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.
In 2012, we’ve planned to complete consistency lot manufacturing and we anticipate licensure approval as early as 2014. The partnership with BARDA, we continue to enhance the value of Valtrex as one of the leading biodefense countermeasures.
These initiatives include obtaining post exposure indication, optimizing the dosing schedule and extending the product shelf life. We are also developing Valtrex in combination with a novel adjuvant in pursuit of a two-dose vaccination schedule administered over a two-week period. In addition, with respect to our other anthrax directive programs, including our RPA vaccine candidates and our two therapeutic candidates, we plan to complete ongoing studies and secure follow-on development funding from BARDA.Read the rest of this transcript for free on seekingalpha.com
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