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Posted On: 05/21/2021 4:05:28 PM
Post# of 145870
Babaji posted a YMB post from Cokadoodledue to the Select Subcommittee on the Coronavirus Crisis. This is the email he sent that resulted in a call from Beth Mueller. NP may have a sleepless weekend since he asked folks not to do this.
Here is a copy of the comments I shared with the US Congressional Select Subcommittee on the Coronavirus Crisis:
Xxxxxxxxxxxxxxxxxxxxxxxxxxx
I discovered massive fraud while comparing Remdesivir's drug trials to that of a competitor's drug, which was forced to fail.
I do not say this lightly. The NIAID (Nat'l Institute of Allergies and Infectious Diseases) sponsored Remdesivir's ACTT trial. It was supposed to be a head to head-to-head trial against all of the available therapies at the time. However, when you look at the trials of both drugs, it becomes glaringly obvious that ACTT trial was designed to make it much easier to succeed. While Leronlimab was forced to conduct 2 very stringent trials, which were designed to make it almost impossible for it to succeed.
For example, Remdesivir's sponsor was the NIAID, not Gilead. As a result, it had the connections and the money to do anything it wanted. Contrast that with Leronlimab, which was sponsored by a very small Company by the name of Cytodyn.
The ACTT trial studied the full range of the Covid-19 continuum from mild to severe. Leronlimab was forced to conduct 2 separate studies; the CD10 that looked at mild to moderate Covid-19 patients. And, the CD12 that was a mortality study of the severe to critical patients.
The ACTT was an adaptive Double Blinded (DB) study, randomized 1:1. The CD10/12 studies were also adaptive. However, despite a title that displays them as Double Blinded (DB), a deeper look into the study revealed that they were actually quadruple blinded (QB) studies. The difference between DB and QB being that the DB drug is simply blinded to the patient and the investigator. QB is blinded to both the patient and investigator like the DB, but also is blinded to the care provider and the outcomes assessor. These differences make it extraordinarily difficult to adapt the trial for any changes. Plus, the 2:1 randomized trial makes it difficult to catch any errors until the end of the trial, when unblinding the results would cause the data to be corrupted, and no longer blinded.
The ACTT trial drug, Remdesivir was supposed to be blinded to other drugs and a placebo. However, aside from the fact that Leronlimab had a different route of administration than Remdesivir, the ACTT trial was changed to stop enrolling patients just days after the CD12 began enrollment, and less than 3 weeks after the CD10 began enrollment. Another drug, Dexamethasone, wasn't given an EUA until over a month after the ACTT trial finished enrollment. Initially, the FDA didn't even want to give an EUA to Dexamethasone, citing a lack of studies (of course, they had even less for their Hydrochloroquine EUA and Convalescent Plasma EUA).
When the series of Remdesivir drug trials ended, the results still required creative writing on the parts of the RAs and the Biostatisticians at the FDA just to give the hints that they were trending towards statistical significance. Remdesivir should never have been used for Covid-19. The clinical disaster that ensued only emphasized that point in the hundreds of thousands who died having been given it, but failed to receive any health benefits from its use.
Remdesivir was limited to a 5-day course of IV treatment and a 10-day course IV treatment, with the 10-day treatment being at least as worse as the placebo (saline solution). CYDY was forced to only give 2 doses, the first at day 1 and the second at day 7. But, Leronlimab showed improvement with more medicine. Remdesivir, showed some improvement at the lowest dose, but failure with more medicine. The fact is, Remdesivir was proven to be not efficacious, compared to saline solution. A fact that would come back to haunt of the patients who would have been better served getting nothing. We are now seeing Leronlimab being used where ALL other treatments have failed, and it is being used for compassionate care around the world to save lives. Remdesivir is still approved by the FDA. And, Leronlimab, which has been proven safe and 'might be effective' per the law isn't even getting the chance to show how great it is on Covid-19. Remdesivir went on to receive a lucrative contract, and Leronlimab's owners are barely keeping afloat.
And just a week after the WHO released its own study claiming how useless Remdesivir was for Covid-19, the FDA approved the drug's New Drug Application (NDA) without an Adcom meeting!!!
One last thing. You have to ask yourself, why would a CEO and his Research Consultant (was a Biostatistician with the FDA prior to starting his own Company) choose the hardest possible way to secure a win for Leronlimab, unless he was forced to do it that way. It just doesn't make logical sense for that to happen.
The Head of the NIAID was Dr. Fauci. The head of FDA was Dr. Hahn. The head of HHS was Dr. Azar (who happens to be a former Lobbyist for Eli Lilly - which received last minute EUA for its mAb cocktail that sits useless on the shelf because of it black box warnings and inpatient IV administration requirement.). We know that there was an almost incestuous relationship between the heads of those 3 departments, because of how so many useless drugs received EUAs and lucrative contracts. Yet, the one drug that could have severely hampered the pandemic's death count still can't even get a fair shake.
Here is a copy of the comments I shared with the US Congressional Select Subcommittee on the Coronavirus Crisis:
Xxxxxxxxxxxxxxxxxxxxxxxxxxx
I discovered massive fraud while comparing Remdesivir's drug trials to that of a competitor's drug, which was forced to fail.
I do not say this lightly. The NIAID (Nat'l Institute of Allergies and Infectious Diseases) sponsored Remdesivir's ACTT trial. It was supposed to be a head to head-to-head trial against all of the available therapies at the time. However, when you look at the trials of both drugs, it becomes glaringly obvious that ACTT trial was designed to make it much easier to succeed. While Leronlimab was forced to conduct 2 very stringent trials, which were designed to make it almost impossible for it to succeed.
For example, Remdesivir's sponsor was the NIAID, not Gilead. As a result, it had the connections and the money to do anything it wanted. Contrast that with Leronlimab, which was sponsored by a very small Company by the name of Cytodyn.
The ACTT trial studied the full range of the Covid-19 continuum from mild to severe. Leronlimab was forced to conduct 2 separate studies; the CD10 that looked at mild to moderate Covid-19 patients. And, the CD12 that was a mortality study of the severe to critical patients.
The ACTT was an adaptive Double Blinded (DB) study, randomized 1:1. The CD10/12 studies were also adaptive. However, despite a title that displays them as Double Blinded (DB), a deeper look into the study revealed that they were actually quadruple blinded (QB) studies. The difference between DB and QB being that the DB drug is simply blinded to the patient and the investigator. QB is blinded to both the patient and investigator like the DB, but also is blinded to the care provider and the outcomes assessor. These differences make it extraordinarily difficult to adapt the trial for any changes. Plus, the 2:1 randomized trial makes it difficult to catch any errors until the end of the trial, when unblinding the results would cause the data to be corrupted, and no longer blinded.
The ACTT trial drug, Remdesivir was supposed to be blinded to other drugs and a placebo. However, aside from the fact that Leronlimab had a different route of administration than Remdesivir, the ACTT trial was changed to stop enrolling patients just days after the CD12 began enrollment, and less than 3 weeks after the CD10 began enrollment. Another drug, Dexamethasone, wasn't given an EUA until over a month after the ACTT trial finished enrollment. Initially, the FDA didn't even want to give an EUA to Dexamethasone, citing a lack of studies (of course, they had even less for their Hydrochloroquine EUA and Convalescent Plasma EUA).
When the series of Remdesivir drug trials ended, the results still required creative writing on the parts of the RAs and the Biostatisticians at the FDA just to give the hints that they were trending towards statistical significance. Remdesivir should never have been used for Covid-19. The clinical disaster that ensued only emphasized that point in the hundreds of thousands who died having been given it, but failed to receive any health benefits from its use.
Remdesivir was limited to a 5-day course of IV treatment and a 10-day course IV treatment, with the 10-day treatment being at least as worse as the placebo (saline solution). CYDY was forced to only give 2 doses, the first at day 1 and the second at day 7. But, Leronlimab showed improvement with more medicine. Remdesivir, showed some improvement at the lowest dose, but failure with more medicine. The fact is, Remdesivir was proven to be not efficacious, compared to saline solution. A fact that would come back to haunt of the patients who would have been better served getting nothing. We are now seeing Leronlimab being used where ALL other treatments have failed, and it is being used for compassionate care around the world to save lives. Remdesivir is still approved by the FDA. And, Leronlimab, which has been proven safe and 'might be effective' per the law isn't even getting the chance to show how great it is on Covid-19. Remdesivir went on to receive a lucrative contract, and Leronlimab's owners are barely keeping afloat.
And just a week after the WHO released its own study claiming how useless Remdesivir was for Covid-19, the FDA approved the drug's New Drug Application (NDA) without an Adcom meeting!!!
One last thing. You have to ask yourself, why would a CEO and his Research Consultant (was a Biostatistician with the FDA prior to starting his own Company) choose the hardest possible way to secure a win for Leronlimab, unless he was forced to do it that way. It just doesn't make logical sense for that to happen.
The Head of the NIAID was Dr. Fauci. The head of FDA was Dr. Hahn. The head of HHS was Dr. Azar (who happens to be a former Lobbyist for Eli Lilly - which received last minute EUA for its mAb cocktail that sits useless on the shelf because of it black box warnings and inpatient IV administration requirement.). We know that there was an almost incestuous relationship between the heads of those 3 departments, because of how so many useless drugs received EUAs and lucrative contracts. Yet, the one drug that could have severely hampered the pandemic's death count still can't even get a fair shake.
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