FBCoach18 wrote: Am I to understand that it's jus
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Posted On: 02/13/2021 10:55:26 PM
FBCoach18 wrote:
Am I to understand that it's just about numbers especially percentages as a comparison to the placebo arm, or is it more about where patients are in their severe or critical stage of the disease compared to the placebo arm? Also, what other factors, if any, are weighed heavily in the final decision?
my response:
I'm surprised that after 5 hours not a person has responded to your questions. From my education obtained here....
The FDA can issue an EUA approval if a drug "May Be Effective" and is known to be safe, thus, Secondary Endpoints can have the deciding influence.
Am I to understand that it's just about numbers especially percentages as a comparison to the placebo arm, or is it more about where patients are in their severe or critical stage of the disease compared to the placebo arm? Also, what other factors, if any, are weighed heavily in the final decision?
my response:
I'm surprised that after 5 hours not a person has responded to your questions. From my education obtained here....
The FDA can issue an EUA approval if a drug "May Be Effective" and is known to be safe, thus, Secondary Endpoints can have the deciding influence.
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