"Two identical, double blinded, randomized placebo-controlled Phase III clinical trials began in the second quarter of 1998. These studies, which included 52 patients each, were designed to assess the activity of rhATIII in reducing the use of fresh frozen plasma to treat heparin-resistant patients while undergoing cardiac surgery requiring CPB. The two studies, conducted at medical centers in Europe and the United States, have been completed, and the primary clinical endpoint was met in both studies with a high degree of statistical significance. Moreover, the drug was well tolerated by patients. There was no detectable antibody formation to rhATIII. There was no statistically significant difference in adverse events reported among the groups of both studies."
Dew,
Why didn't GTCB continue trials in "heparin-resistant patients while undergoing cardiac surgery requiring CPB?"
Why did it take the company six years to get from the point mentioned above (1998) to the filing of an NDA in Europe?
Bladerunner
Market Data 
Markets 
AI
