The FDA did not require any new clinical studies in the CRL. In the CRL, the FDA is seeking more information regarding handles and specifications regarding the manufacturing also, packaging and sterilization of ILUVIEN, which Alimera reviews it is along the way of compiling. Additionally, FDA indicated in the CRL that it experienced observed deficiencies in current good manufacturing practices during facility inspections of two of Alimera’s third-party manufacturers, in August and September of 2010 which were completed, and that all facilities and controls will need to comply with cGMP.Kipps, M.D., Ph.D., Ian Flinn, M.D., Ph.D., Paolo Ghia, M.D., Ph.D., Herbert Eradat, M.D., Thomas Ervin, M.D., Nicole Lamanna, M.D., Bertrand Coiffier, M.D., Ph.D., Andrew R. Pettitt, Ph.D., F.R.C.Path., Shuo Ma, M.D., Ph.D., Stephan Stilgenbauer, M.D., Paula Cramer, M.D., Maria Aiello, M.A., Dave M. Johnson, B.S., Langdon L. Miller, M.D., Daniel Li, Ph.D., Thomas M. Jahn, M.D., Ph.D., Roger D. Dansey, M.D., Michael Hallek, M.D., and Susan M. O’Brien, M.D.: Idelalisib and Rituximab in Relapsed Chronic Lymphocytic Leukemia Chronic lymphocytic leukemia may be the many prevalent leukemia among adults. Standard remedies consist of combinations of purine analogues, alkylating agents, and monoclonal antibodies.