Novavax AND Sanofi (and HGEN?) are waiting to conclude the Phase I and II studies, and then nail down our Approval with a BLA submission. That could be in days, weeks, or a month, or so. And that Approval doesn't have to come from the FDA. Besides, in a perfect world, several US government agencies will be too busy defending themselves against criminal charges, than to try to continue this charade against Humanigen. Just my opinion, of course.

It's reasonable to think as you do, dlog.

But our success is going to have an EXPLOSIVE impact on the market. Major pharmaceutical companies will be absolutely devastated, as the triumvirate of Humanigen/Novavax/Sanofi will immediately have the covid market almost exclusively to themselves. Existing EUA's will be rescinded immediately.

And that will just be the beginning, as we're already starting to see in our targeting of other indications, such as flu, myeloid-driven cancers, aGvHD, etc.

If we are using the lenz IND authorization to effectively conduct Phase IV type trials, we wouldn't see that on the clinical trials website.

No, Humanigen DID NOT announce that, "...the FDA had declined EUA approval..." as stated in the DOJ's Second Indictment.

end of 3rd paragraph
https://www.justice.gov/opa/pr/chief-science-officer-publicly-traded-health-care-company-charged-insider-trading-scheme

Rather, Humanigen announced that the, "FDA has declined Humanigen’s Emergency Use Authorization (EUA) Request."

https://ir.humanigen.com/English/news/news-details/2021/FDA-has-declined-Humanigens-Emergency-Use-Authorization-EUA-Request-for-Lenzilumab-in-Hospitalized-COVID-19-Patients/default.aspx

The DOJ's intentional mischaracterization inaccurately infers that the FDA had made a decision on the company's EUA request. That would constitute material non-public information, which insiders are charged with having ahead of transferring or selling shares.

Quite the opposite is true. The FDA Declined to make a decision on our EUA. The FDA did nothing.

The DOJ notes alleged negative or cautionary feedback to management from the FDA.

The DOJ does NOT acknowledge the FACT that the FDA granted IND Authorization for lenzilumab in April 2020, which remains in effect, and has likely significantly enhanced covid and cancer products from several pharmaceutical companies.

Humanigen's management would know about the benefit lenzilumab is having in instances where it is being used under the FDA 's IND Authorization, if it is. Humanigen's management would also know that the FDA is aware of the full benefits lenz is providing under their IND Authorization, and that they should have approved our EUA.

We've got the 6th largest pharmaceutical company doing Phase I and II studies for us now, in my opinion. I think the heavy lifting is already about to wrap up, with the approval of lenz from the LIVE-AIR trial, or via a Phase IV trial in the form of the IND use of lenzilumab.

We need to establish an armamentarium of lenzilumab for our national defense. We are 100% unprepared for the holy hell we could be facing at any time. After the way the US government has treated Humanigen, they might have to force the production and procurement of lenz by some type of defense procurement orders.

Stockholm Syndrome is the only explanation I can think of for why there is a preponderance to disbelieve that your government is not acting in your best interest, and may actually be orchestrating your demise. The safety of lenzilumab has never been questioned. And it is more reasonable to consider the suitability of Leavenworth for the federal employees involved in the corruption here, than it is to consider Danbury's suitability for management.

Thank you, Private Messager, I will do as you suggested. By the way, I saw an error in my post, which I corrected and resubmitted. It is now post # 43649. It's reprehensible that the SEC would bring charges for stock transactions allegedly made ahead of a negative FDA decision, and no such decision is subsequently made by the FDA. The charges, likely instigated by the FDA, should be dropped.

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.

3m
Replying to
@_flyers77

@VigilantFox
and 3 others
As we see, the FDA did not deny our EUA. They made NO decision. So what crime did mgmt commit by selling shares and equity financing operations after the success of the LIVE-AIR trial was announced? Granting themselves the power to Decline clearly signals they weren't gonna deny.

Now, exactly one year since filing bankruptcy, here we are with Humanigen's management faced with fresh charges, just filed on December 30th, 2024, which read as follows.

"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

But the crime wasn't that management sold stock and engaged in equity financing. They had just released their Phase III LIVE-AIR trial results, as I outlined in my previous post, demonstrating a 54% survival benefit OVER THE STANDARD OF CARE in place at the testing sites.

Rather, the crime was that, "...the U.S. Food and Drug Administration was unlikely to approve Emergency Use Authorization (EUA)," which proved prescient, because the FDA Declined to make a regulatory decision on our EUA.

Continuing since the pandemic are a significant number of covid-related excess deaths. Lenzilumab's ability to reduce the number of covid-related excess deaths needs to be factored into the FDA's determination of a cost/benefit ratio.

Covid reportedly hit America's shores in March 2020, with devastating results from this novel coronavirus. Doctors including Humanigen's management, and clinical trial investigators from Mayo Clinic, who were working with Humanigen evaluating lenzilumab as a cancer therapeutic, quickly recognized the pathogenicity similarities between cancer and covid, and sought FDA permission to use lenz to treat covid patients. The FDA acted quickly to grant this approval.

"Burlingame, CA, April 2, 2020 – Humanigen, Inc., (HGEN) (“Humanigen”), a clinical stage
biopharmaceutical company focused on preventing and treating cytokine storm with lenzilumab, the
company’s proprietary Humaneered® anti-human GM-CSF monoclonal antibody, announced that FDA has
approved the administration of lenzilumab for COVID-19 patients under individual patient emergency IND
applications to patients under the company’s compassionate use program.

The company is advancing plans to conduct a multicenter, Phase III, randomized, double-blinded, controlled,
clinical trial with lenzilumab for the prevention of ARDS and/or death in hospitalized patients with
pneumonia associated with coronavirus 2 (SARS-CoV-2) infection in COVID-19 patients."

https://s28.q4cdn.com/539885110/files/doc_news/archive/42e41d3f-b99b-4214-9d90-b917f07b32ae.pdf

An interim analysis of the ensuing Phase III LIVE-AIR trial was performed.

"Burlingame, CA – September 14, 2020 – Humanigen, Inc., (HGEN) (“Humanigen”), a clinical stage
biopharmaceutical company focused on preventing and treating an immune hyper-response called
‘cytokine storm’ with its lead drug candidate lenzilumab, today announced its Phase 3 registration trial of
lenzilumab in patients with COVID-19 was unanimously recommended for continuation without
modification by an independent DSMB after a planned interim analysis."

https://s28.q4cdn.com/539885110/files/doc_news/archive/78271d32-57a3-4cd5-943d-e6c52dde8999.pdf

This was followed in November 2020 with the announcement that the Department of Defense had entered into an agreement to help develop lenzilumab for Covid-19.

https://s28.q4cdn.com/539885110/files/doc_news/archive/04aeb1ee-cb62-474a-b1c6-ea29e3b7662e.pdf

Within a year of Humanigen launching this effort to treat covid, they announced favorable topline data.

"Humanigen Reports Positive Phase 3 Topline Results
Demonstrating That Lenzilumab™ Improves Survival
Without Need for Mechanical Ventilation in
Hospitalized Patients With COVID-19
3/29/2021"

https://s28.q4cdn.com/539885110/files/doc_news/Humanigen-Reports-Positive-Phase-3-Topline-Results-Demonstrating-That-Lenzilumab-Improves-Survival-Without-Need-for-Mechanical-Ventila-O9C2T.pdf

The trial results were published in May 2021, and additional positive developments carried on for the remainder of 2021, to include a Lancet peer review. A subsequent peer review was published in Thorax in July 2022, and revealed that the "...likelihood of survival without mechanical ventilation (SWOV) was achieved in 90% of LIVE-AIR patients treated with lenzilumab plus standard of care compared to 79% treated with placebo plus standard
of care, which was highly statistically significant (HR 2.54, p=0.0009)."

https://s28.q4cdn.com/539885110/files/doc_news/Humanigen-Announces-Peer-Reviewed-Publication-in-Thorax-Supporting-Early-Treatment-of-Hospitalized-COVID-19-Patients-with-Lenzilumab--LU1CP.pdf

As I recall, Humanigen changed the primary endpoint of the LIVE-AIR trial, to align with the primary endpoint of the designed-to-fail government-sponsored ACTIV-5 trial. Humanigen also accounted for the reasons there was a modified intent-to-treat population, with the main reason being that there was a shortfall of oxygen in Brazilian hospitals. I also don't think a p value of 0.0009 indicates a trial population that is too small.

In short, the FDA has kept lenzilumab's IND authorization in place since it was awarded in April 2020. That will soon be five years of clinical data, likely supplemented with Novavax's use of the lenz IND authorization to enhance their covid vaccine, which Sanofi plans to use with their Covid Influenza Combination vaccine.

It's the successful LIVE-AIR trial, with the Lancet and Thorax peer reviews, along with the IND use of lenz by Humanigen and several partners, that inform management of the safety and efficacy of lenzilumab. The informed feedback should have served as the basis for the FDA's Authorization and Approval of lenz, This lack of justification for the FDA depriving lenzilumab of an EUA was further evidenced by the FDA Declining to make a decision on our EUA.

I can see why the Indictment was sealed. It was not very impressive work, in my opinion. That applies to the factual basis, but perhaps more importantly, it applies to glaring omissions, also. How the heck did Dale lose the Appeal, if he did, if this is all the DOJ has?

I need to push through the analysis paralysis, my unwelcomed nemesis that consumes my day doing research, and culminates with me being so overwhelmed that I don't know where to begin.

It's just so incredulous to me that the FDA can reveal their confidence in lenzilumab by granting it IND authorization within weeks of the covid pandemic, and further evidenced by their continued confidence in lenzilumab, even now, by granting Sanofi Fast Track designation for their lenz-enhanced vaccines produced with Novavax, but yet the FDA refuses to grant Humanigen's EUA for lenz.

There are no excuses for this. They justify this negligence with two claims, a lack of demonstrated efficacy in the ACTIV-5 government-sponsored trial, as well as a lack of data sufficient to determine a risk/benefit conclusion. There is no merit to either claim, as has been clearly demonstrated, and substantiated by the Fast Track approval.

The FDA owes Humanigen a regulatory decision on the EUA, which they have never provided.

Jay Booth 1.4.25
@booth37337
·
2m
The $38M figure stuck in my mind, too. But the 'sells' were $68M, if they really were sells, and not shares transferred from a consolidation or merger, IAW the amended Asset Purchase Agreement.

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

https://x.com/search?q=humanigen&src=typed_query

I'm not talking about this message board. I'm talking this stock quote board:

https://ih.advfn.com/stock-market/NASDAQ/humanigen-HGEN/stock-price

I guess it's possible that we are maintaining a corporate headquarters in the US.

The important thing is that Humanigen's bankruptcy judge did not ignore Humanigen Australia. It is THE key entity making the amended Asset Purchase Agreement, which he approved, viable.

I do have to wonder, though, how Ihub's stock quote board can still reflect that Humanigen is an American company. Always something to learn here.

The company has been restructured in such a way as to be largely unencumbered by the continued criminal abuse of discretionary authority by American government agencies. Humanigen investors and lenzilumab patients are positioned to lead wealthy and healthy lives. We have management to thank for that.

The pieces just keep falling into place, DTG. I am super excited!

"Many public health professionals are convinced that a new serious variant of the original COVID-19 source, will eventually emerge through mutation. By the end of 2023, a total of 772 million people worldwide had contracted COVID and its variants, and a new milestone was passed — 7 million fatalities worldwide (over 1.2 million in the US).

As of this writing (April 2023), people continue to die each day from COVID-19 and its mutations. Source: World Health Organization

Only disciplined application of monoclonal antibody therapies has kept these numbers from being much larger.

When — not if — a new outbreak occurs, Taran will be among the first with the experience and resources to begin addressing that need quickly."

http://www.pacificroyalties.com/resources/taran-therapeutics/

To me, the most significant unanswered question, for some time now, has been in regards to the covid pneumonia reinfection rate in lenz-treated patients. The only hint of the answer to my long-posed question comes from the quoted statement, to the effect that the number of people dying from covid and covid-related indications would be "much larger" were it not for lenz.

We know that lenz has been IND authorized to treat covid since the pandemic was less than one month old, in April 2020.

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

I also believe that Novavax relied on lenzilumab's IND authorization to use Humanigen's patented lenz-vaccine cocktail to enhance their vaccine, for which they plan to submit a BLA application. We further know that Sanofi is using the Novavax vaccine for their Covid Influenza Combination (CIC) vaccine, which the FDA has Fast Tracked. Sanofi indicated the following about Novavax:

"First non-mRNA combination vaccine candidates that include two already licensed vaccines to prevent influenza and COVID-19 infections
•
Two phase 1/2 clinical studies are ongoing to evaluate the safety profile and immune response induced by the combination vaccine candidates."

https://www.sec.gov/Archives/edgar/data/1121404/000119312524278124/d913939dex994.htm

Adding to the body of knowledge about lenzilumab's safety and efficacy are the Phase I and Phase II trials Humanigen has done for other indications, the PREACH-M and RATinG trials being done by our research partners, and the Investigator Initiated Trials by Mayo Clinic, and the fantastic results achieved by Gracell to enhance their CAR-T.

On April 2nd, we will have 5 years of clinical data obtained on lenzilumab's safety and efficacy, achieved under IND authorization. And again, the FDA has fast-tracked the Sanofi CIC candidate. And at some point while this massive amount of data has been accumulated, the FDA cites a lack of data to warrant an EUA?

I have not seen Novavax announce a clinical trial of their lenz-enhanced vaccine. Yet, they plan to submit a BLA application. I think this will effectively be akin to a Phase IV trial, as I discussed a couple of days ago.

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=175591794

Of course, management knows that covid deaths would have been much higher without the IND use of lenz, starting almost 5 years ago, and as further proven with our twice peer-reviewed LIVE-AIR trial results, showing a Hazard Ratio of 2.54, with a p value of 0.0009.

https://thorax.bmj.com/content/thoraxjnl/78/6/606.full.pdf

The ACTIV-5 government trial was designed to fail, excluding hospital scale 4 patients on room air, which was the majority of the LIVE-AIR patients. They also included more severely ill patients, even on mechanical ventilation.

When the FDA Declined to award us an EUA, using their newly self-granted power to refuse to make a regulatory decision, they effectively took lenz off the market, without denying our EUA, which they would have had to justify.

Faced this this blatant willful negligence, which would continue to allow preventable deaths, management decided to continue funding the company's operation by equity financing. And that's assuming that the number of shares alleged to have been sold, WERE actually sold. Again, with the design of the share structure, Black Horse shares marked as sold, may only have been transferred, such as to Humanigen Australia.

These government employees need to be held accountable, and prosecuted to the full extent of the law.

The SEC filed a Second Amended Complaint on December 30th, 2024, including Durrant.

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

On the other hand, as I pointed out previously, on December 11th, 2024, the FDA granted Fast Track designation for the lenz-enhanced (?) Novavax vaccine(s) that Sanofi plans to use.

https://www.sec.gov/Archives/edgar/data/1121404/000119312524278124/d913939dex994.htm

Many times over the years, I pointed out that the Form 4's for the insiders may inaccurately be viewed as 'sells,' when shares were merely transfers. In fact, this could be the mechanism by which Humanigen Australia acquired shares, if they have.

And then there were two. Taran Pharma voluntary dissolved.

https://find-and-update.company-information.service.gov.uk/company/09252520/filing-history

I don't mind whether you post here or not. I welcome commentary from anyone who wants to provide it, including you. I'm looking forward to the resumption of communications from management, as well. But, I admit, I get a little extra enjoyment in having more latitude than they ever will have to talk frankly about the issues we face, from my own perspective.

I think you're totally ignoring how management likely utilized Humanigen Australia, so we will never be on the same page.

Yeah, yeah, yeah. The doom and gloom scenario comes straight from the playbook management used to navigate our way out of the Kalobios bankruptcy, with shareholders kept whole, and following a hugely successful recall of their loaned shares, and after the required number of outside Directors failed to be maintained as required for continued Nasdaq listing. I love sharing this account of those events, as we are preparing to announce details regarding our pending rebirth, again keeping shareholders whole after this CH11 bankruptcy.

https://moxreports.com/kbio-infinity-squeeze/

Big differences between then and now are the onset of covid, and our stellar results of the Phase III LIVE-AIR trial, plus a likely successful Phase IV trial with partners Novavax and Sanofi, which Novavax may have submitted for a BLA approval. Announcement of our successes will lead management to again recall their loaned shares, for which I will have open sell orders at $200 for about half of my shares.

I'm just noticing that I responded to Ritonavir's last post, and less than 30 minutes later I responded again, with no recall of my 1st response. I blame it on shock after seeing positive feedback subsequently provided to his post. I think his post was more conciliatory than normal, and can understand that tone being appreciated. But if the positive feedback is justifiably content-related, I'm going to have to rethink how I expect news of our progress is going to be received. Did the SEC charges cause more harm than I think it did? I really don't think that's the case. I still see a strong bullish outlook on X.com, where ALL of my posts contents are still available.

As I said earlier, "Bottom line is that I think we will merge and fully reunite the share structure with the IP. Until then, appearances may not be reflective of outcomes, as developments unfold." So we'll see how things develop.

...or, that ritonavir is the antiviral drug used in our lenz/vaccine cocktail.

This is just me thinking out loud about why all of your posts are here, and only here. With your nickname, I would expect to see postings from you on the Pfizer board. So, just curious.

All I can think of is that Humanigen is working with Pfizer to improve Paxlovid.

Here's a partial transcript of a discussion between Dr. John Campbell and Dr. Angus Dalgleish regarding a drug similar to lenz.

"21:17
we've done the phase one phase two is does it work every single phase two study we've done it clearly is of
21:23
benefit phase three is the big randomized study which they want before they register to approve it but the
21:29
problem is those large studies cost 20 to 30 million because of the way they upd the regulations but there is a thing
21:39
called uh phase four a phase four study and that
21:44
means that you license it but you haven't given it full
21:50
registration but people are able to sell it use it prescribe it but you have to
21:57
monitor it like it was on a study yeah and you collect that you collect longitudinal
22:04
data in the real world as you go along and it's heavily monitored and if that's
22:09
if that's fine then it's approved"

I think the data collected by lenzilumab's use under IND authorization, to treat hospitalized and hypoxic patients with covid pneumonia, starting in April 2020, and continued usage by Novavax to enhance their covid vaccine, could result in a BLA submission, which Novavax plans to submit, seeking full regulatory approval. Sanofi's Dec 11th press release announced Fast Track designation in the US for their Covid and Influenza combination vaccines, which were the, "First non-mRNA combination vaccine candidates that include two already licensed vaccines to prevent influenza and COVID-19 infections." This is obviously in reference to the Novavax vaccine that Sanofi is using, under a joint licensing agreement. There is no other non-mRNA vaccine licensed in the US.

As I said, I long suspected a partnership and merger to result with us between Novavax and Sanofi, and this is reinforced by the recent Novavax and Sanofi SEC filings.

I was writing my previous post, and did not see your post, before submitting mine. Certainly, we've presented two vastly different outcomes, only one of which I am happy with.

From the SEC filing I first reported on years ago, in which company insiders were designated to act as nominee account holders for the beneficial owner of select shares issued to them (or similarly worded detail), I knew that the Form 4's would not necessarily reflect insiders' personal account information. More importantly, and the reason for this design of the share structure, it would also not be possible to detect the accumulation of company-owned shares in preparation for an event such as a stock-for-stock merger, or other event requiring equity liquidity. I think the purpose for the design of the share structure has now been realized, and that we have merged into our Australian subsidiary, who is now holding the company-owned shares, which will continue to trade under the HGEN ticker (perhaps with a new cusip?).

Our previous emergence from filing a CH11 bankruptcy included a hugely successful recall of our loaned shares. Such a recall now would be absolutely pointless, and it would be very difficult to reach my $200 planned sells, if the company doesn't have any shares they could have loaned for another successful recall. Further, if any of the $38M Dale raised in his last sell went to fund Humanigen's operating expenses, this would be further proof that Dale was not the beneficial owner of the shares he sold, the company was, at least in large part.

The 4 entities between Humanigen and Taran have now become 3, on our way to becoming 2, once Humanigen Australia merges with Taran Therapeutics, which will reunite the share structure with the IP. I think Taran Pharma may then enter into a subsidiary relationship with us, or remain a distinct entity, with about an 8% equity interest, in the entity which will next be formed in a joint merger between the new version of Humanigen with Sanofi.

I think Humanigen beneficially owned a large percentage of the Black Horse shares, which they held as the nominee account holder for the company. We'll see, as the trial unfolds, if not sooner (which I expect). Certainly, if we get a recall of loaned shares, we'll have our answer.

So yes, I do think 'everything is going great,' despite the cost of just keeping us going. I see effort that I very much appreciate, knowing that sometimes, you have to fight fire with fire.

I just don't think things are as bad as they may appear to be.

I answered your post. I'll try again.

What the charges signal to our partners is that we have a capable CEO to steer the ship.

I can't help but to reflect on the fact that Dale filed a motion to expedite this process, and then to consider that Sanofi had a Q4 target acquisition date for 23 or so companies, and that Humanigen may prove to be a joint merger partner, perhaps within this time frame.

Regardless, that issue needed to be quantified, even if it only shows where there is no further cause for concern.

I've been waiting 10 years for the SEC to show their cards in this case. My first posts here were in 2015, two years before we became Humanigen, and I became a shareholder. My interest was in the abuse of discretionary authority by unelected government bureaucrats, and nowhere is that usually more evident than in the litigation brought by the SEC. And Dale is holding them to task, which will prove to be a bruising experience.

But...focus has to be zeroed-in on the immediate circumstances. And in that regard, this legal action represents a key piece of our puzzle being snapped into place. Resolution is always important, as it will be here.

I agree that Novavax 's reception of an amended

Advanced Purchase Agreement, from the commonwealth of Australia, should not be confused with Humanigen's reception of an amended

Asset Purchase Agreement, signed by the bankruptcy court judge. That's why I parenthetically added the type of Agreement in question to my post, and linked the Novavax SEC filing as the source.

I disagree that Novavax's Agreement with Australia is irrelevant to Humanigen. Novavax noted requirements regarding obtaining regulatory approval and an effective commercialization effort for their Covid-19 vaccine. I think we'll see that this is, in part, in regards to Sanofi's use of one of the Novavax vaccines as part of their FluBlok covid/influenza combination (CIC) vaccine. I have seen reports of the CIC market being twice as large as the covid market, which would significantly increase the demand for lenz as an enhancement to the CIC vaccines.

I could say more, about the intended market for the CIC vaccine, but I've already said more than I had initially intended. So I'll refrain from further discussion because I think news is fairly imminent (that's putting it lightly). But this show needs to get on the road, or Santa, and ALL of the reindeer, could end up with red noses.

"I can only imagine..."

Off topic, but every time I see those four words, I hear a song with that title.

https://www.google.com/search?q=song+i+can+only+imagine&sca_esv=b72004035a3299c8&sxsrf=ADLYWILltJ62786C0i1oeJMYFA21TN86yA%3A1734943685637&source=hp&ei=xSNpZ967JJyEp84P1bmemAs&iflsig=AL9hbdgAAAAAZ2kx1Sr6fhRNMc2fyxcGrMl6JY6hlAb_&ved=0ahUKEwiestfwwL2KAxUcwskDHdWcB7MQ4dUDCBE&uact=5&oq=song+i+can+only+imagine&gs_lp=Egdnd3Mtd2l6Ihdzb25nIGkgY2FuIG9ubHkgaW1hZ2luZTIKEC4YgAQYJxiKBTIFEAAYgAQyBRAAGIAEMgUQLhiABDIFEC4YgAQyBRAuGIAEMgUQABiABDIFEC4YgAQyBRAuGIAEMgUQABiABEju3QFQvw1Yx9EBcAF4AJABAJgBnQGgAakRqgEEMTkuNLgBA8gBAPgBAZgCGKAC_BGoAgrCAg0QLhjRAxjHARgnGOoCwgIHEC4YJxjqAsICBxAjGCcY6gLCAgQQIxgnwgIKECMYgAQYJxiKBcICCxAAGIAEGLEDGIMBwgIOEC4YgAQYsQMYgwEYigXCAgsQLhiABBixAxiDAcICDhAuGIAEGLEDGNEDGMcBwgIREC4YgAQYsQMY0QMYgwEYxwHCAg4QABiABBixAxiDARiKBcICDhAuGIAEGLEDGIMBGNQCwgIIEAAYgAQYsQPCAggQLhiABBixA8ICCBAuGIAEGNQCmAMI8QXMxmwuq8YOAZIHBDE2LjigB9TiAw&sclient=gws-wiz#fpstate=ive&vld=cid:69a08fea,vid:8-Y1y_aFL_s,st:0

Rather than to start a new thread, I'll just copy and paste the statement of interest to me.

"The Amendment (to an Advanced Purchase Agreement) further provides for certain remedies for the Commonwealth, including return of unused credit, cancellation of doses or termination of the Agreement, in the event the Company misses or under delivers doses to the Commonwealth or the Company fails to receive regulatory approval of a variant COVID-19 vaccine. The Amendment also provides the Commonwealth with the right to cancel doses if the Company fails to timely notify the Commonwealth of changes to its commercialization plans."

https://www.sec.gov/ix?doc=/Archives/edgar/data/1000694/000110465924129823/tm2431398d1_8k.htm

I will say here, though, that if lenz receives authorization or approval, we could see lenz effectively being used as a pre-exposure prophylaxis as a vaccine enhancement.

It's good to know that the Edgar system will continue operating, even if we start a government shutdown tonight.

I "Liked" your post for a couple of reasons, one of which is that it leads to one of my favorite topics, the covid reinfection rate for lenz-treated patients. There has been a recent development by Novavax in that regard, and it rates a separate thread, which I will be working on. But I would like to post here that your post also brings to mind previous discussions here about the role of lenzilumab as a pre-and/or post exposure therapeutic. Also, you are inaccurately referencing Novartis, instead of Novavax.

"Novartis, for instance, no longer has a vaccine business, but it does have one of the largest and most diverse manufacturing operations in the industry. So we are collaborating to help manufacture two different mRNA-based COVID-19 vaccines – the Pfizer-BioNTech vaccine and the CureVac vaccine – in our facilities."

https://www.novartis.com/stories/novartis-joins-pharma-wide-effort-meet-global-demand-covid-19-vaccines#:~:text=Novartis%2C%20for%20instance%2C%20no%20longer,CureVac%20vaccine%20%E2%80%93%20in%20our%20facilities.

I wonder if the folks at the Patent Office know that there is no way to administer the lenz/vaccine cocktail.

"METHODS FOR TREATING CORONAVIRUS INFECTION AND RESULTING INFLAMMATION-INDUCED LUNG INJURY
Publication number: 20240317846
Abstract: The present invention provides methods for treating a subject infected with 2019 coronavirus (SARS-CoV-2) comprising administering to the subject a therapeutically effective amount of a GM-CSF antagonist or a therapeutically effective amount of a GM-CSF antagonist and a second drug, including an anti-viral agent, an anti-SARS-CoV-2 vaccine, and serum containing human polyclonal antibodies to SARS-CoV-2.
Type: Application
Filed: March 4, 2022
Publication date: September 26, 2024
Applicant: HUMANIGEN, INC.
Inventors: Cameron DURRANT, Dale CHAPPELL"

"...and a second drug..." sounds like how lenz is used in CAR-T, where I believe it is administered about an hour before the CAR-T treatment.

I have no doubt that the HGEN entity we have become is Nasdaq compliant. We've had plenty of time, and the right resources, to execute the developmental plan to gain that compliance.

But we do not operate in a vacuum. We have commercial and regulatory entities that we are dealing with. I'm looking forward to the rollout, which I look for every day.

What I've expressed are my conclusions. Consider them as you have, that's fine. If my conclusions aren't entirely accurate, then I expect they will at least be very proximate. What 'was' has become irrelevant to what 'is.' Nothing I have read, nor anything you have said, even begins to give me pause for reconsideration. What I see is that management has taken just the right steps, and that lenzilumab is just the right drug, to achieve our immutable success. We are incredibly fortunate to already have shares, and we may even have five times as many shares than we have currently, especially if Sanofi ends up holding over 238M HGEN shares.