Biotech Values

[DewDiligence]

>The current hyperconservative FDA has been afraid of its own shadow, and stonewalling Momenta's drug would fit right into that pattern.<

Yes, there’s a pattern of general FDA conservatism that all drug/biotech investors are surely aware of. However, I wouldn’t say there's an established pattern for generic carbohydrate drugs such as Lovenox because there are not yet enough data points.

>The FDA was supposed to move on establishing guidelines for allowing biogenerics this past year, but didn't they decide to put off that decision?<

You can’t blame this on the FDA because Congress is the party that has caused the delay. When Congress finally passes enabling legislation for biogenerics, the FDA will issue guidelines. For the FDA to issue guidelines now would be a waste of time because they wouldn’t yet know what the rules are.