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jb_118

03/08/11 7:09 PM

#116157 RE: ThomasS #116146

On a side note, didn't MNTA do some minor trials for mLovenox, which we never heard about until after approval?



They did do some clinical immunogenicity trails. These trials as I recall are the basis for the SNY lawsuit against the FDA stating that the j pathway doesn't allow for trials showing safety/efficacy. The FDA counters that the immunogenicity trials were for assessing manufacturing purity.