Marshall Edwards has reported that its triphendiol, also known as NV-196, has been granted orphan drug status by the FDA for the treatment of pancreatic cancer and for the treatment of cholangiocarcinoma, or bile duct cancer.
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A grant of orphan drug status provides seven years of market exclusivity for the orphan indication after approval by the FDA, as well study design assistance, and eligibility for grant funding from the FDA during its development.
Alan Husband, group director of research for Marshall Edwards, said: “This grant of orphan drug status is a significant step in the development program for triphendiol as a multipotent anticancer agent.”
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