Jimmy , all right reasons to me..and..
The trial was constructed to win , regardless if this drug is good or bad.
Same done with remdesivir , they saw results during ongoing trial , same as with lenzilumab , they knew who is on the remdesivir and who is on placebo , it will be very easy then to arrange , to keep the placebo patients in the hospital 2-3 days longer ,
And here we are , met primary endpoint.
I am not saying this happened , but it is very strange that ONLY study done by Gilead and dr Fauci showing any improvement with remdesivir in COVID . And the ONLY improvement was 3 days reduction of hospitalization.
Not when Chines did it , and the most interesting , not when WHO did it , this very large 5000 patients study .. properly dose patients .
It showed no benefit from remdesivir in mortality, and no reduction in length of hospitalization. Just no benefits...
The same person , dr Fauci , designed and supervised Lenzilumab study. This is already suspect ..
We really cant trust the results.
But yes , they be approved very soon , even if they don't have a product to treat patients with , and every other company , if not Dr Fauci favorites , will be rejected only for this reason .
But not in leronlimab , we the only drug in a world showing improvement in the most sick , we see that in over 90 EIND , used by very respectable doctors , like doctor Yang , there is no anecdotal information in pandemic , they ALL should be consider , if we really care for human lives ,
also add 62 patients in our "B" group in CD12 , critical patients , and probably over 60 patients in OLE study..
Of course FDA has enough information to give us EUA and phase 4 study,
I will say it was their obligation in this pandemic.
Tocilizumab received for much less , and in less deadly disease.
But instead FDA did a hit letter on the company , most probably trying to affect international market.
They probably will not feel well , when leronlimab will be saving lives , but not American lives..
GLTA longs in CYDY...
All IMO.