Thursday, February 23, 2012 2:57:33 AM
RGEN..$4.26 Will be looking to take a position here soon. Company has priority review for their Secreflo as well as solid data of it in use with an MRI.
Repligen announced that the FDA has accepted for filing and granted Priority Review to the co's new drug application for SecreFlo for the improved detection of pancreatic duct abnormalities in patients with pancreatitis (RGEN) 4.21 : Under the Prescription Drug User Fee Act (PDUFA), the FDA's goal for completing a Priority Review and delivering a decision on marketing approval is reduced to six months, compared to ten months for a Standard Review. The FDA has assigned a PDUFA goal date of June 21, 2012 to the SecreFlo NDA.
Repligen announced that the FDA has accepted for filing and granted Priority Review to the co's new drug application for SecreFlo for the improved detection of pancreatic duct abnormalities in patients with pancreatitis (RGEN) 4.21 : Under the Prescription Drug User Fee Act (PDUFA), the FDA's goal for completing a Priority Review and delivering a decision on marketing approval is reduced to six months, compared to ten months for a Standard Review. The FDA has assigned a PDUFA goal date of June 21, 2012 to the SecreFlo NDA.
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