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I don't understand why the first item listed on the docket summary indicates a "retired" petition, but if this is active, I'm relieved to see that it is a Ch 11 filing.
I was hoping to avoid the additional delay this could represent, since "time" is a resource that I would like to make far better use of expending. I don't see any communication from the company yet in this regard. But I know that this was a component employed for the first recall of our loaned shares.
There was a slight change to Humanigen's corporate account on the X platform today. One post appears to have been deleted. I hope this leads to additional updates soon.
https://twitter.com/humanigen
This at least should bode well for the "HumaNova" vaccine, assuming that there is such a thing outside of the confines of my mind, LOL! I like Florida's Surgeon General.
This is another issue that we'll just have to disagree on, but as I have been saying, you could be right.
I think this is just the consolidation of shares from the various Dale entities into the main beneficial ownership account to be transferred to a partner. Of course, the transferred shares won't be valued at the current price when they are placed with the partner.
Volume "traded" >5M shares so far today. Howdy, partner! Looking forward to meeting you.
You could be right, Tank.
But I read this as an Appeal filed by Black Horse.
"October 4, 2023 Filing 1 CIVIL CASE DOCKETED. Notice filed by Appellants Black Horse Capital LP, Black Horse Capital Master Fund Ltd, Dale B. Chappell and Cheval Holdings Ltd in District Court No. 2-23-cv-03769. (PDB) [Entered: 10/04/2023 10:04 AM]"
Chapter 1 The Scientific Revolution of Therapeutic Care
Humanigen's Lenzilumab is producing results that far exceed the scope of benefit beyond the application of treatment of rare blood cancer, as originally intended.
Here was the plan.
see slide 6:
https://www.humanigen.com/_files/ugd/daef6a_55106aa0f6c94de0bbb24b3e0c510201.pdf
Here is some discussion of CMML and how it can transform into Acute Myeloid Leukemia.
https://www.cancerresearchuk.org/about-cancer/other-conditions/chronic-myelomonocytic-leukaemia-cmml/what-is-cmml
We have seen both success and failure to enhance the Standard of Care drug, azacitidine. We see that Gilead's effort, using Magrolimab, failed.
https://www.gilead.com/news-and-press/company-statements/gilead-statement-on-the-discontinuation-of-magrolimab-study-in-aml-with-tp53-mutations
However, azacitidine plus lenzilumab showed that, "... GM-CSF neutralization with LENZ and AZA resulted in changes in that trended towards normal values."
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10429006/
In CAR-T, lenz does more than just reduce ICANS and neurotoxicity. It also appears to improve the efficacy of the treatment therapeutic.
The degree of improvement in these cancer patients, showing normal hematological parameters, is revolutionary. It is leading to successful bone marrow transplants, as seen in the RATinG study, which could eradicate the cancer in these patients.
However, the biggest impact of lenz, which basically caused management to re-write their book, was seen in Survival Without Ventilation (SWOV) for hospitalized and hypoxic patients with covid pneumonia.
"Effect of CRP<150 mg/L on SWOV and secondary endpoints in
LIVE-AIR
In participants with baseline CRP <150 mg/L, lenzilumab
improved the likelihood of SWOV compared with placebo
(HR: 2.54; 95% CI 1.46 to 4.41; nominal p=0.0009...)"
see page 5:
https://thorax.bmj.com/content/thoraxjnl/early/2022/07/05/thoraxjnl-2022-218744.full.pdf
The NIH Covid-19 Treatment Guidelines recognized this efficacy in their March 24,2022 edition, as seen on Humanigen's home page.
"The updated interpretation of LIVE-AIR concludes “Lenzilumab improved ventilator-free survival in participants with hypoxemia who were not receiving MV, with the greatest benefit among those with lower CRP levels”, based on the increased incidence of ventilator-free survival observed in patients with CRP <150 mg/L (90% vs 79%, HR 2.54; 95% CI, 1.46–4.41; P=0.0009)."
https://www.humanigen.com/
I'm hopeful that Novavax, AstraZeneca, Janssen, and other covid vaccine manufacturers will incorporate lenz with their vaccines, and that the result will be the eradication of covid, as we may be seeing with the eradication of certain Myelodysplastic cancers.
Does this have to do with a conversion of investors' funds by the SEC once again? Did Humanigen have funds in an entity that was convicted by the SEC, with the disgorged funds transferred to the US Treasury Department, instead of being returned to injured investors, such as Dale's entities? Is it to be expected that Dale is the type of person that would file an Appeal, seeking to recover the funds that rightfully belong to his investors, including Humanigen, that the SEC obtained?
I don't know, and haven't looked into it. This abuse of discretionary authority is typical of the SEC. But my focus has been on the abuse of discretionary authority by other government agencies, such as NIAID, the NIH, and the FDA. These agencies are guilty of willful negligence, resulting in the loss of millions of lives already, with the very real prospect of additional millions of preventable deaths on the horizon.
Luckily, Dale has the capacity to multi-task, unlike me, and he knows who the beneficial owners are of Humanigen's shares, where I can only surmise who they are. Go get 'em, Dale!
Happy Q1 !!!
We've never been stronger, and where there is this much potential for regulatory and commercial success, there is likely to be serious financial interest in capitalizing on Humanigen's success.
Will management be able to meet their financial requirements exclusively through a 5:1 forward stock split?
Or will it be necessary to continue the controlled equity offering and initiate a Private Placement as well?
Or, can we mitigate the increase to our Outstanding Shares through the reception of an Advanced Purchase Agreement?
https://www.classicfm.com/discover-music/auld-lang-syne-lyrics-and-origins/
It's the pictures of the nurses' faces that strike me the most: whether they are watching their colleagues trying to resuscitate a covid patient; or attending a vigil for a fallen nursing colleague.
https://www.yahoo.com/news/mask-mandate-reinstated-los-angeles-052707518.html
I realize that several of our LIVE-AIR trial doctors have potentially competing interests relating to this nexus of Big Pharma and Regulatory Agencies.
"Competing Interest Statement
ZT has received research support from Humanigen, Inc, unrestricted education support from Gilead, ViiV, and Merck (all to the institution). CFK has received research support grants (to the institution) from NIH, CDC, Gilead Sciences and ViiV; VCM has received investigator-initiated research grants (to the institution) and consultation fees (both unrelated to the current work) from Eli Lilly, Bayer, Gilead Sciences and ViiV; AK, CD, DC, OA, GC are employees of, or consultants to, Humanigen, Inc. VMC and FC are third-party agency consultants to Humanigen; CP is a paid consultant to Gilead. ADB is supported by grants from NIAID (grants AI110173 and AI120698) Amfar (#109593) and Mayo Clinic (HH Sheikh Khalifa Bin Zayed Al-Nahyan Named Professorship of Infectious Diseases). ADB is a paid consultant for AbbVie and Flambeau Diagnostics, is a paid member of the DSMB for Corvus Pharmaceuticals, Equilium, and Excision Biotherapeutics, has received fees for speaking for Reach MD, owns equity for scientific advisory work in Zentalis and Nference, and is founder and President of Splissen Therapeutics.
Clinical Trial
NCT04351152
Funding Statement
This study was funded by Humanigen, Inc. Burlingame, CA"
https://www.medrxiv.org/content/10.1101/2021.12.30.21267140v1
And I further realize that an objective reporting of the trial conclusions should be all that is required.
But that can't be permitted to cause the harm we are seeing reflected on the faces of our healthcare community, when regulatory approval of lenz could vastly improve their plight and save patients' lives.
All discretionary authority should be rescinded from government agencies. It is not a radical concept to expect them to follow the laws as written.
Preciouslife1's most recent post of a link to the publication of findings that a subgroup of tested MS patients suggested, "...that the stem cell transplant reduced inflammation.
MS is an unpredictable disease that impacts the central nervous system and disrupts the flow of information between the brain and the body, leading to a wide array of symptoms, including numbness, tingling, mood changes, memory problems, pain, fatigue, blindness and paralysis."
https://nypost.com/2023/11/28/lifestyle/stem-cell-therapy-in-brain-to-curb-ms-shows-promise/
This study was typical of the studies that appeared in 2020. And like those studies, the symptoms displayed by patients matched those that began to present in my wife, who had on-again/off-again covid diagnoses, with cancer, and ultimately died of senile degeneration of the brain at 67 years old. So she had to deal with the loss of motor control and sensory depravation, during the time that medical facilities locked-down. This meant that, despite the nurses' best efforts to wheel her to a visitors' window, and hold her cell phone for her, my wife couldn't see me or hear me
The PREACH-M and RATinG trials of lenzilumab lead to include controlling adverse reactions to bone marrow transplants. Since MS treatment is complicated by brain inflammation and neurological disorder, it seems lenz could aid in adverse reaction to stem cell transplantation. But I suspect that this could be just one of a myriad of applications for treatment by lenz.
Awesome find!
Chapter 2 The ancillary benefits
In our first quarter 10-Q, the company described current trials of lenzilumab that were all sponsored by partners. The trials focused on CMML, aGvHD, and CAR-T.
In each indication, lenzilumab promises to have demonstrated game-changing improvement, which could lead to long-delayed Regulatory authorizations or approvals. Shareholders and patients will welcome these authorizations and approvals to get lenz into the market. This was, after all, the primary focus of management, prior to 2020.
cowtown jay
@cowtown_jay
I wonder if AZ will show the same interest in lenz or ifab for a vaccine adjuvant or ADC, that they may have shown in the lenz-enhanced CAR-T by Gracell. Mayo is the only other entity that I know who has studied lenz for both covid and CAR-T, why aren't they advocating for us?
This is why I think Novavax really needs Humanigen's lenzilumab as an adjuvant in their prototype vaccine. They currently produce the only protein-based covid vaccine in the US.
AstraZeneca and Janssen both produce adenovirus covid vaccines approved in Europe. I think lenz could work well as an adjuvant in all three vaccines, and it could result in millions of doses of lenz in demand.
I was wondering the same thing, especially with today's volume. I've been trying to convince myself, though, that Humanigen is the buyer. The problem with that is, I don't know who in their right mind would be selling.
And as soon as I finished that last sentence, it hit me. This volume could just represent the continued accumulation of shares in preparation for a stock-for-stock merger.
Maybe for AZ's Vaxzevria?
I didn't know about Vanda suing for denial of fast track.
https://pink.citeline.com/PS146273/US-FDAs-Fast-Track-Designation-Policy-Faces-Unusual-Legal-Challenge#:~:text=Vanda%20Pharmaceuticals%20contends%20the%20agency,the%20designation%20and%20granted%20173.
Interesting case. I'm not sure how it may relate to us. In general, courts recognize the discretionary authority of agencies where it has been granted.
But, willful or criminal negligence is different, and an AG like Ken Paxton in Texas could look into this, if presented with solid reason as to why he should. I think we may have sufficient reason to investigate, if necessary.
Don't be too sure about that, Yooo. Lenz is currently only authorized with an IND status. This could lead to a full Approval of lenz by the FDA and overseas Regulators.
That's exactly right. If lenz is being used as the game-changing therapeutic that dramatically enhanced Gracell's CAR-T (think 24 hour cycle to customize patient treatment compound, versus 6 weeks+), then that should, at a minimum, represent a licensing fee source of revenue for Humanigen.
Congratulations to former Humanigen Board member Kevin Xie and Gracell Biotech.
"AstraZeneca to buy China's Gracell Biotechnologies in $1.2 billion deal
By Urvi Manoj Dugar and Christy Santhosh
December 26, 20237:17 AM CST"
https://www.reuters.com/markets/deals/aztrazeneca-buy-china-based-gracell-biotechnologies-12-bln-deal-2023-12-26/#:~:text=Dec%2026%20(Reuters)%20%2D%20AstraZeneca,world's%20second%2Dlargest%20pharmaceuticals%20market.
My question regarding Gracell has been if lenzilumab has enhanced the safety and efficacy of their CAR-T therapy.
But why the mystery with the delayed filings, and the peek-a-boo with the latest Form 4, including today? Why buy the Baudax shares? Why present at the ASH conference? Potentially bad news doesn't need to be hidden. We're all aware of that potential. I think management, especially because our future course will be tied to other entities and various outcomes, has taken the course they are on to cloak our progress in these multiple areas, until they have been concluded. It's anyone's guess, but this is mine.
Taking a look at Humanigen's latest discussion regarding the nature of our business, we see the following.
"1. Nature of Operations...
The Company’s lead product candidate, lenzilumab, or LENZ®, and its other product candidate, ifabotuzumab (“iFab”), are Humaneered monoclonal antibodies. The Company’s Humaneered antibodies are closer to human antibodies than chimeric or conventionally humanized antibodies and have a high affinity for their target. In addition, the Company believes its Humaneered antibodies offer further important advantages, such as high potency, a slow off-rate and a lower likelihood to induce an inappropriate immune response or infusion related reactions.
The Company is developing lenzilumab in chronic myelomonocytic leukemia (“CMML”), a rare blood cancer, for which the Precision Approach to Chronic Myelomonocytic Leukemia (“PREACH-M”) study is underway, and is continuing its plans for the Risk Adapted Therapy in Acute GvHD (“RATinG”) study in acute graft versus host disease (“aGvHD”) that occurs in patients undergoing bone marrow transplant, as these studies are majority funded by its partners. In April 2023, the Company announced that as of December 31, 2022, eleven subjects had been dosed with lenzilumab and with current standard of care, azacytidine, in the PREACH-M study. Six subjects were evaluable based on at least three months of follow-up, including those with high risk CMML, and all demonstrated clinical benefit. In addition, LENZ appeared to be well-tolerated. The Company anticipates the first patient dosing in the RATinG study to occur in the second quarter of 2023. A leading network of centers, The Mayo Clinics, is currently progressing with an investigator-initiated trial (“IIT”) of lenzilumab in combination with CAR-T therapies."
see pg.8
https://www.sec.gov/ix?doc=/Archives/edgar/data/1293310/000121465923007002/hgen-20230331.htm
Approval to treat CMML was a target objective that, "I don't see how we could: Miss getting an expedited approval to treat CMML from the Australian government, complete with a possible $100M+ Priority Review Voucher..."
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172877542
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173383975
Results of that effort were presented at the latest ASH conference.
"All patients (5/5) in INNATE-1 showed 100% response (CR or optimal marrow response resulting in <5% blasts) to AZA/LENZ. Two subjects (2/6) in INNATE-2 demonstrated partial responses or haematological improvement thus far.
Conclusion: CMML is a disorder of profound innate immune activation, driven by GM-CSF and other pro-inflammatory cytokines. Early treatment with LENZ/AZA, a precision immunotherapeutic approach, leads to a) efficacy in INNATE-1 that exceeds historical CR rates for hypomethylating agents1,2; and b) evolving efficacy in INNATE-2, in which pro-inflammatory activity is more robust."
https://ash.confex.com/ash/2023/webprogram/Paper179706.html
This tendency for lenz to perform so well in the early stage of disease progression, when cytokine levels are lower, was also exhibited in the ACTIV-5 trial compared to the LIVE-AIR trial, in my opinion. I also believe that it is accurate to say that lenz, for this indication, could prove to be a preventative, versus just a therapeutic, since CMML is myeloid-driven, and lenz modulates the production of those myeloid cells.
Acute Graft versus Host Disease (aGvHD) was also detailed in Humanigen's10-K as a developmental treatment target, and was included in my list of catalysts and was a target that I did not think we could miss. The first patient patient was dosed in the on-going RATinG study (Risk Adapted Therapy in Acute GvHD) as the company announced in August.
https://ir.humanigen.com/English/news/news-details/2023/Humanigen-Announces-First-Participant-Dosed-in-RATinG-Trial-of-Lenzilumab-for-Early-Treatment-of-Acute-Graft-Versus-Host-Disease-Following-Allogeneic-Stem-Cell-Transplantation/default.aspx#:~:text=The%20RATinG%20trial%2C%20a%20Phase,stem%20cell%20transplant%20(HSCT).
In addition to the PREACH-M and RATinG studies Humanigen disclosed were in development, and which I included as target objectives in our list of catalysts, the company also noted Mayo Clinic was conducting an Investigator Initiated Trial (IIT) of the use of lenz in CAR-T therapy. In addition, we see Gracell also conducting an IIT in the US for their CAR-T platform. And we see label updates for Gilead/Kite's yescarta and tecartus. Together, these CAR-T developments before and following the ASH conference could suggest a critical role for lenz in CAR-T.
https://www.sec.gov/Archives/edgar/data/1826492/000110465923126860/tm2332578d1_ex99-1.htm
I could go on and talk about lenz for covid, or about lenz and ifab as ADC's, but the point of the post was to look at what Humanigen stated were the projects they were working on, and how that progress seems to have progressed.
What I would most like to see for Christmas, or in the week following, is Humanigen's announcement of the recall of their loaned shares, coupled with some news in regards to either regulatory approval, or a business combination or partnerships.
Speaking of interesting clinical trial correlations, here's another reporting similar progress.
U.S. FDA Approves Label Update for Kite’s Yescarta® CAR T-Cell Therapy to Include Overall Survival Data
December 21, 2023
https://www.businesswire.com/news/home/20231220595740/en/U.S.-FDA-Approves-Label-Update-for-Kite%E2%80%99s-Yescarta%C2%AE-CAR-T-Cell-Therapy-to-Include-Overall-Survival-Data
When it comes to Yescarta/Tecartus, and the Zuma trials with the different suffixes, I'm totally lost.
We had this from Zuma-19:
ZUMA-19: A Phase 1/2 Study of Axicabtagene Ciloleucel Plus Lenzilumab in Patients With Relapsed or Refractory Large B-Cell Lymphoma
NOVEMBER 15, 2022
https://ashpublications.org/blood/article/140/Supplement%201/10318/489550/ZUMA-19-A-Phase-1-2-Study-of-Axicabtagene
So despite not having a conclusion that I can draw, since I think we pulled out of one of the Zuma trials, I mention this news regarding the FDA approval of the label update, just in case it sheds light on how this treatment progress is being made.
I'd like to know if there are alternative therapies achieving similar results to lenz.
Well, the majority opinion here may be that the latest Form 4, which disappeared briefly again before the market opened today, reflects sells by Dale's entities.
I don't agree with that. I think these shares are being accumulated for transfer to a partner in a stock-for-stock merger agreement. I really hope that is correct, and that the partner proves to be Novavax.
But, a new potential partner's name seems to be developing, perhaps under the same umbrella of companies corroborating with SpringWorks Therapeutics. And we still can't discount that these shares may be going to Baudax/TeraImmune.
I believe either the 10-K or the Q1 10-Q actually mentioned both a possible business combination, as well as partnerships. So if interest in a business combination was re-kindled, we could see shares going to more than just one other entity.
Further, I think the HGEN share price projection could explain the back-and-forth movement of the Form 4.
I second that emotion, Tank.
I see that our latest Form 4 may have been tweaked again this morning. So I hope this thing is good to go.
I'm not selling shares until after lenz gets regulatory approval. So this stock price if frustrating as hell, but it is also irrelevant.
You will see billions in revenue if we get a covid EUA. I think Paxlovid, which was generating about $13B for Pfizer, could lose a substantial part of the therapeutic market to lenz, especially now that studies are showing rebound cases of covid are 10X higher than Pfizer claimed. Their vaccine could also lose market share to Novavax, if their protytype vaccine incorporates a lenz adjuvant.
I think you're smarter than what is reflected in your posts. I hope you will reassess your statements.
You did not document any major mistakes made by management. You stated your opinion that we should have paired with Big Pharma.
I, for one, am a staunch supporter of maintaining our independence, where shareholders will actually be able to feel the effect of billions of dollars in revenue hitting the top line.
Yes, some personal attacks have already started, unless saying that my ego is over the top, and that I'm really bizarre, is not to be taken personally, LOL! Sounds like you're taking online psych classes from WaWa Yooo.
I mean really, when I show you trial data and link peer reviews in support of what management has accomplished, and demonstrate how the ACTIV-5 data was skewed, you come back with some barb about me drinking KoolAide?
There's no excuse for looking at the data, and not concluding that the FDA should have awarded us an EUA. That negligence is permitting the preventable loss of life. Are you seriously condemning management, and defending the FDA?
The trial size was determined with management and the FDA. Compare that trial size to the initial design of ACTIV-5.
"Approximately 200 (100 treatment and 100 shared placebo) subjects will be assigned to each arm entering the platform..."
https://clinicaltrials.gov/study/NCT04583969?intr=lenzilumab&rank=2
Or look at the plan for LIVE-AIR.
"Approximately 516 patients will be randomized to receive lenzilumab + SOC vs. placebo + SOC in a 1:1 ratio."
https://clinicaltrials.gov/study/NCT04351152?intr=lenzilumab&rank=3
If our trial size was too small to qualify, then doesn't that also mean that the ACTIV-5 trial was too small to disqualify? Yes, I know they bumped up the population, but not beyond our trial population.
And what about sabizabulin?
"A total of 204 patients were randomly assigned to treatment..."
https://evidence.nejm.org/doi/full/10.1056/EVIDoa2200145
Of course, Veru claimed that, "The mortality rate was 20.2% (19 of 94) for sabizabulin versus 45.1% (23 of 51) for placebo." Ridiculous.
Is the new antagonist here another of your plebes? Are you trying to show him how it's done?
I have nothing to compare to Humanigen. The development of lenz for the covid indication, along with the already in-progress cancer application development, coincided with my wife's cancer (and covid?) progression, and it gave me an unimaginable appreciation for what this drug could, and should, be doing to save lives.
My biggest fear is that the worst, by far, is still ahead of us.
I take solace, though, in deeply believing that this management team is as capable of performing as is lenzilumab, and that when regulators are forced to depend on us, Humanigen will be prepared to meet the challenge.
I live in Humaniworld, you're right about that. When I have evidence that demonstrates my conclusions, as I have shown you, then I definitely have more regard for my own opinion, than I do for unsubstantiated contrarian views. Call that ego, if you like. I call it confidence.
I think if anyone can look at the clinical trial results, and the peer reviews, and STILL blame management for not having regulatory approval, then congratulations! You are a model citizen and qualify as a Little Brother for the Big Brother Bureaucrats who seek to control your life, for which they have less concern than they have for their own favor.
I see that you're just stuck on your agenda, and wasting my time. Humanigen's LIVE-AIR trial was a huge success.
Millions of family members have suffered the preventable loss of a loved one, because of the FDA's abuse of their discretionary authority. That remains so today.
Anybody incapable of realizing that, and trying to misdirect responsibility for these losses of human life to management, is not someone worthy of my effort.
Please explain what covid failures got us delisted.
Management should not have to run a new covid trial. It would be too expensive, and there is no reason that requires it.
The FDA claims they wanted to see additional safety and efficacy data for lenz.
I think the PANAMO trial (NCT04333420) of Gohibic may have provided some context for Regulatory consideration of lenz, based on what the government-sponsored ACTIV-5 trial determined.
https://www.fda.gov/media/166823/download?attachment
I think Gohibic may have shown slightly better efficacy in treating late-stage patients than lenz did. But I think lenz showed a better safety profile. These patients are too progressed to have been included in LIVE-AIR, but ACTIV-5 may have inadvertently provided a secondary choice for doctors treating these late-stage patients.
In addition, the PREACH-M trial demonstrated game-changing safety and efficacy of lenz in treating CMML cancer.
And a major question regards the trial Novavax conducted for their prototype covid vaccine. I am eagerly awaiting that trial data, to see if lenz was used in the manner we patented as a vaccine adjuvant.
But aside from additional safety and efficacy data for lenz, the true safety and efficacy of Pfizer's vaccine is showing significantly less efficacy than reported in their trial, and the public, as well as the medical community, is rejecting the continued use of their covid vaccine , as well as Paxlovid.
Necessity, as it has always been, will force the regulatory approval of a re-submitted EUA application for lenz.
I call the linked peer reviews of our successful Phase III trial successful.
But I also call the PREACH-M trial of lenzilumab's treatment of CMML successful. Once this blazes the pathway of regulatory success for lenz, I think the FDA will recognize the futility of trying to save the covid market for Pfizer. In fact, that's already a lost cause, no matter how much lipstick the FDA puts on the mRNA vaccines. The public is not buying the hype.
But, the public will need a real covid vaccine and covid therapeutic. They will need lenz.
We just need to announce some news, and take an interim step back onto the OTC pink venue.
As the ACTIV-5 government-sponsored trial of lenzilumab was announced, I felt that it was nothing more than the commandeering of our successful LIVE-AIR trial results. A simple comparison of the trial designs prove that. Look at the patient inclusion criteria for the two trials.
The government-sponsored ACTIV-5 trial inclusion criteria #6:
"Illness of any duration, and requiring, just prior to randomization, supplemental oxygen (any flow), mechanical ventilation or Extracorporeal Membrane Oxygenation (ECMO) (ordinal score 5, 6, or 7)."
https://clinicaltrials.gov/study/NCT04583969?intr=Lenzilumab&rank=2
The company-sponsored LIVE-AIR trial inclusion criteria:
"SpO2 ≤ 94% on room air and/or require low-flow supplemental oxygen and/or require high-flow oxygen support or NIPPV
Hospitalized, not requiring invasive mechanical ventilation during this hospitalization"
https://clinicaltrials.gov/study/NCT04351152?intr=Lenzilumab&rank=3
The government excluded room air patients in their trial, and included patients on IMV and ECMO. Humanigen did not intend to treat patients that were as seriously ill as the government included in their trial.
And in case you haven't seen just how successful the LIVE-AIR trial results were, here are the peer reviews from Lancet and Thorax on this page.
https://www.humanigen.com/
I've been here since 2017. I know the company hoped that ACTIV-5 would corroborate our findings. But including patients in such a late-stage of disease progression in their trial, and excluding the room air patients who did so well in the LIVE-AIR trial, only demonstrates that ACTIV-5 was never going to corroborate the LIVE-AIR trial results.
Lenzilumab is going to be a blockbuster drug (generate over $1B in yearly revenue). Pfizer needs that revenue. But we don't need Pfizer, or any other Big Pharma, to capture this market potential. Durrant has already run 5 blockbuster products through the FDA validation process. And Dale is a specialist in the field of T cell memory function, having been published in his post-doctoral work with the Howard Hughes Medical Institute.
I have shown you the proof of what this management team has done. And I have demonstrated the government's effort to safeguard the revenue of their Big Pharma sponsors. Hopefully, facts will persuade you that the NIH and the FDA are the real culprits here, with the deadly abuse of their discretionary authority.
Covid killed 1.2M Americans so far, not including all those who died of covid-related indications. The CDC has just warned that hospitals could become over-whelmed again by the end of this month. That tells me that the mono-valent vaccines the FDA required are not going to work effectively against this new variant in circulation.
Humanigen's management are MBA's, but they are also doctors. They can't turn their backs on covid, and watch millions of people die, who could be saved by lenz. I don't call that royally screwing up. I call that living up to the ideals of their Hippocratic Oath, even if the business side of them could sway them to capture the less worldly beneficial course of treating cancer.
Place the blame where it belongs. The FDA and the NIH are solely responsible for keeping this company, with it's successful, peer-reviewed Phase III trial results, off the market, by abusing their discretionary authority.
Well, the problem with management providing updates, even with FLS notice, is that dumbasses get sucked into joining a Class Action Lawsuit, alleging that the company was misleading them. It doesn't matter that the tort lawyers used the ACTIV-5 government-sponsored trial of late stage patients, to dispute the results of the company-sponsored, peer-reviewed LIVE-AIR trial of early stage patients.
Why isn't the tort lawyer suing Lancet and Thorax, who validated our findings?
Because they know better. The peer-reviewers do not have the discretionary power the NIH and FDA has. They have to scientifically corroborate our reported results, which they did. There is nothing arbitrary about their findings. Like teachers used to tell us on math tests, they have to "show their work."