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Re: iwfal post# 79342

Wednesday, 06/10/2009 3:27:24 PM

Wednesday, June 10, 2009 3:27:24 PM

Post# of 257268

MNTA: I need to listen to the cc - but would point out that FDA acceptance of MNTA's technology as a troubleshooter (being able to find a large body of mismatches that no other technology could find) is a significantly different thing than acceptance that there are No/none/nada/zilch/zip mismatches of clinical significance that could escape detection.

My comments in #msg-38561800 have nothing to do with MNTA’s troubleshooting of the contaminated heparin from China; rather, the comments apply to the progress of the Lovenox ANDA itself and the observation that assuring the integrity of the bulk-heparin supply chain appears to be the sole remaining roadblock to approval of the ANDA.


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