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September 20, 2012
08:22 EDTBVTI, ABPIBiovest Int'l conducts meeting with EMA advancing EU approval for cancer vaccine
Biovest International (BVTI), a majority-owned subsidiary of Accentia Biopharmaceuticals, (ABPI), conducted a regulatory meeting with the European Medicines Agency in London, at which the EMA provided Biovest with information to help finalize Biovestís pending Marketing Authorization Application seeking EU marketing approval for BiovaxID, Biovestís personalized cancer vaccine for the treatment of non-Hodgkinís lymphoma. The meeting addressed legal, regulatory, and scientific matters for the planned MAA in order to facilitate subsequent validation and assessment of the application. The company anticipates the filing of the MAA for early next year. Upon approval, BiovaxID would be the first cancer vaccine available in Europe for lymphoma patients.
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