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"Lead me in your truth"- An interview with Sasha Latypova
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Sasha Latypova holds a graduate degree in business from Dartmouth College and is a retired pharmaceutical industry, research and development executive with 25 years of experience in conducting clinical trials.
In this episode, we discuss the following:
- Sasha did not work for a pharmaceutical company, she contracted to pharma companies. She conducted clinical trials in imaging, and later in cardiovascular safety monitoring. Most companies now outsource their clinical trials to contractors, like Sasha. So, Sasha was responsible for being in compliance to the regulators at all times, when conducting these trials. She is aware of all the regulations.
- Sasha retired from her work in the pharmaceutical industry before the Covid19 period began. We discuss why she became interested in the Covid situation, both the early treatment and the new vaccines.
- Sasha first became suspicious when the public health officials started to suppress hydroxychloroquine, as she had experience with this drug. They tried to smear this drug with cardiovascular arrythmia, which she was familiar with in her previous work. She knew for sure that hydroxychloroquine did not have that problem, especially when take for a short time frame, as it was for Covid.
- She was the first to notice the batch variability of Covid vaccine adverse events in VAERS. Sasha collaborated with Craig Paardekooper on the website “How bad is my batch”. She knew right away that these products were not Good Manufacturing compliant. This was her conclusion by October 2021. She wrote letters to the CDC and FDA about this. Senator Johnson brought this data to the attention of the CDC and FDA also. The CDC and FDA never did anything.
- At the end of 2021, Mike Yeadon sent Sasha a package of leaked documents from the EMA, about 800 pages worth, and a dozen emails between the regulators (EMA, MHRA, FDA). This package was actually leaked around Nov 30, 2020. It was clear from these documents, that this drug product was substandard, and the worse product she had ever seen. The bulk of the documents were from EMA regulators themselves.
- Sasha tells us the number one thing that the regulators have to approve is the manufacturing. If you can’t manufacture, then safety and efficacy doesn’t matter. And yet all the scientists and doctors are focussing on safety and efficacy and no one is looking at manufacturing. The EMA documents showed evidence that the EMA regulators had raised 100 major objections to the approval of the Pfizer product.
- An example of an objection. Pfizer had provided no evidence they were making the spike protein. And, we later learnt they faked the Western Blots, which was an assay to characterise the spike protein. It was a computer generated fake.
- Sasha shows us the 3 drug approval pathways that are relevant to the approval of the vaccines in the USA. The normal FDA regulatory pathway for market approval. The Expanded Access Use pathway. The Emergency Use Authorisation pathway, and she explains the differences. There was a lot of confusion, and many people thought the Emergency Use Authorisation (EUA) was in fact the Expanded Use pathway, but they are very different.
- The EUA comes under a brand new paragraph of the Food, Drug and Cosmetic Act, called Paragraph 564.
EUA countermeasures can only be issued when the HHS has declared a public health emergency. And they are designated as non investigational. And so none of the laws that normally apply to drugs apply to these countermeasures. EG No IRB (investigational review board), no informed consent for recipients, and good manufacturing practise is not enforced. The only criteria needed, is that the HHS secretary thinks they may be effective.
- For an in depth explanation of the legal framework, there is a good video of Sasha and Katherine Watt (the US para legal who worked with Sasha), explaining all the legal codes that were put in place in the USA, in the years preceding 2020. Sasha explains it took 3 years to unravel all the legal codes around this.
See reference below.
- Sasha shows us the transcript of a meeting, in which Doran Fink (deputy director of Vaccines and Related Biological Products Advisory Committee (VRBPAC) in the FDA, on Oct 22, 2020, stated that the FDA decided to use the EUA pathway rather then the expanded access use for approval of the Covid vaccines. And the reason was that expanded use required IRB and informed consent. That would add complexity. See Reference below.
- Doran Fink is now at Moderna.
- Sasha shows us the Pfizer timeline, showing the activity in terms of approvals etc from March 2020 through to Dec 2024. She points out that Doran Fink says they switched to EUA in Oct 2020, but she believes that in fact the switch happened in July 2020 as that is when Pfizer began mass producing the 30 million doses for the rollout. And, as we discuss, this was before phase 3 even started and before FDA approval of the product . That would have been illegal under IND.
- In addition, the formula for the product was changed 5/6 times during the phase 3 trial ie they changed which drug they were testing. This was found in the 1100 page protocol document.
- The FDA issued a BLA (Biologics License Application) in August 2021. So everyone thought the Pfizer vaccine was fully approved. But Sasha shows us the BLA letter, and it references the 2 Pfizer clinical trials, the Phase1/2 trial and the phase 3 trial, which were NOT clinical trials. So the BLA is fake, its illegal and the FDA is certifying the fraud. That’s why there are 2 products, but in the USA they never shipped the Comirnaty product , only the EUA product (Biontech).
- Sasha explains that as long as the PREP Act is in place, these products “will not be deemed adulterated or misbranded”, and shows us the excerpt from the US code. This is why there is no enforcement of good manufacturing practise.
- We discuss the involvement of the US Department of Defence. The DOD is the CEO of the operation , is totally in charge, and HHS has only an advisory role. The money all came from the DOD.
- Sasha reveals that she has an audio of a discussion at a pharma company regarding a phone call that they received on Feb 4, 2020 from DOD. The DOD told them on that day, to switch from pan influenza (they were part of the P3 consortium) to Covid as Covid had been classified as a national security threat. See references.
- What is the Pandemic Preparedness Program (P3), which was started in 2017. The person in charge of P3 is Colonel Matt Hepburn, and he is the mastermind. He has published TED talks on P3, and has claimed we can predict viruses and we will make vaccines in hours.
- We ask Sasha who she thinks is behind the release of the virus and the injections.
Websites referenced in the Interview;
- Sasha Latypova’s Substack, which is called Due Diligence and Art.
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