This is a significant commitment by the U. S. government and further affirms BioThrax as a critical component of the government’s biopreparedness arsenal for years to come. In response to the government’s stated requirement to build a stock pile of 75 million doses of Anthrax vaccine, we continue to make progress towards licensure of our large-scale facility Building 55. This new facility is designed to manufacture up to 25 million doses of Anthrax per year on a single production line.If needed, this facility could with the addition of a second production line, produce up to 50 million doses per year. We have presented to FDA a comprehensive plan for regulatory approval based on comparability and non-clinical studies without clinical data. During pre-submission discussions, FDA indicated its overall support for our plan that doesn’t require clinical studies and provided a specific guidance on expanding this scope of non-clinical studies. This may translate in obtaining approval potentially one year ahead of schedule.
Emergent Biosolutions' CEO Discusses Q4 2011 Results - Earnings Call Transcript
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