ARTICLE | Company News
Repligen receives complete response letter for SecreFlo
June 23, 2012 12:14 AM UTC
As expected, FDA issued a complete response letter to Repligen Corp. (NASDAQ:RGEN) for an NDA for SecreFlo to improve detection of pancreatic duct abnormalities in combination with MRI in patients with pancreatitis. According to Repligen, FDA asked for an additional clinical trial. Repligen said it is working with the agency to determine the design and scope of a clinical program that will address the agency's requests. Repligen was down $0.43 to $3.95 on Friday. ...