These open-label extension studies—one in Europe and one in the US—serve the purpose of increasing the safety database for Rhucin in HAE. The regulatory status of Rhucin remains unchanged, however: in the EU, Pharming must submit additional data from the US phase-3 study in order to reactivate the MAA; in the US, Pharming plans a BLA submission during 2008.
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”