Biotech Values

[Regulardoc]

The question to ask MNTA/Wheeler is whether or not the m-enox ANDA went to the Office of Biotechnology. If not, (and while it could go both ways) I would surmise that given the litigiuos environment, the FDA may want two separate opinions that support a denial.

As far as "sameness'" I think they are throwing this term around beyond the FDA intent. I don't think anyone disputes that t-Lovenox is an effective anticoagulant, but is it the "same" as m-enox. Most likely it is not.

Additionally, if the ANDA now sits in a different division, they ain't close to approval.