Craigakess, but remember when all of us on this
Post# of 148168
(Total Views: 468)
Posted On: 05/05/2021 2:53:58 PM
Re: craigakess #89065
Craigakess,
Agree with you !!!. I have always maintained that the problem is FDA. And yes, they have nor helped us at all, but more importantly, they have not helped thousands of patients in ICU's grasping for oxygen in the last moment of their lives while a SAFE drug was available that might had made a difference.
The way it works is that one does not get to use a drug just because one has it. Every country has regulatory agencies. This is the way it has to be. Brazil needs to probe to themselves that LL works. Our main problem is that we are a USA company, and need FDA approval to sell LL in the USA.
Hopefully Brazil regulatory agency will be "untainted" and scientifically sound.
Wholeheartedly agree. Please send this to FDA.
As for the Brazilians ... well can't blame them for doing a trial on their own, nor I would blame any country. The way things are with FDA, imo it is worse to trust FDA on any decision they make
Quote:
but remember when all of us on this board were up in arms because thousands of Americans were dying each month while we screamed that leronlimab could have saved so many and the FDA didn't help us at all?
Agree with you !!!. I have always maintained that the problem is FDA. And yes, they have nor helped us at all, but more importantly, they have not helped thousands of patients in ICU's grasping for oxygen in the last moment of their lives while a SAFE drug was available that might had made a difference.
Quote:
How is that different from Brazil deciding that tens of thousands of people dying for the next 7 months is acceptable as they wait for some more trials results when it is CLEAR that leronlimab provides a benefit?
The way it works is that one does not get to use a drug just because one has it. Every country has regulatory agencies. This is the way it has to be. Brazil needs to probe to themselves that LL works. Our main problem is that we are a USA company, and need FDA approval to sell LL in the USA.
Hopefully Brazil regulatory agency will be "untainted" and scientifically sound.
Quote:
the world doesn't need more trials of leronlimab, the world needs leronlimab. NOW.
Wholeheartedly agree. Please send this to FDA.
As for the Brazilians ... well can't blame them for doing a trial on their own, nor I would blame any country. The way things are with FDA, imo it is worse to trust FDA on any decision they make
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