Sunday, November 23, 2014 10:11:14 AM
It looks like it is in Peregrines/Avids best interest to make any such facility, the best it can possibly be. The FDA reorg. talks specifically about new teams that will be dispatched inspecting these facilities and I doubt any such experts were ever in Fargo because shouldn't they have had to check their labeling of vial procedures and the labels themselves?
Heck... maybe one day Bavituximab and PS Targeting agents will be manufactured in as many sites as Actavis has:
http://www.actavis.com/about/global-locations/manufacturing-sites
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"Bavituximab is a first-in-class phosphatidylserine (PS)-targeting monoclonal antibody that is the cornerstone of a broad clinical
pipeline." -- Big Pharmas nightmare... unless they are fortunate enough to have The Bavi Edge!
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