Reading the 2006 FDA Guidance for Industry: Gene Therapy Clinical Trials – Observing Subjects for Delayed Adverse Events today: https://ngvbcc.org/pdf/gtclin.pdf
Interesting possibility - the mass PCR Covid testing program was not intended for diagnostic purposes. It’s the biodistribution part of the ‘real world evidence’ DOD/Pfizer/HHS study on the spike protein and other components of the SARS-CoV-2 virus and the injections, both of which are gene-manipulation products in reality (although not legally, so long as FDA classified them as ‘vaccines’, see bullet point 2 in footnote 1, page 1.)
See p. 9: “If it is unknown whether your vector persists, for the purpose of assessing risk, we recommend that you either assume that it does persist, or perform a preclinical study to assay for vector persistence in a relevant animal species.
Please refer to Section IV.B, “Considerations for Preclinical Study Design to Assess Vector Biodistribution and Persistence,” for help with preclinical trial design and details on the use and expected sensitivity of polymerase chain reaction (PCR) assay for biodistribution studies.
In assays performed after the final administration of vector, persistence is indicated by detectable levels of vector sequences above the threshold level in the PCR assay and absence of an apparent downward trend over several time points.
In contrast, persistence is unlikely if you cannot detect vector sequences with a sensitive PCR assay or if the assay for vector sequences demonstrates a downward trend over time.
We encourage you to consult with OCTGT, CBER for specific advice about determination of persistence and biodistribution in your test system.”
Perhaps the “test system” is construed — for purposes of the SARS-CoV-2 test — as the human population, taken as a single biological organism.
May 26, 2022·edited May 26, 2022Liked by Katherine Watt
Nice. Always, that catchall term for "everything good for security purposes"="countermeasures." And our hard-earned taxes are paying for these measures intended to enslave us. Or murder us.
No one - NO ONE - will ever be held accountable for these crimes. Don't think for a moment that Big Pharma, and the U.S. Empire, and not thought through all potential legal challenges, and concocted strategies to counter them. We are up against powerful people who own all of government, all media, all law enforcement, all entertainment, basically everything. We will not be able to stop them using the system they have devised to protect themselves. We are on our own.
Implications of 10 USC 2371b, the federal contracting provision cited by Pfizer
Horrific. More evidence our corrupt government wants us dead.
More great work Katherine. Research is your wheelhouse. Everyone has their niche and this appears to be yours.
Reading the 2006 FDA Guidance for Industry: Gene Therapy Clinical Trials – Observing Subjects for Delayed Adverse Events today: https://ngvbcc.org/pdf/gtclin.pdf
Interesting possibility - the mass PCR Covid testing program was not intended for diagnostic purposes. It’s the biodistribution part of the ‘real world evidence’ DOD/Pfizer/HHS study on the spike protein and other components of the SARS-CoV-2 virus and the injections, both of which are gene-manipulation products in reality (although not legally, so long as FDA classified them as ‘vaccines’, see bullet point 2 in footnote 1, page 1.)
See p. 9: “If it is unknown whether your vector persists, for the purpose of assessing risk, we recommend that you either assume that it does persist, or perform a preclinical study to assay for vector persistence in a relevant animal species.
Please refer to Section IV.B, “Considerations for Preclinical Study Design to Assess Vector Biodistribution and Persistence,” for help with preclinical trial design and details on the use and expected sensitivity of polymerase chain reaction (PCR) assay for biodistribution studies.
In assays performed after the final administration of vector, persistence is indicated by detectable levels of vector sequences above the threshold level in the PCR assay and absence of an apparent downward trend over several time points.
In contrast, persistence is unlikely if you cannot detect vector sequences with a sensitive PCR assay or if the assay for vector sequences demonstrates a downward trend over time.
We encourage you to consult with OCTGT, CBER for specific advice about determination of persistence and biodistribution in your test system.”
Perhaps the “test system” is construed — for purposes of the SARS-CoV-2 test — as the human population, taken as a single biological organism.
Nice. Always, that catchall term for "everything good for security purposes"="countermeasures." And our hard-earned taxes are paying for these measures intended to enslave us. Or murder us.
Keep turning those rocks and exposing the vermin underneath!
No one - NO ONE - will ever be held accountable for these crimes. Don't think for a moment that Big Pharma, and the U.S. Empire, and not thought through all potential legal challenges, and concocted strategies to counter them. We are up against powerful people who own all of government, all media, all law enforcement, all entertainment, basically everything. We will not be able to stop them using the system they have devised to protect themselves. We are on our own.
Pharma are good at closing legal loopholes against them, in advance.
These people are evil in the extreme.
This research is really amazing. Impressive work.