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Re: ghmm post# 12860

Friday, 07/11/2008 3:58:14 AM

Friday, July 11, 2008 3:58:14 AM

Post# of 19309
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.

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