>>Why did it take from 1998 to 2001 to have a meeting with the FDA?<<
The two CABG trials had to be completed.
>>Will the drug be tested again in the U.S. for the same indication as it was in 1998?<<
Very unlikely. Testing ATryn in CABG surgery in 1998-2000 was a poor decision that cost the company a lot of time and credibility, not unlike COR’s mishaps with CX-516.
The initial U.S. indication for ATryn will probably be elective surgery in patients with antithrombin hereditary deficiency –the same indication that is pending in Europe.
The company has stated that the next indication to be tested will be burns. A burns trial may be started as soon as the second half of this year.