 can be safely consumed