Indeed GTC has created all the FOBs and has paraded them before the generic companies so far with no takers. The problem is the fear the FDA will insist because of GTC's NPPS (novel protien production system) that the Mabs will be required to go back to the preclinicical stage and run through the whole process.
This is a shame because GTC's Mabs are not the the same as CHO Mabs. They are better. Entirely due to serendipity the goat mammary outfits GTC's Mabs with a glycolosation patern which conveys great activity than seen in the CHO Mabs. This is particularly important in ACCD.....
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