PRESS RELEASE: Open letter to TGA and FDA

OPEN LETTER: THE ABSURDITY OF SILENCE
TO:
Dr. Robert Califf, Commissioner of the FDA (USA)
Professor Anthony Lawler, Head of the TGA (Australia)
CC:
The Hon. Robert F. Kennedy Jr.
The Hon. Mark Butler MP
Global Media Outlets
DATE: February 5, 2026
SUBJECT: The Absurdity of Your Silence in the Face of 20 Million Deaths
Commissioners,
I am writing this because the situation has passed beyond bureaucratic inefficiency into the realm of the absurd.
Cardiovascular disease (CVD) is the single largest killer on the planet. It kills 20 million people a year. That’s the same as 690 fully loaded jumbo jets crashing every week with no survivors.
If a single lettuce leaf is found with E. coli, your agencies launch a nationwide recall within hours. If one Jumbo Jet crashes, the world stops until the cause is found.
Yet, when presented with a treatment (Cavadex) that is reversing atherosclerosis, halting amputations, and dissolving plaque in peer-reviewed case studies—your response is not investigation. It is silence.
THIS IS ABSURD.
You have the manpower to seize my shipments at the border. You have the resources to aggressively attack me. You have the time to block a starch-based product that holds GRAS (Generally Recognized As Safe) status. You allow this exact molecule (Cyclodextrin) to be injected into billions of people as an inactive ingredient in vaccines because it is safe. Yet when we use it to strip cholesterol from arteries to save lives, you treat it as a threat. Where is the logic?

But you do not have the time to pick up the phone?
Why have you not contacted me? Why is there no curiosity?
I am offering you the solution to the world’s biggest health problem.
• We have the science: Peer-reviewed papers from multiple scientists.
• We have the data: Patient scans showing 80% blockages reduced to 25% within months.
• We have the outcomes: Vascular surgeons cancelling amputations because circulation was restored after weeks of use.
• We have your own people: Staff within the FDA actually buy and use Cavadex themselves because they know it works.
The science is undeniable. The stakes are huge. Why isn’t this being investigated?
It is intellectually dishonest and morally bankrupt to claim you are “protecting the public” by blocking a product that is saving them, while offering them nothing but the same failed standard of care that sees 2,500 Americans die today, and another 2,500 tomorrow.
I AM NOT ASKING FOR A FAVOR. I AM ISSUING A CHALLENGE.
I am challenging the FDA and TGA to do your jobs:
1. Form a Rapid Response Team immediately.
2. Take the patients you have given up on—the ones scheduled for amputation, the ones with inoperable angina.
3. Give them Cavadex for 3 months.
If I am wrong, you lose nothing but a few boxes of starch.
If I am right “and the data proves I am” we can turn heart disease around in 18 months.
I am happy to hand over all the science, including patient scans and outcomes. I am not interested in financial reward; I just want to get back to my life in AI and quantum mechanics. But I cannot walk away when I know I am holding the fire extinguisher while the world burns.
The silence from your offices is deafening. It is time to wake up. Stop blocking the solution and start investigating the results.
My phone is on. I am waiting for the call that saves millions.
Sincerely,
Kyle Hodgetts
Founder, Cavadex

Media Contacts:

Name: Kyle HodgettsCompany: Cholrem - CavadexEmail: Phone: +61424830574

About Cholrem - Cavadex

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Cholrem Pty Ltd is an Australian pharmaceutical research company dedicated to advancing cyclodextrin-based therapies for the treatment of atherosclerotic cardiovascular disease.