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ThomasS

09/06/10 7:56 PM

#103560 RE: randychub #103559

MNTA: what would happen if the 2nd drug being approved was closer to being fully characterized then the first drug approved?

1. If MNTA achieved full characterization, then the above statement isn't possible.
2. If MNTA did not, then the FDA presumably won't pull the MNTA product off the shelves, since they already met some "standard." Such standard would then become "adequately characterized." (Which it may already be)

Anyone else care to speculate on Randy's question?

A separate logical point which is actually not very revealing:
Teva is pursuing hundreds of potential product candidates, mostly elementary molecules.
MNTA, (and MIT) on the other hand, has been singularly focused on Heparin-based compounds. This does not necessarily imply that MNTA has greater expertise when it pertains to generic Lovenox, but, surely it argues the case well, imho.