Update: FDA Petition, FDA Finds DNA, AUS Criminal Brief
.. a happier New Year?
good Substack Folk,
welcome to 2025 .. five years almost to the day when a false pandemic was declared and forced onto the entire planet, in preparation for the rollout of undisclosed gene therapies and GMOs
Folk .. we have remained busy throughout the holiday season .. we hope you managed to find some quality time with friends and family
.. this is a longish one, too long for your email, so best click the title and head on over to substack for the full thing
now .. the first cab off the rank
FDA Citizen Petition
together with Kevin McKernan, Dr Jessica Rose, Dr David Speicher, and Maria Gutschi, i drafted a detailed Citizen Petition that was filed with the FDA on 20 January by Katie Ashby-Koppens of PJ O’Brien & Associates
.. you can download a copy below or go to the US Regulations.Gov page HERE
the Petition presents just two grounds as the basis for seeking the FDA suspend or revoke the approvals given to the Covid-19 products of Pfizer and Moderna ..
.. let me break-down the first ground
the Environmental Assessments (EAs)
some will ask ..
“How could EAs have effected the approval process for the Pfizer and Moderna products?”
well, good Folk, when you read the entire Petition you will see that any company or individual who seeks a US agency approve something for them (like the FDA) - in this case the Covid-19 (non) vaccines - everyone has to include in their application an Environmental Assessment that speaks to whether .. if the application is granted .. that their product (or activity) will have no adverse impacts upon the environment
.. and the Environment includes Human Health .. the human environment
when it came to the Biologics License Applications (BLAs) submitted by Pfizer and Moderna in 2020 for their Covid-19 products, both companies were required to include EAs pursuant to US law 25 CFR 21.15(a)
.. but Pfizer and Moderna did not do that .. instead, they claimed a Categorical Exclusion from having to submit EAs
and here is the problem - the FDA said “Sure, you guys don’t need to submit EAs .. come on in for a coffee”
and the problem for the FDA - the FDA illegally and wrongly said Pfizer and Moderna did not have to submit EAs
at all times Pfizer and Moderna were required by law to submit EAs
and the grounds upon which the FDA said they didn’t
were false
and knowingly false
.. in other less-kind words .. the FDA went out of its way - illegally - to assist Pfizer and Moderna from having to submit EAs
returning to the question: “So what’s the big deal?”
had Pfizer and Moderna submitted Environmental Assessments as required by law, the contents of their EAs would have clearly disclosed - and effectively admitted - that their Covid-19 products always met the FDA’s own Guidance for being properly deemed Gene Therapies .. meaning, NOT vaccines .. but Gene Therapies
Dr Maryanne Demasi covered this critical issue in her recent substack article on our Citizen Petition, noting
and just like a GMO drug has to undergo extensive risk assessment and invite public submissions in Australia, it is the same-same for Gene Therapies in the US
first ..
instead of the FDA’s rubber-stamping Vaccines and Related Biological Products Advisory Committee (VRBPAC) reviewing the Covid-19 products for approval (which is what happened), the proper committee would and should have been the Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC)
.. just like Pfizer and Moderna should have gone first to our Gene Technology Regulator and in turn before our Gene Technology Technical Advisory Committee (GTTAC) here in Australia .. but didn’t .. corruptly
second ..
had Pfizer and Moderna properly and lawfully had their EA materials considered by the Cellular, Tissue and Gene Therapies Advisory Committee, then the CTGTAC would have been required by US law to open-up a period to receive public submissions and comments about the products
.. and yes good Folk, that means
(a) despite seeking approvals under EUAs (emergency use authorizations), the CTGTAC process would have required many months, meaning they would have deliberated on whether to approve the products, or not, well into 2021 .. likely Q2 of 2021 .. and
(b) the whole World would have learned the Covid-19 products of Pfizer and Moderna were and are Gene Therapies, and via what would have likely been 100s if not 1,000s of public submissions, would have learned that their products were not only experimental, but as seen in countless studies using modRNA-LNPs leading up to 2020, they were also deadly
yep .. deadly
so you can see why the FDA wrongfully, improperly, and illegally agreed that Pfizer and Moderna could claim Categorical Exclusions from having to submit EAs, because if the FDA didn’t
the cat would have been out of the bag
.. the public would have learned they were really being ‘asked’ to receive
gene therapies
with an established history of significant deaths
.. and failed efficacy
and
this information alone meant
approvals for the drugs would likely not have been granted
[[.. an important aside: in Australia our legal definitions require calling them GMOs instead of Gene Therapies ]]
so you can see Pfizer and Moderna had everything to lose if their buddies at the FDA did not play ball and illegally agree that Categorical Exclusions could be claimed
.. and we kind of know those in the FDA responsible for this illegal action knew that what they were doing was .. well, a fraud on the people and their own President at the time (Trump) .. because they kept this particular issue of the Categorical Exclusion hidden from everybody in 2020, and only made it known due to .. you know, the agency being ‘transparent’ .. when in late 2021 they released summaries of their approval processes for each of Pfizer and Moderna
.. nearly a whole year after illegally and intentionally having the wrong rubber-stamping committee approve these genetic poisons
mission accomplished FDA, because by late 2021 the ill-gotten billions were in everyone’s bank accounts, and the deadly poisons in the bodies of most Folk
yet despite this collusion by the FDA to conceal the true nature of these genetic poisons from everyone, and their getting the damned things rubber-stamped and into most everyone’s cells, just because Pfizer and Moderna did receive approval does not in any respect mean those approvals are valid at law .. quite the contrary
an administrative decision by a government department that was required
by law
to receive and consider information critical to evaluating the risks to human health
is not a legally valid decision
when the information for evaluating the risks to human health
was never received
.. it means, at law, that the approval decisions were void ab initio
or void from the beginning
meaning
those 2020 EUA approvals mean nothing
meaning
the Covid-19 products of Pfizer and Moderna
have always been illegally in the marketplace
because they never received legally valid approvals
ouch FDA .. you did a naughty naughty thing
this first ground of the Citizen Petition requires the new FDA Commissioner or their superior, the new Secretary for Health and Human Services to suspend or revoke the bogus approvals granted to Pfizer and Moderna, and immediately recall the products from the marketplace
.. and after last night’s Committee vote in favour of RFK Jr. (Bobby) we all have a good idea of who the next new Secretary of HHS is likely going to be
while even more helpfully .. we know several Folk who know Bobby well enough to personally present the Citizen Petition to him .. and that has occurred, from several directions
now for the second ground ..
Excessive DNA Contamination
readers who have been following our efforts here on Jules On The Beach know a lot of the back story of now 9 independent labs confirming excessive synthetic DNA contamination in the Pfizer and Moderna Covid-19 products, and the recent revelations and evidence we organised to be presented to the Australian Prime Minister confirming the same contamination within the blood of Australians
.. the Citizen Petition goes into the details of all those separate lab findings, and summarises how this contamination only represents .. essentially .. an existential threat .. and is otherwise an illegal contaminate
there has occurred and continues to occur
a genetic poisoning of Humanity
.. and it must stop
the Petition with legal precision breaks down everything the FDA Commissioner or Secretary of HHS needs to know for immediately suspending the products and initiating all required investigations
.. the synthetic DNA contamination details are in the Petition which I won’t repeat here, except for the section speaking on the known harms consequent upon synthetic DNA poisoning
.. as for the Turbo Cancers everyone has been talking about, the good Dr Ah Kahn Syed .. a’la Arkmedic .. covered the whole topic with his usual blend of expertise and salient honesty just a few days ago
.. you, the Public - from anywhere in the World - can lodge submissions in support of our Petition via the Comment button seen at the upper left HERE .. or just click-on the image
so far 232 supporting submissions/Comments have filed, though only 6 can be viewed .. Katie Ashby-Koppens followed-up with the FD yesterday requesting an extended period for Comments and for all 232+ Comments/supporting submissions filed to date, to be made publicly accessible
.. next .. and we have
FDA Lab Confirms DNA Contamination
.. as Hoody & Johnny Larter would say: “You just can’t make this stuff up”
yes Folks, a few days after my 23 December substack where we told you about this synthetic DNA contamination being confirmed in the blood of Australians, which Russell Broadbent MP immediately conveyed to the Prime Minister .. there came then the peer-reviewed paper by Wang et al 2024
.. the superlative Maryanne Demasi broke the story on 3 January
.. the nub of the story and the Wang paper breaks down to this
the study, A rapid detection method of replication-competent plasmid DNA from COVID-19 mRNA vaccines for quality control, authored by three students supervised by senior FDA scientists and conducted in the FDA’s White Oak lab, analysed vials of Pfizer's Covid-19 product
unsurprising to many here
the findings confirmed synthetic DNA contamination at levels between 6 and 470 times above the regulatory safety threshold
yep .. FDA scientists .. FDA lab .. peer-reviewed results
and yet .. the FDA had the gall to distance itself from the findings
because ..
“Not FDA”
.. only FDA supervised
.. that is how stupid the FDA thinks we are
agan .. “You just can’t make this stuff up”
the ever expert and most helpful Kevin McKernan reviewed the findings of the Wang et al paper, taking everyone through just how well these smart High Schoolers did
.. and that is where we are at Folks .. 2025 and High School kids are now proving this excessive contamination as part of a school exercise
but the TGA, FDA, EMA, and MHRA just haven’t been able to get a single one of their 1,000s of PhD scientists into a lab to do the same .. why not?
it’s not your health they are concerned about
after all, billions are already poisoned
no .. its all about legal liabilities on national scales
unprecedented payouts
and what we can all expect will be historical strains on health systems
having to deal with lots of SV40 related cancers and genetic diseases
anyhoo, it is what it damn well is .. another conclusive finding .. this time brought to you by the FDA, no less
which lands us properly at the last Update item .. and appropriately
Australian Criminal Brief Against Pfizer & Moderna
many here will recall we have had a few goes at this .. not due to any shortcomings on our part, but because
(a) Australia’s Attorney-General Mark Dreyfus refused to reply .. not even a Hello
containing this Criminal Brief for the Attorney-General
which we later updated with further information on the synthetic DNA contamination ..
but .. after Mark gave us and Australians the cold shoulder, we then went to the Australian Federal Police
(b) however .. someone inside or outside the Australian Federal Police told them to tell us “Nothing to see here .. bugger off” .. a polite example of trying to cover-up the involvement of Australia’s Gene Technology Regulator in the serious criminal offences of Pfizer and Moderna dealing with their products here without GMO licenses
.. so then
(c) we then presented the same Criminal Brief to our Commonwealth Director of Public Prosecutions (CDPP)
and surprise surprise
.. the CDPP returned the Brief
.. but not while saying our evidence was no good, or that our allegations were rubbish
.. no, just that we had not presented our evidence and allegations ‘in the right form’
i kid you not ..
.. this is me spit-balling the real thoughts of the CDPP
“Mate, we’re not saying your evidence is sh*t
but basically
we are being leaned on from up-high to have nothing to do with you
.. Mate, your evidence could bring the whole government down, and the government before them ..
but we at the CDPP don’t want to be implicated in perverting the course of justice so we are just going delay matters a little
and hand you back your Brief
and ask you nicely
please place it in “the proper form”
.. so good Folks, that is what we have done .. with the expertise of former senior criminal prosecutor, and the fellow whose name is on the door of PJ O’Brien & Associates no less, Mr PJ O’Brien himself
to wit .. a little before Christmas and Katie Ashby-Koppens delivered the following Criminal Brief back to the CDPP .. Ralene Sharp KC .. now in “the proper form”
and the CDPP have cordially acknowledge receipt of same and have been mulling over its contents ever since
..
…
yes, some of you will ask why .. when we started presenting this Criminal Brief information back in October of 2023, why we didn’t get it back to the CDPP “in proper form” earlier than December 2024?
.. because so much damn new evidence has kept on coming in, not least of which was the Australian contamination report from Dr David Speicher, and the several other lab studies confirming similar contamination in other countries
so do forgive us .. but with a lot to present the CDPP precisely and what with all the other fronts of activity you have seen us and see us operating on, we did what we could
anyhoo, the CDPP now has eyes on the Criminal Brief and is considering it
.. we will let you know more when we know more
that’s all for now Folks
.. Thank You all for your continued support, it really does mean a bunch to us
Please share widely and Restack if you can