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Julian Gillespie's avatar

thank you Dr Demasi,

I also reviewed the legislative steps that Moderna had taken in respect of this approval, and the legislation in place as to whether or not this new incoming team of Kennedy, Bhattacharya, Makary, and Prasad could have done anything different, knowing as we all do their deep seated oppositions towards this modRNA drug platform - which all here know has killed and maimed millions

short answer is this - Moderna had lodged their application for this approval way back in September 2024 - before the new Trump administration - so all of the legislative machinery in place at that time (September 2024) applied to this approval, irrespective of recent statements from Prasad and Makary about a new regime of clinical trials 'to be adopted' for drugs targeted at the generally healthy

the language of recent statements is important and needs to be wighed with the changes in US legislation that need to be made to make those statements into new law

.. on 30 April 2025 the HHS stated that “all new vaccines will undergo safety testing in placebo-controlled trials prior to licensure”

.. note "new"

on 20 May FDA leadership published a New England Journal of Medicine perspective stating any new COVID-19 vaccine “must now be evaluated in placebo-controlled studies” for healthy people under 65

.. note "now" .. meaning, from May 2025

so for this application lodged last September, the FDA applied the pre-existing framework to mNEXSPIKE .. and as Dr Demasi points out, the final approval carved out aligns exactly with the new policy: mNEXSPIKE was licensed only for the high-risk populations - age ≥65 or 12–64 with underlying conditions - for whom FDA continued to rely on immunogenicity and comparative efficacy

so bound by pre-new-administration regulations, and keeping to the new policy, this approval was able to squeeze through the gate

and a final consideration of note - new FDA guidance is typically prospective, not retroactive - meaning again, applied moving forward from the date it is announced .. had the FDA sought, in some fashion, to retrospectively apply the new guidance and policy statements to this approval, then they would likely seen themselves carted off to court by Moderna to have a court point out this point of 'prospective' enforcement .. a battle the FDA in the absence of being able to include 'emergency' reasons for having done so, would have been unlikely to win

.. I will park the sundry emergency issues we could all point to .. Bobby et al do not need reminding, nor do I believe they will ever surrender those points .. they are just waiting for a better day to use them, with effect

returning to it ..

yes, many here like me hate that this approval squeezed through .. but the very real Leviathans which are the pharma infected FDA, CDC, and NIH cannot be tamed and brought under a new controlling force and influence after just a few short months of this new administration

much new legislation needs to be drawn for reform, and that reforming legislation needs to be passed by what still remains a largely Pharma owned Congress and Senate .. many corrupt Senators and Congressmen and Congresswomen need to be brought to heel first, to pass the laws Bobby Kennedy Jr and his team require for ousting the disease which is Pharma which infests the very corridors Bobby is meant to have authority over, but which he quite simply doesn't .. for now

despite the above reservations and caveats I still do not give this Moderna approval a pass due to one issue - the drug was approved once again as a 'vaccine' and not as a Gene Therapy

how long must this charade be maintained for?

recall, we set out the legal framework showing these products to be indisputably Gene Therapies by direct reference to the FDA's own guidance and laws, in our Citizen Petition we know Bobby and Jay have read and are pondering how to answer: https://www.regulations.gov/document/FDA-2025-P-0335-0001

Bobby and his team well know this 'new' product is not a vaccine, and like its Covid-19 pandemic predecessors, should have also been dealt with as a Gene Therapy application requiring a whole different suite of approval steps, let alone a battery of additional safety studies to be submitted by Moderna, well before final approval considerations could have begun

here again the same lie has been trotted out in everyone's face, to the readers here and abroad who again understandably feel their their intelligence has been insulted .. well, it has been .. that "gut punch"

for mine, though Bobby and Vinay and Marty could have finally ended this lethal lie using emergency powers to step-in and pause the approval, and require Moderna to go down the Gene Therapy pathway where it belonged, that would have come at huge political and economic costs

.. as had they done so a massive can of worms would have been opened in respect of the Covid era 'vaccines', with ramifications I will not go into detail here, but will say are ramifications that have global consequences not of a favourable kind .. being likely outcomes and consequences for having this Gene Therapy truth finally addressed, in respect of this drug platform, that many here would pause for and reflect upon

which is to say, though I abhor the continuation of this lethal fiction, addressing it without being very careful could also be lethal to innocent folk

sorry to be somewhat cryptic on this issue, but it is complex and is being dealt with carefully behind the scenes

and that really is the view and take away from this recent affair in the whole context of the Covid betrayal and all the falsehoods we had to bear .. undoing this great saga cannot be done overnight

many vested interests have made billions and can and do apply those profits to maintaining lies and fictions and keeping their next investments in the same space on safe keels

while the very act of transforming the US Congress and Senate to a state where it is no longer inhabited by countless corrupted representatives, paid well by big Pharma to block every legislative reform Bobby, Jay, Mary, and Vinay need to see, for restoring the FDA and CDC to the People .. and as a guiding beacon for the globe

.. well .. that will be one of the historic feats of MAGA/MAHA we have to simply remain in our seats for, to see happen

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Crevvie's avatar

So the upshot is - more people are going to be killed!

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