GTC Biotherapeutics (fka GTCB)

[wjlknew]

vinmantoo,

I do not know if Genzyme interceded with the EMEA or not, although I doubt it, but I do know that your facts are not straight either.

The EMEA excluded some childbirth patients in the European trial because GTC changed the protocol (from what was agreed to) during the trial. After GTC appealed, the EMEA gave ATryn what amounts to a "conditional" approval, for indications other than childbirth, with the understanding that GTC would provide additional data when the U.S. trial is complete. As a result, ATryn is NOT approved for childbirth patients in the EU at this time. That probably accounts for some of the slow sales to date.