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"Based on the patient inclusion criteria, the LIVE-AIR patients were conservatively in ordinal scales 4 or 5 of the WHO's disease severity scale."
Unfortunately, I can't be conservative by reducing the ordinal scale range of patients in the LIVE-AIR trial.
I have to say that LIVE-AIR patients were in ordinal scales 3, 4, and 5.
And that ACTIV-5 patients were in ordinal scales 5, 6, and 7.
This is due to two facts. One fact being the NIH Covid-19 Treatment Guidelines, which recognized that, "Data from a double-blind randomized controlled trial of lenzilumab did show a significant improvement in the primary endpoint of ventilator-free survival through Day 28 among those who received the GM-CSF inhibitor..." and that, "...the lenzilumab and mavrilimumab studies primarily included patients on room air or low-flow oxygen and excluded patients receiving mechanical ventilation."
https://www.covid19treatmentguidelines.nih.gov/therapies/immunomodulators/gm-csf-inhibitors/
And secondly, the company had reported that ~60% of the LIVE-AIR patients were on room air +. Plus what, I don't recall the degree of supplemental oxygen.
I made a big deal about this previously, as I think I should have.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=169869278
Further evidence of the sustained reduction in cytokine levels is all that I want to see from this sham of a trial. It should certainly be all we need for an EUA or foreign approval.
Evidence that ACTIV-5 was designed to sabotage the reported results of the LIVE-AIR trial is clear and irrefutable.
Let me use the WHO's COVID-19 disease severity scale to illustrate my point. It's not the scale I used some years ago in illustrating my point, but it is close enough to avoid my spending hours of time to search my posting history. Besides, LIVE-AIR did not specify the numerical clinical scale of disease progression for the trial patients, they merely described the disease progression. ACTIV-5 used a numeric designation, in addition to a description.
"The WHO scale is an 8-point ordinal scale ranging from ambulatory (1 = asymptomatic, 2 = mild limitation in activity) to hospitalized with mild to moderate disease (3 = room air, 4 = nasal cannula or facemask oxygen), hospitalized with severe disease (5 = high-flow nasal cannula or noninvasive positive pressure ventilation, 6 = intubation and mechanical ventilation, 7 = intubation and mechanical ventilation and other signs of organ failure [hemodialysis, vasopressors, extracorporeal membrane oxygenation]), and death (score of 8).
https://www.acpjournals.org/doi/10.7326/m20-3905#:~:text=The%20WHO%20scale%20is%20an,cannula%20or%20noninvasive%20positive%20pressure
Let's look now at the relevant portion of the LIVE-AIR patient 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/ct2/show/NCT04351152?term=lenzilumab&draw=2&rank=3
Based on the patient inclusion criteria, the LIVE-AIR patients were conservatively in ordinal scales 4 or 5 of the WHO's disease severity scale.
Turning now to look at the relevant portion of the ACTIV-5 patient inclusion criteria.
"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/ct2/show/NCT04583969?term=lenzilumab&draw=2&rank=4
There could be a difference between baseline ordinal scale condition, versus condition at the time of randomization. But in this case, I think we can be submissive of that possibility. Patients on IMV or ECMO were eligible for inclusion in ACTIV-5, as shown by the testing site from UT San Antonio.
https://lsom.uthscsa.edu/infectious-diseases/clinical-trial/bet-activ-5/
The link below is for me. It will save me time if I have to further address this issue.
https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(21)00494-X/fulltext
Again with talk of dilution.
"I don't think the company intended to sell shares after April 5, 2021."
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=170094120
We really did, dlog. All of the back-and-forth discussions and guidance from the FDA, only for the FDA to hide behind a Decline determination announced after, what was it? 104 days?
I look at pictures and videos of Marsha, and the thought that lives, to this day, are still being needlessly lost...and even more incredibly, that we have less defense now than we did...I mean, what's it going to take for this country to safeguard itself?
Just the opposite is true. Do you think NIH/NIAID would have commandeered our LIVE-AIR trial if it wasn't worth billions in revenues to their Big Pharma sponsors?
There ought to be a Temporary Use Authorization (TUA), specifically for small companies who have successfully completed and peer-reviewed a Phase III trial, and then are selected (really, 'subjected' is a better descriptive) for further study by NIH/NIAID.
Small companies likely put most of their limited resources into achieving a successful trial. It is imperative that they be allowed to start a revenue stream by selling their product. The FDA should no longer be allowed to shirk their decision-making function behind a Decline determination, which just places an undue financial burden on companies who are deprived of revenue by not being able to sell their product. And NIAID/NIH should not be allowed to change trial parameters as they did here.
You mean the management that successfully completed the peer-reviewed LIVE-AIR trial? The same management that may have completed a promising CMML trial?
"Texas Medicaid is a joint federal and state health insurance program for low-income families, older adults, and persons with disabilities. The federal government matches each state's Medicaid spending at a predetermined rate that varies by state."
https://www.hhs.texas.gov/providers/medicaid-supplemental-payment-directed-payment-programs#:~:text=Texas%20Medicaid%20is%20a%20joint,rate%20that%20varies%20by%20state.
Several of the ACTIV-5 clinical test hospitals are in Texas.
United States, Texas
Hendrick Health - Hendrick Medical Center
Abilene, Texas, United States, 79601
Baptist Hospitals of Southeast Texas Site
Beaumont, Texas, United States, 77701
Baylor Scott & White Health - Baylor University Medical Center - North Texas Infectious Disease Consultants
Dallas, Texas, United States, 75246
Methodist Hospital - Houston
Houston, Texas, United States, 77030
University of Texas Health Science Center at San Antonio - Infectious Diseases
San Antonio, Texas, United States, 78229-3901
https://clinicaltrials.gov/ct2/show/NCT04583969?term=lenzilumab&draw=2&rank=4
We know that patients in ordinal scales 5, 6, and 7 were eligible for trial enrollment in ACTIV-5, as shown by the UT San Antonio test site.
https://lsom.uthscsa.edu/infectious-diseases/clinical-trial/bet-activ-5/
This patient inclusion criteria matches that specified in the above referenced clinicaltrials.gov guideline.
"Inclusion Criteria:
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)."
Now, to step away for a minute, let's assume that I was speaking to AG Paxton, and he asked me why the primary outcome measure was not to reflect those patients in ordinal scale 7.
"Primary Outcome Measures :
Occurrence of mechanical ventilation or death at any point through Day 29 in subjects with ordinal scores of 5 or 6 at baseline [ Time Frame: Day 1 through Day 29 ]
Subjects in ordinal scores 5 or 6 at baseline with a CRP<150 mg/L at baseline and age<85 years"
How would I answer? I couldn't. I don't know why patients in ordinal scale 7 were eligible for enrollment in ACTIV-5.
Management might. I don't think there is anything wrong with us questioning the trial design, and asking management to inform the AG about this issue.
And it is an issue under the purview of the AG, especially if state funds were used in a trial that was designed with criminal intent.
Now you tell me!
I'm only posting here almost everyday because I think management is working on our and patients' behalf everyday, and I want to do my utmost to support them and lenz. So the least I could do is try to understand what they're up against, and how they are proceeding.
If I should prove somewhat useful with these posts, I hope management is saving anything of any value, because they may need to re-post anything that could get... lost.
"Veru Reaches Agreement with FDA on Confirmatory Phase 3 Clinical Trial for Sabizabulin Treatment of Hospitalized COVID-19 Adult Patients at High Risk for ARDS
Reached agreement with FDA on confirmatory Phase 3 clinical trial design in 408 subjects with primary endpoint of all-cause mortality at Day 60
Study to expand treatment population to include all WHO-4, WHO-5, and WHO-6 hospitalized adult COVID-19 patients at high risk for ARDS regardless of the presence of comorbidities
Two interim efficacy analyses are planned; study may be stopped if statistical criteria are met for efficacy
If confirmatory Phase 3 clinical trial meets statistical significance, Veru may consider submission of a new request for EUA and/or NDA
Enrollment is expected to initiate in the second half of 2023 and the first planned interim efficacy analysis expected in 2024"
Check FDA Approvals section
https://newsfilter.io/
I know that Dale and Cameron have enough on their plates already without adding to it. But my attention is drawn is to this research regarding Idiopathic CD4 lymphocytopenia. The thought of this immune deficiency possibly proliferating is very concerning.
https://www.nih.gov/news-events/news-releases/nih-researchers-uncover-new-details-rare-immune-disease
Hi, Newtg.
I don't think lenz is much different than other covid products in terms of shelf life. And we have seen the expiration dates for some of those products extended (after we had destroyed 300k vials of lenz that reached the expiration date). And maybe the FDA will allow physicians to prescribe lenz, even without a confirmed diagnosis of covid, as they have for other covid therapeutics.
Sarcasm aside, it's somewhat of a moot point, especially if we can get authorization for lenz to be used prophylactically, with our patented vaccine/anti-viral co-therapies. Also, if stockpiled, our major hurdle will be in producing enough product. We would likely need to see Defense Procurement Orders to meet initial demand.
You're entirely correct that lenz needs to be stockpiled for national defense purposes. As even Fauci just noted, "We got to do better not only in the continued response to the current outbreak but in preparation for the inevitability of future outbreaks." And his colleague at the time, Deborah Birx, just said that she's, "...been really upset that the federal government has not prioritized next-generation vaccines that are more durable, next-generation monoclonals, and long-acting monoclonals,” Birx told Fortune in an interview at the magazine’s Brainstorm Health conference, held earlier this week in Marina del Rey, Calif.
Omicron is mutating to bypass the initial arsenal of weapons developed for use against it. Already, Omicron’s changes have rendered every universal monoclonal antibody treatment—administered to people at high risk of hospitalization and death—useless. Eventually, it will take down Paxlovid, too, (Birx) says."
I guess these two are driving without rearview mirrors. The same could be said regarding Randi Weingarten, President of the American Federation of Teachers, for the degradation of school curriculums, before her input into the subject of school closures. Throw Rochelle Walensky of the CDC into the mix, too.
I have found that any effort I make to right the wrongs I see with our government, are most effective when I am empowered to force the action I am seeking.
Force how? For example:
https://casetext.com/brief/usa-v-metter-et-al_motion-to-amendcorrect-forfeiture-order-and-shareholders-claim-to-forfeited
The abuses we suffer at the hands of our government are because of our negligence in allowing agencies "discretionary power." All such power should be rescinded. And the abuse of such power should be brought to light by showing just cause to obtain Discovery to reveal that abuse, as I am likely to do here, if necessary.
All branches of our military have failed to reach recruitment goals, and those serving are subject to woke ideology indoctrination. In addition, the disproportionately large weapons transfer we have made to Ukraine has depleted our armamentarium.
It's ridiculous how much we have weakened ourselves.
This is relevant discussion here. It makes biowarfare the best option to defeat us. And that makes the stockpiling of lenz a national priority.
Treat yourself to a google search of Glee, flash mob, marriage proposal.
In response to a Private Message, I can see, but not respond, to those. I appreciated your comments. Please consider making your message available for the board to see.
Texas Attorney General Ken Paxton would do well not only to look at how trials are conducted by Big Pharma, but perhaps more importantly, he should also look at how government-sponsored trials are conducted for small-cap biotech products. ACTIV-5 excluded early-stage patients in ordinal scale 4, which accounted for most of the success realized in the LIVE-AIR trial. ACTIV-5 also included late-stage patients in ordinal scales 6 and 7, which the company felt were too far advanced in disease progression to be included in the company-sponsored trial. This divergent patient inclusion criteria between the government versus the company sponsored trials, accounts for why LIVE-AIR showed unparalleled efficacy (up to an 8-fold improvement for Black/African American patients), but still failed to show statistical significance in the government-sponsored trial.
I believe this could be a pattern for when small cap biotechs demonstrate tremendous success in markets where Big Pharma has, or wants, to establish a market. Another example of this could end up adversely affecting Innovation Pharmaceuticals, who recently announced, "...that based on positive findings new testing of Brilacidin in additional in vitro and in vivo models against hard-to-treat fungal pathogens is planned by NIH/NIAID..."
https://invest.ameritrade.com/grid/p/site#r=jPage/https://research.ameritrade.com/grid/wwws/research/stocks/news/article?c_name=invest_VENDOR&docKey=100-074u5602-1
The government-sponsored trials delay revenue streams to these small-cap companies, and induce financial stress that could lead to their demise, allowing Big Pharma to buy the intellectual property of these companies for a fraction of what they are worth.
And if Texans, and others, suffer preventable deaths in this immoral process, so be it.
"Paxton to investigate COVID vaccine makers...
Long an opponent of COVID-19 safety mandates, Texas Attorney General Ken Paxton said Monday he will investigate three major pharmaceutical companies for deceptive practices, arguing that they may have misrepresented the effectiveness of vaccines and the likelihood of becoming infected after receiving a vaccine.
Paxton said in a news release his office would investigate whether “profit motive or political pressure” played a role in any of the “pandemic interventions forced on the public.”
The investigation will also look into the potential manipulation of trial data by Pfizer, Moderna and Johnson & Johnson, said Paxton, a fierce opponent of mandates on lockdowns, vaccinations and masking prompted by the COVID-19 pandemic...
Paxton said his office would investigate if the pharmaceutical companies went awry of the Texas Deceptive Trade Practices Act and would look at activity that would fall outside of the legal immunity granted to manufacturers of the COVID-19 vaccine."
https://thefacts.com/free_share/paxton-to-investigate-covid-vaccine-makers/article_d2190110-b6ac-53bc-b955-126143bf0e31.html
Tell you what, Ken. Your investigation should not be merely retrospective. If a new covid virus strain (not with lineage to delta, omicron, etc.), should begin to circulate, Texas, and the world, would be defenseless to combat it.
The patented, variant-agnostic, clinically-proven lenzilumab modulates the human immune response and significantly reduces the inflammation that kills covid-infected patients. It should be stockpiled for the Texas National Guard and other state agencies, especially as Title 42 is set to end within weeks.
https://www.newsnationnow.com/us-news/immigration/title-42-migrant-surge/#:~:text=Title%2042%20is%20a%20public,million%20times%20since%20March%202020.
Texas is on the front line, and we should spearhead the effort to protect our citizens by offering this life-saving therapeutic. I've already lost my Alamo-descendant wife, who could have been saved with lenzilumab. Help prevent even more needless loss of Texan lives.
"U.S. military is tracking another mysterious balloon...
The U.S. military has been tracking it since late last week and has determined that it poses no threat to aerial traffic or national security and is not communicating signals, one official said."
https://www.yahoo.com/news/u-military-tracking-another-mysterious-205620805.html
How can a balloon, floating at an altitude of 36,000 feet, not pose a threat to aerial traffic? If this balloon is not communicating signals, should we really be assured by that? Or should we be worried about what the hell the balloon is carrying?
Sheesh.
Thanks for pointing that out. I hadn't accessed the Beta version of clinicaltrials.gov before, so I didn't know there was note of the data having been submitted. Nor did I know that quality control review would be a function of clinicaltrials.gov.
dlog, I see where the ACTIV-5 results were submitted to ClinicalTrials.gov, as shown on the Beta version of their website.
Is this the source data you were looking at?
https://beta.clinicaltrials.gov/study/NCT04583969?tab=results
Today is the 120th day after our previous fiscal year, which is a deadline for reporting certain data omitted in our 10-K. The 10-K/A, filed five days ago, may have addressed this issue.
But I'm not sure that it did. If a prospectus is required, then I think it is due today.
I initially thought the omitted data was a missed "copy and paste" section of boilerplate. I should have known better. I now think the issue is possibly related to our proposed business combination. In fact, I suspect that it might also explain why Hohneker and Xie were added to our Board in October of 2021. A matter of those gentlemen having "been there, done that."
We'll see.
What happens when our next national quarantine isn't implemented by us?
"Sudan’s lab leak threat marks a terrifying new age of biological warfare
Matt Ridley
Sun, April 30, 2023 at 2:00 AM CDT"
https://www.yahoo.com/news/sudan-lab-leak-threat-marks-070000821.html
Forget about the debate between open-carry, vs concealed weapons, vs outright firearm bans. Lenz is the self-defense measure we will need, and government stockpiles need to be accumulated and maintained.
“I’ve been really upset that the federal government has not prioritized next-generation vaccines that are more durable, next-generation monoclonals, and long-acting monoclonals,” Birx told Fortune in an interview at the magazine’s Brainstorm Health conference, held earlier this week in Marina del Rey, Calif.
Omicron is mutating to bypass the initial arsenal of weapons developed for use against it. Already, Omicron’s changes have rendered every universal monoclonal antibody treatment—administered to people at high risk of hospitalization and death—useless. Eventually, it will take down Paxlovid, too, (Birx) says."
https://www.yahoo.com/finance/news/covid-eventually-evade-one-few-100000243.html
I think lenz teaches our immune system how to react to future viruses. Maybe one day, I'll see the reinfection rate in lenz-treated patients, which I can't believe that we haven't seen yet.
Thanks for the reply, Djia. Without knowing why the Humanigen investors board was closed to my viewing for a couple of days, I was reluctant to open an account, as Twitter notified me would be necessary to continue to view postings.
But it has worked out for the best, as I note what I perceive as subtle courtesies extended there that are appreciated.
Well, maybe Humanigen will continue to have national media exposure through Tucker on the One America News Network.
"Tucker Carlson Leaves Fox Nation
Maybe Fox News' loss could be
@OANN's gain, Founder and CEO
@RobHerring would like to extend an invitation to Carlson to meet for negotiation.
https://oann.com/newsroom/tucker-carlson-leaves-fox-news/
#OAN #TuckerCarlson #FauxNews #FoxNews
@TuckerCarlson
Fauci: "We got to do better not only in the continued response to the current outbreak but in preparation for the inevitability of future outbreaks,” Fauci added...The report said “bad governance” prevented stakeholders from taking advantage of “wondrous scientific knowledge” available.
https://www.yahoo.com/news/fauci-acknowledges-problems-scathing-report-153911034.html
I've seen information that Biden ended the national emergency declaration earlier, but then I see other information that it is scheduled to end on May 11th. I've also seen it reported that EUA's will still be granted for Covid treatments.
I recently had to sign into Twitter to see ANY posts. Did you have the same restriction?
Without getting into the weeds, I think Gohibic showed more benefit than lenz in treating late-stage patients. From recall, I think we're looking at improvement of 30% vs 17% in Gohibic vs lenz.
But how will that change when new variants arrive? How could Humanigen improve late-stage efficacy if lenz is combined with their newly-patented anti-viral co-therapy treatment?
It's not a market segment the company wants to pursue. But a very lethal variant could develop at any time, forcing governments to further embrace mAbs.
If I had designed the ACTIV-5 trial, I wouldn't want to publish the trial data, either. This goes beyond the run-of-the-mill graft. Lenz could have saved millions of lives that were lost as a result of this sacrifice before the altar of legacy vaccinations. There could, and should, be repercussions for keeping lenz off the market, and allowing these preventable deaths to occur.
Still, the fact that patients in ordinal scales 6 and 7 were included in ACTIV-5, will provide some data from these late-stage patients that LIVE-AIR did not and never intended to treat. We can compare those data to Gohibic, which recently got an EUA for treatment of those late-stage patients.
https://www.inflarx.de/Home/Investors/Press-Releases/04-2023-InflaRx-Receives-FDA-Emergency-Use-Authorization-for--Gohibic--vilobelimab--for-Treatment-of-Critically-Ill-COVID-19-Patients-.html
Further detail on the patient you mention are provided in the case report.
https://osf.io/xusr9/
Thanks, Yooo.
I guess that oversight was caught in preparation of the Q1 10-Q.
You're very welcome, oakhill3.
Happiness overload. It's a treat to see that experienced by other people. But it's what I anticipate we will feel once lenz is authorized or approved to save millions of lives that would otherwise be lost.
"Las Vegas Strip Has a Scary Covid-Created 'Fatal Fungus' Problem...
Covid-19 likely increases the risk for fungal infections because of its effect on the immune system and because treatments for Covid-19 (like steroids and other drugs) can weaken the body’s defenses against fungi," the CDC says on its website."
https://www.thestreet.com/travel/las-vegas-strip-has-a-scary-covid-created-fatal-fungus-problem?puc=yahoo&cm_ven=YAHOO
An uptick in ICU cases is supposedly the trigger for the inclusion of lenz into a large platform study. You would think that a decrease in average life spans, or an unexplained increase in excess deaths, might factor into a continued study of lenz, or at least into granting an EUA to fulfill an unmet medical need. Frankly, I think the uncovered damage being revealed by covid infections would cause a prospective business partner to combine resources with Humanigen, with any cash exchanged resulting in net revenue for the company, not cash from the company.
The lengths to which Big Pharma and regulators will go to safeguard the profit status-quo is unconscionable.
I really hope that the concluding CMML study proves to be the key to starting our revenue engine, and ideally, to maintaining our independence, if feasible.
Shared the previous post on Twitter. They had blocked me from viewing posts unless I was signed-in, so I had to open an account there. If Dorsey or Dorsey v 2.0 was still in charge, I wouldn't have opened an account. But the more I hear from Elon Musk, the more I like him, and I thought it was fair to ask for an account to be set up, to read the message board.
It gave me a chance to use the link to Twitter that Ihub provides.
A $1.00 share price would give us a market cap of only about 10% of what it once was, before we began seeing positive trial data.
Too many people are focused on the preliminary topline data from the ACTIV-5 trial. They have let that unpublished data define us, instead of the LIVE-AIR trial data which was peer-reviewed in two journals, and supplemented with post hoc safety and efficacy data, which has also been peer-reviewed.
We don't need to see additional insider buying or buy-backs. We need to data-mine the ACTIV-5 trial data to extract the available data from the ordinal scale 5 patients they treated, and discard all their other data as the trash that it is.
On top of that, we are seeing clinical benefit in all of the evaluable CMML patients treated with lenz in the on-going clinical trial, which may be fully enrolled by now.
In addition, we see very few treatment options for the coming covid variants. Even the Astra-Zeneca mAb under study to replace sotrovimab, is only going to be able to treat the known covid variants, if successful.
To me, Newtg. it appears that Nasdaq recognizes the likelihood of Humanigen regaining compliance with the listing standards.
Well, in looking at a 5 day chart, I wasn't expecting to see us trade in a range of $0.0001 for 5 minutes, LOL!!! We've seen some good movement on the 12:30 bar a couple of times in the last week. Maybe being short sell restricted came into play today.
Let's see if we get a nice little bump in about 25 minutes.
I'd like to think so, Newtg.
Extension granted until August 21, 2023.
https://www.sec.gov/ix?doc=/Archives/edgar/data/1293310/000121465923005603/p4182308k.htm