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Posted On: 07/23/2023 12:51:28 PM
Post# of 148870
My Reddit account is temporarily suspended so I appreciate these long posts to be placed here prior to the webcast.
Senses Tuned For Alignment
I will make every attempt to abide by the following: "Contents posted must be evidence based. Personal opinions must be clearly stated and backed with logical reasoning ."
Let's start with a question and that is "How do you know?" What is it that causes belief, even when there is no real proof? Despite the multitude of doubts, you continue to believe. Why? So a few of us find ourselves in this camp, and we answer that we don't know how it is that we know it, we simply know that we know it.
Many of us here have expounded on what the recent CytoDyn has said and what they have forecasted. We have had evidence that they did what they said they would do. We have heard and have witnessed the confidence in their work and in the data revealing LL's effectiveness. The accumulation of such evidence and expository communications all lead to our confidence despite the sea of doubt surrounding it. So to us, the doubts represent the lies and falsifications while believing in the molecule and in the work of CytoDyn's leadership is where many of us place truth and belief.
ALL of the following is my opinion. I don't know why I believe it, but I believe it happens because the company has said that it will happen and much of it was said in the 12/7 R&D Update.
So then, how close are we to something happening? We are one day prior to the 7/24/23 Webcast which was announced 12 days in advance. 12 days in advance. Does that mean that CytoDyn knew 2 weeks ago, that they already had an answer from the administration, even back then? Or did it mean that they knew 2 weeks ago, that they would not have an answer from the administration for the 24th? As time moves forward, we draw closer at least to a decision from the administration. If you've read what I have put down, you know that I'm thinking that it will be a conditional lift. My belief is that they already knew 2 weeks ago, exactly what the answer was or would be from the administration, and that the answer was a conditional lift. (Remember, I am Speculating.) I surmise that the interval of 2 weeks time period was required to discuss the details of this conditional lift. That CytoDyn is required to run a small safety trial in HIV, but by doing so, the hold is immediately lifted but the 2 week interval of time was required to determine exactly how CytoDyn will achieve this new task of running this small safety trial.
I am fairly confident that prior to his getting sick, Cyrus completed his work and submitted everything previously requested by the administration and that even the requested new protocol on HIV was also submitted, but after he became sick and while on his MLOA. Based on company statements and on what I've documented in the past, I believe that the administration is satisfied with everything, but still requires a small new safety trial in HIV. Cyrus was adamant not to abandon the HIV indication. Remember the laugh in the last webcast on 4/11/23? I like the way "generactor" put it on Investor's Hangout, "Obviously it's still an issue judging from Cyrus' comments last call when he laughed in exasperation talking about the FDA still needing more to clear the hold, including declaring (null?) any future HIV plans (would they ask Gilead that?). And Cyrus implied that he didn't want to upset the FDA by starting the NASH trial until the hold is lifted even though we technically could . You gotta play the game."
Cyrus is back, but has been reduced in capacity and reduced in rank. Given the delays and given his opportunity to walk away, I take this as good news. If he thought his work was so shoddy and not worth the paper it was printed on, then why would he return for lesser pay and lesser rank? Of course he is 100% confident in his work. Let him work from home; if he didn't get sick, he could have moved upward instead. Maybe he is making room for someone?
We heard strong news in the previous Press Release that the administration has taken regulatory action against CytoDyn's previous CRO Amarex. That statement was run by CytoDyn's attorneys. The Press Release in fact was likely written by CytoDyn's attorneys, not NP. The implication is that the administration seems to see a lot of wrong in the CRO's argument in the current arbitration thereby giving CytoDyn's attorneys the confidence to point to a minimum of a $100 million settlement that will be reached no later than the final hearing date which was also requested of the Arbiter. That date is not known yet, but it may be announced on tomorrows webcast. The way I see it, $100 million is middle of the road, but it is a number that CytoDyn's attorneys may accept if it were offered early enough in the settlement process. If the offer comes too late, then, SA may decline Amarex's offer and go with the decision of the Arbiter on the final hearing date. I'm speculating here, but possibly, the mal-practice policy is $150 or $200 million and both SA and the Arbiter knows this. If the mid way offer comes day 1 following the announcement of the final hearing date and CytoDyn needs that cash now, then, they may accept. But if its only 2 weeks before the final hearing date and then they offer $100 million, they may decline and wait for the Arbiter to determine the settlement award. Remember, the Arbiter is aware of the regulatory action against Amarex and the face amount of the mal-practice policy.
Going back to 12/7/22 R & D Update. Funding is expected for NASH when the hold lifts. My speculation is that the hold lifts, but conditionally, dependent upon the agreement to run a small safety trial in HIV. So with the hold lifted, Cyrus and NDA partners are more comfortable running the NASH trial and the funding is released with the conditional lift of the hold. With the hold out of the way, the oncology trial tied to the MD Anderson combination study of LL and Keytruda proceeds to its next Stage. If the NDA permits, the Top Line Results might be disclosed. If it doesn't permit, then, those results remain tucked away.
Again, more of my speculation, but I think the conditional lift of the hold happens in tomorrow's webcast because I believe that everything has been submitted and enough time has elapsed to allow for back and forth negotiation and discussion. I believe that two weeks ago, CytoDyn knew, but had to iron out the details with in the past 2 weeks. On the 24th, the Outcome is made known. The status of the Amarex arbitration can be much more certainly assessed. Using the R & D Update, we can know the next steps with respect to NASH and Oncology. The condition being that a small safety trial be run in HIV. Yes, a small speed bump, but the hold is lifted.
More speculation: I've alluded to in a post on my page, which I will not fully discuss here, but if you've read my most recent post on Litigation, you know that I believe SA is not done with the Amarex arbitration. The main advantage of this is to keep CytoDyn free from further sabotage because the main saboteurs shall be detained and quarantined with in this (hypothetical) upcoming litigation and away from interfering with CytoDyn's multiple trials, thereby allowing CytoDyn to flourish in these partnerships for the next 3 - 4 years. This allows CytoDyn to actually be productive and to actually do something. I've speculated that when this next criminal trial is over, these entities again return to bring down CytoDyn, but they find that they are too weak at that point and that CytoDyn then, together with its multiple partners are too strong for them to defeat or overturn. At this point, the saboteurs are done, their strength is fully depleted.
I believe Cyrus has only exuded confidence ever since his original hiring. He saw the task at hand and knew it would be a huge undertaking, but he also saw LL, its undeniable effects and the data which confirmed his understanding of it mechanism of action. The Scientific Board of Expert Advisors stand by him in their confidence as well. With all of the delays that were incurred in the submissions, Cyrus saw that it was even more difficult than his original expectation. Then he became sick to the point, where he had to take leave and had to give up leadership of the company to Antonio Migliarese who already had this role prior. Cyrus took his MLOA, and then returned at a reduced salary and at a reduced position, but he returned with these words: " I am excited to feel well enough to return from medical leave and contribute to CytoDyn. This new role will allow me to support CytoDyn and the development of leronlimab , which I continue to believe in and am very confident and optimistic about the potential of , while continuing to tend to my health." What is the new role? " The Company also announced that Dr. Cyrus Arman has returned to the Company, following his medical leave of absence, as Senior Vice President of Business Operations , a new role in which he will be working reduced hours ." CytoDyn brought Cyrus Arman in so that he could implement the idea of getting the hold lifted, and I believe he did that, but it results in a conditional lift.
What we are seeing right now taking place at CytoDyn, just everything that we are seeing..., we know that CytoDyn has been practicing for and arguing for a multi-front clinical indication pipeline. NASH, Oncology and HIV have been discussed over and over again over the past year. However, because of the clinical hold, CytoDyn appears to have grown weak and is seen as weakened by many because of everything taking place within CytoDyn right now. However, the recent statements made by our attorneys in the last Press Release concerning the arbitration and the return of CA point to only a few strengths. SA has shown to be a saving grace for this company and I don't believe their work here is done with the Amarex settlement. I have thought that enough was presented for the administration to make their decision, but because CytoDyn made the decision for a webcast 2 weeks ago, I believe they have had the answer already and needed the 2 week time interval to work out the details. As the time moves forward, the time for a decision only becomes less and less, so I believe the decision was made already, and that the details regarding that decision were worked out in the 2 week interval.
As shareholders, we are doing what we need to. Keeping our eye laser focused on what is happening. I think tomorrow sheds a lot of light on what has happened since April and what shall happen going forward and overall, it will be very good for CytoDyn. The problem is that the NDAs are only revealed as the stepping stones are met. The Stages of the NDAs may not be discussed until each threshold criteria is met. But with the lift of the hold, even if it is only conditional, the threshold criteria is met to reveal the next Stage of each NDA. We know that the arbitration resolves by the final hearing date. Then, onto the next, thereby expunging enemies away from CytoDyn's presence allowing CytoDyn to work with its partners devoid of interference.
Senses Tuned For Alignment
I will make every attempt to abide by the following: "Contents posted must be evidence based. Personal opinions must be clearly stated and backed with logical reasoning ."
Let's start with a question and that is "How do you know?" What is it that causes belief, even when there is no real proof? Despite the multitude of doubts, you continue to believe. Why? So a few of us find ourselves in this camp, and we answer that we don't know how it is that we know it, we simply know that we know it.
Many of us here have expounded on what the recent CytoDyn has said and what they have forecasted. We have had evidence that they did what they said they would do. We have heard and have witnessed the confidence in their work and in the data revealing LL's effectiveness. The accumulation of such evidence and expository communications all lead to our confidence despite the sea of doubt surrounding it. So to us, the doubts represent the lies and falsifications while believing in the molecule and in the work of CytoDyn's leadership is where many of us place truth and belief.
ALL of the following is my opinion. I don't know why I believe it, but I believe it happens because the company has said that it will happen and much of it was said in the 12/7 R&D Update.
So then, how close are we to something happening? We are one day prior to the 7/24/23 Webcast which was announced 12 days in advance. 12 days in advance. Does that mean that CytoDyn knew 2 weeks ago, that they already had an answer from the administration, even back then? Or did it mean that they knew 2 weeks ago, that they would not have an answer from the administration for the 24th? As time moves forward, we draw closer at least to a decision from the administration. If you've read what I have put down, you know that I'm thinking that it will be a conditional lift. My belief is that they already knew 2 weeks ago, exactly what the answer was or would be from the administration, and that the answer was a conditional lift. (Remember, I am Speculating.) I surmise that the interval of 2 weeks time period was required to discuss the details of this conditional lift. That CytoDyn is required to run a small safety trial in HIV, but by doing so, the hold is immediately lifted but the 2 week interval of time was required to determine exactly how CytoDyn will achieve this new task of running this small safety trial.
I am fairly confident that prior to his getting sick, Cyrus completed his work and submitted everything previously requested by the administration and that even the requested new protocol on HIV was also submitted, but after he became sick and while on his MLOA. Based on company statements and on what I've documented in the past, I believe that the administration is satisfied with everything, but still requires a small new safety trial in HIV. Cyrus was adamant not to abandon the HIV indication. Remember the laugh in the last webcast on 4/11/23? I like the way "generactor" put it on Investor's Hangout, "Obviously it's still an issue judging from Cyrus' comments last call when he laughed in exasperation talking about the FDA still needing more to clear the hold, including declaring (null?) any future HIV plans (would they ask Gilead that?). And Cyrus implied that he didn't want to upset the FDA by starting the NASH trial until the hold is lifted even though we technically could . You gotta play the game."
Cyrus is back, but has been reduced in capacity and reduced in rank. Given the delays and given his opportunity to walk away, I take this as good news. If he thought his work was so shoddy and not worth the paper it was printed on, then why would he return for lesser pay and lesser rank? Of course he is 100% confident in his work. Let him work from home; if he didn't get sick, he could have moved upward instead. Maybe he is making room for someone?
We heard strong news in the previous Press Release that the administration has taken regulatory action against CytoDyn's previous CRO Amarex. That statement was run by CytoDyn's attorneys. The Press Release in fact was likely written by CytoDyn's attorneys, not NP. The implication is that the administration seems to see a lot of wrong in the CRO's argument in the current arbitration thereby giving CytoDyn's attorneys the confidence to point to a minimum of a $100 million settlement that will be reached no later than the final hearing date which was also requested of the Arbiter. That date is not known yet, but it may be announced on tomorrows webcast. The way I see it, $100 million is middle of the road, but it is a number that CytoDyn's attorneys may accept if it were offered early enough in the settlement process. If the offer comes too late, then, SA may decline Amarex's offer and go with the decision of the Arbiter on the final hearing date. I'm speculating here, but possibly, the mal-practice policy is $150 or $200 million and both SA and the Arbiter knows this. If the mid way offer comes day 1 following the announcement of the final hearing date and CytoDyn needs that cash now, then, they may accept. But if its only 2 weeks before the final hearing date and then they offer $100 million, they may decline and wait for the Arbiter to determine the settlement award. Remember, the Arbiter is aware of the regulatory action against Amarex and the face amount of the mal-practice policy.
Going back to 12/7/22 R & D Update. Funding is expected for NASH when the hold lifts. My speculation is that the hold lifts, but conditionally, dependent upon the agreement to run a small safety trial in HIV. So with the hold lifted, Cyrus and NDA partners are more comfortable running the NASH trial and the funding is released with the conditional lift of the hold. With the hold out of the way, the oncology trial tied to the MD Anderson combination study of LL and Keytruda proceeds to its next Stage. If the NDA permits, the Top Line Results might be disclosed. If it doesn't permit, then, those results remain tucked away.
Again, more of my speculation, but I think the conditional lift of the hold happens in tomorrow's webcast because I believe that everything has been submitted and enough time has elapsed to allow for back and forth negotiation and discussion. I believe that two weeks ago, CytoDyn knew, but had to iron out the details with in the past 2 weeks. On the 24th, the Outcome is made known. The status of the Amarex arbitration can be much more certainly assessed. Using the R & D Update, we can know the next steps with respect to NASH and Oncology. The condition being that a small safety trial be run in HIV. Yes, a small speed bump, but the hold is lifted.
More speculation: I've alluded to in a post on my page, which I will not fully discuss here, but if you've read my most recent post on Litigation, you know that I believe SA is not done with the Amarex arbitration. The main advantage of this is to keep CytoDyn free from further sabotage because the main saboteurs shall be detained and quarantined with in this (hypothetical) upcoming litigation and away from interfering with CytoDyn's multiple trials, thereby allowing CytoDyn to flourish in these partnerships for the next 3 - 4 years. This allows CytoDyn to actually be productive and to actually do something. I've speculated that when this next criminal trial is over, these entities again return to bring down CytoDyn, but they find that they are too weak at that point and that CytoDyn then, together with its multiple partners are too strong for them to defeat or overturn. At this point, the saboteurs are done, their strength is fully depleted.
I believe Cyrus has only exuded confidence ever since his original hiring. He saw the task at hand and knew it would be a huge undertaking, but he also saw LL, its undeniable effects and the data which confirmed his understanding of it mechanism of action. The Scientific Board of Expert Advisors stand by him in their confidence as well. With all of the delays that were incurred in the submissions, Cyrus saw that it was even more difficult than his original expectation. Then he became sick to the point, where he had to take leave and had to give up leadership of the company to Antonio Migliarese who already had this role prior. Cyrus took his MLOA, and then returned at a reduced salary and at a reduced position, but he returned with these words: " I am excited to feel well enough to return from medical leave and contribute to CytoDyn. This new role will allow me to support CytoDyn and the development of leronlimab , which I continue to believe in and am very confident and optimistic about the potential of , while continuing to tend to my health." What is the new role? " The Company also announced that Dr. Cyrus Arman has returned to the Company, following his medical leave of absence, as Senior Vice President of Business Operations , a new role in which he will be working reduced hours ." CytoDyn brought Cyrus Arman in so that he could implement the idea of getting the hold lifted, and I believe he did that, but it results in a conditional lift.
What we are seeing right now taking place at CytoDyn, just everything that we are seeing..., we know that CytoDyn has been practicing for and arguing for a multi-front clinical indication pipeline. NASH, Oncology and HIV have been discussed over and over again over the past year. However, because of the clinical hold, CytoDyn appears to have grown weak and is seen as weakened by many because of everything taking place within CytoDyn right now. However, the recent statements made by our attorneys in the last Press Release concerning the arbitration and the return of CA point to only a few strengths. SA has shown to be a saving grace for this company and I don't believe their work here is done with the Amarex settlement. I have thought that enough was presented for the administration to make their decision, but because CytoDyn made the decision for a webcast 2 weeks ago, I believe they have had the answer already and needed the 2 week time interval to work out the details. As the time moves forward, the time for a decision only becomes less and less, so I believe the decision was made already, and that the details regarding that decision were worked out in the 2 week interval.
As shareholders, we are doing what we need to. Keeping our eye laser focused on what is happening. I think tomorrow sheds a lot of light on what has happened since April and what shall happen going forward and overall, it will be very good for CytoDyn. The problem is that the NDAs are only revealed as the stepping stones are met. The Stages of the NDAs may not be discussed until each threshold criteria is met. But with the lift of the hold, even if it is only conditional, the threshold criteria is met to reveal the next Stage of each NDA. We know that the arbitration resolves by the final hearing date. Then, onto the next, thereby expunging enemies away from CytoDyn's presence allowing CytoDyn to work with its partners devoid of interference.
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