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lostmyballs:
It is very dangerous for any of us to presume to know the intent of another. Therefore I do not presume to know the intent of NP. Any can ascribe intent to NP, but knowing his intent is not the same.
Sure seems pretty clear, at least on my computer.
stealth,
Cytodyn stated that they received authorization to administer leronlimab to a patient in Canada with tnbc.
The LOA (letter of authorization) is the mechanism by which this information was conveyed to Cytodyn.
Alternative, but less appropriate, mechanisms to convey this limited regulatory approval include phone calls, emails, carrier pigeons, smoke signals and stone tablets.
Jake,
What I posted is what has been shared with me. I believe that the question posed was whether Cytodyn is able to charge for administration of Leronlimab to tnbc patients treated under this authorization.
The identity of the individual am making this inquiry is IMO not germane.
GLTU
Bill,
Both trials are listed, moderate and critical.
I know as I compiled the list. The populations of the cities are from Wikipedia and the participating hospitals from https://plataformabrasil.saude.gov.br
Here is the same data formatted for better clarity.
Critical covid trial better late than never.
Covid will eventually fade to endemic levels from pandemic, but the need for Leronlimab will remain.
Brazilian cases remain far from Spring highs, but are now up 24% week over week.
https://www.worldometers.info/coronavirus/weekly-trends/#weekly_table
Thankfully, trial sites have been added as promised. Listed are trial sites and the populations of the cities in which these facilities are located.
Let's (en)roll!
Text of chancellor's dismissal of 13D appeal.
IN THE COURT OF CHANCERY OF THE STATE OF DELAWARE
PAUL A. ROSENBAUM, JEFFREY R. BEATY, and ARTHUR L. WILMES, Plaintiffs,
v.
CYTODYN INC., SCOTT A. KELLY, NADER Z. POURHASSAN, JORDAN G. NAYDENOV, ALAN P. TIMMINS, SAMIR R. PATEL, and GORDON A. GARDINER, Defendants.
C.A. No. 2021-0728-JRS
ORDER DENYING PLAINTIFFS’ MOTION FOR AN INJUNCTION PENDING APPEAL
WHEREAS, on October 13, 2021, the Court entered a Post-Trial Memorandum Opinion (the “Opinion”) rejecting Plaintiffs’ claim that Defendants breached the advance notice bylaw within the bylaws of CytoDyn Inc. (“CytoDyn” or the “Company”) and denying Plaintiffs’ request for declaratory and injunctive relief;
WHEREAS, on October 15, 2021, Plaintiffs, Paul A. Rosenbaum, Jeffrey P. Beaty and Arthur L. Wilmes, moved for an injunction prohibiting Defendants from proceeding with the Company’s annual meeting pending appeal (the “Motion”);
WHEREAS, on October 19, 2021, Defendants filed their opposition to the Motion;
NOW THEREFORE, THE COURT FINDS AND ORDERS AS FOLLOWS:
1. The Motion is DENIED.
2. Under Court of Chancery Rule 62(c) and Supreme Court Rule 32, this
Court has discretion to grant an injunction with respect to its judgment pending appeal. In exercising that discretion, the Court is guided by the so-called Kirpat factors.2 Those factors direct the Court to: (i) make a preliminary assessment of the movant’s likelihood of success on appeal; (ii) assess whether the movant will suffer irreparable harm if the injunction is not granted; (iii) assess whether any other interested party will suffer substantial harm if the injunction is granted; and (iv) consider whether the public interest will be served if the injunction is granted.
3. When considering the Kirpat factors, because the trial court is asked to assess the strength of its own reasoning and judgment, “the ‘likelihood of success on appeal’ prong cannot be interpreted literally or in a vacuum.”4 Instead, “f the other three factors strongly favor interim relief, then a court may exercise its discretion to reach an equitable resolution by granting a[n] [injunction] if the petitioner has presented a serious legal question that raises a ‘fair ground for litigation and thus more deliberative investigation.’”5 With this guidance in mind, the court often considers the first three factors before assessing whether the movant has presented a question that raises a fair ground for review by our Supreme Court.
4. In applying the Kirpat factors, the court must remember that they “are not a checklist; they are balanced with ‘all of the equities involved in the case together.’”
“Such a balancing of equities is particularly complex when, as here, the interests at issue are not limited to an award of money.” Indeed, “an application for an injunction pending an appeal is likely to fail if, as is often the case, the Court has already denied an application for injunctive relief.” This is so because “similar relief already has been sought and denied on the merits in the first instance.”Given this dynamic, “the entry of an injunction pending an appeal” that would mimic or expand the request for relief already rejected “is an unusual occurrence.”
5. Under Kirpat factor (ii), Plaintiffs argue they will suffer irreparable harm if the injunction is not granted because, without it, their appeal likely cannot be decided by the Delaware Supreme Court prior to CytoDyn’s annual meeting on October 28. Under the circumstances presented here, however, that claimed harm falls short of the irreparable harm required to support the injunction Plaintiffs seek. “The Court may deny a motion pursuant to Rule 62(c), and enforce its judgment against the party seeking appeal, even if doing so may harm that party by ‘undermin[ing] its opportunity for Supreme Court review of the judgment.’” (
“Defendants claim that denying a stay would result in irreparable harm to them because . . . [it] would provide Plaintiff with final relief and moot Defendants’ current appeal. If I were to accept Defendants’ argument, every Order of this Court that contains a form of injunctive relief would justify a stay of that Order pending appeal on the basis of Rule 62(c).”).
While I recognize that prohibiting a stockholder from exercising her franchise rights can amount to irreparable harm, in this case, any such harm is, in large measure, self-inflicted. Because Plaintiffs chose to submit their nomination notice on the eve of the deadline set by the advance notice bylaw, and then chose to wait weeks after that submission before they initiated litigation, this case did not reach Chancery until August 24.
Since then, the Court has been fully accommodating, including by ordering expedited proceedings, scheduling trial as requested, and entering an opinion three business days after the matter was submitted for decision. Inexplicably, no appeal has been filed, and no expedited treatment has been sought. Plaintiffs cannot now, claiming irreparable harm, ask the Court to grant a motion that essentially affords them the injunctive relief they were denied in the plenaryaction in order to relieve time pressure caused by a build-up of steam they themselves helped to generate.
6. Factor (iii) of Kirpat weighs heavily in favor of Defendants because they will experience substantial harm if the Motion is granted. Again, if Defendants are enjoined from holding their annual meeting, then Plaintiffs will have obtained much if not all of the relief they sought and were denied after a trial on the merits. Plaintiffs lost after trial. That means they were afforded an opportunity to prove that Defendants breached the advance notice bylaw by rejecting Plaintiffs’ nomination notice, but they failed to present sufficient evidence to prove that claim. Given that the very purpose of an advance notice bylaw is to “permit orderly . . . election contests,”17 to deny CytoDyn the benefit of its advance notice bylaw by forcing a delay of its annual meeting, particularly after it prevailed at trial, would cause harm to the Company.
7.Not only would an injunction pending appeal frustrate the very purpose of the duly enacted advance notice bylaw in this case, it would also likely facilitate “an attempt to circumvent” the substance of the Opinion.18 Even if the attempt is As Defendants observe, Plaintiffs bid to force CytoDyn to delay its annual meeting might reasonably be viewed as a belated attempt at a do-over. Regardless of the results of the appeal, having disrupted and delayed the conduct of the duly noticed annual meeting, the product of good faith, the fact remains that Plaintiffs had an opportunity to prove that the annual meeting should not proceed without the inclusion of their slate of director nominees but their proof fell short. They may seek an appeal of that determination but, in doing so, they may not cause the Company to suffer the very harm Defendants avoided by prevailing at trial.
8. Defendants would be harmed in other respects as well. CytoDyn’s stockholders have been informed that a meeting will be held on October 28.19 All steps necessary to conduct that meeting have been taken. Cancelling it a week before it is to go forward would result in substantial costs and serious confusion.
9. Factor (iv) of Kirpat asks the Court to determine whether the public interest will be served if the Motion is granted. Who controls the board of directors, although “critically important to the litigants” and other stakeholders, implicates the “private interests of particular corporate constituencies,” not the public interest. To the extent the public interest is served in defending stockholder rights, which rights are “sacrosanct,”Plaintiffs’ interest in exercising their franchise is balanced
Plaintiffs may well have the opportunity to submit a new nomination notice that corrects the significant deficiencies in their failed notice.
In this case by the order and predictability that the advance notice bylaws seek to create and that Defendants and other CytoDyn stockholders are entitled to under the Opinion. Plaintiffs will have their chance to nominate their director slate, and to do so in compliance with the advance notice bylaw, at CytoDyn’s 2022 annual meeting.
10. Based on the foregoing, I am satisfied that Kirpat factors (ii)–(iv) and the balance of equities weigh in favor of denying the Motion. And Factor (i) cannot save Plaintiffs’ Motion because “the other three factors” do not “strongly favor interim relief,” and granting the Motion would not otherwise be an “equitable resolution.” Indeed, in my view, factor (i) weighs in favor of denying the Motion.
Plaintiffs’ attempt to liken this case to Icahn P’rs LP v. Amylin Pharms., Inc., 2012 WL 1526814 (Del. Ch. Apr. 20, 2012) is misleading. In Icahn, plaintiffs sought and were granted expedited scheduling of their claim to cause the target company to waive its advance notice bylaw because the company was facing a “critical time” after it was presented with an acquisition proposal, resisted by the board, that would have delivered a substantial premium to stockholders. Id. at *3.
According to Plaintiffs, CytoDyn is also confronting a “critical time” as evidenced by its recent disclosure that “there is substantial doubt as to the Company’s ability to continue as a going concern.” Of course, Plaintiffs neglect to mention that the Company has made that identical public disclosure on a regular basis for more than a decade. This is not at all surprising given that CytoDyn is a clinical stage biopharmaceutical company that has yet to bring a product to market.
The Opinion did not break new legal ground or radically extend settled law. Following our Supreme Court’s clear direction in Saba, in the absence of evidence of manipulative behavior by Defendants that might have affected how Plaintiffs chose to prepare and submit their nomination notice, I determined that Blasius did not apply to my construction and application of an advance notice bylaw validly enacted on a proverbial clear day. I did, however, reserve room for Plaintiffs to invoke equitable considerations of fairness to ensure the shareholder franchise is protected. Ultimately, however, Plaintiffs failed to prove any basis to invoke equity to force CytoDyn’s board of directors to accept a facially deficient nomination
Plaintiffs point out that I stated in the Opinion’s introduction that “the law in this area may not be as settled as one would think.” Opinion at *1. While Plaintiffs correctly quote the Opinion, they fail to quote it completely or in context. The entire sentence reveals that the Court was simply expressing surprise that the parties could not agree on the standard of review given “the density of our jurisprudence in the ‘advance notice bylaw’ space.” See id. (“In a twist that suggests the law in this area may not be as settled as one would think, particularly given the density of our jurisprudence in the ‘advance notice bylaw’ space, the parties have offered two very different perspectives of the standard of review by which I should review the evidence and ultimately adjudicate the dispute.”).
DATED: October 20, 2021
/s/ Joseph R. Slights III
Vice Chancellor
Chuckles,
Have you ever seen the DOJ take the lead investigating a violation of securities laws and keep the SEC (the Securites and Exchange Commission!!) in the dark?
Having difficulty appreciating the nuance of some of what has been shared with me, I went to the SEC website to find this explanation.
Scooter,
Which part of the 10-k statement:
"The SEC has informed the Company that this inquiry should not be construed as an indication that any violations of law have occurred or that the SEC has any negative opinion of any person, entity or securities trading activity."
do you construe as:
Dark nadir,
Perhaps you can direct me to any source that the DOJ provides such assurances to any entity?
Where in the 10K (or any subsequent 8-k) does it say that Cytodyn is under investigation by the DOJ? That would seem to be a material event, requiring an 8-k. Perhaps I missed it, can you find it for me?
Please and thank you.
I believe the information sought by the DOJ is related to the Cintron report and manipulation of June 30, 2020.
Report issued, 10 M shares dumped, SP plummeted 50%, SP rebounded, report removed (but saved by many, would you like a copy?).
I assume you are aware that the DOJ investigates other branches of the government. Perhaps this is part of a long-overdue investigation of the FDA.
Many possibilities. Who knows, maybe the long overdue bankruptcy will happen (this week, next week, 2031?) us all lots of effort trying to ferret out the truth.
Only 10 months until the next 10K with more tantalizing tidbits.
Patience!!
Scooter,
I went to page 125 of the 10K.
This is the exact statement:
I've been patient.
Really, really patient. But what the heck, where is the promised bankruptcy?
Scooter,
Please be patient. I’ve heard that Leronlimab trials are enrolling quickly.
I assume that is what you’re referencing with “ terrible track record of get enrollments done”.
Which comes first for humanigen, another reverse split or completion of additional enrollments sufficient to fail, again?
Chuckles,
Yours math is just fine, unless we’re shooting for low scores (Ryder Cup was on the other channel, great job USA!).
Plus, Leronlimab demonstrated 82% reduction in mortality, not merely reduction in ventilator-free mortality.
Who wants to to spend the rest of his days on a ventilator?
No thanks.
Scooter,
Perhaps you have missed that both severe and critical Brazilian Leronlimab trials are enrolling.
Cytodyn hit, wait, crushed mortality endpoint, at 14 days in critical Covid.
Lenzilumab, not soo much.
For all who appreciate the methodical process of scientific trials, let’s check back in November,
Until then, the race for the MLB pennant is a good diversion.
#RedsoxNation
SmileyRiley,
Thanks for sharing. I am a huge fan of Dr. Seethamraju, aka “hero doc”. Profoundly intelligent, learned and under stated.
His presentation of the Montefiore of EIND patients at the ISIRV conference was profoundly compelling.
https://d1io3yog0oux5.cloudfront.net/cytodyn/files/video/ISIRV+Harish_Seethamraju+Presentation.mp4
However, I remain profoundly confused.
How possibly can we be considering new directors when we were promised that Cytodyn would be bankrupt by September 22 at 13:18:07?I seemed to have missed the PR announcing the bankruptcy filing.
Really stinking weird.
Cytodyn was supposed to be bankrupt today (somehow I missed the PR) and yet Cytodyn up 10% amd 90% over the last 9 trading days.
Jdf,
Would you like me to find the video where Bruce Patterson, in his evaluation of patent responses to Leronlimab noted, “Anecdotes don’t come off life support”?
I thoroughly appreciate the effort Brazilian researchers and administrators are putting into the Leronlimab covid trials, updating trial information in the wee hours of the morning and even on weekends.
Perhaps the announcement that the Philippine FDA has requested additional discussions with Cytodyn has compelled them to act with greater urgency.
Regardless, the ANVISA trial registry has listed multiple trial site updates over the past week, including one already for today.
Feel free to follow along at home through this very helpful link:
https://plataformabrasil.saude.gov.br/login.jsf
Daemon,
We’re ***** Going!
From PR:
There appears to be a lot of concern whether Brazilian trials are continuing.
Remember, Samsung make Leronlimab, but fill and finish done stateside.
No one has asked for my assistance with inventory, but I am confident there is more than sufficient product for the trials. A week back others were lamenting the loss due to expiration of Leronlimab. That is only any issue for finished product, not bulk Leronlimab which can be kept frozen seemingly forever.
Brazilains continue their preparations for the trials, with three updates posted today.
I’ll offer that they are not likely to engage in this activities were the trials not about to commence.
I am not excited that the Brazilian trials have taken so long to begin. The web of regulatory impediments are far beyond my ability to unravel, but I trust that Biomm is managing this.
However, I am excited to find a comprehensive list of trial sites, stolen without shame from another site.
It looks as though, once initiated, the trials should enroll quickly.
Kgromax,
Your assessment of the clinical trial results is substantially more negative than mine, but each to his own.
I have lost track of the thread, but it seems that some are struggling to appreciate that ANVISA has in fact approved the Cytodyn Covid trials
There has not yet been an announcement of patient dosing, much to my consternation. There are invariably a myriad of explanations, from the incredibly banal to the outlandish. I’ll wait for verifiable information from trusted sources.
Nonetheless, here are screen shots from the source, ANVISA, both in Portuguese and the translated version in English.
Also, included is the link so any may search for himself.
https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2021/estudo-clinico-com-o-anticorpo-monoclonal-leronlimabe-e-autorizado-pela-anvisa
Finally, here is the master list of approved trials in Brazil.
https://www.gov.br/anvisa/pt-br/assuntos/medicamentos/pesquisaclinica/arquivos/ensaios-clinicos-covid.pdf/@@download/file/Ensaios%20Cl%C3%ADnicos%20autorizados%20para%20COVID-19%20pela%20Anvisa_20.08.2021.pdf
Leronlimab is listed on page 21, items 103 and 104 for the moderate and clinical trials respectively.
This is a pdf document in Portuguese which I have made the effort to translate, but remains clear in its purpose nonetheless.
kgro,
I guess I'm caught in your "trap"
The CD12 data demonstrates that the incidence of SAEs with the administration of Leronlimab is, at worst, equivalent to incidence of SAEs with placebo.
Soooo, Leronlimab is safe, even in Covid patients.
Thanks! I guess you're in the trap as well.
To rehash previous discussions, yes the subgroup analysis of critical/intubated patients in CD12 examines a subset of an already relatively small trial.
Nonetheless, these results are a great indicator of the efficacy of Leronlimab in ameliorating immune dysfunction in critical covid.
Scientific method in action. Refine the experiment and test the hypothesis once more.
The results of CD12 align with the hypothesis that antagonism of CCR5 by leronlimab down-regulates immune hyper-activation and cytokine storm with, as Dr. Patterson demonstrated last year, immune restoration, reversal of T cell lymphopenia and elimination of viremia.
How does one refine the experiment?
Great question. Better clinical trials.
Thus, CD16 and CD17 Brazilian trials
Separate trials for moderate (severe) and critical populations
Add IV administration for critical patients (improved pharmacokinetics - route of administration is important by the way)
Utilizes four doses rather than two (10 day half-life, again the issue of pharmacokinetics)
More than doubles the trial size (612 moderate, 316 critical)
Will be conducted by Albert Einstein Hospital, as best I can appreciate a significant step up from Amarex.
Make certain placebo and treatment arm populations have similar characteristics (I fully expect that there will be no issues of age assortment in these trials).
Ombowstring,
There is no denying IMO that Dr Patterson is a remarkable scientific talent, in spite of the many posters who have said that the only real researchers are PhDs.
Nonetheless, the Brazilian Covid trials are we designed and will undoubtedly be well executed by Albert Einstein. There is no need for Dr Patterson or anyone else to hold their hand.
Time would be better spent contemplating Brazilian beach or cuisine.
Glad to hear you’re a Bucks fan.
They’re championship was long overdue.
Clinical trials are the means by which researchers determine if a treatment is effective AND safe for the patient.
The clinical benefit of medications must not be outweighed by any deleterious effects from the medication.
How is this evaluated?
Ideally by comparison to a placebo arm in randomized, blinded clinical trials like CD12 and the upcoming CD 16 and CD17.
Severe adverse events happen, unfortunately, in both the patient population administered the medication under investigation AND in the Placebo group.
So what is one to assume if the incidence of adverse events is the SAME in both the placebo and treatment arms?
One assumes that the treatment medication did not cause adverse events, as the incidence of such events is not increased above the baseline incidence (the same incidence as experienced by patients in the placebo group).
Ombowstring,
I believe authorized shares 800m, with ~650m issued.
Please provide any evidence supporting your belief that there are no shares.
That is the first I’ve heard this.
Thanks
Ombowstring,
I believe that it is only Cytodyn paying for the trials. While we have been told by posters here that Cytodyn will be bankrupt in a few scant weeks, I doubt that Fife will stop lending to Cytodyn, as debt is quickly converted to shares and sold.
I’d look for an update on the SEC filing page of Cytodyn.com
Cytodyn will soldier on.
Weasel,
I believe it is around 20 hospitals systems for each trial, a few more with moderate than critical.
That being said, some of the trial site listings are for hospital systems, with multiple locations for the system. There is a relative paucity of information online relative to the US, so it is difficult to find great detail.
The https://plataformabrasil.saude.gov.br/login.jsf system is easily translated to English in Manaus browsers, but is still a bit clunky at times.
There are absolutely hospital running both trials.
I’ll work on a summation of the institutions hosting each of the trials.
Evil Rabbit,
Everyone must think I'm a rube. I was asked to contribute $7500 if my share count was over 50,000.
The sliding fee scale you posted indicated that the prospective 13D member, whose information you shared, was only asked for $7500 if he held a position over 100,000 shares.
Brazilian ANVISA lists BOTH Leronlimab covid trials as approved.
Outstanding that this document was released on Friday the 13th. Very helpful for those suffering triskaidekaphobia and concerns that there is some scam afoot that has embroiled dozens of Brazilian hospitals and thousands of physicians.
Phewwww!
Lest any be concerned that these documents are fabricated by an ostensible Paramedic with preternatural photoshop skills, here is a direct link.
Thanks to google for translation, as I am only fluent in English.
https://www.gov.br/anvisa/pt-br/assuntos/medicamentos/pesquisaclinica/arquivos/ensaios-clinicos-covid.pdf/@@download/file/Ensaios%20Cl%C3%ADnicos%20autorizados%20para%20COVID-19%20pela%20Anvisa_13.08.2021.pdf
Ter um grande dia!!
Amber,
Your assessment is spot on. The 2:1 certainly magnified the impact of unequal assortment.
The upcoming trials are better constructed in a number of ways.
If these trials fail to demonstrate benefit I will gladly eat my words.
C-20,
The CD12 trial was one severe/critical rolled into one, which did not work well for a number of contested reasons.
The two trials in Brazil are designated moderate (would be severe by US criteria) and critical.
The critical is only intubated and ECMO patients, replicating the patient sub-population of 62 with the previously discussed 82% reduction in mortality at 14 days. That has not yet been approved and their have been updates on clinical trials registry within the last week.
I expect an announcement from Biomm and/or Cytodyn at any time, but no confirmation yet that the critical has started.
I know this is more than you asked, but hope not to leave out any details in my explanation.
Thanks.