Great Post from one of the Facebook pages: This
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Posted On: 07/09/2020 11:27:28 PM
Great Post from one of the Facebook pages:
This is off yahoo MB by Filvax
This answers why we are not unblinding the severe-critical trial at 50 patients.
“Interim Analysis
The data is blinded. Many of us Novavax investors know how an interim analysis works, as this topic & strategies were disucssed at length in regards to Novavax which went from $5 to $105 in 4 months.
An interim doesn't unblind the data. All it is is a "yes/no" answer that the FDA's Data Safety Monitoring Board gives management so as to have them decide to either fold or continue with a trial. Its a process for the business side of things, not a clinical answer to a trial's unblinded results.
An interim is a milestone that an independant board (from the FDA) uses to monitor the "safety" of drugs. That milestone is way passed and a non event (not even a material dislclosure item) as we all know that Leronlimab is non toxic and proven extremely safe already via the HIV trials.
An interim is a "point in time" snap shot, of course its not properly powered. Else why even design clinical trial sizes if everyone thought only a 1/4 of patients are needed for an FDA approval.
Management NEVER gets unblinded data from an interim. Only a "yes/no" answer WITH a statistical confidence interval which by the very nature of the trial size being attained is going to give you P vàues that are below what the "gold standard" for FDA approval ought to be.
So why risk it? Management can unblind a trial whenever they choose too. This trial or any other trial. But nobody does that, since that would go against everything that the trial was designed and powered to achieve.
What we know is that they are already WAY passed the 50 patients (140 I believe). Since it makes sense to want to unblind the mild/moderate BEFORE the severe/critical, so what VARIABLE would even want them to unblind this trial before that happens? None. Would be stupid and amateurish, which believe me, they are being councilled by the best in the industry.
Everyday that passes and that new patients are added to the sample, the FDA's DSMB can, and have the power to STOP the trial based on the GROWING statistical P Value's in light of the ethics behind the LL versus the placebo arm's clinical outcomes. The DBSM only take these decisions at pre-established "milestones" , with the 50 patient mark having been the first one. For all we know even with passing P values, the FDA may STILL think that this trial is SO IMPORTANT that it NEEDS a bigger sample. This drug IS the possible covid19 future standard of care. Think about it. They can't allow this trial to be botched even if this costs placebo lives, sadly.
So this has nothing to do with CYDY at this point but is all in the hands of the DBSM to which the FDA connects with only at pre-established intervals.
So to all I say, patience little grasshoppers, patience. This is a historic trial.”
This is off yahoo MB by Filvax
This answers why we are not unblinding the severe-critical trial at 50 patients.
“Interim Analysis
The data is blinded. Many of us Novavax investors know how an interim analysis works, as this topic & strategies were disucssed at length in regards to Novavax which went from $5 to $105 in 4 months.
An interim doesn't unblind the data. All it is is a "yes/no" answer that the FDA's Data Safety Monitoring Board gives management so as to have them decide to either fold or continue with a trial. Its a process for the business side of things, not a clinical answer to a trial's unblinded results.
An interim is a milestone that an independant board (from the FDA) uses to monitor the "safety" of drugs. That milestone is way passed and a non event (not even a material dislclosure item) as we all know that Leronlimab is non toxic and proven extremely safe already via the HIV trials.
An interim is a "point in time" snap shot, of course its not properly powered. Else why even design clinical trial sizes if everyone thought only a 1/4 of patients are needed for an FDA approval.
Management NEVER gets unblinded data from an interim. Only a "yes/no" answer WITH a statistical confidence interval which by the very nature of the trial size being attained is going to give you P vàues that are below what the "gold standard" for FDA approval ought to be.
So why risk it? Management can unblind a trial whenever they choose too. This trial or any other trial. But nobody does that, since that would go against everything that the trial was designed and powered to achieve.
What we know is that they are already WAY passed the 50 patients (140 I believe). Since it makes sense to want to unblind the mild/moderate BEFORE the severe/critical, so what VARIABLE would even want them to unblind this trial before that happens? None. Would be stupid and amateurish, which believe me, they are being councilled by the best in the industry.
Everyday that passes and that new patients are added to the sample, the FDA's DSMB can, and have the power to STOP the trial based on the GROWING statistical P Value's in light of the ethics behind the LL versus the placebo arm's clinical outcomes. The DBSM only take these decisions at pre-established "milestones" , with the 50 patient mark having been the first one. For all we know even with passing P values, the FDA may STILL think that this trial is SO IMPORTANT that it NEEDS a bigger sample. This drug IS the possible covid19 future standard of care. Think about it. They can't allow this trial to be botched even if this costs placebo lives, sadly.
So this has nothing to do with CYDY at this point but is all in the hands of the DBSM to which the FDA connects with only at pre-established intervals.
So to all I say, patience little grasshoppers, patience. This is a historic trial.”
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