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Posted On: 03/19/2021 1:30:33 AM
Post# of 148908
BLA/LH - Dr. Bruce Patterson runs this:
https://covidlonghaulers.com/
https://twitter.com/brucep13
Jan.20, 2021
"You don’t think blaming the BLA delay on IncellDx’s RO assay, when we didn’t even run it in the combo trial and only a third of the mono trial, is bad? It is so critical in all CCR5 trials because of the variation in CCR5 level day to day.
"Thanks for the answer Bruce. I have never heard it said that clearly. It begs the question, why wasn't this done properly with the Combo trial then? Who did this responsibility ultimately fall on?
"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
"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.
Jan.15, 2021
@brucep13 could use your help understanding https://fda.gov/media/145128/download the potency assay document. Is the FDA suggesting that stat sig in CD12 is only part of what’s needed for an EUA and that potency assays need to be described, justified, qualified, and validated before approval?
Answer: "They are describing the basis and power of precision medicine and how diagnostics are needed in COVID to monitor effective therapy.
**************
"Elevated in 67% of long haulers - "The Chemokine MIP-1α/CCL3 impairs mouse hippocampal synaptic transmission, plasticity and memory. The reason why Maraviroc in LH has improved brain fog.
"New from http://COVIDlonghaulers.com. 79% of long haulers with brain fog have elevated VEGF which is reduced following Maraviroc.
"SARS-CoV-2 Is Not Detected in the Cerebrospinal Fluid of Encephalopathic COVID-19 Patients(But inflammatory mediators are.
"Maraviroc 300 mg twice a day as a PILL has done the same in keeping people out of the hospital.
"25% of long haulers have low CD8 and we are finding viral protein in long lived macrophages.
"a large percentage of long haulers don’t have antibodies but may have cell mediated immunity.
"Don’t underestimate cell-mediated (non-antibody) immunity. Cell-mediated immunity can still be protective but 2 patients in our study of hundreds have gotten reinfected.
"How do you distinguish between reinfection and re-emerging persistent virus? Sequencing!
"A high percentage of long haulers do not have antibodies!
"The first group of #longhaulers #longcovid we tested and treated are showing some incredible responses. This won't be an overnight recovery- we are looking at weeks to a few months but we have been floored by the initial responses to various medication combinations.
"Dammit, Janet"
https://covidlonghaulers.com/
https://twitter.com/brucep13
Jan.20, 2021
"You don’t think blaming the BLA delay on IncellDx’s RO assay, when we didn’t even run it in the combo trial and only a third of the mono trial, is bad? It is so critical in all CCR5 trials because of the variation in CCR5 level day to day.
"Thanks for the answer Bruce. I have never heard it said that clearly. It begs the question, why wasn't this done properly with the Combo trial then? Who did this responsibility ultimately fall on?
"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
"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.
Jan.15, 2021
@brucep13 could use your help understanding https://fda.gov/media/145128/download the potency assay document. Is the FDA suggesting that stat sig in CD12 is only part of what’s needed for an EUA and that potency assays need to be described, justified, qualified, and validated before approval?
Answer: "They are describing the basis and power of precision medicine and how diagnostics are needed in COVID to monitor effective therapy.
**************
"Elevated in 67% of long haulers - "The Chemokine MIP-1α/CCL3 impairs mouse hippocampal synaptic transmission, plasticity and memory. The reason why Maraviroc in LH has improved brain fog.
"New from http://COVIDlonghaulers.com. 79% of long haulers with brain fog have elevated VEGF which is reduced following Maraviroc.
"SARS-CoV-2 Is Not Detected in the Cerebrospinal Fluid of Encephalopathic COVID-19 Patients(But inflammatory mediators are.
"Maraviroc 300 mg twice a day as a PILL has done the same in keeping people out of the hospital.
"25% of long haulers have low CD8 and we are finding viral protein in long lived macrophages.
"a large percentage of long haulers don’t have antibodies but may have cell mediated immunity.
"Don’t underestimate cell-mediated (non-antibody) immunity. Cell-mediated immunity can still be protective but 2 patients in our study of hundreds have gotten reinfected.
"How do you distinguish between reinfection and re-emerging persistent virus? Sequencing!
"A high percentage of long haulers do not have antibodies!
"The first group of #longhaulers #longcovid we tested and treated are showing some incredible responses. This won't be an overnight recovery- we are looking at weeks to a few months but we have been floored by the initial responses to various medication combinations.
"Dammit, Janet"
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