Hahn's standard of “may be effective” applies
Post# of 148163
Will you ever open your eyes, guys, to the real world?!
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After watching for days/weeks the conversations around p values and mortality rates, its clear to me no one knows so I’m just going to wait for the report . But I go back to Hahn’’s interview with Dr Topol dating back to October 9 th ..” there are two important points of EUA..One is that, from a treatment or a therapeutic point of view, the standard is “ may be effective”. There has to be evidence that something may be effective.
“The other one is an assessment of the risk benefit ratio.and that’s where safety comes in..
Based on those comments, if the FDA sticks to the Dr Hahn approach, a few lives saved with a safe drug will get an EUA ...
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Le-Ron-Li-Mab, and they have not.