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raistthemage

06/19/08 3:49 PM

#11848 RE: wjlknew #11844

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.


Yes in a way the EMEA asked them to.


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vinmantoo

06/19/08 5:25 PM

#11857 RE: wjlknew #11844

You are correct that I am not precisely accurate so I apologize. However, my point is to counter the misopreprentation that GTCB used legal trickery to get approval on a technicallity, as John and another poster implied or outright claimed, respectively. It was simply that GTCB wanted all the patients to be included in the study and that is what happened.