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Re: DewDiligence post# 9108

Sunday, 03/20/2005 2:17:37 PM

Sunday, March 20, 2005 2:17:37 PM

Post# of 252589
Dew,

You may find this document, although from 2002, also very worthreading. I do not know if you already have read it.

http://www.emea.eu.int/pdfs/human/bpwg/222099en.pdf

The title is:

"Note for guidance on the clinical investigation of plasma derived antithrombin products"

It gives some interesting insides.

Could it be that the EMEA just treats ATryn as if it is a substitution for the plasma derived alternative? Ifso, the new guidelines could have lead to the additional questions, wouldn't you think so?

Looking forward to your thoughts,

Rgeards,

Elmono


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