GTC Biotherapeutics (fka GTCB)

[exwannabe]

RE: "Since the current study does not have a placebo arm"

Yes and no. There is a comparator arm that GTCB would not know the results of (presumably). Thus, to some extent, to try and guess results from the active arm is still guessing the control arm goes as historical (less so, obviously, than the standard trial).

Q for Dew:

Why did the FDA accept this trial design? Because they believe that ATryn is effectively the same as plasma derived antthombin and, are therefore are mainly only looking for AEs?