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Posted On: 01/30/2022 12:55:08 PM
Post# of 153925
Could this help us?
"Both Lilly and Regeneron say they have next-generation drugs in development that do hold up against Omicron, and Lilly says it’s completed Phase 2 trials and that it has hundreds of thousands of doses already made. On Twitter this week, former FDA Commissioner Dr. Scott Gottlieb called for a regulatory pathway that would authorize new antibodies quickly based on human safety data and lab evidence of effectiveness against new variants. Is that something that’s on the table under consideration here?
Certainly. In February, FDA published guidance for industry on what we would do, for example, if variants escaped diagnostic tests and how we would monitor for that. If the variants escaped vaccines, what would we do there to get additional vaccine available from the same platform, and what we do about monoclonals. And so there we talk about what companies would need to do, and it is a very streamlined program compared to what was done originally with the monoclonal antibodies."
https://www.statnews.com/2022/01/28/janet-woo...-vaccines/
"Both Lilly and Regeneron say they have next-generation drugs in development that do hold up against Omicron, and Lilly says it’s completed Phase 2 trials and that it has hundreds of thousands of doses already made. On Twitter this week, former FDA Commissioner Dr. Scott Gottlieb called for a regulatory pathway that would authorize new antibodies quickly based on human safety data and lab evidence of effectiveness against new variants. Is that something that’s on the table under consideration here?
Certainly. In February, FDA published guidance for industry on what we would do, for example, if variants escaped diagnostic tests and how we would monitor for that. If the variants escaped vaccines, what would we do there to get additional vaccine available from the same platform, and what we do about monoclonals. And so there we talk about what companies would need to do, and it is a very streamlined program compared to what was done originally with the monoclonal antibodies."
https://www.statnews.com/2022/01/28/janet-woo...-vaccines/
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