FDA has expressed concerns regarding the risk benefit assessment of ZALBIN dosed at 900-mcg every two weeks. Although the BLA review is ongoing, HGS has concluded that licensure of this dosing regimen is unlikely.
Hardly a big surprise.
In April, the Albuferon MAA was formally withdrawn (#msg-49185693), which is the typical M.O. in Europe for handling a hopeless application.
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”