Ark's Cerepro clears EMEA validation stage
London, UK-based Ark Therapeutics says that the Marketing Authorization Application for Cerepro, its novel gene-based therapy for operable malignant glioma that was recently filed with the European Medicines Agency (EMEA), has cleared the validation stage. The MAA now commences formal review via the centralized procedure which is the standard route for all advanced therapies.
Cerepro was originally filed for marketing approval under exceptional circumstances in late 2005 and was reviewed by the EMEA with reliance on Phase II data.
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