Wednesday, April 13, 2022 12:56:37 PM
Arpemd , this is exactly what happened , CYDY did the study for severe / critical .. Critical patients are the one on a ventilators and ECMO , company asked in the protocol for 4 doses ( 4 weeks ) , this is once a week SC injection , drug with half life of 10 days..
FDA changed the protocol to 2 injections , so instead having SC shot at
0 ,7 , 14 and 21 days , those severe/critical patients have only 2 shots , one at 0 , and one at 7 days and then nothing..
This is a drug used in HIV once a week for 7 years now without one serious side effect , Why FDA changed the protocol to 2 shots..I will love to know that ..to me they sabotage this study , they know how good this drug is , bur remdesivir need to be sold...imo..
Anyway with 2 shots at 0 and 7 days results in critical patients showed ...
--78% mortality benefit at 7 days above all SOC drugs ( standard of care,,)
--82% mortality benefit above all SOC at 14 days.
--50% mortality above all SOC at 21 days,
--and 31% mortality benefit above all SOC drugs at 28 days , the time when leronlimab was long not in the system..
So it is very easy to see that drug works great and need more then 2 doses..
One will think that FDA in May or so of 2021 will see this , and give EUA for critical , since people dying and no good drug approved..
But no , not our FDA , our FDA put a hit letter on the company , saying they will not look at " some " subgroup..
Well this " some subgroup " are our friends and family dying needlessly ..
I always will like to know how many hundreds thousand less Americans will die if we have EUA for leronlimab one year ago....
But I think important point was , remdesivir made a lot of money this year..
This is why I want all this to be investigated..
And this is why I am not very hopeful for approval of Tollovir soon in USA..
And all IMO. as always...
Go Tollovir/Tollovid.
FDA changed the protocol to 2 injections , so instead having SC shot at
0 ,7 , 14 and 21 days , those severe/critical patients have only 2 shots , one at 0 , and one at 7 days and then nothing..
This is a drug used in HIV once a week for 7 years now without one serious side effect , Why FDA changed the protocol to 2 shots..I will love to know that ..to me they sabotage this study , they know how good this drug is , bur remdesivir need to be sold...imo..
Anyway with 2 shots at 0 and 7 days results in critical patients showed ...
--78% mortality benefit at 7 days above all SOC drugs ( standard of care,,)
--82% mortality benefit above all SOC at 14 days.
--50% mortality above all SOC at 21 days,
--and 31% mortality benefit above all SOC drugs at 28 days , the time when leronlimab was long not in the system..
So it is very easy to see that drug works great and need more then 2 doses..
One will think that FDA in May or so of 2021 will see this , and give EUA for critical , since people dying and no good drug approved..
But no , not our FDA , our FDA put a hit letter on the company , saying they will not look at " some " subgroup..
Well this " some subgroup " are our friends and family dying needlessly ..
I always will like to know how many hundreds thousand less Americans will die if we have EUA for leronlimab one year ago....
But I think important point was , remdesivir made a lot of money this year..
This is why I want all this to be investigated..
And this is why I am not very hopeful for approval of Tollovir soon in USA..
And all IMO. as always...
Go Tollovir/Tollovid.
