Nabi Biopharmaceuticals (NABI) Receives Scientific Advice On NicVAX From the European Medicines Agency
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Nabi Biopharmaceuticals (Nasdaq: NABI) announced it has received scientific advice from the European Medicines Agency (EMEA) on NicVAX regarding the requirements for marketing authorization submission as it relates to the appropriate design of the pivotal phase III clinical studies and safety data base . This advice helps ensure the performance of appropriate clinical studies so that no major objections regarding the design of the studies are likely to be raised during evaluation of the marketing authorization application. Following the EMEA's advice increases the probability of a positive outcome.
The EMEA is responsible for the scientific evaluation of applications for European marketing authorization for medicinal products. Applicants submit a single marketing authorization application to the EMEA. Once granted by the European Commission, a centralized marketing authorization is valid in all European Union (EU) and EEA-EFTA states (Iceland, Liechtenstein and Norway).
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