Yes, that is exactly what they are saying. Take a look at the disclaimer at the top of the CYDY website.
"On February 11, 2022, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to CytoDyn, Inc.
(CytoDyn) regarding a video interview (video) with Dr. Nader Pourhassan (the former CEO of CytoDyn)
conducted by Proactive Media. FDA viewed the video, which was dated September 22, 2021, and was, at that
time, accessible via a link on the CytoDyn corporate website,as including statements that represented CytoDyn’s
investigational drug, leronlimab, as safe and effective for the treatment of COVID-19 . Leronlimab has not been
approved or authorized by FDA for any indication, and the video has been removed from CytoDyn’s website"
We are posting this letter on our website at the request of FDA’s Office of Prescription Drug Promotion (OPDP).]
Claims identified in the FDA Warning Letter (underlined emphasis added)
• “In the United States, we did a trial of 394 patients which included severe and critically-ill population. In
the critically-ill population, our results were really strong. . .”
• “Our critically-ill population that we did in the United States when we gave a dose of leronlimab, the
survival rate was 78%. Once we gave them another dose, the survival rate went up to 82%.”
• “Imagine, if 78% went to 82, the next one would be maybe 88, and then 95. I am making up numbers, but
if it goes to that kind of numbers, if it just follows the same pattern what we learned, this is going to be
the most fantastic results anybody could ever imagined to have. Now I’m not saying that’s what we’re
going to get, but I’m saying that’s what the results are showing.”
• “The primary endpoint...is the discharge, the rate of patients who get on ventilator and get discharged.
]FDA notified CytoDyn of the Agency’s view that the claims cited above suggested that leronlimab had been
established as safe and effective for the treatment of COVID-19. FDA expressed additional concerns that the
video mischaracterized the clinical trial data for leronlimab in the treatment of COVID-19. On May 17, 2021,[/b
FDA issued a statement1 regarding the results of the leronlimab trial that CytoDyn conducted in patients with
severe COVID-19 disease (CD12), expressing its views that the data currently available do not support the
clinical benefit of leronlimab for the treatment of COVID-19. This letter clarifies that leronlimab is an
investigational new drug, for which the product’s indication(s), warnings, precautions, adverse reactions, and
dosage and administration have not been established
Signed by Antonios acting CEO.
This argument is now closed.
