GTC Biotherapeutics (fka GTCB)

[jessellivermore]

QD

As I am sure aware the guidelines re. FOBs have not as yet been established. At present the FDA is pretty "sticky" about the way "biologics" (therapeutic protiens) are manufactured. The recent problem GENZ had is a good example. I do not think the "generic" companies are being irrational about their concerns re. the FDA's likely attitude toward GTC, NPPS FOBs. and yes GTC's Mabs are different, they are superior, they seem particularly attractive in the area of solid tumors.

Despite the issues with the regulations. a partner may decide the clinical advantages of using GTC's Mabs may be worth going forward.