Tetra Bio-Pharma (TSXV:TBP) announced the submission of “multiple” orphan drug designation applications to the the US Food and Drug Administration (FDA) for its treatment of various forms of rare cancers and ocular diseases with cannabinoids.
As quoted in the press release:
The applications align with Tetra’s strategy to develop cannabis prescription drug products for the treatment of several rare cancers and to expand its market exclusivity in the treatment of ocular diseases. If successful, the designation of cannabinoids as an Orphan Drug will open the door for fast track approval, tax credits on clinical research, and reduced registration fees, in addition to other opportunities. It further provides Tetra with a 7-year period of market exclusivity in the US.
“Managing rare forms of cancer presents a huge challenge for physicians,” said Dr. Guy Chamberland, M.Sc., Ph.D., interim CEO and Chief Scientific Officer of Tetra Bio-Pharma. “Our R&D team has submitted numerous Orphan Drug Designation applications to the FDA over the past 6 months, which not only holds promise to improve patient care but lines up with our corporate strategy to develop and commercialize cannabinoid prescription drug products for both rare cancers and ocular diseases in the United States.”