Thursday, January 24, 2013 9:35:08 AM
Bio_pete, Re DVAX: Yes, we both agree on not holding through the PDUFA date, the risk/reward doesn't justify it.
I know that you're fully aware of this, but as a side-note for biotech investors: adjuvant isn’t a dirty word!
It’s just a substance —usually aluminum salts, one of the most common elements in nature, or it can be merely oil and water—that’s added to the vaccine to increase the body’s immune response to the vaccine. They’ve been in vaccines for over 70 years, including tetanus, hepatitis, diphtheria and many others.
The FDA does take a very close look at any new ones. With DVAX, they didn't say that HEPLISAV is unsafe, just that they’d like a larger safety study performed, especially in various ethnic groups.
The GSK swine flu is an adjuvanted vaccine but there's not yet enough data or evidence to suggest a causal link to possible problems and further investigation is needed.
I know that you're fully aware of this, but as a side-note for biotech investors: adjuvant isn’t a dirty word!
It’s just a substance —usually aluminum salts, one of the most common elements in nature, or it can be merely oil and water—that’s added to the vaccine to increase the body’s immune response to the vaccine. They’ve been in vaccines for over 70 years, including tetanus, hepatitis, diphtheria and many others.
The FDA does take a very close look at any new ones. With DVAX, they didn't say that HEPLISAV is unsafe, just that they’d like a larger safety study performed, especially in various ethnic groups.
The GSK swine flu is an adjuvanted vaccine but there's not yet enough data or evidence to suggest a causal link to possible problems and further investigation is needed.
All that is needed to make a happy life is within yourself, in your way of thinking. -Marcus Aurelius
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