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Key regulatory milestones
CA4P secured the US FDA's fast track designation and orphan drug status in certain thyroid cancers.
-- Fast Track Status. The U.S. Food and Drug Administration (FDA) granted fast-track status to CA4P for the treatment of advanced anaplastic thyroid cancer, the rarest and deadliest form of the disease. The FDA's fast track program is designed to facilitate the development and expedite the review of new drugs intended to treat life-threatening conditions for which there is no approved therapy.
-- Orphan Drug Designation. The FDA awarded the orphan drug designation to CA4P for the treatment of anaplastic, medullary, Stage IV papillary and Stage IV follicular thyroid cancers. Orphan drug designations are granted to provide economic incentives to stimulate the research, development and approval of promising products that treat rare diseases. The Orphan Drug Act guarantees seven years of market exclusivity in the United States to the first sponsor that obtains market approval for an orphan drug-designated product.
