>>Going back to 98/99/00 - can we read between the lines exactly why GTCB failed with the heparin-resistant population ? It is not exactly clear why - was it really the need for more trials ? - I don't think so. Was it then the side-effects, given that the inidcation was not too high-risk ?<<
The original U.S. ATryn trial was badly executed and hence the data could not be relied upon, according to the FDA. This outcome had nothing at all to do with ATryn’s side effects -- ATryn does not have any side effects relative to plasma-based antithrombin.
>>…is this population still in their gun-sights?<<
An indication in an acquired (non-hereditary) antithrombin deficiency is definitely in the company’s plans. However, after approval in HD, the next clinical trial will probably be in burns. CABG (the indication of the original U.S. ATryn trial) is pretty far down on the list of indications to be pursued for label expansion.
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