The following errors were included in a story on Pozen Inc. in the Feb. 4, 2002, issue of BioWorld Today: The company has never submitted an NDA on MT 100, so saying it would “resubmit” an NDA was inaccurate. Instead, the company expects to request permission this year for an NDA filing once the FDA has seen mouse carcinogenecity data. The preliminary results disclosed last week should have said no carcinogenicity was seen in transgenic p53 mice (not in rats), and that results from ongoing carcinogenicity studies from rats (not p53 mice) are expected in 2003. Finally, the naproxen sodium used as part of the MT 100 formulation is not an extended-release version.
Editor’s note: The changes have been made in BioWorld Online.