Replies to post #54594 on Biotech Values

[oldberkeley]

You've probably answered this,

(if so my apologies,a message # will suffice)but to the best of your knowledge when might we learn about the nature of this "impediment"?

[gfp927z]

Dew, Concerning Momenta, in the January MF article (excerpt below) they mention that "others have so far failed". Have other companies already tried to get their generic versions of Lovenox approved, but were shot down by the FDA? Thanks


>>> If all goes well -- there's the rub. First, there's that list of hurdles I mentioned. Momenta and Sandoz have to get FDA to approve the generic Lovenox, a feat that relies on Momenta's technology satisfying FDA demands of bioequivalence where others have so far failed. (And for Momenta to really succeed, FDA must continue not to approve rival generics).<<<