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@ScottGottliebMD It's not whether the announcement today met EUA criteria, Scott. It's about claiming it is a breakthrough, 35% improved survival, with no hard data. I know you would never have pulled a stunt like this; you were an extraordinary leader at FDA
@ScottGottliebMD In this statement, @SteveFDA claims 35 per 100 people treated with plasma would be saved. The Mayo observational data indicates that would be 3 people saved at 7 days, or 5 at 30 days. And that was via exploratory analyses. Not only blatantly wrong; an egregious public statement.
@ScottGottliebMD @SteveFDA The @US_FDA tweeting this subgroup of a subgroup of a subgroup analysis just adds to this disgraceful claim of 35% survival improvement.
@ScottGottliebMD @SteveFDA @US_FDA Now, tragically, there is zero credibility for the upcoming @US_FDA review of #SARSCoV2 vaccines in the months ahead. The @CDCgov was muzzled months ago. All this, as far as I know, is unprecedented in American history.
@ScottGottliebMD @SteveFDA See @f2harrell's critique of the Mayo Clinic @DrMJoyner preprint used by FDA to make the baseless claim of a 35% survival improvement. discourse.datamethods.org/t/observationa…
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