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Thursday, September 22, 2011 1:06:30 PM
However if AW launch in Q42011 as in the PR, then wouldn't that invalidate your conjecture ?
Isn't the key to whole mystery of AW a-enox approval is that whether Amphastar can reproduce Lovenox without somehow using Mnta IP ?
And like you say, only they know the answer to that. We don't know that and to some degree MNTA does not know that .
The same logic applies to m-copax. The FDA can/will grant approval to m-copax once they are satisfied with whatever make them happy. Whether MNTA lose their shirt in court or not does not concern them, nor does that legal consideration should enter into their decision to approve or not approve.
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