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Misiu, I did not think of this. But from the standpoint of trial results, getting out of the hospital is a good thing for endpoints like "Length of Hospital Stay". So, the question is what about the patients who get discharged early and later get worse? Is the option to get more doses closed if they leave the hospital once?
If being discharged once means the treatment option is discontinued for that patient, then it would be unfair to us if there is a relapse, the patient cannot get LL, perhaps even dies, and that gets counted in the mortality statistic for our trial. And of course it would be terrible for that patient if some rigid rule prevents them from getting further doses even though their condition has regressed back to hospital-level.
I would think this is more of a technical glitch in the protocol that they (the hospital) can informally work around, in case a patient is feeling good enough to be discharged and later there is reason to continue the treatment. The patient is probably considered still a part of the trial and they can be formally "re-hospitalized" (and given the LL) within the 28 day period.
I feel ANVISA, Cytodyn, Biomm, and the Hospital there should have sorted out the logistics taking these situations (which may be of low probability) into consideration, and figured out how to record data for these cases without undermining the results. They have the experience. At this time we have to trust all will go well. In any case you have made the point to Nader and SK, so if there is anything further they can do here, they will make the effort. (But no surprise they cannot reply to you on email for this type of question. We can ask if we want in their next cc.)
ok. Then we can only hope that changes were not forced upon us like with FDA's 2 doses; and instead were sensible to both sides as giving our drug the best chance for success.
For those who understand this medical science,
Is it a general rule that IV simply makes the reactions happen faster than subq (though perhaps smaller 1/2 life)? So whatever happens with subq will happen with IV, only quicker.
The fact that we are not seeking IV for severe suggests it is not as simple as “IV is better always.” But our team is wanting IV for all 4 doses in critical and none for severe.
What is the logic here? Why not for each dose, give 1/2 in IV and 1/2 in subq?
Also do we have any prior experience with administering LL through IV and seeing results, or is our confidence strictly based on this general medical knowledge about how IV will work?
Thanks. Phew indeed. Big step forward to have critical also approved.
Thanks to ANVISA and big credits to our Management as well. They would have had to communicate smartly and convincingly with ANVISA in their meetings, to get over the deleterious effects of the FDA letter, for ANVISA to approve the trials without modifying our dosage.
I am curious whether the trial protocols were modified in any manner following discussions with ANVISA. For the critical, one thing that struck my attention is that the trial only accepts patients who got into ECMO within previous 72 hours. Maybe this was there from the beginning. It shows how we have refined our understanding based on cd12 etc and identified the optimal target patient population to prove LL’s efficacy. cd12 will prove to be the first successful step in a two step process if results in the Brazil trials are as we hope.
Next, we will look forward to a PR next week confirming this news. Then recruitment has to start and move forward smoothly.
Well it surprises me; seems rather damning. Take it for granted you have contacted our management and given over such data.
Isn't Brazil already enrolling for the first trial? If not, why is it getting delayed after approval?
Important statement
ok, I think that is where the call for their formal plan comes, where they explicitly make it clear that it is ALL TRUE. You and I saying such things is not enough.
Is it true that if 13D wins:
The Brazil trials, data collection, processes of application to regulatory bodies, the connections (potentially) already established by Cytodyn with organizations like Biomm and Chiral, etc. will transfer and transition over smoothly to the new management, which (according to their plan yet to be told) will take the process to its natural conclusion without a undue time delay or a complete revamp and repeat? If not, how so?
Longs are optimistic about the Brazil trials and our chances in Covid severe/critical as well as LH. The working assumption is that we will see success in these trials and that the present management will leave no-stones-unturned in taking it forward from there. Anything that will end up hindering our progress on that front is absolutely unacceptable.
So, first thing I want to know is a guarantee in their plan yet-to-be-presented that the transition to a new board will in no way obstruct or delay our present objectives and efforts in Covid. That they are also on the same page in terms of goals, timelines and focus. If further they have ideas like "We will stop talking about covid, cancer, Nash and focus all efforts on HIV", then they better say that in a proper plan before the vote. Investors can vote for or against with full knowledge of what is coming.
IMO 13D is already causing great hindrance, cost-wise, time-wise, focus-wise, to the company and shareholders. I see them as playing directly the role of shorts and effectively trying to cripple our efforts at a crucial time - then blame Nader for the effects of all this damage they are causing. Quite possibly, many of these people are this anti-Nader because of some personal animosity and past interactions and not simply based on a professional assessment of his work.
They cannot be rooting for Cytodyn's success in its projected goals for this year, but betting on failure. What is in their best interest?:That ANVISA approves Critical? That Brazil interim results are spectacular? I don't think so. With HIV, I think present management has turned the corner and will cross that bridge definitively; but perhaps others don't want to risk with Nader and co. I can understand the logic based on the previous BLA, but again not for this year. Cancer and all are farther away; if they were the only indications, then a transition at this time may not mean so much. But right now, 13D seems to think Covid can be a sacrificial lamb, that the possibility of HIV BLA completion this year can be negated for their own fresh restart next year. Shareholders need to consider the outcomes of their vote in terms of these immediate goals of the present management and whether we are willing to surrender all of that that seems this close.
Keep note, anyone can say "I am a mathematician and this is my conclusion. If you want to know how, go read the books." Pointless indeed.
The Company is making the case of greed and conflicts of interest among 13D members including Dr. BP.
Dr. BP had mentioned of the Company's request in a tweet many days ago, so we knew how that part of the response was going to come. Does not change the facts of the request like 350 million, and more questionably the assertion of 123 million (as I recall?) personal profit etc. Perhaps it was Dr. BP's way of formally rejecting the request by quoting what the Company may think is beyond reasonable. Perhaps he was being way too greedy. Perhaps he really thought $350 million is the right evaluation for IncellDX. But that was the price he gave out. 13D wants to push it under the rug as if irrelevant to judgment call on which people has the shareholder's interest in front of theirs. The Company thinks it is significant when judging Dr. BP and his future priorities with regard to Cytodyn and IncellDX, especially if they get in and have a greater say on whether Cytodyn chooses to buy IncellDX.
Shareholders can decide how to interpret the fact that 13D is not making a big deal, being or trying to be legally technical, over the need to divulge such points, whereas the Company is making a big deal over them.
With regard to patents, that seems even more of a push under the rug in 13D's response to that charge. I doubt people are going to switch sides based on such an anemic
Ok. Very good. Thank you for all the info you have given. Hope your son gets fully cured in the coming weeks, without any LH effects; and you also can get needed rest.
Misiu, let us know what the opinion of your son's main doctor was, based on what he (or she) saw before and after LL was given to your son. Whether he feels strongly this is not a placebo or just some natural effect making your son feel better, but rather that based on his past experience with covid patients of this kind, the change must have something to do with the drug just administered. Will he consider or advocate our drug for other covid patients? Maybe its too early to make such judgments; but for the main doctor Leronlimab must be a new thing; one wonders how he processes all this in his mind and based on his prior experience.
Melon Toy's experience was also an early anecdote that gives insight into how quickly LL can work on otherwise healthy patients (though her case was probably not as severe).
She talks about how she felt after each of her 2 doses of LL (she thinks it must have been LL; not sure if she confirms this later elsewhere) in min 14 - 17
Sent to IR:
Quote
So, once again, the forum of skeptics roars with questions of why and with what justification the management gets bonuses and shares, whether you really bought from your own cash or were awarded for reasons beyond the retail's imaginations. For truth, you are all already millionaires and have made millions while managing Cytodyn. No problem, that is the system and you get your salaries for your sincere work. But why more and why now - even while under all this scrutiny? Can you not buy from your own cash in the open market (as shorts repeatedly challenge), or just stop actions that bring question to your empathy for shareholders and prioritization of your personal financial interests at their expense, until we reach definitive results that will guarantee revenue-status for the company and some hope for your investors that they will make it out without financial ruin of their investment. You have your basic salaries, well and good - why not just buy shares with that or limit to replacing such with shares, and no further gimmickry beyond the transparent (like "for things already done"). What, has the BLA been completed in time and approved? Have the Brazil trials succeeded and we got EUA anywhere? Are we overflowing in new cash and revenue and is not the stock price stuck in quicksand below $2?).
All this said in good faith of the likelihood that your actions are within the sensible limits of the system, that you have integrity and understanding of our situation as well, and that I am likely presenting things in worse manner than it really is in this business. Still, that is the sensible charge of your opponents that your supporters struggle to respond to, and personally I am baffled as well. Possibly you can clarify such in your next cc.
Unquote
Misiu and Chuckles' colleague family can help us out further by putting on a scientist hat and getting as much patient-specific data as possible from these anecdotes, that can try nail down the connection to LL in their road to recovery. Misu can ask our management whether and how she can help in this regard, within the bounds of Right-to-Try.
For example, can we get blood samples of the patients from before and after Leronlimab was administered, for bio-marker analysis? Probably we already missed the chance to do this for before LL; but even now we can monitor the progress over the next couple of weeks.
If such is not possible, they can still jot down the small details of the patient's struggles before and day-by-day recovery after LL was given, along with the general characteristics of the patient like age, comorbidities, vaccination status, and anything else that will give us insight into why they may have gone into critical stage and why Leronlimab was likely the key cause for their recovery and how it may have made this difference. The monitoring doctor's affirmation in this regard will also be important.
These anecdotes resemble some of the early eINDs that showed dramatic impact of Leronlimab within a very short time. The recovery of oxygen levels is something we heard often. We also got such ideas from Estrada camp initially, of the 'wonder drug', but then silence thereafter - as if they dared not speak out specifically for LL later. Yet we know that not everyone had such miraculous recovery and in so short a time. Or they relapsed later due to lack of repeat dosage and that had masked the initial effect of LL. Even with Marksch's wife, I don't think the change was this stark and swift. What possibly made our patients specially suited to LL?
So, we have opportunity to build a proper data-based analysis and a bias-free scientific case for these patients who seem to be recovering because of LL and who are close to our forum members.
How much is bought with their own money and not awarded to them??
What do these explanations mean? Both seem to be some type of awards and not actual purchases with their own money. Am I misunderstanding?
"(1) Represents shares received in lieu of 50% of a cash incentive bonus paid for services performed during the fiscal year ended May 31, 2021, which may be paid (a) 100% in cash or (b) 50% in stock and 50% in cash, as determined by the issuer's compensation committee of the board of directors.
(2) Represents shares received in satisfaction of performance share award based on the achievement of specified performance goals for the fiscal year ended May 31, 2021, as determined by the issuer's compensation committee of the board of directors."
Is IV allowed under Right to Try? I thought the earlier eINDs were all subcutaneous and FDA will not allow IV now, though we have asked ANVISA for approving IV for the critical trial.
Buyers stepping in. Good sign if it can go past yesterday high 1.38 and stabilize.
Really sorry to learn this. I am a bit careless about appreciating the seriousness of this disease, that it can be this dangerous even to vaccinated young people. In fact vaccinated people are supposed to be relatively free of danger, so I thought your son would recover naturally after an interim period of struggle. Hope he does soon and LL if it is used can work its magic as well.
Does Cytodyn get reimbursed for providing Leronlimab upon request from patient’s doctor? Or must the company absorb all these right-to-try and OLE charges?
Ok I tried.
Go ahead with whatever you were saying.
Screen shot? The link you cited does not go to this English "screen shot". If you can provide the right link and it is still not corrected there, then someone can request clarification as to why there is discrepancy between their Portuguese link (that I gave) and the one you are claiming to exist.
Google translated the first sentence as:
"Anvisa authorized, on Monday (2/8), the realization of the clinical study to assess the safety and efficacy of the drug leronlimab for the treatment of moderately ill patients with pneumonia caused by Covid-19."
https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2021/estudo-clinico-com-o-anticorpo-monoclonal-leronlimabe-e-autorizado-pela-anvisa
Anvisa 2nd trial approval with our trial design, getting both the covid trials completed; getting HIV BLA finished correctly - these are the big things for this year. Would greatly help Cytodyn and investors if these happen as per plan. Progress in LH, NASH, Cancer are smaller goals. As of now, I am confident that the severe trial will happen as planned. The rest are still in the air; but there is cautious optimism that the critical will happen as well - not seeing why ANVISA will spoil the party. BLA is still a finger-cross; management has to make it happen.
Who is selling at this price?
The volume of trading has gone significantly higher since 8/2.
7/29: Volume 605K
7/30: 1.2M. (price seemed to recover on this day)
8/2: 4.8M. (PR that 13D invalid; new legal team. Intraday news of Brazil trial approval)
8/3: 2.8M. (PR on Brazil trial approval)
8/4: 2.9M
8/5: 3.1M (Lawsuit against 13 D)
Is the selling primarily due to
1. Shorts increasing their position
2. Longs selling because of disappointment that 13D may not happen and conviction that LL will not succeed under current management.
3. "Longs" selling in order to depress/manipulate the price
4. Cytodyn doing some type of ATM dilution to raise funds
Any other reason?
ANVISA needs to approve the second critical trial without modification of our design, and both the Brazil trials need to go to completion as planned. If that does not happen, then surely we can point that out. The drug needs to get a fair chance and the Brazil trials are that opportunity.
From a practical standpoint, given our financial constraints, the Brazil trials are probably the line-in-sand for severe/critical covid. One cannot predict whether something novel may show up warranting further research, but most likely we will decide not to pursue this indication if we don't get hit PE and/or SE and get the attention of ANVISA or other agencies based on the results here.
cd12 was "hypothesis generating" which means there was sufficient data that suggested potential of LL. We are justified in seeking to conduct new trials based on cd12, to find out whether the hypotheses can be SS verified. cd12 was not a failure in that sense; for longs, it turned out to be the first step in a two step process. Brazil is the second step.
I want to ask longs who think LL has great potential in Covid.
The goal of the trial seems to be whether Leronlimab can prevent patients in severe stage from reaching the Cytokine storm crticial-stage. Whereas the past data has shown primarily that LL may be statistically significant for patients who are already in critical stage.
So, is there reason to be optimistic that this Brazil trial for severe cases will work out well? Was there anything from cd12 that suggested that changing trial design (4 doses etc.) will help severe patients as well? Or are we just hoping that a well-powered trial will show this even though the past data did not give this info?
Critical Stage => Cytokine Storm => CCR5 blocking needed => LL will make impact (This made sense)
Severe Stage: Is Cytokine Storm happening at such a level that LL will make the difference? A good portion of severe stage patients may not go into the critical stage normally.
I really hope ANVISA sees a similar logic and approves the critical trial concurrently.
Unless the company is required to issue an 8-k when she resigns or is terminated (given her position), there is no case to build on even if she is no longer an employee. Are people accusing the company of faulting an SEC rule by not issuing the 8-k? We have to first identify her official position and show the SEC rule that is breached. If that is not known then this is just "what-if" speculation that is being churned to bring some negative image on the company that no one can prove one way or other.
It may have something to do with her official position in the company that may not require a formal 8-k. I don't see her termination (if that is the case) or leaving the company as something big that we have to go out of the way to issue an 8-k, unless formally required. Shareholders felt her presence as the legal support; but once the company decides to part ways, it may not be as big a deal as this forum makes it out to be. Our legal issues and the 13D challenge -once they started mounting and required a more professional handling, the management likely decided Ariane was not up to the mark and we needed to move on.
I don't recall anyone referring to an 8-k regarding departure of Rahman. Is he different?
That last part on patents definitely was a knife in the back. Cytodyn had to move away from him. It is not explicit whether Dr. P applied for patents even while being in association with Cytodyn, or whether he applied after their relationship was broken. I assume the former.
It seems to be the Moderately III or "severe" trial that is approved for 612 patients instead of 594. The aim is to see how LL prevents progression to ecmo stage.
https://www.clinicaltrials.gov/ct2/show/NCT04901676?term=Cytodyn&cond=%22Coronavirus+Infections%22&draw=2&rank=5
https://www.clinicaltrials.gov/ct2/show/NCT04901689?term=Cytodyn&cond=%22Coronavirus+Infections%22&draw=2&rank=4
We want the critical stage trial because that is the one for which the eINDs gave some important "dramatic" results and that is the subgroup for which cd12 gave promising results. Hope ANVISA does not stall us in that trial.
Also, we need to know from management whether the trial was approved under the same design/protocol as we wanted, or whether there were dose or other modifications.
Timely support for Cytodyn and standing for his convictions. He chose to speak out and call out instead of remaining silent to all this bullying. Thanks Dr. Lalezari
FDA letter, SEC+DOJ investigation. One just has to think ANVISA is getting this info (including from a stream of shorts) and it will create doubt and hesitation about approving the Brazil trials. Tough situation from Cytodyn and longs given our great hopes for these trials to start.
I am regretting and saddened of some of my postings here regarding contacting IR. I thought anonymous posts online should be just that, but who knows how SEC and DOJ might use such to do their fact-finding?
Don't follow this. Which 3rd party has patent rights over LL? Is this Dr. Patterson? Any clue when their patent expires?
The statement that the 3rd party's patent expires before we commercialize, is that not a good thing for us since after expiration that 3rd party no longer "has the right to prevent others from making ..."?
Yes it can. By Beaty and the 13D crew. Refute the statements if that is not their intent: "Hey we never made such online posts or such statements in the cc. It is not our intention to ..."
Normally companies may not but our company is sort of sitting on fire of criticism and expectation, so I think they should PR completing the first part of the CDC summaries. Not doing so would get interpreted as not having met the deadline. The July 15 one was Administrative and we need not be surprised that a PR on that was skipped.
However the PR if it is coming should be more expected Monday morning, not today.