OK , I am talking only facts here , all the time ..
Our design of phase 2 was very difficult to be SS with all endpoints ..
But it was SS with NEWS2 at 14 days.
The problem was that to many patients , healthy with very little symptoms and no comorbidity , were admitted to the study,
And young and healthy patients they do get better often on it own.
At 3 days leronlimab treated patients were much better , but not at 28 days since most recovered on its own.
I am sorry they didn't do immediately phase 3 for moderate with comorbidity , this will be easy to prove,
But even here NEWS2 endpoints , the most significant endpoints from all , at 14 days being SS showed us power of this drug.
In CD12 , with severe/critical we had no chance.
FDA sabotaged our study before it was started.
What was a reason to refuse 4 weeks treatment , not because it was not safe ,
Some HIV patients are on weekly dose for close to 7 years now. Not one serious side effect, so why this restriction for severe/critical COVID to 2 weeks treatment only..
Please listen to Dr Lalezari, in sticky Stockorus post.
Then is severe , bad luck also , or something , all the the oldest patients were enroll to drug arm , and the youngest in placebo.
Study was 2:1 and oldest patents enroll was 3:1. Drug to placebo.
And in critical the picture is the most clear..
Even with 2 doses of leronlimab , given at 0 and 7 days
The mortality benefit ABOVE SOC drugs , remdesivir , tocilizumab , dexamethasone , was VERY impressive ..
at 7 days -78%
at 14 days -82%
at 21 days -50%
at 28 days -31%.
Everyone must agree that even with 2 doses at 31% mortality benefit at 28 days ,mean saving lives above present SOC drugs ..
And lets just look at 14 days when leronlimab was still in the system , mortality BENEFIT ABOVE SOC is 82%...
Everyone will agree looking at this numbers that leronlimab is saving lives and that 4 weeks of treatment is needed ,
Why will anyone even question this results .. These numbers tell the story..
How many people life's could be saved if only leronlimab will have EUA at least , months ago,
And add to this about 100 patients in EIND , many lives were save ...
Oh yes right , FDA dont care about EINDs numbers , why will FDA not care to see the results from this patients , are we not in pandemic and already over 600K patients died , many needlessly .
Why will FDA NOT CARE to save lives !!!!
Why worthless drugs like Alz drug from Biogen , and remdesivir and tocilizumab and baricitinib for covid are approved for severe patients ,
And drug with some real improvement in covid like : aviptadil , lenzilumab and the best from all leronlimab are not.
I will think that we all want to have a drug helping us to survive if need will come.
Everyone should know , no one is immune to get bad immune stage of the disease , my son was vaccinated , I know others ..
We all should fight for these drugs to be approve , with phase 4 , as it should be,
No, this worthless Alz drug from Biogen should not be approve with phase 4 , but leronlimab should be long time ago.
There is NOTHING to treat patients with immune stage right now .
Dexamethasone I believe kept my son off the ventilator , but it was not for long..
Everyone should think about all this , we ALL at risk with one or another variant.
And variants coming..
All IMO.
