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Re: io_io post# 12099

Monday, 06/13/2005 5:49:08 PM

Monday, June 13, 2005 5:49:08 PM

Post# of 257273
>>Trials adding up to 100 patietns - that's hardly an order of magitude compared to 31 patients.<<

The current U.S. ATryn trial has only 17 new patients to be enrolled, not 31. The other 14 (31-17) are being taken from the data set submitted to the EMEA in support of the European MAA.

>>I can't help thinking that perhaps there is eitehr an efficacy or safety issue.<<

There are none that I am aware of. ATryn seems to work as well as plasma-derived antithrombin, which is not surprising because it is the same protein. As for safety, ATryn will in due course prove to be superior to plasma-derived antithrombin for the simple reason that it averts the risks of plasma-borne pathogens.

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