Teva has myriad agreements with licensors, developers, and suppliers that are not disclosed in SEC filings. There’s no reason I can think of why the hypothetical agreement we’re talking about would be.
This affects our assessment of its approvability in what way?
If one knew that the drug in question came from a third party with no particular expertise at characterizing heparin-based drugs, it might be reasonable to infer that the drug was not close enough to branded Lovenox to pass muster with the FDA.
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