GTC Biotherapeutics (fka GTCB)

[DewDiligence]

>the two things from [today’s] announcement that jump out at me are that:
1.) GTCB may have saved the FDA fee of $1,178,000 with Orphan drug status. That is not a small amount to this company.
2.) The time line for top-end data just slipped into Jan. 08 from end of 2007.<

More consequential than either of the above, IMO, is that the FDA recognizes the superior safety of recombinant plasma proteins vs their plasma-derived counterparts. Were this not true, the FDA would not have granted ATryn an orphan-drug designation for the HD indication.