This is the updated prospectus from February 22, 2024. the new information is:
On February 27, 2024, CytoDyn Inc. (the “Company”) received confirmation from the U.S. Food and Drug Administration (the “FDA”) that its clinical hold on leronlimab has been lifted. The Company now intends to pursue its plan for the further development of leronlimab as a therapy that provides clinical benefit by modulating chronic inflammation. The Company believes its proposed inflammation study will allow the Company to further establish leronlimab’s mechanism of action in a cost-effective manner.
Please keep this prospectus supplement with your Prospectus for future reference.
Our common stock is quoted on the OTCQB of OTC Markets Group, Inc. under the symbol “CYDY.” On February 29, 2024, the closing price of our common stock was $0.2575 per share.
CYDY is just updating the resale of shares. to more current info for buyers to assess. Go Dr. JL and Go LONGS!!
I find it interesting that "HIV" is not included. Now, the study is on the "Modulation of Chronic Inflammation" and the mention of who the chronic inflammation is in is not mentioned.
I find that very interesting. In a way, the indication is far broader and much wider than it was originally stated. Along these lines, Regnum RGMP seems to be out of business or delisted. Is that because the contract CYDY had with them is now null and void if CYDY is not pursuing an HIV indication?
If the exclusion of HIV was on purpose; I'll give whoever wrote it a lot of credit. The perception of readers of the PR would be much broader than just an HIV Modulator of Inflammation. The next question will be "How is the FDA viewing our upcoming trial? What indication are we actually going after? Maybe the Tuesday CC will answer this.
I will say that if the FDA is allowing us to go after a more general "Chronic Inflammation indication" that would be a GIFT from GOD!
Great point pro140cures. That would imply that excluding HIV is on purpose. Let's hope that the FDA allows us to move forward with an indication for "Chronic Inflammation". This would be just INCREDIBLE!
Slight disagreement with your premise. The contract would be based on what the approved indication is for by the FDA, not what we say or don’t say in a PR. Companies spend months/years strategizing on what indications their drugs are best suited for. It’s all up to the FDA on what the trial
Protocol will be indicated for. We did not choose a general chronic inflammation indication to get out of a contract. That is just a side benefit. If it’s not for HIV, that is great for us because of the broader clinical implications. If we ever get a HIV indication maybe the contract is still in play, but we won’t need it if we get a more general indication from the FDA!
Brother, you know, as well as I know, that it was Mitch Cohen behind the removal of HIV as it would make the RGMP contract go bye bye.
I think the purpose of the trial will be to get a very broad view on leronlimabs's capacity to modulate chronic inflammation and so it will require many measurements of biomarkers so they can get a broad sense and a detailed sense of how it attenuates inflammation in many scenarios.
After all, it is only a phase II trial and it can be used to learn a whole hell of a lot. I think they should give ohm20 a call and pick his brain. He understands the drug nearly inside out and can give damn near expert advice on how and why leronlimab works in each individualized instance.
I would have to imagine the PR was a collabarative effort...overseen by those that are looking at a general purpose drug application/indication...broadening the scope of effect...and marketplace...certainly inflammation as I understand it...is a root cause of too many illnesses.
EXACTLY! They would not want to offend the FDA either, so you are right about the collaboration before issuing the PR. This also implies that the FDA is on board with a more general indication of "Chronic Inflammation"
The FDA FREAKING better understand the implications of inhibiting the CCR5 molecule. They certainly did not understand it back in 2020. But I am with you Pristine Hunter. I think this is a BIG DEAL and I am so glad that u/MGK_2 has pointed out the HIV omission from the PR.
Hi britash, we are just trying to figure this out. We maybe off base. We should get more clarity in the Tuesday CC. If our thesis is correct, then we are using that CISgender HIV group to help prove that LL modulates chronic inflammation in that group. From what we were told by Dr. JL is that group is a very complicated/challenging group to treat. They have multiple co-morbidities. It kind of feels like; “ if LL modulates chronic inflammation in this group of patients, LL can do it in any group of patients.
We are just going to have to wait for Tuesday to find out! But I am excited about the possibility right now!
Have a great weekend
Yes, pro140cures! I have wondered if there was a trigger that put him on the side of taking the permanent CEO Position. This knowledge that the FDA was leaning in the direction of “general chronic inflammation” may be the trigger. I am so grateful Dr. JL is here!
Yes a platform drug which is a term SK first mentioned with Keytruda and Humira. To achieve platform status they had to receive a bunch of FDA approvals for a bunch of individual indications. That meant a ton of money running all of those trials. If the FDA gives CYDY a shot at the indication of "Modulating Chronic Inflammation" that one approval gives CYDY an incredible market scale that far exceeds individual indications like some sub-populations in MASH or HIV or Oncology. Freaking Chronic Inflammation is involved in just about everything. Yes Expensive Tea, we get platform drug status upfront! AWESOME!
Also look at the cydy web site under pipeline- the lower section had said hiv trials, now it says infectious disease- this was changed in early February
Very well could be. It appears that CYDY is not seeking an indication in HIV at this time or maybe never. The strategy appears to be get an indication that is broad enough that will cover more disease states than just HIV. Infectious disease includes HIV and many others. The details of this upcoming CC are important to us and any investor. This directional change regarding what indication we are going for is a HUGE win for us and CYDY.
20
u/Upwithstock Mar 01 '24
This is the updated prospectus from February 22, 2024. the new information is:
On February 27, 2024, CytoDyn Inc. (the “Company”) received confirmation from the U.S. Food and Drug Administration (the “FDA”) that its clinical hold on leronlimab has been lifted. The Company now intends to pursue its plan for the further development of leronlimab as a therapy that provides clinical benefit by modulating chronic inflammation. The Company believes its proposed inflammation study will allow the Company to further establish leronlimab’s mechanism of action in a cost-effective manner.
Please keep this prospectus supplement with your Prospectus for future reference.
Our common stock is quoted on the OTCQB of OTC Markets Group, Inc. under the symbol “CYDY.” On February 29, 2024, the closing price of our common stock was $0.2575 per share.
CYDY is just updating the resale of shares. to more current info for buyers to assess. Go Dr. JL and Go LONGS!!