ohm20.. WHAT A PITY.. We sure could use your expertise on this and the CYDY BOARD... !!!
Would ask a favor from you..!!!
Could you PLEASE explain to our board ..that an EUA for COVID DOES NOT REQUIRE LERONLIMAB TO SHOW EFFICACY AGAINST COVID..INSTEAD IT SHOULD SHOW SAFETY AND ....POSSIBLE EFFICACY...!!!
Our 1000 HIV patients over YEARS..CD10... AND now our CD12.. Could Show the SAFETY...!!!
DSMC..Asking us to continue Our CD12.. With NO CHANGE..Signifies...POSSIBLE EFFICACY..!!!
The P value with which most on our board are stuck ....HAS NO VALUE IN REQUESTING FOR AN EUA.. !!!
If The FDA continues to play hardball with us..We could take our drug to the UK..EU or the Phillipines..And see if they care more about their people..than their Big Pharma..!!!
I had promised our board ..No more about Unblinding..So will shut up now.. !!!
But ..If misiu 143 and You... could contribute your 4 cents..I would be obligated..!!!
He also wrote that: What the agencies want to see is clinical outcome backed by statistical significance that backs up the likelihood the clinical outcome is true. In m/m we had clinical significance but not statistical significance because of trial size. Also m/m only fits in with EUA regarding progression to severe.
S/C guaranteed we have better than p = .05 and we're saving lives.
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