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Monday, July 28, 2025

‘COA-72 not approved by FDA for clinical trials for HIV’

The COA Research and Manufacturing Limited Company (COARMLC) has officially denied claims suggesting that its product, COA-72, is undergoing clinical trials as an anti-HIV drug.

According to the company, a widely circulated report published by the Daily Graphic on Wednesday, July 16, 2025, is inaccurate and does not reflect the facts presented during a recent visit by the Parliamentary Select Committee on Health to its facility.

In a statement signed by management and released on Monday, July 28, 2025, COARMLC described the media coverage as misleading and reiterated its commitment to scientific integrity, regulatory procedures, and honest communication with the Ghanaian public and international partners.

“The publication misrepresented our position. Nowhere did we state that COA-72 is in active clinical trials for HIV treatment,” the company emphasized. “We are compelled to issue this clarification to prevent the public from being misled and to reaffirm our integrity as a science-driven institution.”

The controversy arose from a working visit by the Parliamentary Select Committee on Health to COARMLC’s facility on Monday, July 14, 2025.

While the visit aimed to showcase the company’s ongoing research, COARMLC says the Daily Graphic article inaccurately suggested that COA-72 had entered official clinical trial stages.

Following the publication, COARMLC promptly contacted the Daily Graphic, which later issued a rejoinder published on Thursday, July 17, 2025.

The Food and Drugs Authority (FDA) Ghana also released a disclaimer confirming that no clinical trial on COA-72 for HIV treatment had been approved—further validating COARMLC’s position.

“We commend the FDA for their swift response in correcting the public narrative,” the company stated.

COARMLC further clarified that its founder and CEO, Samuel Ato Duncan had shared his long-standing vision of discovering a natural solution to HIV during the committee’s visit.

“On November 30, 2005, Duncan publicly committed to researching a natural cure for HIV. That vision has guided nearly two decades of plant-based pharmaceutical work,” the statement noted.

This research has led to the development of several products—including COA Mixture, COA Plus, COA-MT, and COA Capsules—but none of these, including COA-72, are currently approved for HIV treatment.

The company explained that COA-72 is a new formulation that has shown promising results in pre-clinical and internal studies. While early findings suggest potential antiviral and anticancer properties, COA-72 has not undergone formal, FDA-sanctioned clinical trials.

“At no time did we state that COA-72 is undergoing FDA-approved clinical trials. What we did do was introduce the product as a promising development and appeal for support to begin formal investigations,” the statement emphasized.

COARMLC estimates that if COA-72 proves successful through official trials, it could contribute as much as $76.8 billion annually to Ghana’s economy and create thousands of jobs.

In 2019, COARMLC formally applied to the FDA to initiate clinical trials on COA-72. The application was acknowledged through a letter dated October 29, 2019, referenced as FDA/SMC/CTD/CTA/19/0059.

The letter outlined the requirements for beginning clinical testing. However, the company has not yet fulfilled all conditions necessary for approval.

“Though preliminary studies—both local and international—have yielded encouraging results, such as reduced HIV viral loads and, in some cases, viral clearance, these must not be misconstrued as clinical evidence,” the company stressed.

“They do not replace the need for formal, FDA-approved clinical research.”

COARMLC reaffirmed its commitment to working within regulatory frameworks and with credible global institutions.

“We remain dedicated to working with the FDA, WHO, and accredited research institutions to advance COA-72 responsibly. Public trust and regulatory compliance are not optional—they are non-negotiable,” the company concluded.

COARMLC also expressed regret over any confusion caused by the misreporting and called for greater responsibility in health-related journalism.

Read the Full press release below:

COA-RMLC Sets the Record Straight on COA-72 Clinical Trials

The management of COA Research and Manufacturing Limited Company (COA-RMLC) wishes to clarify recent media reports regarding the status of COA-72, following a publication in the Daily Graphic on Wednesday, 16th July 2025, headlined: “COA-72 Undergoes Clinical Trials as Anti-HIV Drug.”

This statement aims to address the misinformation in the said article and reaffirm our unwavering commitment to scientific integrity, regulatory compliance, and transparent communication with the public.

On Monday, 14th July 2025, the Parliamentary Select Committee on Health paid a working visit to our facility. During this engagement, COARMLC management discussed ongoing research and development efforts. Unfortunately, subsequent media reportage inaccurately suggested that COA-72 is currently undergoing clinical trials for HIV treatment.

To address this, COARMLC contacted Daily Graphic, resulting in a rejoinder published on Thursday, 17th July 2025. We appreciate the Food and Drugs Authority (FDA) Ghana for issuing a public disclaimer that affirms no clinical trial involving COA-72 for HIV treatment has been approved, which aligns with our official position.

During the meeting, our Founder and CEO, Mr. Samuel Ato Duncan, shared his personal and professional journey, which continues to fuel our mission:

On November 30, 2005, Duncan publicly committed to pursuing a natural cure for HIV.

This commitment has led to extensive research in plant-based medicine and the development of key products including COA Mixture, COA Plus, COA-MT, and COA Capsules.

These products are not approved for HIV treatment, but the research behind them laid the foundation for the development of COA-72—a new formulation that early studies suggest may have antiviral and anticancer potential.

At no point during the visit did COARMLC claim that COA-72 was undergoing FDA-approved clinical trials. Instead, management took the opportunity to:

Introduce COA-72 as a promising product based on internal and collaborative research.

Emphasize the need for further rigorous scientific studies.

Appeal for support from government and institutions to begin formal clinical trials, which require substantial resources.

COARMLC believes that if validated through clinical trials, COA-72 could contribute approximately $76.8 billion annually to Ghana’s economy and create thousands of jobs.

Regulatory Status Clarified

In 2019, COARMLC submitted a formal application to the FDA requesting approval to begin clinical trials on COA-72.

The FDA acknowledged this application via a letter dated October 29, 2019 (Ref: FDA/SMC/CTD/CTA/19/0059), titled: “Acknowledgement: Application for Anti-HIV/AIDS Clinical on COA-72.”

The letter outlined specific steps required to initiate the trial, including partnerships with accredited research institutions and adherence to international protocols.

As of today, COARMLC has not met all the FDA’s conditions to begin these trials.

Key Clarifications

COARMLC has never claimed that FDA approval has been granted for COA-72 clinical trials.

While pre-clinical and pilot studies have shown promise—including reduced HIV viral loads and, in some cases, complete viral clearance—these do not constitute formal clinical evidence.

The company remains committed to scientific, ethical, and regulatory standards at all stages of product development.

Our Commitment Moving Forward

COARMLC remains dedicated to:

Fulfilling all regulatory requirements as outlined by the FDA, WHO, and other global health bodies.

Collaborating with qualified stakeholders to secure funding and support for formal clinical trials.

Engaging in transparent, respectful communication with the public and global health community.

We regret any confusion the media coverage may have caused and trust that this statement provides clarity on the status of COA-72.

COARMLC remains focused on responsibly advancing plant-based medicine for public health and national development.

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