https://bailiwicknews.substack.com/p/on-the-significance-of-21-usc-360bbb
If any FDA regulations had been legally operative, then the whole project would have been stopped by FDA long before human sham-trials could even begin.
Red flag stopping points showed up in the very earliest animal studies, one of which was conducted between July 16, 2020 and Sept. 24, 2020, concurrent with the sham human trials, and eventually provided by Pfizer/Acuitas/DOD to FDA in November 2020.
Another version was provided to Japanese regulators by February 2021, after mass rollout worldwide began in December 2020. It was subsequently translated into English and discussed by Byram Bridle in May 2021 reports and on Bret Weinsten’s June 2021 Darkhorse podcast, highlighting that the data showed the lipid nanoparticles (payloads unidentified) accumulate in rat organs, among other toxicity evidence.
…At this point in early Summer 2021, four facts became more widely understood among the community of people trying to understand the biotechnology, risks and benefits of the products marketed as ‘Covid-19 vaccines.’
1. The inflammatory lipid nanoparticles and their payloads collect in the ovaries and other key organs, are not rapidly cleared from the human body and are toxic.
2. Pfizer scientists knew this before seeking EUA approval from the FDA through the 11/20/2020 EUA application.
3. FDA scientists led by Marion Gruber knew this when authorizing the product for emergency use on 12/11/2020.
4. Pfizer, FDA and Gruber withheld this information from the public and knowingly lied each time they described the products as “safe and effective…”
The Pfizer-DOD death machine submitted the Wistar rat data to the fake FDA reviewers as part of the EUA package, including a document called “Phase 1/2/3, placebo-controlled, randomized, observer-blind, dose-finding study to evaluate the safety, tolerability, immunogenicity and efficacy of SARS-CoV-2 RNA vaccine candidates against Covid-19 in healthy individuals.”
In that sham “clinical trial” protocol at p. 72, Pfizer-DOD flatly stated that the “study” had not and would not assess pharmacokinetics, pharmacodynamics, biomarkers or genetics.
The aggregate evidence for the intent and function of 21 USC 360bbb-3(k) as a blanket waiver of the American drug regulation system to facilitate and pre-cover-up a covert, criminal bioweapons production and deployment program — can be summed up as “the dog that didn't bark.“