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The FDA has requested additional information on the clinical and the CMC (Chemistry Manufacturing and Control) sections of the BLA.
About meningococcal disease
Meningococcal disease can manifest as bacterial meningitis - an infection of the protective coverings of the brain and spinal cord - or meningococcemia - a bloodstream infection[2]. Such forward-looking statements reflect the current views of management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with Menveo to be materially different from any future results, performance or achievements expressed or implied by such statements. Nor can there be any guarantee that Menveo will achieve any particular levels of revenue in the future. These include:
-- Flexible Treatment Paradigm – AEOL 10150 is intended for the treatment of patients post-exposure, even in those who are already exhibiting symptoms, eliminating the need for immediate administration in a predefined treatment window.
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In the US, the prevalence of serogroup Y has increased over the last few years (from 9% of reported cases in 1990-92 to 39% in 2006)[3]. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
Novartis AG provides healthcare solutions that address the evolving needs of patients and societies. Focused solely on healthcare, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic pharmaceuticals, preventive vaccines, diagnostic tools and consumer health products. 2008;299(2): 173-184 [2.htm [3. A number of treated animals continued to be monitored until the end of six months and analysis of those animals is currently underway.05) survival advantage, statistically significant differences in body weights and wet lung weights were seen over the first six weeks of the study.
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