IS THIS TRUE?...from SA I pm’d a number of yo
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Posted On: 01/21/2021 9:26:11 AM
IS THIS TRUE?...from SA
I pm’d a number of you about this...publicly people on this board took Nader’s side...and suddenly Bruce Patterson who was lionized became a hack that didn’t know what he was talking about...so...IS THIS CORRECT yes or no?
Some more details care of Dr. Patterson on twitter regarding the HIV BLA delay:
twitter.com/...
"Personally and knowing the FDA from the Maraviroc and Vicriviroc trials in the early 2000’s, I think they have questions about the tropism assay that qualifies a patient for CCR5 therapy. Tropism assays are highly variable and confounding."
And in response, "misiu 143" tweeted:
"When combo study was going on , there was no Receptor Occupancy Test .
It started sometimes second part of mono study...Why FDA is asking for it in combo after all this time , no one will know...IMO"
WHOA! I didn't know all this! These paint a whole DIFFERENT picture -- IF accurate. I mean, the tropism assay was NECESSARY to insure that the subject would, in fact, be susceptible to CCR5 blockade. So NOW Patterson is DISSING those assays as "highly variable and confounding"? Is that the problem that needs to be addressed? If correct, that could be a really BIG problem -- capable of overturning the entire trial.
And then the "misiu" tweet implies the issue is with the receptor occupancy test. That is just a means to determine the extent to which sufficient receptors are occupied so they will induce a significant decrease in viral load. Now with maraviroc, it was determined that "receptor occupancy close to the maximum is required to induce a significant decrease in viral load":
www.ncbi.nlm.nih.gov/...
And Cytodyn didn't even START to measure occupancy until SOME time in the mono trial? That sounds like it could take a LOT of work AND time if they need to make up the difference.
I pm’d a number of you about this...publicly people on this board took Nader’s side...and suddenly Bruce Patterson who was lionized became a hack that didn’t know what he was talking about...so...IS THIS CORRECT yes or no?
Some more details care of Dr. Patterson on twitter regarding the HIV BLA delay:
twitter.com/...
"Personally and knowing the FDA from the Maraviroc and Vicriviroc trials in the early 2000’s, I think they have questions about the tropism assay that qualifies a patient for CCR5 therapy. Tropism assays are highly variable and confounding."
And in response, "misiu 143" tweeted:
"When combo study was going on , there was no Receptor Occupancy Test .
It started sometimes second part of mono study...Why FDA is asking for it in combo after all this time , no one will know...IMO"
WHOA! I didn't know all this! These paint a whole DIFFERENT picture -- IF accurate. I mean, the tropism assay was NECESSARY to insure that the subject would, in fact, be susceptible to CCR5 blockade. So NOW Patterson is DISSING those assays as "highly variable and confounding"? Is that the problem that needs to be addressed? If correct, that could be a really BIG problem -- capable of overturning the entire trial.
And then the "misiu" tweet implies the issue is with the receptor occupancy test. That is just a means to determine the extent to which sufficient receptors are occupied so they will induce a significant decrease in viral load. Now with maraviroc, it was determined that "receptor occupancy close to the maximum is required to induce a significant decrease in viral load":
www.ncbi.nlm.nih.gov/...
And Cytodyn didn't even START to measure occupancy until SOME time in the mono trial? That sounds like it could take a LOT of work AND time if they need to make up the difference.
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