Moving on with the enhancements. So, today BioThrax is labeled for a pre-exposure. The government is buying it in the stockpile for a post-exposure application. So, if you're exposed to anthrax, the regimen is to go on broad-spectrum antibiotics for the initial toxins that are released and to go on BioThrax at the same time. Anthrax spores can exist in your lungs up to nine months and during that time, can release toxins and kill you. So the thought is you come off the antibiotics, you've been on the vaccine, and you're now protected.
We have filed a supplemental BLA with the FDA. That would take the five doses over 18 months down to three doses over six months with a triennial boost. We're hoping to hear back from the FDA on that in early 2012. Again, this is – this would facilitate the government procurement. They are buying assuming a three-dose regimen. So when one talks about the stockpile of 75 million doses, they're assuming three doses per person.
We've also filed for five-year dating. As I said, four-year dating is the longest dated vaccine. What the probability is of getting five-year dating from the FDA is a question. In order to get the four-year dating, we've got samples of 6, 7, 8, 9 and 10 years showing stability over that point in time. But you're going to need lots of data points for the FDA to be convinced.
And then the ambient temperature stability is the next key component for a stockpile asset and that's trying to break the cold chain. Our studies have shown that BioThrax can be stable for up to six months at room temperature.Read the rest of this transcript for free on seekingalpha.com
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