Humanigen Inc (HGEN)

The reason tik tok was banned in America is not because if spying by China, tik tok was business venture to compete with instagram facebook and was cheaper in cost. same with China EV cars. There is no spying the the Chinese military in these companies like Alibaba too. They are private business ventures and mandate is to make money like any private business.

it always about the money.

What does this have to do with humanigen? Well the drug that Humanigen has is 'competition' with moderna vacccine mRNA. If humanigen lenzi drug was approved to treat people who were infected with corvid, it would be competition to moderna 50 billion/year vaccine business. There are lots of anti-viral drugs that can work with treating corvid but it cost millions to submit a FDA drug trial. No company will waste millions now since corvid hype is low and nodoby is interested in applying for FDA approval. Anti-viral drugs are not as profitable as other drugs like weight loss drug with millions of patients which is why some biotech company don't even have a infectious disease dept. the market is not that big for infections disease drugs. entire world less than couple of billion in revenues annually the entire market. entire country less than 2 billion even if approved. .

Well said,  Jay. That is very accurate from my experience throughout this ordeal. 

Bump.

Marty, please, you have to be aware of how your own comments serve to exasperate the very failures of the FDA that you lament.

Let me share my perspective on what you said here: “We have a bit of a public trust problem,” Makary said. “I think there’s a void of data. And I think rather than allow that void to be filled with opinions, I’d like to see some good data.”

I passionately agree with you that there is a public trust problem in the FDA. Let me get case specific here as it relates to my investment in Humanigen, and my faith in their Lenzilumab (lenz) leading drug candidate. The void in our safety and efficacy data is because the FDA Declined to review our EUA request. My comments at the time were as follows.

"Posted by: cowtown jay
In reply to: None
Date: 01/10/2025 05:59:07 PM
Post #: 43,649 of 43,854
Vigilant Fox,

The FDA granted IND (corrected) authorization to treat covid for Humanigen's Lenzilumab on April 2, 2020, just weeks after the pandemic started. So by May of 2021, it is likely they had full knowledge of the outstanding safety and efficacy lenz demonstrated under this IND authorization.

https://ir.humanigen.com/English/news/news-details/2020/FDA-Approves-Emergency-IND-Use-of-Humanigens-Lenzilumab-for-Compassionate-Use-in-COVID-19-Patients/default.aspx

Management communicated with the FDA during this year-long process, and the FDA knew the company was prepared to request an EUA based on their LIVE-AIR Phase III trial to treat hospitalized and hypoxic patients with covid pneumonia.

What did the FDA do? On May 25, 2021, "...The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:...As noted in the guidance, for the remainder of the current pandemic, the FDA may decline to review and process further EUA requests other than those for vaccines whose developers have already engaged with the agency as described in the agency’s guidance, “Emergency Use Authorization Vaccines to Prevent COVID-19.”

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-may-25-2021

Three days later, May 28, 2021, "Humanigen Submits Application to FDA for Emergency Use Authorization for Lenzilumab in COVID-19." The FDA Declined to make a decision on our EUA application, based on their newly self-granted power to Decline to make a decision.

https://ir.humanigen.com/English/news/news-details/2021/-Humanigen-Submits-Application-to-FDA-for-Emergency-Use-Authorization-for-Lenzilumab-in-COVID-19/default.aspx

Lenz has the ability to program an appropriate immune response, which is also variant-agnostic. This poses a threat to a multi-billion dollar annuity revenue stream Big Pharma, who are major providers of government agencies' operating budgets, and grantors of royalties to government agencies' scientists, all currently enjoy."

https://investorshub.advfn.com/boards/manage_msg.asp?message_id=175649690

In addition, NIAID and the NIH conducted a "confirmatory" ACTIV-5 Bet B study of lenz. I voiced my opinion of that in expressing my reason for wanting no part of the litigation brought against the company in the Class Action suit.

"Re: [External]Exclusion from Litigation


Jay Booth

From:
jayatthelake2003@yahoo.com
To:
Ann Cavanaugh

Sat, Feb 3 at 6:15 PM

Dear Ms. Cavanaugh.

Your instruction that I must send a letter by mail, and that I must provide transaction details in Humanigen securities, to be excluded from litigation, impose requirements that I don't feel well enough to comply with. I will simply comply with page 2 of the Notice of Pendency:

"DO NOTHING Get no payment."

I strongly disagree with the Lead Counsel, as I have publicly declared in the following.

cowtown jay

Re: bencozey post# 41218

Tuesday, December 19, 2023 7:38:43 PM

Post#
41220
of 41817 Go
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.

Humanigen, Inc.

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."

Thank you,
Jay Booth

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173768831

But, the government's deadly abuse of their discretionary authority doesn't stop there.

The FDA evidently told Humanigen's management that they were unlikely to approve the EUA. Keep in mind that the FDA ultimately Declined to even review the EUA application, despite positive peer reviews of the LIVE-AIR trial by both Lancet and Thorax publications. The FDA got the SEC and the DOJ to file charges for selling shares in the company despite the bogus concerns of the FDA, (except for the devastation it would cause their sponsors, Moderna and Pfizer).

"According to the SEC’s complaint, between June and August 2021, Chappell and Durrant sold Humanigen stock while in possession of material nonpublic information that the U.S. Food and Drug Administration was unlikely to approve Emergency Use Authorization (EUA) for Humanigen’s newly developed COVID-19 drug, lenzilumab."

https://www.sec.gov/enforcement-litigation/litigation-releases/lr-26206

Do the right thing, Marty. Fill the data void you recognize by ordering your agency to Authorize or Approve lenz based on a review of the company's EUA request in 2021, and review the Lancet and Thorax peer reviews. Humanigen, it's shareholders, and patients, deserve the benefit of the paradigm shift lenz has facilitated as part of Generation Gold Standard, which I think it is. Approve the Novavax vaccine in accordance with the postmarketing commitment.

and reason the company is in limbo is due to insider trading charges of DALE by the SEC. the made millions in ill gotten gains from insider trading. maybe he wanted to get busted and prolong the legal limbo and SEC has no access to his money either. he probably laundered his money in crypto or put in Russia. Whether Dale gets any jail for his 'crime' is up to the judge and SEC and not much info on it. considering how serious the crime it is says the SEC

The value of the humanigen s shares is still dependent on whether the lenzi molecule is worth anything to anyone. does moderna who received 60 million in funding to develop some vaccine want lenzi? 60 million do develop a vaccine and not sure if 60 million is even enough and you know how dangerours and risky to develop vaccine for EBOLA virus that has 90% fatality and current no cure? and you trust some CEO of moderna which once said everyone should be vaccination every year? these for profit company like moderna..you cannot trust them. they are too greedy. in making money. you have FDA chair who was fired because he doesn't want to approve any mRNA drugs anymore due to the risk. death is not acceptable in any vaccine.

taran who bought all the ip assets for $2 million was also owned 95% of this company. what don't you understand. minority retail owners don't own this company. only way taran can get relisted on nasdaq or sell their assets is buyout humanigen minority shares. that is the only 'value' now..how much they pay is anyone guess. or they pay nothing but it will be very hard for taran to get listed on nasdaq or sell there assets to anyone since it has a lien on it. assuming the ip assets they got for free is worth anything. which is what FDA approval etc will mean, they can get the lenzi drug to another test with FDA.

Yes, they just have a bunch of numbers assigned to them now.

So if there is no hope for this stock why are you guys posting over here??? If our shares are worthless and all getting cancelled what's the point of posting on this board? Just asking for a friend LOL

https://www.zerohedge.com/medical/how-contagious-ebola

you think they would have developed a vaccine years ago right. it's a known virus and they only commissioned a virus research after virus breakout? this anti-viral drug research is more complex than people think. each virus is different if the vaccine was that easy would they have made it already without a $60 million in funding to moderna? of all the company they let moderna who invented the mRNA vaccine which has shown to have some risk.

do you really trust moderna to mess with the ebola virus? they would have to have contact with ebola, sequence the dna of ebola and what if modernal messup and during that process make virus even more dangerous than ebola? this stuff of mRNA is experimental science. these biologist dont know what they are playing here. the moddification of virus DNA stuff is advance stuff. they let moderna take on the project..? moderna corvid mRNA vaccine cause a lot of health issues which was covered up and now moderna is responsible for creating for vaccine for one of the most deadly virus that has 50% death rate. and there is no vaccine. they would have gotten the vaccine if it was possible to make one. right. what you think moderna are magiciians? quarantine only way to stop these viral breakouts. and to have this stuff in labs and they are modifying the virus is crazy.

these virus are like snake bites , there is no vaccine. only anti-dotes. or anti-viral drugs.

the fear is that the virus is currently only transmissable by fluid like AIDS..what if it becomes airborne like corvid or flu. with 90% fatality that is the nightmare if moderna labs messup during some experiment trying to sequence the mRNA and messup in the sequenecing. you really trust moderna?

CAR-T using DNA modification and cures leukemia in blood cancers but not solid tumors as for lenzi doesn't cure luekemia and doesn' cure cancer it's more like anti-viral drug. where did I say it cures leukemia, there are other car-t drugs being developed by lots of other biotechs using car-t that has cured luekemia but not solid tumors in the brain. which is currently uncurable. leukemai is blood cancer which is easier to cure than targeting tumors, it can reduce the size or stop the growth that is other biotech company not lenzi. CAR-T drugs using DNA modification stuff like mRNA of moderna uses.
there hundreds of biotech companies workign in CAR-T drugs. and some companies they have drugs that can prolong luekemia patients even cure some blood cancers but not some solid tumor ones.
and there are lots of diseases and illnesses and you need medical trials to see if it works. why you think it cost so much to get FDA approval or drugs development. it cost upwards to $100 million in testing drugs to see if it works. mostly wages and consulting fees and lab fees.
and if people who don't know what blood cancer it is a disease of the blood. maybe lenzi prevents the blood cells from self-distruction or does the the job of the blood cells.

Wow. "There are lots of drugs using CAR-T that already cures leukemia. " You obviously know NOTHING about Lenzilumab AND very little about CAR-T. Your ignorance is showing more and more with every post. Lenz doesn't cure leukemia and was never intended to affect leukemia in any way. You should stop showing us what you don't know. But of course, you are entitled to.

the thing about lenzi if you are infected with corvid and "NOT Vaccinated." and you take lenzi, you can still survive WITHOUT ventilation or hospitalization. meaning you don't need moderna mRNA vaccine. no need for 'vaccine' which is big money like billions in profits. people who didn't take lenzi had to get hospitlizaiton and ventilations. but still recovered on their own.

and my interest in this stock was in the drug..so you don't need moderna's mRNA vaccine and still survive if you not vaccinated. and infected with corvid. the lenzi drug is "post infection drug" treatment. like anti bacterial infection or anti virus anti dote....modernal mRNA vaccine is "pre-infection drug" two different types of treatments drugs or different mechanisms

if it was 'worthless' why would taran waste millions to bid for the assets. if it was worthless you get no bids. and company just dissolves. no need for bankruptcy court. the only asset was the ip. and 2 million in cash and accounts receivables.

Are the shares worthless?

Dale and managmeent owns the company one company owns like 95% of the common shares. there is no preferred shares and no debt except 45 million in fake creditor claims reason for the chapter 11
The assets or the ip was sold for free to teran..they own the ip and got it for free. just ask who owns teran the same people who own humanigen shares.

The Black Horse bid for Humanigen was made by Taran Therapeutics, Inc., which acted as the stalking horse purchaser during Humanigen's Chapter 11 bankruptcy proceedings.

The people who who own Taran Therapeutics inc also own 95% of humanigen shares. they paid $2 for $2 million cash and accounts receivables and got the leniz assets for free in closed bid. nobody was allow to bid for the assets in bankruptcy court.

Donald Trump applied for bankruptcy chapter 11 6 times before 2010 from what i heard and got richer evertime he got out of filing for chapter 11. so Trump knows what i'm talkin about

Does anyone still own Hgen shares?

here something the public doens't want to hear about big pharma. lots of drugs which is big pharma biggest money makers like weight loss drugs, anti-depressants. are not necessary and people can just take natural remedies. or natural cure. using herbal medicines or only cure is surgery.

there is no need for for arithitis drugs or even insulin. that you need to take chronically or anti-depressants etc. but is sold to the public and they want you to take i daily. forever
one time cures are not profitable like corvid vaccines or any drug that can cure a disease.

The FDA didn't approve it because it was not effective. not that anyone died like moderna mRNA which has shown to cause lots of deaths lik suddent athtlete deaths which you no longer hear in the news. The FDA who was fired even talking about not renewing moderna or any mRNA drugs and that is says a lot
either this drug was competition or someone wants to own the drug for themselves

what information you need 520 patients and months of testing..and they want more testing?


The Phase III trial for lenzilumab showed that 84% of patients in the treatment group survived without requiring invasive mechanical ventilation, compared to 78% in the placebo group, indicating a 54% greater likelihood of survival without ventilation among those treated with lenzilumab. Additionally, the safety profile of lenzilumab was similar to that of the placebo, with no deaths reported due to adverse events.

In the trial for COVID-19, lenzilumab was compared to a placebo and available treatments such as remdesivir and corticosteroids.

The FDA has requested further data to conclude the benefit-risk profile of lenzilumab as a COVID-19 treatment, particularly regarding its safety and efficacy in recently hospitalized patients

FDA's Requirements for Lenzilumab Approval

The FDA has requested further data to assess the benefit-risk profile of lenzilumab as a treatment for COVID-19. This request is particularly focused on the following areas:
Key Areas of Data Needed

Safety and Efficacy: Additional evidence is required to evaluate the safety and effectiveness of lenzilumab in recently hospitalized COVID-19 patients.

Clinical Trial Results: The FDA is looking for more comprehensive results from clinical trials, particularly the Phase III LIVE-AIR trial, to better understand the drug's impact on patient outcomes.

Benefit-Risk Analysis: The FDA needs more information to determine whether the known and potential benefits of lenzilumab outweigh its risks when used in the context of COVID-19 treatment.

Conclusion

The FDA's decision to decline the emergency use authorization for lenzilumab was based on the inability to conclude its benefit-risk profile without this additional data. The agency has invited Humanigen to present further data when it becomes available.

Overview of Humanigen's Phase III Trial

must have cost a fortune to have 520 patients

Humanigen conducted a Phase III trial for its monoclonal antibody, lenzilumab, aimed at treating hospitalized patients with COVID-19. The trial included 520 patients who were not on mechanical ventilation and took place across 29 sites in the United States and Brazil.
Key Findings

Treatment Group: Patients received three intravenous infusions of lenzilumab.
Control Group: Patients received a placebo along with standard treatments like corticosteroids and remdesivir.
Outcomes: The trial reported a 54% greater likelihood of survival without needing invasive medical ventilation for those treated with lenzilumab compared to the placebo group.

Reasons for FDA Non-Approval

Despite some positive outcomes, the trial did not receive Emergency Use Authorization (EUA) from the FDA. The reasons include:

Unclear Added Value: The FDA indicated that the added benefit of lenzilumab over existing treatments was not sufficiently demonstrated.
Need for More Data: The agency required additional data to confirm the efficacy and safety of lenzilumab compared to other therapies already available.

Summary of Efficacy and Safety Concerns
Aspect Lenzilumab Treatment Placebo Treatment
Ventilator-Free Survival 84.4% 77.9%
Mortality Rate 9.6% 13.9%

The trial's results showed a favorable trend in mortality but were not powered to demonstrate a significant difference in mortality rates. This uncertainty contributed to the FDA's decision to withhold authorization.

In conclusion, while lenzilumab showed promise, the lack of clear advantages over existing therapies and the need for further evidence led to its failure to gain regulatory approval.

The patient died which is why it was not approved.

Overview of the Phase III Trial

The Phase III trial conducted by Humanigen was focused on testing lenzilumab, an antibody designed to treat cytokine storm in hospitalized Covid-19 patients.
Key Details about Lenzilumab
Mechanism of Action

Lenzilumab is engineered to attach to and neutralize granulocyte-macrophage colony-stimulating factor (GM-CSF).
It aims to prevent the severe immune response known as cytokine storm, which can occur in Covid-19 patients.

Trial Objectives

The primary goal was to assess the efficacy of lenzilumab in improving patient outcomes, particularly in preventing the need for invasive mechanical ventilation (IMV).
The trial enrolled hospitalized patients who were experiencing respiratory distress but had not yet progressed to requiring IMV.

Results

The trial demonstrated that lenzilumab improved the relative likelihood of survival without the need for IMV by 54%.
It achieved significant improvements in ventilator-free survival, indicating its potential as a foundational therapy for newly hospitalized Covid-19 patients.

This trial represents a critical step in evaluating lenzilumab's effectiveness in treating severe Covid-19 cases.

There are lots of drugs using CAR-T that already cures leukemia. maybe the company made the wrong FDA application and didn't apply for corvid or infectious diseses. One drug can have multiple uses like it's like baking soda, you can use it for a lot of things. that is what lenzi is. The company may not want to get approved by the FDA. or they know the drug doesn't work for what they were applying for. or the FDA appliation was rejected due to 'technicalities etc. this lenzi drug was not applied to cure corvid infections it 'was for luekimeia and there are better drugs for luekemia. there is already drugs that work to cure luekemia using CAR-T that has better results and reason for the FDA not approving for luekemia was the patient died.. that is a sure way to not get approved if patient dies. or they patient that part of trial was in late stages of luekimia and no drug can cure it. or condition was too bad ..if the drug was given earlier it may have saved patient. like the flu, a patient can survive if drug was given "early stages" but not if patient was given in the last stages of the flu. or late stages of the disease. it's like an bacterial infection. if caugh early it's easily cured' but if lates stages of bacterial infection. it' kills or you need amputuation of the leg. and if the infection reaches the head or heart it can lead to death..like corvid. people get heart attacks that led to death. becaue the virus reached critical organs like the head or heart.

"...with insider information that the drug would not be approved. that was his 'crime'"

What Material Non-Public Information (MNPI) could there have been with the results presented by Management and the Mayo Clinic?

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=175678449

the only "criminal charge" was Dale was charged with insider information. but is irrelevant to whether the lenzi drug has any value. Dale alledgedly sold millions of dollars worth of shares to retail investors when he knew the drug was not being approved by FDA on phase three and gave retail shareholders positive news and how great the trials were. may FDA was part of the insider trading. rare for drug to reach phase three and then not approved. The recent issues with the FDA regarding corvid speaks for itself. you have drugs that approved when it has severe side effects that cause death yet FDA still approved it. or that some big pharma want less regulationss or more regulations on safety of drugs. FDA is not neutral in drug approvals and too political and too much interference from big pharam etc. either the drug works or not or effective or not. there should be no discretion on whether a drug is good or bad, FDA has too much discretion whether a drug is approved or not.

What case was the gag order? more like company insiders dont want incriminate themselves while they are under investigation or charge with criminal charges by the SEC or something. they can still talk to shareholders but anything they say can be used against management. SEC is charging management or Dale for insider trading charges that he sold his shares with insider information that the drug would not be approved. that was his 'crime' he was 'trading' on insider information. the insider case is heard by a judge there is no jury. gag orders are usually for media not to report a case as it may influence jurors opinion of the case. known as guilty by the media news. the judge bans cases from being reported in the news so the case is not tainted with news. media. essentially the cases is tried by the media if no gag order. and the juror is the media without gag order. or court tried by the media not buy his peers. Dale can spend 2 years in prison if insider trading charges are real. and he has to give up all his gains. he sold via insider trading to shareholders who bought it from him

As the criminal case concludes, the gag order will be lifted and the company can disclose the progress made in the bankruptcy reorganization case. I'm hoping that we will see that Humanigen was merged with IPIX and will reverse merge with GBLX. Taran may even reverse merge at some point, and Hesai may have a role here also. I addition, I anticipate a share recall with announcements regarding regulatory Approvals.

The fact that cowtown-jay who is obviously and AI chatbot is still not turned off is a good. normally they go dark and shut down everything if the company was just a shell company and owns no assets and no real business. and this stock is not even in investorshub. the drug they had lenzi was phase 3. which is last phase before commercialization. unsure why FDA would reject it. on technicalities due to errors in application etc. the drug doesn't work in corvid or cures any luekemia. an patient had bad side effect or something. but to reach phase 3 is unusual. the drug probably has uses in other applications like infections of virus but not for luekemia which there are lots of the car-t drugs that works better. the car-t drugs actually work using mofication of DNA like moderna rDNA which is what is amazin about it actuually works. but like all drugs has some side effects in some patients. and not all patients can use it.

the company still has over 30 creditors who believe they are entitled to any money. but their lawyers still billing them millions. the law firm representing humanigen billed over 6 million in legal fees in 2 years used up all the cash down to $6000 left in cash of the 'corporation' there is no money in this company no reason anyone still have any claims or this case is still active for? because the law firms representing the creditors still billing their corproate clients who are claimin over 30 million and if they do get any money, the law firm gets 50% of that money. the chance of this fake creditors getting any money is like lottery ticket zero chance, but law firm still billing their corporate clients who see that 30 million lawsuit which they have no chance of getting any of the money like Trumps 10 billion lawsuit on the US gov't. it's like Trump thinks someone will GIVE trump 1 billion for some defamation lawsuit? the company wanted to get sued and wanted to go bankrupt. if you know what i mean.

this new car-T stuff actually works...it use DNA technology like Moderna rDNA stuff to work and it actually works compared to previous chemo methods. this is a result of the DNA project that took decades of research. the scientist mapped entire human DNA and mastered the DNA technology and these CAR-T stuff is quite advance and actually works

the law firm was till billing it's corporate client for the claim. that is why the claim is still not closed for other creditors

Docket # 388
Filed Jun 01 2026
Notice of Withdrawal of Appearance. John R. Knapp, Jr. has withdrawn from the case. Filed by PCI Pharma Services. (Knapp, John)
Case Number 24-10003 Humanigen, Inc.

https://document.epiq11.com/document/getdocumentbycode?docId=4581498&projectCode=HUM&source=DM

Transition Eve? I'm very grateful to be as prepared as I am for our success, as that time nears.

I wonder if we'll hear from March Bell next week. The FDA's criminal negligence, abusing Discretionary Authority to not only hide Lenzilumab's clinically-proven safety and efficacy by Declining to review and process Humanigen's EUA request, but then to subsequently try to hide the harmful effects of Moderna's mRNA vaccine by initially Declining to accept their Approval request, demands answers from the Inspector General of HHS.

And I think United States District Judge Karen M. Williams needs to be apprised of any criminal negligence in this case by the FDA or the SEC, to include the fabrication of Material Non-Public Information (MNPI), which is the basis for charges in this case.

I think your approach is appropriate and that it supports the apparent pathway Bhattacharya is trying to establish, which is not hypocritical at all, despite efforts to paint it that way.

"Trump’s ‘Medical Freedom’ Hypocrisy Exposed in New Lockdown"
https://www.yahoo.com/news/politics/articles/trump-medical-freedom-hypocrisy-exposed-170255014.html

I recommend that you don't respond to this post. I'm getting a lot of interference with my computer access.

https://www.yahoo.com/news/articles/trump-fda-chief-leaving-angering-173903214.html
never good if top boss in FDA is fired due to complaints from big pharma that it is regulating. it's like big pharma telling the FDA what to do and how they should be regulated? it doesn't work that way.

there is billions of dollar incentive to get FDA approval even if the drug can kill with some side effects. not much different from fentanyl dealers. all they care about is making profit. they don't care if drug users die.---one of the DARKSIDE of capitalism..profit from miserty and death. like selling bombs and weapons to countries who use it to kill civilians.

The public has given the FDA the power to regulate the drugs they are recommeneded to be safe and effective.
The fact that Doctors and Big pharma are in argument says a lot of what is being sold to the public. Furthermore, what does any politician or trump know about drugs and it's effectiveness and risk?
there is no need for any political interference that Big pharma is complaining about. only reason is gov't is the reason they are making billions and without the gov't giving them patents, they have nothing. patents are not a right but privillege given to them.
Big pharma think the public should be grateful for them. it the billionaires and big pharma that should be grateful to the public. the public dont need billionaires or big pharma who have patents 'given' to them by the public. and don't need Trump. there should be NO debate, no questioning if a drug works or not. or worth the risk.

The reality is big pharma can go bankrupt and lose or making billions if a drug is approved by FDA. so as a result. you have Trump being lobbied and want whitehouse interference. what does Trump know about drugs?

You even the gov't arguing whether a drug is bad or good? there should be no doubts whether a drug is safe or not. ALL drugs have side effects even tylenol if taken too long. its whether the risk is worth the cure. for people with terminal diagnosis with no treatment like ebola...any test or beta trial drug is better than no drug.

what you have two major gov't agency that has lost its integrity and trust and honor. FDA and SEC

you have a trained doctor saying these vaccines were cause of death. i mean. you trust the doctor or trust some big business mand in some big pharma who needs his milliion dollar bonus to get FDA approval? or Trump what does Trump know about anything about 'medicine' or kennedy' they probably don't have brains to make in medical school.

and here is something big media is not reporting . a lot of the drugs prescribed is not even necessary an just vitamins or snake oil. but since it paid by medicaid or insurance who cares.

Jay, thanks for that. I have forwarded that contact information to Serge, the international medical organization that has sponsored Dr. Stafford. With luck, that will have some consequence.

The Doctor and his family should be in all of our prayers.

Thanks again.
rjurko

Thank you, eb. I was hoping to hear from you in this regard.

The email I received from Durrant indicated the following contact information.

Dr. Cameron Durrant MD, MBA, DRCOG, MRCGP, FLSW

Chairman and Chief Executive Officer

Humanigen (NASDAQ: HGEN)

cdurrant@humanigen.com

+1-908-672-9908

I suggest contacting Durrant and requesting it. He was ready and happy to give me compassionate use when I was to get CAR-T therapy. However, my oncologist did not want to jump through his own organization's hoops for permission, since they had their own trial using a different drug focused on dampening IL-6 to control the cytokine storm. I wasn't real happy with that decision since Lenz had success already with a CAR-T trial. Durrant and I emailed a couple of times back then. That would have been early in 2023.

We have a large investor here who has deeper experience in terms of talking to Durrant about Compassionate Use. I have no doubt that Durrant will do everything he can for your colleague. I understand the importance of speed and will follow-up if a pathway isn't opened up for you today. Please advise.

Public Reply to VanGan on Humanigen Inc (fka HGENQ)

Thank you for your initiative, VanGan.

My opinion remains that the DOJ's evidence is parsed and fails to address ancillary issues which would be expected in a full-throated presentation of the facts, to include discussion of the Public Offering which was executed simultaneously with the sale of the already existing shares. But focus on details relative to Dale's actions only serves to divert attention away from the key component of this case, which hinges on the question of Material Non-Public Information (MNPI).

I've made my opinion clear, before there was even a case filed by the DOJ. The truth is crystal clear. The video presentation of the Mayo Clinic-led LIVE-AIR Phase III trial of Lenzilumab (lenz) has been presented repeatedly, along with the Lancet and Thorax peer-reviews. Third-party-proof-positive of the outstanding safety and efficacy of lenz to treat hospitalized and hypoxic patients diagnosed with covid pneumonia.

Thank you for your initiative, VanGan.

My opinion remains that the DOJ's evidence is parsed and fails to address ancillary issues which would be expected in a full-throated presentation of the facts, to include discussion of the Public Offering which was executed simultaneously with the sale of the already existing shares. But focus on details relative to Dale's actions only serves to divert attention away from the key component of this case, which hinges on the question of Material Non-Public Information (MNPI).

I've made my opinion clear, before there was even a case filed by the DOJ. The truth is crystal clear. The video presentation of the Mayo Clinic-led LIVE-AIR Phase III trial of Lenzilumab (lenz) has been presented repeatedly, along with the Lancet and Thorax peer-reviews. Third-party-proof-positive of the outstanding safety and efficacy of lenz to treat hospitalized and hypoxic patients diagnosed with covid pneumonia.

Jay,
I am sure that my doctor colleague from Richmond who is ill from Ebola would greatly appreciate access to lenz--for himself as well as for others affected by the outbreak. (He is also a fellow Virginian.) I cannot even begin to imagine how his family worries here. And his wife and children may of course yet show signs of infection...Heartbreaking...and even moreso when there may be a quite effective treatment.

rjurko

FYI, they did file a reply

https://filebin.net/sqyqmd2i641gxd7m

Not only that, Bob, but hantavirus is also a Disease X candidate, possibly an mRNA vaccine side effect, and Moderna has been working with their University partner for 2 years on, (what else?) an mRNA vaccine for that indication.

We know that lenz is variant agnostic, and I agree with you in that lenz will also be effective in treating various cytokine-producing indications.

My last two posts to you were disappeared before they saw the light of day.

Jay, I note that both the Ebola virus (a global emergency now, per WHO) and the Hantavirus kill largely via cytokine storm. Hopefully someone has contacted WHO about offering to try lenz for this indication.

Seems as though this would be a no-brainer.

Best,
rjurko

"Dr. Tracy Beth Hoeg will be replaced as FDA's acting drug center director by Dr. Mike Davis, who has been serving as deputy director, according to an email sent to agency staff Friday that was obtained by The Associated Press.

Hoeg said in a social media post late Friday that she was “fired,” from the agency, adding: “I learned so much and leave with no regrets.”"

https://www.yahoo.com/news/articles/fda-official-scrutinized-covid-shots-042815325.html

I don't understand this.

Maybe more than GOOD?