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jb_118

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jb_118

Re: ThomasS post# 116146

Tuesday, 03/08/2011 7:09:13 PM

Tuesday, March 08, 2011 7:09:13 PM

Post# of 252870

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.
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