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Home » ‘COA-72 not approved by FDA for HIV clinical trials’ – Manufacturer corrects misleading reports

‘COA-72 not approved by FDA for HIV clinical trials’ – Manufacturer corrects misleading reports

johnmahamaBy johnmahamaJuly 30, 2025 Ministerial News No Comments4 Mins Read
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COA Research and Manufacturing Limited Company (COARMLC) has refuted claims suggesting that its product, COA-72, is undergoing clinical trials as an anti-HIV drug.

The company says the widely circulated report, published by the Daily Graphic on Wednesday, July 16, 2025, was inaccurate and did not reflect the facts shared during a recent visit by the Parliamentary Select Committee on Health to its facilities.

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 upholding scientific truth, regulatory procedures, and honest communication with the Ghanaian public and global partners.

“The publication misrepresented our position. Nowhere did we state that COA-72 is in active clinical trials for HIV treatment,” the company stressed. “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 stems from a working visit by the Parliamentary Select Committee on Health to COARMLC’s facilities on Monday, July 14, 2025.

While the engagement was meant to showcase ongoing research initiatives, COARMLC says a Daily Graphic article wrongly interpreted the interaction to suggest that COA-72 had entered official clinical trial stages.

Following the publication, COARMLC promptly contacted Daily Graphic, leading to a rejoinder published on Thursday, July 17, 2025.

The Food and Drugs Authority (FDA) Ghana also stepped in, issuing 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 statement read.

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

“On November 30, 2005, Mr. Duncan publicly committed to researching a natural cure for HIV. That dream has informed nearly two decades of plant-based pharmaceutical work,” the company explained.

This research has birthed several products: COA Mixture, COA Plus, COA-MT, and COA Capsules, but none of these, nor COA-72, are currently approved for HIV treatment.

COARMLC said COA-72 is a new formulation that has shown encouraging potential in pre-clinical and internal studies.

According to the company, COA-72 may possess antiviral and anticancer properties, but it has not entered 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 emphasised.

The company 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 via a letter dated October 29, 2019, under reference FDA/SMC/CTD/CTA/19/0059, which outlined the prerequisites for initiating clinical testing. However, the company has yet to meet all the conditions required to proceed.

“Though preliminary studies, both local and international, have yielded promising results such as HIV viral load reduction and, in some cases, viral clearance, these outcomes must not be misconstrued as clinical evidence,” COARMLC said. “They do not replace the need for formal FDA-approved clinical research.”

Reaffirming its commitment, COARMLC stressed that it is aligned with all regulatory bodies and international best practices. “We remain dedicated to working with the FDA, WHO, and qualified research institutions to advance COA-72 responsibly. Public trust and regulatory compliance are not optional; they are non-negotiable,” the company concluded.

COARMLC expressed regret over any public confusion caused by the misreporting and called for responsible journalism moving forward.

DISCLAIMER: The Views, Comments, Opinions, Contributions and Statements made by Readers and Contributors on this platform do not necessarily represent the views or policy of Multimedia Group Limited.

DISCLAIMER: The Views, Comments, Opinions, Contributions and Statements made by Readers and Contributors on this platform do not necessarily represent the views or policy of Multimedia Group Limited.



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