Navidea Biopharmaceuticals Inc (NAVB)

[LasNubes]

LymphoSeek United States Regulatory Status:

"On November 13th, the FDA accepted Navidea’s Lymphoseek resubmission with a Class II review period of up to 6 months with a Prescription Drug User Fee Act (PDUFA) date of April 30, 2013. As the Lymphoseek resubmission was solely focused on their contract manufacturer’s cGMP deficiencies we do not believe the FDA will re-review the entire NDA making it possible for Navidea to receive an FDA approval prior to the April 30th PDUFA date.
We expect Cardinal Health’s (NYSE: CAH) significant sales force (currently generating sales over $100B) as well as their operating nuclear pharmacies and cyclotron facilities to launch Lymphoseek quickly."