>>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.
“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”