Biotech Values

[RockRat]

>>You can lead a horse to water, but…<<

Cuts both ways. If you've directly addressed the molecular weight discrepancy between Lupenox and branded enoxaparin, and the regulatory implications of that discrepancy, I don't recall it. Maybe it just boils down to what we think the FDA's MO would be if presented with Lupenox as a substitute for branded enoxaparin. It might be possible that what we've seen from the regulatory process so far could relate to Lupenox, but I doubt it. Unfortunately, since the regulatory process is pretty new, even for an ANDA, neither of us can present truly compelling precedents.

So here we are at the oasis . . .

Regards, RockRat