Thursday, May 26, 2022 9:12:11 PM
Another very strange thing , first FDA refused , without any reason to allow 4 injections of leronlimab to severe/critical patients , and then what DSMC advised after the interim results was not less suspicious ..
Results with 2 injections of leronlimab , at 0 and 7 days were very clear.
Mortality benefit ABOVE all these SOC drugs below .
--78% at 7 days,... ( second , and last leronlimab given )
--82% at 14 days ..( no more leronlimab )
--50% at 21 days,..( no leronlimab )
--31% at 28 days....( no leronlimab )
From these results everyone may see very clearly that 2 more injections needed , and that should be the only DSMC advice...
But instead DSMC advised to continue 2 doses , to do another interim at 75% of enrollment , and instead at 28 days , to check mortality at 42 days..
Why ?.. since no more leronlimb was given , we could only expect higher mortality at 42 days .
Anyway , we finished first 100% enrollment with 28 days mortality , then 75% with 42 days , and this was done.
After seeing Topline results it is impassible to understand DSMC advice.
We learned later that one member was connected to Gilead , was that a problem , I don't know ,...but there was a problems somewhere , this was not a proper advice...
So this was our DSMC experience in CD12.
GLTA longs.
All IMO.
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