Sasha Latypova and Katherine Watt have put together a timeline of FDA meetings showing that the FDA issued their approval based on data that was collected for non-investigational use of non-experimental product (EUA countermeasure).
I wrote about this topic here, and we are continuing to compile the research on this issue. As we knew before, the “clinical trials” were a sham and the BLA approval from the FDA is also a sham. We have been able to piece together a more solid evidence from changes to pharmaceutical and other relevant law, and put together a timeline that demonstrates that Poison-19 is a “non-investigational, unapproved” product, aka an illicit drug, poison or weapon trafficked across state lines and internationally by the DOD lead government-pharma cartel.
Pharma companies started on a presumably proper BLA pathway by opening Investigational New Drug applications (exemption for investigational clinical trial use of experimental biologics) in April 2020, then, by October 2020 they switched to the EUA Countermeasures pathway. The EUA pathway is “non investigational”, i.e. no clinical trials are possible for it in compliance with FDA regulations of clinical research.
Brook Jackson observed and documented fraud in Pfizer trials because all of it was fraud. The FDA, pharmas and DOJ were all in on it and DOJ declined to prosecute, then Judge Truncale dismissed the case finding that knowledge of fraud, while not disputed, was immaterial to the FDA decision to approve. That’s correct. Fraud was the essential part of this campaign to intentionally deploy this poisonous, cell transfecting, immune system destroying substance on millions of people – getting “access” to millions of subjects in an illegal medical experiment without consent. The criminals behind this – USG/DOD/FDA/Pharmas knew they will kill and injure millions of people world wide and did not care at all. They planned and prepared for it.
More detailed summaries of this will be coming shortly.
- Nov. 4, 2023 – Do C-19 Vax Manufacturers Violate cGxP? (Sasha Latypova)
- Nov. 7, 2023 – Sasha Latypova and Katherine Watt talking about non-regulation of non-medicines. (Link to Rumble video, 38 min)
- Nov. 8, 2023 – FDA “Approval” for Covid-19 Vaccines Was Fake – based non-investigational use of a non-experimental unapproved substance (a poison) (Sasha Latypova)
US Code, Title 21, Food and Drugs, Chapter 9, Federal Food Drug and Cosmetics Act (FDCA).
Notes include title/topic and year passed by US Congress,1 signed by US Presidents. Most provisions have been amended many times since 1997 when the foundation was laid.
- 21 USC 360bbb = FDCA Section 561, Expanded access to unapproved therapies and diagnostics. Added 1997.
- 21 USC 360bbb-0 = FDCA Section 561A, Expanded access policy required for investigational drugs. Added 2016.
- 21 USC 360bbb-0a = FDCA Section 561B, Investigational drugs for use by eligible patients. Added 2018.
- 21 USC 360bbb-1 = FDCA Section 562, Dispute resolution. Added 1997.
- 21 USC 360bbb-2 = FDCA Section 563, Classification of products. Added 1997.
- 21 USC 360bbb-3 = FDCA Section 564, Authorization for medical products for use in emergencies [Legal conditions governing product manufacturing] – “…the use of such product…shall not be considered to constitute a clinical investigation…” Added 2003.
- 21 USC 360bbb-3a = FDCA 564A, Emergency use of medical products. [Legal conditions governing product use.] Added 2013.
- 21 USC 360bbb-3b = FDCA 564B, Products held for emergency use. [Legal conditions governing product stockpiling and “introduction into interstate commerce.” Added 2013.
- 21 USC 360bbb-3c = [Enacted as part of PL 115-92; not entered into the FDCA], Expedited development and review of medical products for emergency uses. Added 2017.
- 21 USC 360bbb-4 = FDCA 565, Countermeasure development, review and technical assistance. Added 2006.
- 21 USC 360bbb-4a = FDCA 565A, Priority review to encourage treatments for agents that present national security threats. Added 2016.
- 21 USC 360bbb-4b = FDCA 565B, Medical countermeasures master files. Added 2019.
- 21 USC 360bbb-5 = FDCA 566, Critical Path Public-Private Partnerships. Added 2007.
- 21 USC 360bbb-5a = FDCA 566A, Emerging Technology Program. Added 2022.
- 21 USC 360bbb-6 = FDCA 567, Risk communication. Added 2007.
- 21 USC 360bbb-7 = FDCA 568, Notification. Added 2012.
- 21 USC 360bbb-8 = FDCA 569, Consultation with external experts on rare diseases, targeted therapies, and genetic targeting of treatments. Added 2012.
- 21 USC 360bbb-8a = FDCA 569A, Optimizing global clinical trials. Added 2012.
- 21 USC 360bbb-8b = FDCA 569B, Use of clinical investigation data from outside the United States. Added 2012.
- 21 USC 360bbb-8c = FDCA 569C, Patient participation in medical product discussion. Added 2012.
- 21 USC 360bbb-8d = FDCA 569D, Notification, nondistribution, and recall of controlled substances. Added 2018.
FDA Legal Preparedness Slide Decks (partial list)
- 2012.10.12 Courtney FDA Legal Preparedness MCM EUA
- 2014.06.06 Sadove Courtney FDA Whats New MCM and EUA Post-PAHPRA
- 2016.09.16 FDA Sadove MCM
- 2018.02.13 Courtney FDA MCM EUA
- 2020.08.25 Sadove FDA CDC Regulatory Updates Use of MCMs Table p. 18
Related Bailiwick reporting and analysis:
- April 25, 2022 – The investigational drugs that weren’t.
- June 9, 2022 – COVID-19 injectable bioweapons as case study in legalized, government-operated domestic bioterrorism.
- Nov. 22, 2022 – Stopping conditions.
- Feb. 7, 2023 – D4CE presentation video – Doctors4Covid Ethics. Katherine Watt (36 p. slide deck presentation, 75 min).
- Feb. 9, 2023 – On the significance of 21 USC 360bbb-3(k): “use” of EUA products “shall not constitute clinical investigation.”