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Andreas Kalcker's avatar

Thank you for the article. The issue arises when regulatory bodies such as the FDA, EPA, Swissmedic, and others officially issue warnings against a substance, as has happened with chlorine dioxide. In these situations, medical associations may revoke physicians' licenses. For research purposes, approval from an ethics committee is required to use CDS. To obtain this approval, you must present preclinical in vitro studies demonstrating non-toxicity. After that, a research protocol must be developed. Once the ethics committee approves it, a multicenter study (conducted at multiple sites) can be organized, allowing a team of doctors to legally work with chlorine dioxide solution—saving lives.

However, you now need a GMP-licensed manufacturer to produce your CDS with substances whose origin can be traced at every stage. This manufacturer must have pharmaceutical-approved machinery to produce chlorine dioxide solution. Before the GMP manufacturer can provide you with a pilot product, they must prove the shelf life of the substance, which takes another year. You cannot use fast-track methods involving heat because chlorine dioxide is a volatile gas, and if you use MMS, chemical reactions will occur. Once all this is completed, your pilot batch must be correctly labeled with lot numbers, and you must retain a sample of each lot. Once done you have to go thru customs of ech country and inform your medical regulatory body ( FDA, EPA, etc.) and get aprooval in some countries.

By following these steps, you can legally conduct a clinical trial with CDS, provided you distinguish it from MMS (Miracle Mineral Solution), address regulatory concerns with robust safety data, and maintain compliance with international standards (e.g., ICH Good Clinical Practice). Early engagement with regulators (e.g., FDA pre-IND meeting) is recommended to clarify requirements and overcome CDS’s controversial reputation.

Preclinical Studies: Added in vivo studies and pharmacodynamics to meet regulatory requirements for IND/CTA submissions.

Regulatory Submission: Included IND (FDA) and CTA (EMA/Swissmedic) applications, specifying required components like CMC and clinical protocol.

Ethics Committee: Specified informed consent, liability insurance, and DSMB, which are mandatory for approval.

GMP Manufacturing: Clarified stability testing, analytical methods, and batch documentation while keeping it concise.

Trial Registration: Added mandatory registration in public databases (e.g., ClinicalTrials.gov, EudraCT).

Customs: Streamlined to focus on import permits and local compliance for multicenter trials.

Trial Execution: Included adverse event reporting, interim analysis, and DSMB oversight.

Regulatory Strategy: Emphasized distinguishing CDS from MMS and engaging regulators early to address stigma.

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Unapologetically Me's avatar

Do you know the work of Dr. Tulio Simoncini?

This Italian oncologist spent 5.5 years in an Italian prison after being found culpable of "manslaughter" after the death of a cancer patient in 2011.

He treated this patient with bicarbonate of soda.

https://youtu.be/Ou81Lj-52ps

Dr. Simoncini died in May of 2024, shortly after serving his entire sentence.

Meanwhile: Thousands of oncologists "treat" cancer patients with toxic chemotherapy drugs, afterwhich their patients die, however none are ever charged with 'manslaughter' as far as I know?

I posit the theory that had Dr. Simoncini treated this Stage 4 cancer (written off) patient with "gold standard" oncology drugs rather than his innovative treatment? He would NOT have been charged with manslaughter after his patient died...

I'm not sure I'd choose to attempt to open an alternative cancer care clinic in Italy.

Just saying...

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