GTC Biotherapeutics (fka GTCB)

[DewDiligence]

Re: Orphan status for inhaled AAT

>I can see a third way: Kamada has a small plant limiting their AAT production capability.<

Good point, although Kamada’s production capacity could presumably be increased at some point.

I think the strongest argument for GTC’s breaking Kamada’s orphan exclusivity (assuming that inhaled AAT products from Kamada and GTC are eventually approved) is the safety benefit of a recombinant product. The FDA is presumably convinced of this already insofar as it granted an orphan designation for ATryn in HD. Regards, Dew