Biotech Values

[ThomasS]

MNTA: I do not see "full characterization" as the thesis in the Lovenox case. (Although most of us continue to speak of it.)
I believe it is a case of "adequately characterized," and whether or not Teva has matched MNTA in that capability. MNTA has an approval and Teva, IMO, must equal the task or risk non-approval or a less than substitutable approval.

MNTA may have fully characterized; regardless, the FDA determined that their characterization was "adequate."

Also, what was the date of such ruling? Clearly, technology advances at such a fast pace that FDA stances must advance to keep up. I.E., if full characterization is actually possible TODAY, why shouldn't the FDA adopt a more stringent policy TODAY?