It certainly could be true that the FDA reviewers
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Posted On: 01/11/2021 6:55:10 PM
It certainly could be true that the FDA reviewers of CD12 data will have no interest in CCR5 RO.
But I doubt that.
CCR5 covid is a totally new and original concept for medicine.
If CD12 misses on the primary endpoint and I am an FDA reviewer I would look at the absence of support for the new, original MOA from the CD12 data package as just incredibly unbelievable.
The other thing I don't understand is the FDA protocol for data access in clinical trials. As you point out in your post:
"Clinical trials are double blinded for good reasons. Scientific rigor and the removal of doubt that investigators are influencing the outcome. Performing RO tests without FDA endorsement, would be monumentally stupid. It would essentially be cheating."
I agree with you that it seems like "blinded" means that nobody knows the real time progress of a trial towards its endpoint.
But is this an actual structural implementation or merely some sort of unwritten rule enforced by some sort of unwritten gentlemens agreement?
For example, I believe we know with 100% certainty that Patterson was running RO on CD12 and CD10 patients at the beginning of those trials.
Was CYDY running unauthorized tests?
I doubt it.
Was it the FDA's intention to prevent RO tests for the purpose of maintaining blinding?
No chance whatsoever!!!
CCR5 antagonism is a totally new, totally original theory of medicine.
No chance on earth that the FDA would purposely not examine the primary feature of this totally new theory in a totally new disease. No chance whatsoever.
In my opinion, our discussion here on this thread on this message board as to blinding has already been mooted by actual laws, rules, and regulations that govern the maintenance of human clinical trial data.
Either CYDY has an electronic copy of all CD12 patient records, including any RO tests, or CYDY does not.
This disposition is a matter of law and/or regulation.
The FDA has already anticipated this situation and has executed laws, rules, and regulations for this exact situation.
For example, every cancer trial has clinical data on the progression of the cancer like xrays and mris. some of the medicines that people take for cancer are dangerous and need to be monitored for safety. So for many cancer trials the level of the medicine needs to be monitored in the bloodstream. In this obvious case, if you have access to the medical records you know which patients are placebo and which are treatment.
So what are the FDA rules and regulations for this situation?
Is it some sort of honor system where the data is accessible but no one looks at it? That doesn't make any sense.
Is the data color coded somehow so that the sponsor can look at some data but is easily able to avoid looking at the parts that reveal blinding?
So I think our discussion is moot as Cytodyn's CD12 RO situation, like many human trials before, has already been structured by the FDA.
I just wonder what that structure is.
It may be that trial progress blinding is regulated more by financial regulations from the SEC than by FDA regulations.
But I doubt that.
CCR5 covid is a totally new and original concept for medicine.
If CD12 misses on the primary endpoint and I am an FDA reviewer I would look at the absence of support for the new, original MOA from the CD12 data package as just incredibly unbelievable.
The other thing I don't understand is the FDA protocol for data access in clinical trials. As you point out in your post:
"Clinical trials are double blinded for good reasons. Scientific rigor and the removal of doubt that investigators are influencing the outcome. Performing RO tests without FDA endorsement, would be monumentally stupid. It would essentially be cheating."
I agree with you that it seems like "blinded" means that nobody knows the real time progress of a trial towards its endpoint.
But is this an actual structural implementation or merely some sort of unwritten rule enforced by some sort of unwritten gentlemens agreement?
For example, I believe we know with 100% certainty that Patterson was running RO on CD12 and CD10 patients at the beginning of those trials.
Was CYDY running unauthorized tests?
I doubt it.
Was it the FDA's intention to prevent RO tests for the purpose of maintaining blinding?
No chance whatsoever!!!
CCR5 antagonism is a totally new, totally original theory of medicine.
No chance on earth that the FDA would purposely not examine the primary feature of this totally new theory in a totally new disease. No chance whatsoever.
In my opinion, our discussion here on this thread on this message board as to blinding has already been mooted by actual laws, rules, and regulations that govern the maintenance of human clinical trial data.
Either CYDY has an electronic copy of all CD12 patient records, including any RO tests, or CYDY does not.
This disposition is a matter of law and/or regulation.
The FDA has already anticipated this situation and has executed laws, rules, and regulations for this exact situation.
For example, every cancer trial has clinical data on the progression of the cancer like xrays and mris. some of the medicines that people take for cancer are dangerous and need to be monitored for safety. So for many cancer trials the level of the medicine needs to be monitored in the bloodstream. In this obvious case, if you have access to the medical records you know which patients are placebo and which are treatment.
So what are the FDA rules and regulations for this situation?
Is it some sort of honor system where the data is accessible but no one looks at it? That doesn't make any sense.
Is the data color coded somehow so that the sponsor can look at some data but is easily able to avoid looking at the parts that reveal blinding?
So I think our discussion is moot as Cytodyn's CD12 RO situation, like many human trials before, has already been structured by the FDA.
I just wonder what that structure is.
It may be that trial progress blinding is regulated more by financial regulations from the SEC than by FDA regulations.
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