FDA approves REMDESIVIR in kids, based on 53 pediatric patients at least 28 days old & weighing 7 pounds with confirmed SARS-CoV-2 infection & mild, moderate or severe COVID-19; this is bogus methods
by Paul Alexander
FDA has to come clean today with the actual data, we need to see the comorbidity data, we need all data; that they would approve it on 53 children? This is criminal as this drug is liver/kidney toxic
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Where is the safety data? Where is the pharmacokinetic data? How could they approve based on such a small sample that is undersized, cannot detect the safety signals, and of such short duration? This is methodological insanity and where is the EBM world calling this out?
There is zero data to back up this approval, none…CDC and NIH are criminal here.
We know near 100% of children will be fine with COVID and CDC reports 75% of children are already infected with COVID so these children, most have some form of immunity, so why move to approve this dangerous failed EBOLA drug?
How could you extrapolate from 53 children, this is insane. CDC has the information and we need it.