This statement also needs to be emphasized as unju
Post# of 154034
(Total Views: 593)
Posted On: 12/23/2022 1:21:28 PM
Re: Hyperbolic #131882
This statement also needs to be emphasized as unjustified in the DOJ filing: “ failed to achieve the results necessary to obtain any form of FDA approval for use as a treatment for COVID-19…”. Emphasis on “any form of FDA approval.”
FDA felt justified to approve Remdesivir under an EUA despite trial results failing to hit statistical significance. Moreover, that drug whose mechanism of action is antiviral was used almost exclusively for moribund inpatients for whom the virus is no longer replicating and the pharmaceutical interventions needed should address the cytokine storm. What could be more reasonable than to assume an EUA might be granted to Leronlimab? Safe, and possibly effective are the criteria for an EUA. Leronlimab had already been demonstrated to be safe and the preponderance of evidence even if not over the line as statistically significant was highly significant clinically.
I think history will demonstrate the FDA made a mistake here with the pandemic and their response to Cytodyn. With Remdesivir it was “might work, give it a chance” but it didn’t work and trashed your kidneys in the bargain; with Leronlimab it sure as hell does work but we are not going to give it a chance. When you are on a war footing with a global pandemic with millions dying you have to exercise some liberties and call the right audible, especially with a proven SAFE drug that showed a LOT of evidence it could make a difference.
While the DOJ filing is now history, I would find it enlightening to know what triggered the investigation and whether some of those complaints or the most vociferous among them might have originated from people with secondary gain. I won’t name names as the individuals and entities at work against Cytodyn have been fully aired out on this board for anyone around 2020 on. Who knows what lurks inside the mind of men…the Shadow knows.
FDA felt justified to approve Remdesivir under an EUA despite trial results failing to hit statistical significance. Moreover, that drug whose mechanism of action is antiviral was used almost exclusively for moribund inpatients for whom the virus is no longer replicating and the pharmaceutical interventions needed should address the cytokine storm. What could be more reasonable than to assume an EUA might be granted to Leronlimab? Safe, and possibly effective are the criteria for an EUA. Leronlimab had already been demonstrated to be safe and the preponderance of evidence even if not over the line as statistically significant was highly significant clinically.
I think history will demonstrate the FDA made a mistake here with the pandemic and their response to Cytodyn. With Remdesivir it was “might work, give it a chance” but it didn’t work and trashed your kidneys in the bargain; with Leronlimab it sure as hell does work but we are not going to give it a chance. When you are on a war footing with a global pandemic with millions dying you have to exercise some liberties and call the right audible, especially with a proven SAFE drug that showed a LOT of evidence it could make a difference.
While the DOJ filing is now history, I would find it enlightening to know what triggered the investigation and whether some of those complaints or the most vociferous among them might have originated from people with secondary gain. I won’t name names as the individuals and entities at work against Cytodyn have been fully aired out on this board for anyone around 2020 on. Who knows what lurks inside the mind of men…the Shadow knows.
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