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Posted On: 10/31/2022 9:35:24 AM
Post# of 148899
I saw this last week and it is spot on
Perspective: Round-About Belly
All of us need to know the importance of the times and of the seasons.
Think about exactly what work has been done recently at CytoDyn. They received from Amarex data on various trials which amounted to the safety and effectiveness data on several trials. However, the data was not in the FDA approved format and therefore, the data had to be re-formatted and then it had to be aggregated to the satisfaction of the FDA. It had to be re-formatted in such a way and made presentable to the FDA so that it may become acceptable for admission on a re-submitted of the BLA for HIV. In addition, it had to be prepared for the purpose of getting the clinical hold lifted.
How many months has it been? CytoDyn closed the $6.5 Million Bond with David Welch in mid-March 2022. I don't have an exact date, but it was about 7.5 - 8 months ago. We obtained the raw, unformatted data from Amarex in April when the reformatting and aggregating work began.
2022 in no uncertain terms, was for CytoDyn hell. It could be considered a year the furnace flamed 7 times higher and CytoDyn was thrown into the furnace. 7 times $0.40 is $2.80. Someone knowingly turned the heat up 7 times for most of the longs in 2022 and it all started once Pourhassan left. The Judge ruled that CytoDyn had the right to the data, but that CytoDyn had to put up a $6.5 M bond, which, thanks to David Welch, CytoDyn did. About that time, the FDA placed a partial ban of Leronlimab on HIV and a full ban of Leronlimab on CoVid. A Warning Banner was placed on every one of CytoDyn's webpages and CytoDyn was forced to completely overhaul its website and eradicate any video on the web that had any reference to exaggerated statements or unverified statements by the FDA.
The company went into a drawn out mode of Silence. They wouldn't say a word. The share price fell to as low as $0.23 at one point for about a week or two and things got rather gloomy so as to speak, and to say that it was a hell hole, its not an exaggeration. It was a hellish 2022 and despite the long incubation, CytoDyn ain't out of the oven yet.
This is not to say that CytoDyn has not made incredible efforts to overcome the difficulty thrown its way over the past 3/4 year. Antonio Migliarese took the role as CEO in place of Nader and did a bang up job. Tanya Urbach relieved Scott Kelly of COB and continues as such. The company hires Cyrus Arman as interim President and is slated to be CEO by 1/9/2023.
Cyrus expands the board greatly and turns it into an Independent Board, rather than an Internal Board. Later, Internal Director Scott Kelly is taken off the board entirely and replaced by Independent Director Stephen Simes. Cyrus has his rear guard assembled and they await their command, but the master remains patient, as he plans his strike.
A tremendous Internal Effort has been levied and waged, by the company to properly format and aggregate this data. Dr. Chris Recknor, along with the CRO for Pharmacovigilance, both of whom, supervised and managed by internal project manager and senior director of clinical operations, Joe Meidling and CytoDyn's Vice President of Project Management, Bernie Cunningham. CytoDyn also has a regulatory consulting firm who helped with the preparation and review of the various regulatory communications to the FDA. A Reputable Consulting Firm led by former FDA regulators, that is the Regulatory Strategy Advising Group helps CytoDyn format and aggregate the data in accordance with FDA Type Good Clinical Practice Guidelines. This has been going on for nearly 9 months.
Like I've said in prior posts, this company is in labor. It is having travail and birthing pangs and the baby is on its way. CytoDyn is tough. She doesn't make a stink, nor cry out loud, but she hurts in pain while delivery approaches.
With all of these loose ends in play, Cyrus considers the field. Recently, the Investigator's Brochure along with the Integrated Summaries for Safety and Efficacy were submitted to the FDA. This can only mean one thing, and that is that CytoDyn is damn near close to completion in the aggregation and submission of all the data back to the FDA. Yesterday, Cyrus announced that the Annual Shareholders Meeting is on December 9, 2022. He states: "The matters to be presented for action at the Annual Meeting are (i) the election of five directors to our Board of Directors; (ii) ratification, on an advisory (non-binding) basis, of the appointment of our auditors; and (iii) approval, on an advisory (non-binding) basis, of our executive compensation. We may also act on such other business as may properly come before the Annual Meeting." From the day of this writing, it is about 5 weeks until the Annual Shareholder's Meeting. What such business may Properly come before then?
What is Cyrus expecting? I think he is expecting a baby. Is it only a baby or could it be twins? Could it even be triplets? Let's see, a baby would be that the Clinical Hold gets lifted. Twins would be that in addition to the Clinical Hold being lifted, it is also decided that the BLA for HIV be re-submitted. Triplets would be that in addition to the Twins being born, a Partnership is also signed and ratified. Is 12/9/22 a late date for this? That would mean that 9 months earlier, or 3/9/22, CytoDyn started its pregnancy and with all the shit Amarex has caused CytoDyn, the labor of pregnancy is an analogy not too far out on a limb to make.
Water is about to break. But CytoDyn hides its gestation. Nobody even knows that she is pregnant. Nobody knows that she is about to give birth. Nobody knows that she is about to go into labor and that her water is about to explode. What happens prior to a birth of a child? Daily, CytoDyn labors together with its mid-wife, the External FDA Type Good Clinical Practice Auditing Authority, aka, the Enforcer and, along with the Internal Audit Committee as well as Ryan Dunlap, who is CytoDyn's Independent Director on the Board head of the Audit Committee, all work daily, in unison, determining each and every move to make to satisfy the requirements discussed in the Type A and Type C meetings CytoDyn had with the FDA earlier this year, maybe in its second trimester.
Every little problem that the FDA had with CytoDyn was discussed in the Type A and Type C meetings and from the Type A meetings, CytoDyn learned precisely what it needed to do to get the Clinical Hold lifted and that is what CytoDyn is dealing with now. In the Type C meeting, CytoDyn learned what would be expected of it, should the BLA for HIV be re-submitted, and therefore, it is being written now, as the data is getting aggregated, in accordance with the Type C meeting stipulations.
There is a group though, who do know that CytoDyn is pregnant. They are the short cabal. They know CytoDyn's water is about to break. And they go to great lengths to listen for that warning sign. And they will cover heavily when that happens. But Cyrus may conceal CytoDyn's water breaking. If Cyrus reveals something that points that the Hold will be lifted imminently, then the shorts will cover. The stronger the sign, or the signal, the greater the flood of water, the more they will want to cover. They will want to protect themselves from an inevitable short squeeze, if they don't get out when the levee breaks. Really, though, I don't think this cabal is too smart though. You would think the submission of the Investigator's Brochure, the ISS, the ISE and the External FDA Type GCP Auditing Authority, aka Enforcer would be that water breaking, but it not. Something else is coming as a sign that the child comes, but it may not be announced.
When the child comes, Cyrus will be at the ready only when Scientific Advisory Board is elected as Directors by the Shareholders on the Annual Shareholders Meeting. Cyrus requires them in place first before they may be mobilized following the birth. Less than 1 year from when Nader Pourhassan exited CytoDyn, Cyrus Arman earns his stripes by January 9, 2023. He becomes a daddy. What a show it will be and yet, it will mark only the very beginning. He will have many more.
The baby will be amazing, I think its name might be NASH and she will grow up very quickly with no time wasted.
Perspective: Round-About Belly
All of us need to know the importance of the times and of the seasons.
Think about exactly what work has been done recently at CytoDyn. They received from Amarex data on various trials which amounted to the safety and effectiveness data on several trials. However, the data was not in the FDA approved format and therefore, the data had to be re-formatted and then it had to be aggregated to the satisfaction of the FDA. It had to be re-formatted in such a way and made presentable to the FDA so that it may become acceptable for admission on a re-submitted of the BLA for HIV. In addition, it had to be prepared for the purpose of getting the clinical hold lifted.
How many months has it been? CytoDyn closed the $6.5 Million Bond with David Welch in mid-March 2022. I don't have an exact date, but it was about 7.5 - 8 months ago. We obtained the raw, unformatted data from Amarex in April when the reformatting and aggregating work began.
2022 in no uncertain terms, was for CytoDyn hell. It could be considered a year the furnace flamed 7 times higher and CytoDyn was thrown into the furnace. 7 times $0.40 is $2.80. Someone knowingly turned the heat up 7 times for most of the longs in 2022 and it all started once Pourhassan left. The Judge ruled that CytoDyn had the right to the data, but that CytoDyn had to put up a $6.5 M bond, which, thanks to David Welch, CytoDyn did. About that time, the FDA placed a partial ban of Leronlimab on HIV and a full ban of Leronlimab on CoVid. A Warning Banner was placed on every one of CytoDyn's webpages and CytoDyn was forced to completely overhaul its website and eradicate any video on the web that had any reference to exaggerated statements or unverified statements by the FDA.
The company went into a drawn out mode of Silence. They wouldn't say a word. The share price fell to as low as $0.23 at one point for about a week or two and things got rather gloomy so as to speak, and to say that it was a hell hole, its not an exaggeration. It was a hellish 2022 and despite the long incubation, CytoDyn ain't out of the oven yet.
This is not to say that CytoDyn has not made incredible efforts to overcome the difficulty thrown its way over the past 3/4 year. Antonio Migliarese took the role as CEO in place of Nader and did a bang up job. Tanya Urbach relieved Scott Kelly of COB and continues as such. The company hires Cyrus Arman as interim President and is slated to be CEO by 1/9/2023.
Cyrus expands the board greatly and turns it into an Independent Board, rather than an Internal Board. Later, Internal Director Scott Kelly is taken off the board entirely and replaced by Independent Director Stephen Simes. Cyrus has his rear guard assembled and they await their command, but the master remains patient, as he plans his strike.
A tremendous Internal Effort has been levied and waged, by the company to properly format and aggregate this data. Dr. Chris Recknor, along with the CRO for Pharmacovigilance, both of whom, supervised and managed by internal project manager and senior director of clinical operations, Joe Meidling and CytoDyn's Vice President of Project Management, Bernie Cunningham. CytoDyn also has a regulatory consulting firm who helped with the preparation and review of the various regulatory communications to the FDA. A Reputable Consulting Firm led by former FDA regulators, that is the Regulatory Strategy Advising Group helps CytoDyn format and aggregate the data in accordance with FDA Type Good Clinical Practice Guidelines. This has been going on for nearly 9 months.
Like I've said in prior posts, this company is in labor. It is having travail and birthing pangs and the baby is on its way. CytoDyn is tough. She doesn't make a stink, nor cry out loud, but she hurts in pain while delivery approaches.
With all of these loose ends in play, Cyrus considers the field. Recently, the Investigator's Brochure along with the Integrated Summaries for Safety and Efficacy were submitted to the FDA. This can only mean one thing, and that is that CytoDyn is damn near close to completion in the aggregation and submission of all the data back to the FDA. Yesterday, Cyrus announced that the Annual Shareholders Meeting is on December 9, 2022. He states: "The matters to be presented for action at the Annual Meeting are (i) the election of five directors to our Board of Directors; (ii) ratification, on an advisory (non-binding) basis, of the appointment of our auditors; and (iii) approval, on an advisory (non-binding) basis, of our executive compensation. We may also act on such other business as may properly come before the Annual Meeting." From the day of this writing, it is about 5 weeks until the Annual Shareholder's Meeting. What such business may Properly come before then?
What is Cyrus expecting? I think he is expecting a baby. Is it only a baby or could it be twins? Could it even be triplets? Let's see, a baby would be that the Clinical Hold gets lifted. Twins would be that in addition to the Clinical Hold being lifted, it is also decided that the BLA for HIV be re-submitted. Triplets would be that in addition to the Twins being born, a Partnership is also signed and ratified. Is 12/9/22 a late date for this? That would mean that 9 months earlier, or 3/9/22, CytoDyn started its pregnancy and with all the shit Amarex has caused CytoDyn, the labor of pregnancy is an analogy not too far out on a limb to make.
Water is about to break. But CytoDyn hides its gestation. Nobody even knows that she is pregnant. Nobody knows that she is about to give birth. Nobody knows that she is about to go into labor and that her water is about to explode. What happens prior to a birth of a child? Daily, CytoDyn labors together with its mid-wife, the External FDA Type Good Clinical Practice Auditing Authority, aka, the Enforcer and, along with the Internal Audit Committee as well as Ryan Dunlap, who is CytoDyn's Independent Director on the Board head of the Audit Committee, all work daily, in unison, determining each and every move to make to satisfy the requirements discussed in the Type A and Type C meetings CytoDyn had with the FDA earlier this year, maybe in its second trimester.
Every little problem that the FDA had with CytoDyn was discussed in the Type A and Type C meetings and from the Type A meetings, CytoDyn learned precisely what it needed to do to get the Clinical Hold lifted and that is what CytoDyn is dealing with now. In the Type C meeting, CytoDyn learned what would be expected of it, should the BLA for HIV be re-submitted, and therefore, it is being written now, as the data is getting aggregated, in accordance with the Type C meeting stipulations.
There is a group though, who do know that CytoDyn is pregnant. They are the short cabal. They know CytoDyn's water is about to break. And they go to great lengths to listen for that warning sign. And they will cover heavily when that happens. But Cyrus may conceal CytoDyn's water breaking. If Cyrus reveals something that points that the Hold will be lifted imminently, then the shorts will cover. The stronger the sign, or the signal, the greater the flood of water, the more they will want to cover. They will want to protect themselves from an inevitable short squeeze, if they don't get out when the levee breaks. Really, though, I don't think this cabal is too smart though. You would think the submission of the Investigator's Brochure, the ISS, the ISE and the External FDA Type GCP Auditing Authority, aka Enforcer would be that water breaking, but it not. Something else is coming as a sign that the child comes, but it may not be announced.
When the child comes, Cyrus will be at the ready only when Scientific Advisory Board is elected as Directors by the Shareholders on the Annual Shareholders Meeting. Cyrus requires them in place first before they may be mobilized following the birth. Less than 1 year from when Nader Pourhassan exited CytoDyn, Cyrus Arman earns his stripes by January 9, 2023. He becomes a daddy. What a show it will be and yet, it will mark only the very beginning. He will have many more.
The baby will be amazing, I think its name might be NASH and she will grow up very quickly with no time wasted.
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