This was a disgusting spectacle. The FDA caved
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Posted On: 08/23/2020 6:07:52 PM
This was a disgusting spectacle.
The FDA caved to political pressure.
Now we grant emergency authorizations without randomized clinical trial(s).
This makes it more difficult for the rest of us to enroll patients in other trials.
Plasma was widely available anyway before. Does not change much in this fashion.
So, the bar now is 35% reduction on a sub-group of the patients (not on mechanical ventilators).
We will beat this easily.
Really ??? What about US for Pete's sake !!. We actually did a double-blinded trial.
Ah !!!. Where is Leronlimab EUA ??? Tomorrow ???
This was not breakthrough announcement , no sir, this was a political nothing-burger.
Period.
The FDA caved to political pressure.
Now we grant emergency authorizations without randomized clinical trial(s).
This makes it more difficult for the rest of us to enroll patients in other trials.
Plasma was widely available anyway before. Does not change much in this fashion.
So, the bar now is 35% reduction on a sub-group of the patients (not on mechanical ventilators).
We will beat this easily.
Quote:
Is SAFE and shows promised efficacy
Really ??? What about US for Pete's sake !!. We actually did a double-blinded trial.
Quote:
Meets FDA standards
Ah !!!. Where is Leronlimab EUA ??? Tomorrow ???
This was not breakthrough announcement , no sir, this was a political nothing-burger.
Period.
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