Biotech Values

[gfp927z]

Dew, Holding up these other ANDAs for 4 years, that would indicate a pattern of extreme reluctance on the FDA's part to allow a generic Lovenox. The complexity of the chemical structure would seem like an obvious reason for FDA reluctance.

The FDA was supposed to move on establishing guidlines for allowing biogenerics this past year, but didn't they decide to put off that decision? While Lovenox isn't a MAB or protein, its structure is also very complex. The current hyperconservative FDA has been afraid of its own shadow, and stonewalling Momenta's drug would fit right into that pattern.