Oky, the ATryn program in the U.S. has nothing to do with sepsis, and plasma antithrombin is not a cause of sepsis.
The program does not have Fast Track, but it may qualify for Priority Review, which entitles a drug to be reviewed in 6 rather than 10 months. That decision will be made by the FDA after GTC submits the BLA.
“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”