Repligen Corporation (NASDAQ: RGEN) today announced that the Company has concluded a pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) related to its lead product candidate, RG1068 for improvement of magnetic resonance imaging (MRI) of the pancreas. The purpose of the meeting was to discuss the positive results of the “re-read” of the radiographic images from the Company’s Phase 3 clinical trial and to reach agreement on the content and format of the proposed NDA for RG1068. Based on this meeting, we intend to submit our NDA as previously planned.
