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
Check Out Our Best Services for Investors
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Model portfolio
- Stocks trading below $10
- Intraday trade alerts
More than 30 investing pros with skin in the game give you actionable insight and investment ideas.