Purpose: Clarify the legal status of EUA Medical Countermeasures (MCMs) Pursuant to Section 564 of the FD&C Act, as amended by PAHPRA, 2013, and the Supremacy Clause of the United States Constitution (Article VI, Clause 2), EUA MCMs have potentially been exempted from testing using Good Laboratory Practices, Good Clinical Practice, including informed consent, and from being assessed to determine if Risk Evaluation and Mitigation Strategies (REMS) are necessary.
This is so well written. I would propose that this be in the package insert for all EUA products until they are abolished forever. Doctors and pharmacists should be required to read this aloud to the recipient before administering or recommending one of these substances. Perhaps states could consider adding that as a requirement as we work to dismantle this system.
The facts as laid out here are essentially a revolutionary text akin to "Common Sense" and widespread knowledge of this would lead to a collapse of confidence in our governing institutions. Under the false auspices of these rules, they could liquify ham sandwich and inject it into you with total immunity.
"Trust us" is the entire basis for the EUA system.
New FDA final rule in the national registry just went into effect 3 days ago allowing for clinical trial research/experiments without informed consent on all humans regardless of age, health etc.
I’ve read the whole thing. It indicates that no informed consent needed however I can’t find anything that would prevent opting out by informing our healthcare providers to cease and desist in any and all clinical medical research/experiments upon our person(s) without our express written consent. This new final rule is really horrific. Sasha can you help to break this down and tear this apart and get word out about this. Thank you so much 🙏
Thank you so much, Sasha! You are a hero to humanity! I have been in the IRB (Institutional Review Board) industry within academia, for 21-years. I have been wondering whether this (nefarious) 'biological product' is actually a 'combination product' (a device, a software, a biologic, and a DNA-changer). God bless you!
"In summary, the process through which the EUA products enter interstate commerce and claims about their safety, efficacy or contents are based solely on the HHS Secretary opinion, which requires no supporting scientific evidence. Misrepresentation of safety, efficacy or contents of EUA products is allowed by federal law. Thus, claims provided by the federal health authorities or manufacturers cannot be considered reliable sources of information. "
This is genious!
Ask the question " What reliable information do you have that supports your theory that these countermeasures are safe and effective?" of your provider. They will probably give you an answer that will allow you to assert a claim of "enticement to commit suicide or gross bodily harm".
In any event, they cannot posssibly provide informed consent and any coercive action at all is unreasonable under the circumstances.
This summary is phenomenal, super clear. For those with short attention spans or who learn visually, would you consider adding a few of your most excellent charts to this package of points?
Thank you ever so much from the bottom of my heart for posting this this information is invaluable. Yes, I have followed all of this from the beginning, but to have this in a format, that we can present to the school or your employer is invaluable. Blessings always for all the good that you do🦋💕🦋
Great synopsis and very well documented. I would add the following introductory sentences:
"This document reveals the extraordinary loophole that has been created in US medical laws and rules to allow COVID-19 "vaccines" to be produced, distributed and administered without following Good Laboratory Practices, Good Clinical Practice, Good Manufacturing Practices, informed consent, and without being scientifically assessed via clinical trials to determine if Risk Evaluation and Mitigation Strategies are needed. In other words, all normal safety procedures that were originally established to protect Americans from harmful drugs have been avoided in Operation Warp Speed."
Sasha a per usual you bring the Receipts. Fresh Hell. Now what? Do our best to disengage from the system and fight back. We must be Brave and Courageous. Knowledge is power. Thank u for all your hard work and effort. This Evil Surrounds us but we must not despair. Your continued contributions are so appreciated. Knowledge is power. Spelling will be their downfall. Thank you as always for the enlightenment.
You continue to amaze. I am deeply grateful there are talented, knowledgeable professionals like yourself willing to explain this incredibly convoluted criminality to people like me.
Thank you, Sasha. This fits in with my opinion that no one should ever be authorized to declare a so-called ‘emergency’. We all now know why they do it, and the results of same.
Brilliant. Thanks. Sadly, every institution in the West (especially the US Axis powers) is so hopelessly corrupt and anti-Human that one can expect NO justice for the people within its borders. ...And, we were told the Soviet Union was evil.. They were kindergardners compared to our Ruling Psychopathy.
This is for those to use in their "legal fiction" capacity - who are and choose to be in contract with legislative democracies at all levels (local to fed) - none of the "govt" entities listed curently operate as Republican forms of government - they are all registered corporations and do not follow the original Constitution. When you live in the private - you are not in contract with them
This is so well written. I would propose that this be in the package insert for all EUA products until they are abolished forever. Doctors and pharmacists should be required to read this aloud to the recipient before administering or recommending one of these substances. Perhaps states could consider adding that as a requirement as we work to dismantle this system.
The facts as laid out here are essentially a revolutionary text akin to "Common Sense" and widespread knowledge of this would lead to a collapse of confidence in our governing institutions. Under the false auspices of these rules, they could liquify ham sandwich and inject it into you with total immunity.
"Trust us" is the entire basis for the EUA system.
New FDA final rule in the national registry just went into effect 3 days ago allowing for clinical trial research/experiments without informed consent on all humans regardless of age, health etc.
https://www.govinfo.gov/content/pkg/FR-2023-12-21/pdf/2023-27935.pdf
I’ve read the whole thing. It indicates that no informed consent needed however I can’t find anything that would prevent opting out by informing our healthcare providers to cease and desist in any and all clinical medical research/experiments upon our person(s) without our express written consent. This new final rule is really horrific. Sasha can you help to break this down and tear this apart and get word out about this. Thank you so much 🙏
Thank you so much, Sasha! You are a hero to humanity! I have been in the IRB (Institutional Review Board) industry within academia, for 21-years. I have been wondering whether this (nefarious) 'biological product' is actually a 'combination product' (a device, a software, a biologic, and a DNA-changer). God bless you!
Lovely painting, Sasha. The roses seem to glow from within. Thanks for sharing it.
(I appreciate the EUA memo, too)
"In summary, the process through which the EUA products enter interstate commerce and claims about their safety, efficacy or contents are based solely on the HHS Secretary opinion, which requires no supporting scientific evidence. Misrepresentation of safety, efficacy or contents of EUA products is allowed by federal law. Thus, claims provided by the federal health authorities or manufacturers cannot be considered reliable sources of information. "
This is genious!
Ask the question " What reliable information do you have that supports your theory that these countermeasures are safe and effective?" of your provider. They will probably give you an answer that will allow you to assert a claim of "enticement to commit suicide or gross bodily harm".
In any event, they cannot posssibly provide informed consent and any coercive action at all is unreasonable under the circumstances.
This summary is phenomenal, super clear. For those with short attention spans or who learn visually, would you consider adding a few of your most excellent charts to this package of points?
You presented some excellent charts in your discussion here (https://sashalatypova.substack.com/p/full-recording-of-the-briefing-with). I took a few screen shots and printed them for my own use.
Or consider these three:
1. https://drive.proton.me/urls/JKHS9D1BPC#NnmyGu2ZweQQ - slide 12
2. From https://sashalatypova.substack.com/p/do-fentanyl-dealers-violate-cgxp
2a: https://substackcdn.com/image/fetch/f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2Fac535065-fbe5-4b4f-8287-5c44e7b14602_3993x2355.png
2b: https://substackcdn.com/image/fetch/f_auto,q_auto:good,fl_progressive:steep/https%3A%2F%2Fsubstack-post-media.s3.amazonaws.com%2Fpublic%2Fimages%2Fd28f4f62-7736-4ebb-9c2e-c4af9633378f_1601x958.png
❣️❣️❣️Love, love, love the roses! 🌹🌹🌹🌹
Thank you ever so much from the bottom of my heart for posting this this information is invaluable. Yes, I have followed all of this from the beginning, but to have this in a format, that we can present to the school or your employer is invaluable. Blessings always for all the good that you do🦋💕🦋
Great synopsis and very well documented. I would add the following introductory sentences:
"This document reveals the extraordinary loophole that has been created in US medical laws and rules to allow COVID-19 "vaccines" to be produced, distributed and administered without following Good Laboratory Practices, Good Clinical Practice, Good Manufacturing Practices, informed consent, and without being scientifically assessed via clinical trials to determine if Risk Evaluation and Mitigation Strategies are needed. In other words, all normal safety procedures that were originally established to protect Americans from harmful drugs have been avoided in Operation Warp Speed."
Sasha a per usual you bring the Receipts. Fresh Hell. Now what? Do our best to disengage from the system and fight back. We must be Brave and Courageous. Knowledge is power. Thank u for all your hard work and effort. This Evil Surrounds us but we must not despair. Your continued contributions are so appreciated. Knowledge is power. Spelling will be their downfall. Thank you as always for the enlightenment.
Looking at #11, they can put literally anything they want to put in the vial.
You continue to amaze. I am deeply grateful there are talented, knowledgeable professionals like yourself willing to explain this incredibly convoluted criminality to people like me.
Beautiful roses!
Thank you, Sasha. This fits in with my opinion that no one should ever be authorized to declare a so-called ‘emergency’. We all now know why they do it, and the results of same.
Brilliant. Thanks. Sadly, every institution in the West (especially the US Axis powers) is so hopelessly corrupt and anti-Human that one can expect NO justice for the people within its borders. ...And, we were told the Soviet Union was evil.. They were kindergardners compared to our Ruling Psychopathy.
Well rounded synopsis. Too bad my state legislators only read fascist fiction.
This is for those to use in their "legal fiction" capacity - who are and choose to be in contract with legislative democracies at all levels (local to fed) - none of the "govt" entities listed curently operate as Republican forms of government - they are all registered corporations and do not follow the original Constitution. When you live in the private - you are not in contract with them
all related parties definitely need this thrust before their faces. even if they feign ignorance or believe their own b.s., they can't argue they didn't see it. amazing all the psychological defense mechanisms with these people... https://eccentrik.substack.com/p/so-many-are-still-in-denial-about?r=8ypo0&%3Butm_campaign=post&%3Butm_medium=web&%3BshowWelcome=true%20#vaccineinjuries%20#VaccineGenocide