OK what I know from Philippines ,
Former president was sick for about 2 weeks , admitted to the hospital , he was on HCQ I read , but not sure if right in the article , He was on Remdesivir , this I am 100% sure , and I am not sure about dexamethasone ,
Nothing from this worked , he was still progressing , then intubated ..
And then sometime later they got Leronlimab , and one or two days after receiving it , he was removed from the ventilator and still improving , so far after one SC shot of Leronlimab..
Yes , what you are saying , this history of progress is not really important, in order to prove if it was a Leronlimab , they should make him go on double blind , placebo control study , but which one ??
The one Remdesivir and Lenzilumab went , when management looked at the results during the study , and pick up the SS results, and changes primary endpoints..
Or the one done for Leronlimab, no one could see anything during this study , really blinded ..
At the end it was SS significant for every patient with length of hospitalization, but since this was not call that by a company , even when people dying , FDA saying , oh no , you should change the name before the end of the study..otherwise don't count .
They also dramatically SS in mortality with subgroups , but for FDA this is also not that important...This is just people dying , we used to it by now..
So according to FDA , if we change the name of primary endpoint to length of hospitalization 2 weeks before , we could have EUA and save lives today.
But since we didn't change the name , but we have the same results , lets people die , and we need to continue studies until we hit proper name..
Of course they know we saving lives , and now it may take us few more months with more studies , and probably 100,000 more deaths , but we must be right how we calling saving lives.
Yes , very important points for our FDA. Not how many people lives could be save , but how you call the endpoint
All IMO.
