GTC Biotherapeutics (fka GTCB)

[DewDiligence]

Re: U.S. ATryn timeline

>…any estimates on the approx timeline for Atryn's approval in the US, assuming all goes well clinically?<

The guidance is as follows:

1H07: Complete enrollment;
2H07: Submit BLA;
2H08: FDA action on BLA assuming a standard review (subtract four months if the FDA grants a priority review).

This timeline has slipped very slightly from the prior guidance of 1Q07, 3Q07, and 3Q08, respectively.