The Second Door

We find ourselves in the New Phase. We can know we are in it, and we do know for sure. It has been told us. We just haven't realized it yet. Its real and its coming to fruition is panning out.

The problem behind much of this is that CCR5 is still being uncovered and discovered. Yes, we know by ohm20's huge list, about the great potential, but it hasn't been proven yet. Little by little, a little more is discovered it seems each and every day, but there is only one CCR5 blockade out there, and it has many adverse side effects, and it is only a partial allosteric blockade. That time when CCR5 blockade is tried and true is close, proximal, but it is not 100% here, it hasn't yet fully arrived and hasn't been tested hardly at all, other than in HIV, some cases of cancer, covid, MASH and you know all the others.... CytoDyn is the main company, taking the steps necessary, and getting ready to lead the way in the art of CCR5 blockade.

Here is what we know. In order for CytoDyn to deliver leronlimab to the world, it needs to be one day approved. This means that the enemies of CytoDyn, those that want to block the CCR5 blockade awaking, need to go home. Does this second hold surprise anyone? The fact that CytoDyn was issued a second hold, is it surprising to anyone? I guess initially, when I first heard it, I was surprised, but now, I say to myself, "What else is new?" Everything but the kitchen sink has been thrown against this blockade in an effort to thwart its power, but, when I took a second look at this second block, I see it as the second door.

So, what am I looking for now? The lift of the second hold. This whole entire adventure has been about the overcoming of our enemies, has it not? What is the next step in the process of overcoming our enemies? Getting the hold lifted completely. This entire charade has from day one, been about freeing CytoDyn up from the hinderance and distraction of their enemies thereby allowing them to continue freely to carry out its destined achievement of CCR5 blockade. What is that destiny? Leronlimab authorized.

The cold hard fact here is that CytoDyn doesn't stop till leronlimab is authorized. This is the overriding principle of CytoDyn which is to get the drug authorized and to remain afloat with its head above water until that is achieved. 2024 won't be the year of complete authorization, but the year becomes a means to the end. In like manner to how the original clinical hold was necessary to get us where we are right now, striving to get the second hold lifted. Remember the fact that Had it not been for the original clinical hold, CytoDyn would have completely wasted its every move and its every effort had it acted in any direction, given the shambles its house was in. Its house was in shamble, inadequate and not in order. Nothing would ever have been approved had CytoDyn continued without first addressing the items the first clinical hold forced CytoDyn to address primarily. The company was so far off the standard mark that any submission simply would have failed. So, the first clinical hold served to put CytoDyn down the proper path thereby saving the company from further waste. Really, it was the most direct path towards approval.

Now, the FDA throws another curve ball at CytoDyn, another hold, a second hold. So, accordingly, I ask how does this FDA move further along the FDA's goal in leading CytoDyn down the yellow brick road towards getting this CCR5 blockade authorized? How is this move capable of refining CytoDyn to becoming the kind of company that is within the crosshairs of what is necessary to compete in this playground that CCR5 blockade is capable of? So, we ask, what is the FDA requesting? CytoDyn is now refining the clinical protocol of this new Inflammation and Immune Activation in HIV transgender patients to the point, that the company achieves what no other pharmaceutical drug is capable of achieving for this generalized indication. This new protocol becomes a unique one to CytoDyn, and not just to CytoDyn, but, rather, it is unique in Big Pharma in general. It is also a unique protocol to leronlimab, because leronlimab has only been used against the disease itself, but, not in the reduction of Inflammation and certainly not in the reduction of Immune Activation. So, for the time being, this new indication might be something that no other drug could achieve, until drugs that block CCR5 as completely and as safely come along, which may be a long time from now. So, this is what the FDA wants from CytoDyn, this new clinical protocol, that will work the first time, a protocol that makes both the drug and the company stand out. Something, that sets the drug apart from all the rest. Something that makes it unique. This something is being designed and critiqued right now.

Once CytoDyn receives approval for this new clinical protocol, then, essentially, the second hold is also lifted. At that point, hopefully, the FDA imparts no further holds upon CytoDyn and allows them the full freedom to grasp and maneuver the reigns of their horse. So, getting to the point, the real reason for the second hold is to get CytoDyn to where they can fully operate the reigns of their horse. Maybe the Safety of the 1st clinical hold is akin to the Security of the 2nd hold. The first clinical hold proved out leronlimab's Safety while the second hold reinforces CytoDyn's capacity to Secure its Stability in the arena it is destined to play in. Leronlimab doesn't just fight disease, it puts at ease Immune Activation and quells Inflammation, thereby conquering disease secondarily. Inflammation & Immune Activation is its primary target.

When CytoDyn Stabilizes, it is Secure like it is already Safe, it is then when CytoDyn is at peace. All of this effort is wearing thin on CytoDyn. Yeah, we know CytoDyn is walking a fine line. Heck, the CEO is working for minimum wage. We are not even clear how the employees get paid. But the employees believe strongly and steadfastly in what they are doing. Otherwise, don't you think they would have walked out?

What happens when the FDA lifts the second hold? When, CytoDyn reaches the new goal of Stability and Security, as it has already reached Safety? How does CytoDyn build back up the team? Like I said, CytoDyn is down to maybe a team of 7-10. That is it. How do they pull off the coming trial? I suspect that some who have gone, might come back. That's what I think happens.

So now, CytoDyn prepares to take on CCR5 in a way no other can. The next crack at this, CytoDyn triumphs. This can be known because, the FDA will not lift the second hold until they are pleased with the new protocol. The FDA first needs something which is satisfactory, approvable, before it allows CytoDyn to squander away the few resources they have before the trial commences. They as well as CytoDyn both need to know that if leronlimab fires on all cylinders, does what it needs to do, then they want to know that there will be nothing else that could stand in the way and prevent or deny them from denying the advancement to a Phase III trial.

This is undeniable. This is how it is laid out. Although it appears like hold after hold, really, it is the FDA holding CytoDyn's hand in an effort to insure CytoDyn's advancement unto the next Phase. This is the manner; it is hard to deny. This is meant for the ultimate approval of leronlimab. This is what the FDA wants and is evidenced by the proceedings which CytoDyn is undergoing right now.

CytoDyn has been slowed down by the FDA for reasons which are known to help CytoDyn get leronlimab over the finish line on this next final drive. The finish line is in sight, but the path and the execution require a trial run on paper, practice makes perfect, and then clinically tested once paper proven. The trial only commences when all that shall be necessary for success and advancement, would be leronlimab's flawless execution which we can already count on. This is not only being done by the FDA, but it is also actively being done by CytoDyn so that they do not jeopardize the possibility of failing or of harming their own investors. This is how they have strategically figured this out. They don't tell us that though.

The new clinical protocol eliminates competition. When CytoDyn gets the second hold lifted, the competition has been eliminated. It is then only a matter of simply running the trial and we know how leronlimab executes. We can know that Safety, Security and Stability are found when the lift of the second hold happens, because we know already what leronlimab can do, which is reduce both Inflammation and Immune Activation. The clinical protocol becomes a resounding go. So then, it becomes only a matter of execution. Peace, Rest, Safety. This is the outcome I'm expecting.

I am nobody. I have no authority. Can't take my word for it. Draw your own conclusions. In an open forum, you can say whatever you want. Birds of a feather flock together. Thank you for hanging out here.