Cell Pathways NDA not approvable

CLPA announced after market close on Friday that it has been orally notified by the FDA that its NDA for Aptosyn exisulind to treat familial adenomatous polyposis (FAP) is non-approvable. The company said it expects to receive a letter from the agency noting the deficiencies in the NDA, following which CLPA said it will request a meeting with the FDA to discuss the filing, and then determine its next steps with respect to the FAP indication. The FDA accepted CLPA's NDA for filing last November, even though a Phase III trial failed to show efficacy due to a greater than expected reduction in polyps in the placebo arm. At the time, CLPA said it believed the results were due to enrollment of patients who did not meet its desired entry criteria of patients who would form 10-40 polyps per year (see BioCentury, July 10). ...