Replies to post #209345 on Cytodyn Inc (CYDY)

[justdafactss]

Why exactly did CYDY (ahem) "volunteer" to remove 100's of press releases dating back at least several years to the present?

[theswordman]

So after paying for $$$ Christine Corrado videos CYDY trashed on their own?? That sure seems like a waste of shareholder $$

[Chuckles759]

I honestly think it is part of the "Cultural Revolution" ongoing at CytoDyn.

All things "NP" are slowly being erased from existence.

There only remain a few "NP" tainted aspects to be dealt with.....

....I'm half expecting a PR that Mahoob is coming back. I really do need to find out what happened when his dog ran away when he was SEVEN years old...then I can finally sleep....

[HyGro]

Well it is quite the coincidence that all the old press releases disappeared the same day that the following notice was posted prominently on the CYDY website:

"IMPORTANT CORRECTION OF INVESTIGATIONAL DRUG INFORMATION
On February 11, 2022, CytoDyn, Inc. received a Warning Letter from the U.S. Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion in which FDA asserted that statements made in a video created a misleading impression regarding the safety and efficacy of leronlimab. Leronlimab is an investigational drug that has not been approved (or authorized) by the U.S. FDA for the treatment of COVID-19 or for any indication. For more information, click here to access a Dear Healthcare Provider (DHCP) Letter: View Here."

Many of the press releases had boiler plate statement about LL's CoV trials that were false and misleading.

[that_little_voice]

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.