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Friday, May 15, 2015 1:19:22 PM
Dew I think I remember that after reading about the Pharmacopeia entry (lo these many years ago) that that the Pharmacopeia "official test" was actually a manifestation of the very Momenta patent to confirm purity of Lovenox that is being contested and that Amphastar argued they were required to use this method since it was "official" . At this point its all pretty circular and I guess we have to wait. Would the SG ever interview FDA officials to get more info before rendering an position as requested by the CAFC or will they opine based on the available paper? Regards, bp
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