GTC Biotherapeutics (fka GTCB)

[jessellivermore]

GenzTR...2000

The reason why GenzTR dropped the late P3 trial was the data the FDA was looking for was AT3 use without concomminant heparin use. For a number of reasons, some of them medical-legal, the cardiac surgeons were not willing to abandon heparin...and quite simply the company had no choice but to drop the trials.

The overall pathophysiology is better understood today and the rationale "clearer".... I'm sure both Ovation and GTC have consulted both the FDA and have lined up cardiac surgeons..This is perhaps the part of the reason for delaying the announcement of the partnership....

":>) JL