Which adds to there was no risk to FDA approving u
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Which adds to there was no risk to FDA approving us for covid.
The FDA probably still thinks that leronlimab is an immunosuppressant in the same vein as corticosteroids. The difference is that corticosteroids and other immunosuppressants do a complete knockout of part of the immune system. leronlimab only suppresses interactions with CCR5 while still allowing normal immune actions with other receptors. Quite confounding is that the FDA recommended corticosteroids for severe/critical Covid.
In the trial leronlimab was the equal of SOC (placebo arm) which in many cases was corticosteroids. In the trial corticosteroids or other treatments could have been used before the patient entered the trial thus giving them 4 or more weeks of treatment. Most likely those same treatments were used throughout the 4 weeks of the trial. Is it any wonder leronlimab didn't show statistical significance with only 2 weeks of use.