BottomLine FDA Firewall Statistician Nader states
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Posted On: 11/08/2020 3:41:35 PM
BottomLine FDA Firewall Statistician
Nader states strongly we are all unblinded, only one person has the unblinded (interim) data, and then adds DSMC has it and the FDA firewall statistician.
IMO, the FDA Firewall Statistician probably does not work for the FDA, and regardless, nobody at the FDA who has any authority to do so, will be looking at the s/c interim data to possibly grant any type of access to Leronlimab. Not presently anyway, not as of the recent CC.
IMO, the FDA "should" access our s/c interim data if there is any pathway for them access, and "should" grant some type of immediate access to Leronlimab.
Because of Leronlimab's pristine safety and the dire crisis desperate need to slow and/or defeat this winning virus, access to Leronlimab "should" be a no brainer immediate action.
Nader states strongly we are all unblinded, only one person has the unblinded (interim) data, and then adds DSMC has it and the FDA firewall statistician.
IMO, the FDA Firewall Statistician probably does not work for the FDA, and regardless, nobody at the FDA who has any authority to do so, will be looking at the s/c interim data to possibly grant any type of access to Leronlimab. Not presently anyway, not as of the recent CC.
IMO, the FDA "should" access our s/c interim data if there is any pathway for them access, and "should" grant some type of immediate access to Leronlimab.
Because of Leronlimab's pristine safety and the dire crisis desperate need to slow and/or defeat this winning virus, access to Leronlimab "should" be a no brainer immediate action.
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