The primary objective for a steering committee lik
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Posted On: 01/21/2021 3:10:46 AM
The primary objective for a steering committee like the DSMC is to assure the safety for the patients in a clinical trial. Their oversight determines if a clinical trial continues or is halted based on safety and/or efficacy.
(https://www.eurekalert.org/pub_releases/2021-01/b-ntf011921.php)
When a trial is not demonstrating a trend towards meeting its primary endpoint, the DSMC will work with the trial sponsor to make adjustments (increase trial size, modify or change primary endpoint, etc...). We’ve seen numerous examples of this recently. Or, in a case like tocilizumab, when far too many deaths occur in the treatment arm, a trial is halted to insure the safety of future participants.
Some are trying their damndest to convince us those two reviews performed by the DSMC with CYDY should not be considered positive when we’ve seen other trials with endpoint changes and/or halted like was just described. They’ve double-down and gone dug their grave even deeper by telling you the results won’t even be turned over for review to the FDA. In the words of our 46th President, “Will you shut up, man?
CytoDyn, with it’s lead drug leronlimab, is the only company to successfully complete a Phase 3 randomized clinical trial for severe-to-critically ill Covid-19 patients with mortality as an endpoint!!! Wait for it... DON’T BLINK
Then this article passed around (http://www.ipharminc.com/new-blog/2021/1/20/the-rise-of-coronavirus-variants-early-signs-of-immune-escape) along with the following quote: “If covid is a lab synthesized virus it was manufactured to override any single known therapeutic. Including the worthless '90s drug leronlimab. Therapeutics are failing to reach primary endpoints left and right. Time for a new approach against covid.“
CytoDyn, with it’s lead drug leronlimab, is the only company to successfully complete a Phase 3 randomized clinical trial for severe-to-critically ill Covid-19 patients with mortality as an endpoint!!! You don’t have to be a virologist to know that a drug with a mortality as a primary endpoint completes two DSMC reviews with no changes, to know that means the drug is working as it was intended in the trial design.
If it’s important for the writer to hear from a virologist, the answer to the question was addressed by Dr. Bruce Patterson (https://m.youtube.com/watch?v=PinRdTOHhtY) when he talked about emerging viruses (e.g., viruses our bodies have never seen before) and the need to stockpile a therapeutic like leronlimab that have a general broad application against pathogens we may not even know about to help manage the challenges b/c, it’s going to take at least 12-18 months to develop pathogen specific therapies or vaccines along with his eloquent description of leronlimab’s MOA in Covid-19 during his TEDx talk in June of 2020...
If you want an abbreviated version of the core message from Dr. Patterson’s TEDx talk as it relates to Covid-19 you can find it here... (https://m.youtube.com/watch?v=uSfzhwkByf0) where he mentions the three things you need in a therapeutic for Covid... a.) Quiet the cytokine storm, b.) restore the immune response, and c.) stop the virus... “This drug leronlimab did all three of those, it quieted the cytokine storm, it restored immunosuppression, and it drop the virus.”
#1 Dr. Patterson is a very distinguished and well respected virologist
#2 his research and manuscript as it relates to leronlimab and Covid-19 has been published after peer review.
What do you say when you’re told leronlimab is a water shot, that it will never work in Covid, and/or that CytoDyn is a fraud? Ask yourself or someone you trust who understands the science... “Does the science demonstrate that leronlimab blocks CCR5 and Rantes, that it brings back T-cell functions/#’s, and that it decrease the viral plasma load?” Everything else is noise in my opinion and, at the end of the day, I stick with the science behind leronlimab!!!
(https://www.eurekalert.org/pub_releases/2021-01/b-ntf011921.php)
When a trial is not demonstrating a trend towards meeting its primary endpoint, the DSMC will work with the trial sponsor to make adjustments (increase trial size, modify or change primary endpoint, etc...). We’ve seen numerous examples of this recently. Or, in a case like tocilizumab, when far too many deaths occur in the treatment arm, a trial is halted to insure the safety of future participants.
Some are trying their damndest to convince us those two reviews performed by the DSMC with CYDY should not be considered positive when we’ve seen other trials with endpoint changes and/or halted like was just described. They’ve double-down and gone dug their grave even deeper by telling you the results won’t even be turned over for review to the FDA. In the words of our 46th President, “Will you shut up, man?
CytoDyn, with it’s lead drug leronlimab, is the only company to successfully complete a Phase 3 randomized clinical trial for severe-to-critically ill Covid-19 patients with mortality as an endpoint!!! Wait for it... DON’T BLINK
Then this article passed around (http://www.ipharminc.com/new-blog/2021/1/20/the-rise-of-coronavirus-variants-early-signs-of-immune-escape) along with the following quote: “If covid is a lab synthesized virus it was manufactured to override any single known therapeutic. Including the worthless '90s drug leronlimab. Therapeutics are failing to reach primary endpoints left and right. Time for a new approach against covid.“
CytoDyn, with it’s lead drug leronlimab, is the only company to successfully complete a Phase 3 randomized clinical trial for severe-to-critically ill Covid-19 patients with mortality as an endpoint!!! You don’t have to be a virologist to know that a drug with a mortality as a primary endpoint completes two DSMC reviews with no changes, to know that means the drug is working as it was intended in the trial design.
If it’s important for the writer to hear from a virologist, the answer to the question was addressed by Dr. Bruce Patterson (https://m.youtube.com/watch?v=PinRdTOHhtY) when he talked about emerging viruses (e.g., viruses our bodies have never seen before) and the need to stockpile a therapeutic like leronlimab that have a general broad application against pathogens we may not even know about to help manage the challenges b/c, it’s going to take at least 12-18 months to develop pathogen specific therapies or vaccines along with his eloquent description of leronlimab’s MOA in Covid-19 during his TEDx talk in June of 2020...
If you want an abbreviated version of the core message from Dr. Patterson’s TEDx talk as it relates to Covid-19 you can find it here... (https://m.youtube.com/watch?v=uSfzhwkByf0) where he mentions the three things you need in a therapeutic for Covid... a.) Quiet the cytokine storm, b.) restore the immune response, and c.) stop the virus... “This drug leronlimab did all three of those, it quieted the cytokine storm, it restored immunosuppression, and it drop the virus.”
#1 Dr. Patterson is a very distinguished and well respected virologist
#2 his research and manuscript as it relates to leronlimab and Covid-19 has been published after peer review.
What do you say when you’re told leronlimab is a water shot, that it will never work in Covid, and/or that CytoDyn is a fraud? Ask yourself or someone you trust who understands the science... “Does the science demonstrate that leronlimab blocks CCR5 and Rantes, that it brings back T-cell functions/#’s, and that it decrease the viral plasma load?” Everything else is noise in my opinion and, at the end of the day, I stick with the science behind leronlimab!!!
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