Today we announced that we have submitted an Orphan Drug Application to the U.S. Food and Drug Administration (FDA) for COTI-2 for the treatment of ovarian cancer.
If COTI-2 is granted Orphan Drug status, the financial benefits in the future could be substantial and COTI-2 would be directed down a unique development pathway within the FDA, including the possibility of an expedited regulatory process and the potential for fewer patients to be required in clinical trials.
We believe that COTI-2 represents a significant therapeutic advantage over treatments currently available for ovarian cancer. When the drugs cisplatin and carboplatin stop working, the cancer is said to be platinum resistant and oncologists currently have no treatment options to offer these patients. New treatments are needed. COTI-2 appears to offer the best answer at this time for drugs in development.