Rubraquercus, Good morning. I_luv_cydy, I ge
Post# of 153886
(Total Views: 534)
Posted On: 04/15/2020 6:53:56 AM
Re: Rubraquercus #27640
Rubraquercus,
Good morning.
Precisely, it is not written in stone. We have discussed this here before. Have you heard of PAHPRA? it enhances the authority of the U.S. Food and Drug Administration to support rapid responses to public health emergencies.
FDA may then issue an EUA for a product if FDA finds that:
Let me pose it to you that COVID-19 is a serious life-threatening disease … Isn't it ???
Leronlimab may be effective in treating COVID. Right ???
Damn yes, no adverse effects and people are dying for Pete's sake !!! it outweighs the known potential risks (there aren't any). IS a case of death against some possible pain in injection site.
Is there ???
FDA should be using PAHPRA to issue a EUA (Emergency Use Authorization) They have the autorithy.
Good morning.
Quote:
I_luv_cydy, I get it, I just don't understand how anyone could be so twisted up over something that is carved in stone and one we can't change either. And for the love of all things sacred, it just started. But kvetching seems to be the norm in these parts.
Precisely, it is not written in stone. We have discussed this here before. Have you heard of PAHPRA? it enhances the authority of the U.S. Food and Drug Administration to support rapid responses to public health emergencies.
FDA may then issue an EUA for a product if FDA finds that:
Quote:
The agent specified in the declaration of emergency can cause a serious or life-threatening disease or condition
Let me pose it to you that COVID-19 is a serious life-threatening disease … Isn't it ???
Quote:
Based on the totality of scientific evidence available, it is reasonable to believe that the product may be effective in diagnosing, treating, or preventing the serious or life-threatening disease or condition, or a serious or life-threatening disease or condition caused by a product authorized approved, cleared, or licensed by FDA for diagnosing, treating, or preventing the disease or condition;
Leronlimab may be effective in treating COVID. Right ???
Quote:
The known and potential benefits of the product outweigh the known and potential risks of the product when used to diagnose, prevent, or treat the serious or life-threatening disease or condition, taking into consideration the material threat posed by the agent or agents identified in a declaration by the DHS Secretary, if applicable;
Damn yes, no adverse effects and people are dying for Pete's sake !!! it outweighs the known potential risks (there aren't any). IS a case of death against some possible pain in injection site.
Quote:
There is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating such serious or life-threatening disease or condition
Is there ???
FDA should be using PAHPRA to issue a EUA (Emergency Use Authorization) They have the autorithy.
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