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The FDA has requested additional information on the clinical and the CMC (Chemistry Manufacturing and Control) sections of the BLA.
"Meningococcal disease is a devastating illness that can result in rapid death or have long-lasting repercussions for survivors and their families," said Andrin Oswald, CEO of Novartis Vaccines and Diagnostics. Chiron, the blood testing business, is dedicated to preventing the spread of infectious diseases through the development of novel blood-screening tools that protect the world's blood supply. 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. For more information, please visit www. Untreated mice experienced a steady decline in body weight over the six weeks, while treated animals experienced weight gain that was just slightly less than that seen in the controls (animals not receiving radiation).
Results to date from this study will be used in the second two parts of the Duke study which will look at dosing, duration of treatment and the maximum length of time after exposure that the drug can be given. These results have also been used to design a proof of principle study in non-human primates, which is expected to begin within the next thirty days.
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The study protocol called for four groups of animals, two of which would be studied for 6 weeks to look at the acute effects of Lung ARS and the potential efficacy of AEOL 10150 as a countermeasure, and two which would be studied for six months to look at the chronic effects of Lung ARS and the potential efficacy of AEOL 10150 as a countermeasure. “We believe AEOL 10150 could be a compelling countermeasure for Acute Radiation Syndrome (“ARS”) and are committed to working with our partners at Duke University, the University of Maryland and the National Institutes of Health (NIH) National Institutes of Allergies and Infectious Diseases (NIAID) to accelerate the development and approval of this product with the goal of providing protection against nuclear and radiological threats to the citizens of our country. Additionally, the Company has initiated animal studies necessary to seek approval of the compound as a treatment to protect the lungs from exposure to radiation. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Aeolus' actual results to be materially different from historical results or from any results expressed or implied by such forward-looking statements.
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