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A $1M per patient treatment cost, and the treatment is ineffective for 30% of the treated patients.
Sounds like a job for lenzilumab.
But surely not, right? How could lenz possibly eliminate most of the treatment cost, and also improve the complete response rate for patients, when Humanigen's stock price it teetering on one cent?
Dare I to think that this unrealized potential presents promise almost beyond comprehension? Could share price be transient, yet result in lenzilumab demonstrating results that are robust and durable?
This is just about one of the many active opportunities for lenz. I'm here for the realization of all of lenzilumab's opportunities.
And political power is not a factor for this indication. Nor does Big Pharma regulatory influence come into play. When a product is as good as lenz, it can't be denied for everything, and forever.
While I have previously recognized lenzilumab's potential to enhance CAR-T efficacy as it may relate to TeraImmune, I think Gracell's CAR-T technology expands on that, and illustrates a broader scope for lenz in CAR-T.
The list of catalysts I'm anticipating doesn't note CAR-T enhancement, that now likely warrants being included in my list of catalysts. I'll add it now.
>CAR-T enhancement
>Our merger with Baudax
>The resubmission of our EUA application to the FDA with copy to MHRA in UK
>Tentative regulatory approval for lenz to treat CMML, granted by Australia's Therapeutic Goods Administration
>A finding to continue the study of lenz based on results from the first 20 patients in the aGvHD trial, which could prove to be a cure for certain cancers
>The declaration of a 5:1 forward stock split, depending perhaps on concluding a planned business combination.
>The recall of our loaned shares.
But when you KNOW what to expect from Regulators (not a damn thing, until they must), and you KNOW how revolutionary this drug will be (in both the covid and cancer markets), it presents unparalleled life-changing, as well as life-saving, opportunity. I think management is just quietly taking advantage of this opportunity, ahead of the recall of their loaned shares.
I wonder if Humanigen had a role in the Investigator Initiated CAR-T study of the Gracell platform. And we may also have invested Humanigen funds for the Baudax/TeraImmune acquisition. I suspect investment firms could be queued-up for a private offering. And with the Jefferies and Cantor investor presentations, maybe we will see a controlled equity offering, as well. Shares could become available if the company announces a 5:1 forward stock split, and if we also deplete our open shelf registration for $80M+.
I was able to add at $0.01, and at $0.0098.
Yes, that amazing improvement was discovered as a result of an Investigator Initiated IND clinical "FasT CAR" trial in the US. I'm hopeful that lenz was the Investigational New Drug that was used.
https://www.gracellbio.com/pipeline/
I don't know how Gracell's presentation to the Stifel 2023 Immunology and Inflammation Virtual Summit was received yesterday. The webcast wasn't archived. But the Jefferies and Cantor presentations scheduled for Tuesday and Wednesday will be available to review.
https://ir.gracellbio.com/news-events/events-and-presentations
I am hopeful that we will see our second quarter 10-Q by the 25th, before next week's presentations. If we can soon see news regarding the approval of lenz for CMML in Australia, followed-up with this news of our CAR-T enhancement, and possibly including TReg news from TeraImmune, that would be amazing!
Yes, I think I caught a bad case of chutzpah from management. It's obvious they are afflicted with it. Why else, with all the negativity about being demoted to Pink Limited listing status, would management echo my sentiment about the "good reason" for being so positioned? I love these guys.
"I think there is a very good reason that the second quarter 10-Q has been held up, taking us to Pink Limited listing status. If, as I suspect, the company recalls their loaned shares (which I think comes to 110M shares), short sellers, forced into buying by this recall, will have a very, very hard time of buying that volume of shares on this venue."
'"Will you walk into my parlour?" said the Spider to the Fly."
https://www.poetrybyheart.org.uk/poems/the-spider-and-the-fly
Double digit gains from a fraction of a penny in share price movement are as tempting, as they are dangerous.
No short volume reported in almost two months here:
http://shortvolumes.com/?t=HGEN
And with what I think is an impending recall of loaned shares, what could possibly go wrong for short sellers, betting against Humanigen's success?
Regarding T cells becoming exhausted, that is an issue being addressed by Gracell with their FasTCAR platform. Gracell filed an F-3 Registration statement in this regard last month.
"Company Overview
We are a global clinical-stage biopharmaceutical company dedicated to discovering and developing breakthrough cell therapies to address major industry challenges and fulfill unmet medical needs in the treatment of cancer. We aim to develop next-generation, transformational CAR-T cell therapies to broaden the use of this potent treatment modality across a wide range of disease indications in hematological malignancies, solid tumors and beyond.
Our pioneering platforms, FasTCAR and TruUCAR, are designed to provide significant advantages as highlighted below:
•
FasTCAR. With FasTCAR, we are able to deliver younger, less exhausted T cells for autologous cell therapies with enhanced activities and next-day manufacturing versus the industry norm of one to six weeks. FasTCAR is designed to address the most pressing challenges associated with autologous therapies, such as lengthy manufacturing time, suboptimal cell quality, high therapy cost and poor T cell fitness."
See Prospectus Summary, page 1.
https://www.sec.gov/Archives/edgar/data/1826492/000110465923094883/tm2324412-1_f3.htm
It's interesting to think that not only does lenz improve the efficacy of treatment therapeutics, but perhaps that extends to improving the efficacy of the treatment method.
I really appreciate that, eb. Thank you.
How would you know how far from reality my posts are? The reality is something I'd really like to know. Let me know if my starting to think that it is unrealistic to think that Gracell may enter into a partnership agreement with us.
Why ask me? I think they have a lot of things going, as I told you before, and they could be anywhere.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172790011
Maybe so, Yooo. But for anyone who is considering making an investment, or whether or not to sell their existing shares, it may be relevant to their decision.
It's interesting to note that Gracell does have a US Phase Ib/2 IND study on-going for their "FasT CAR" program.
https://ir.gracellbio.com/static-files/318a2250-ad01-4a5b-8f93-fdf5a96088ad
Over the next 9 days, the first of three investor conferences Gracell will participate in is scheduled in two days.
"Stifel 2023 Immunology and Inflammation Virtual Summit
Fireside Chat: Wednesday, September 20th at 10:15 am ET
Presenter: Dr. Kevin Xie, Chief Financial Officer
Location: Virtual"
https://ir.gracellbio.com/news-events/events-and-presentations
I mention that for what it is worth because I think there is enough reason to do so, and it may be worth consideration for the next couple of days.
"COVID levels are so high, they’re hovering near 2020’s initial peak, as the WHO urges those at high risk to take any booster they can get their hands on"
Erin Prater
Sat, September 16, 2023
The reported headline, as well as some of the content in the article, is so surprising, and some of it makes so little sense, that I almost didn't post the link. But there is some input from Eric Topol, so I'm making the post.
https://finance.yahoo.com/news/covid-levels-high-hovering-near-094500374.html
"... I looked at the Baudax filings the day before Ed resigned, to see if there was a clue provided."
Maybe the clue I was looking for regarding Ed can be found in Gracell's Press Release.
"I wonder if our 10-Q and news will dim Gracell's spotlight, or if lenz (will) have a role in their news." It seems like they may need a top level Commercialization officer, and would certainly benefit by Ed's hands-on experience with lenz for CAR-T.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172819198
I actually think lenz is better than a vaccine.
Yet, here we are with vaccines for everybody, starting at the age of 6 months.
Standard of care should be an infusion of lenz, with an activating agent, such as used in the traditional vaccines.
It makes far more sense to program an appropriate immune response to a respiratory infection, whether it is viral, fungal, parasitic, or bacterial in nature.
We're not there, yet. Lenz may be there, but we're not.
We'll take each victory as it comes. We know that the CMML trial data is revolutionary. Combine that with the recall of our loaned shares, and our success will be manifested. As far as I'm concerned, that is nothing more than a factual assessment of our situation.
Those aren't just your thoughts, Friend, many of us probably feel the same way you do.
And contrary to my feeling that lenz is some kind of vaccine, I don't feel that way at all. I think it could become part of a vaccine, when used with the Novavax or Janssen traditional vaccines, an anti-viral, and perhaps with the polyclonal antibodies we mentioned in our patent.
Nonetheless, I think we do pose a significant threat to the mRNA vaccine market. Again, I wish I had data on covid pneumonia reinfections for those patients who had lenz. I suspect reinfections of lenz patients to be negligible, AT MOST. You did not note the role of T cell memory imbued by lenz, which could prevent the progression of any future covid infection. And in that case, rather than lenz providing many more living people to be vaccinated, I think that market will diminish to the point that lenz could be used as a treatment for any covid cases that do develop.
I agree with you that the government wants their citizens to rely on them for virtually every aspect of their lives, and that lenz will remove a large degree of that control when it comes to healthcare. But look around. We're seeing unusual presentments of various types of infections, to include fungal and bacterial infections, in addition to viral. Not only that, we're seeing hypervirulent and antibiotic-resistant strains of some of these infections. This passive-aggressive bio-war will evolve to the point where it will become necessary to effectively combat these infections.
Lenz will earn it's stripes in fighting CMML and related cancers. The only reason we'll be permitted to do that is because decades have passed without Big Pharma being able to provide a solution. We are showing that progress now, and I have to think our effort will result in regulatory approval in Australia. I also think MHRA may then decide to grant lenz Conditional Marketing Authorization for covid, as well as CMML.
"Necessity" has always been one of the required components for our success. Government interference has hindered us. But ironically, the adversarial actions of other governments may force the hand of our government to protect their citizens. We've got to make our 535 national legislators rescind discretionary authority from government agencies. They should be required to follow the laws as written, and any deviation should require a full vote of both Houses to be permitted.
I find what the Item 5.02 DOESN'T say, more curious than what it does say. There was none of the language expected when announcing the departure of a Chief officer of the company. I was so curious that I looked at the Baudax filings the day before Ed resigned, to see if there was a clue provided. There was none that I could see.
The catalysts that can propel us forward are in place and active. There's no denying how effective lenz has shown to be in CMML and covid. Nothing is going to erase lenzilumab's demonstrated performance.
I just don't want any corporate actions undertaken to delay our reward. More importantly, I don't want any more regulatory inaction to delay our reward.
I'm sorry to see that, JA3. Ed has always struck me as being as real asset to the company, willing to serve in whatever way he can, whether it was assisting Cenexi (as I recall) in establishing a European distribution and commercialization network, or writing press releases for Investor Relations. I wish him well.
The tenths of a penny that our share price fluctuates is meaningful to you. I get that.
But the daily data that interests me is the following CMML trial data. especially for the Primary Endpoint, and Secondary Endpoints 4, 5, 6, and 7, all of which should have reportable data by now.
"Primary outcome [1] To assess the frequency of complete response (CR) and partial response (PR) at any point during the first 12 cycles of active therapy according to Savona Criteria. (composite outcome)
Timepoint [1] Any point during the first 12 cycles
Secondary outcome [1] Overall survival (as measured by medical records/follow-up.)
Timepoint [1] 2 years from Cycle 1, Day 1
Secondary outcome [2] Progression-free survival (as measured by medical records/follow-up)
Timepoint [2] 2 years from cycle 1, day 1
Secondary outcome [3] The proportion of participants who derive a clinical benefit according to Savona Criteria
Timepoint [3] The proportion of participants who derive a clinical benefit at any point during the 24 cycles of active therapy. This will be evaluated at the conclusion of study.
Secondary outcome [4] Assessment of the impact of treatment on physical capacity by serial assessment of Multidimensional Geriatric Assessment.
Timepoint [4] At baseline, Cycles 3, 6. 9, 12, 18, 24 and Early withdrawal.
Secondary outcome [5] Toxicity evaluation, both haematological and non-haematologic for both arms of the study by assessment of adverse event reporting and test results.
(Composite outcome)
Tests include blood tests and bone marrow tests. Toxicity will also be evaluated by asking participants about their health at every visit.
Timepoint [5] Throughout the 24 cycles of active therapy. (Assessed throughout as serious adverse events reported immediately). Participants will be asked about their health at every visit (baseline, cycle 1 days 1, 2, 4, 7, 15 & 22 and then day 1 of each cycle (maximum of 24 cycles). Blood tests will be collected every visit (baseline, cycle 1 days 1, 2, 4, 7, 15 & 22 and then day 1 of each cycle (maximum of 24 cycles). Bone marrow tests will be collected after 3, 6, 12 & 24 cycles of treatment.
Secondary outcome [6] Assessment of the impact of treatment on functional capacity by serial assessment of Multidimensional Geriatric Assessment.
Timepoint [6] At baseline, Cycles 3, 6. 9, 12, 18, 24 and Early withdrawal.
Secondary outcome [7] Assessment of the impact of treatment on social wellbeing by serial assessment of quality of life questionnaires.
Timepoint [7] At baseline, Cycles 3, 6. 9, 12, 18, 24 and Early withdrawal."
https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380941&isReview=true
Former Board member Kevin Xie will be on familiar stomping grounds on behalf of Gracell and their, "potential to overcome major industry challenges that persist with conventional CAR-T therapies, including lengthy manufacturing time, suboptimal cell quality, high therapy cost, and lack of effective CAR-T therapies for solid tumors and autoimmune diseases."
https://www.globenewswire.com/news-release/2023/09/14/2743346/0/en/Gracell-Biotechnologies-to-Participate-in-Three-Upcoming-Investor-Conferences.html
I wonder if our 10-Q and news will dim Gracell's spotlight, or if lenz have a role in their news.
I wonder if our interest in TeraImmune, through Baudax, is reflective of Moderna's interest in collaboration with Immatics NV. I've got to look at what TeraImmune and Immatics are doing, in comparison to each other. Immatics does have a simple 5 minute video illustration of their effort to develop the right T cell receptors to target cancer immunotherapies.
https://immatics.com/ See "Our mission"
FYI: "Regarding oncology, Moderna announced on Monday a multi-year collaboration with biotechnology company Immatics NV, on a variety of products, including antibodies produced through mRNA and cancer vaccines."
https://finance.yahoo.com/news/moderna-covid-shots-grow-revenue-105341755.html
This just sounds like the Treg work TeraImmune is doing, as well what our latest CAR-T patent is advancing.
"Method of increasing the efficacy of CAR-T immunotherapy using lenzilumab
Patent number: 11673962
Abstract: Methods of inhibiting or reducing the incidence or the severity of immunotherapy-related toxicity in a subject, the method comprising a step of administering a recombinant hGMCSF antagonist to the subject, wherein said administering inhibits or reduces the incidence or the severity of immunotherapy-related toxicity in said subject, are provided. An hGMCSF antagonist for use in methods of inhibiting or reducing the incidence or the severity of immunotherapy-related toxicity in a subject also are provided.
Type: Grant
Filed: October 2, 2018
Date of Patent: June 13, 2023
Assignee: HUMANIGEN, INC.
Inventors: Cameron Durrant, Dale Chappell"
https://patents.justia.com/assignee/humanigen-inc
Quite the contrary. It looks like I've got 10 sell orders at price-specific levels that are pre-programmed. I'd probably have to re-enter them if we get a ticker change and/or a forward stock split.
You share price post was actually helpful today. I had to go to the doctor's office, Dollar General, post office, etc., this morning, and forgot to log back into the trading platform after I got home, until I saw your post.
I don't think I'm going to have a chance to add more shares. I think great CMML news will be announced before I can buy more shares. I'm excited!
I have been writing about the catalysts I have been eagerly awaiting for some time now.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172790011
The longer I write about them, the closer they come to fruition.
Ultimately, I run the risk of stepping on the news of the fulfillment of some of those goals. I don't want to do that.
That honor rightfully belongs to management.
I hope people will recognize the significance of these fungal and bacterial infections present in patients with covid viral infection. This seems very suspicious to me.
I think there is a very good reason that the second quarter 10-Q has been held up, taking us to Pink Limited listing status. If, as I suspect, the company recalls their loaned shares (which I think comes to 110M shares), short sellers, forced into buying by this recall, will have a very, very hard time of buying that volume of shares on this venue.
I've said that before, and included this article before, talking about our previous recall of our loaned shares. This isn't an apples-to-apples comparison. We are in a much stronger position now to inflict considerably more pain on short sellers who will be forced to cover their positions.
https://valueofstocks.com/2022/06/01/share-recall/#google_vignette
It seems to me that we could be approaching the time to begin reporting the Primary Endpoint outcomes from the PREACH-M trial for CMML. The Primary Endpoint, "To assess the frequency of complete response (CR) and partial response (PR)...," could apparently be reported at any point during the first 12 cycles of active therapy.
https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380941&isReview=true
In June, we also had 10 of those patients already meeting certain Secondary Endpoints, such as Overall survival, Progression-free survival, The proportion of participants who derive a clinical benefit, and perhaps more. "All ten evaluable participants had a rapid clinical response."
https://s28.q4cdn.com/539885110/files/doc_news/Humanigen-Presents-Promising-New-Hematologic-Data-from-PREACH-M-Trial-for-Chronic-Myelomonocytic-Leukemia-Treatment-at-the-2023-Europ-OYZCQ.pdf
Dr, Thomas, the trial investigator, told 'Medscape' "the investigators have been "pleasantly surprised” at how well patients tolerated the monoclonal antibody.
"We haven't had any infusion reactions, we haven't had any pulmonary alveolar proteinosis, we haven't had any fevers from the infusion, from the antibody,” he said."
Each parameter (blood monocytes, bone marrow blast percentage, platelet count, blood hemoglobin concentration, and spleen size) has exhibited a durable return to normal or near normal values, with statistical significance. Two of the ten participants have been in the trial for 18 months, the longest of any participants, and exhibit lasting improvement. No participants have relapsed. One participant is now a candidate for stem cell transplantation, which may lead to a potential cure in that patient." Does this indicate a Complete Response?
I'm very interested in the opposing views expressed by JA3 and DTGoody in regards to taking the new vaccine. I hope others will share their views.
So you respond to a post I had written about a merger with Baudax by scoffing at my enthusiasm, suggesting that I am ignoring our share price. Contrary to your oft-repeated claim, I am under no delusion about the impact of a share price that likely is worth only about 5% of the amount I have invested here. I have been adding to my small account, but without any profit dollars to reinvest, I am adding here from my fixed income. So believe me, I am under no delusion about the effect of our share price. It is a stark reality for me.
But, merger news with Baudax is only one of catalysts I included in a post I had written about the news I am eagerly awaiting. Here are the news items I said I was awaiting.
">Our merger with Baudax
>The resubmission of our EUA application to the FDA with copy to MHRA in UK
>Tentative regulatory approval for lenz to treat CMML, granted by Australia's Therapeutic Goods Administration
>A finding to continue the study of lenz based on results from the first 20 patients in the aGvHD trial, which could prove to be a cure for certain cancers
>The declaration of a 5:1 forward stock split, depending perhaps on concluding a planned business combination.
>And most importantly, and perhaps with the markets being closed Monday, announcement of the recall of our loaned shares. Our previous loaned shares recall was announced on a Thanksgiving Day..."
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172737078
It's the realization of this potential that drives my enthusiasm. So I'll take my 100% wrong 0-6 record, based on the above, and let you gloat in your 100% correct record, which seems to thrill you to no end. I can't even imagine how you can find fulfillment in quoting the stock price, it's not like we need you to tell us that.
Do something informative, like disputing the potential I recognize above, if you are convinced that I am delusional, and that management is incompetent. I'll help you, we did not use Labor Day to announce the recall of our loaned shares while the market was closed, which I said may perhaps have been the day management selected to make that announcement.
But, THAT news will ROCK this stock price, when management decides to announce it, even if it starts from a stock price of $0.0146. And yes, that probably is another understatement.
I was going to comment on the effort by Baudax to raise funds, but realized that we may actually have bought our Baudax shares from MAM Eagle Lender. It seems likely that we did.
https://www.sec.gov/Archives/edgar/data/1780097/000119312523177609/d490305ds3.htm
And even the S-1 Registration statement filed Sept 5th is for the resale of shares by Alumni Capital. There is still no effective notice for that Registration. I wonder if we're going to take a even larger stake in Baudax.
https://www.sec.gov/Archives/edgar/data/1780097/000119312523228641/d609744ds1.htm
After reading the article you attached, I can say that I am definitely glad to have had the plaque removed from the artery in my left leg a couple of weeks ago.
But again, we have research doctors at least trying to understand excess deaths, including from vaccine-related myocarditis, but they are unable to appreciate their unintended role in exacerbating these circumstances. They can't be faulted for being unaware of information that is withheld from them.
The researchers accept that the mRNA vaccines produce , "... a small risk of developing myocarditis (inflammation of the heart muscle) in the weeks after getting an mRNA COVID vaccine made by Pfizer-BioNTech or Moderna. However, the risk of myocarditis after having COVID is much higher. A study by the Centers for Disease Control and Prevention reported that males ages 12 to 29 — who have the greatest risk of vaccine complications — were four to eight times more likely to develop myocarditis following a COVID infection than in the three weeks after receiving a dose of vaccine. For males 30 and older, the risk of myocarditis was 28 times higher from COVID than from the vaccine."
your link: https://news.yahoo.com/covid-affects-heart-120521925.html
They note that elevated hypertension is another covid-related indication.
But they don't know how Nuvaxovid may provide better results than the mRNA vaccines. And they certainly don't know how lenz could reduce heart and hypertension-related indications by treating and preventing progression of inflammation that leads to developing these indications.
The CMML trial design:
Primary endpoint with 7 secondary endpoints.
https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380941&isReview=true
Trial data needs to be updated. We know that we had 17 active participants as of June 9th.
"Response: The study currently has 17 active participants, ten of which were evaluable on June 9, 2023 when the EHA poster was presented...
Each parameter (blood monocytes, bone marrow blast percentage, platelet count, blood hemoglobin concentration, and spleen size) has exhibited a durable return to normal or near normal values, with statistical significance. Two of the ten participants have been in the trial for 18 months, the longest of any participants, and exhibit lasting improvement. No participants have relapsed. One participant is now a candidate for stem cell transplantation, which may lead to a potential cure in that patient."
https://medicalresearch.com/cancer-_-oncology/preach-m-trial-humanigen-study-evaluates-lenzilumab-and-azacitidine-for-cmml/
In addition, we have the on-going RATinG study for, "... patients who have undergone allogeneic hematopoietic stem cell transplantation and been diagnosed with high-risk aGvHD. The trial will be conducted at up to 22 sites across the UK transplant network in two stages. The first stage of the study will treat 20 patients with lenzilumab before halting for an interim assessment of safety, efficacy, and futility. If an independent data monitoring committee deem the second stage to be feasible, then the trial will progress... " It is this recommendation I am eagerly anticipating.
https://ir.humanigen.com/English/news/news-details/2021/Humanigen-Announces-Clinical-Trial-Collaboration-to-Evaluate-Lenzilumab-in-Acute-Graft-Versus-Host-Disease/default.aspx
Questions worth knowing the answer regarding Klebsiella pneumoniae:
"The researchers also are exploring why MDR hvKp are more susceptible to human immune defenses than hvKp: Is this due to a change in surface structure caused by genetic mutation? Or perhaps because combining components of hypervirulence and antibiotic resistance..." are having an effect?
What lab may cooking up a hypervirulent strain of the bacteria, that is also resistant to antibiotics?
"Wednesday, September 6, 2023
NIH investigates multidrug-resistant bacterium emerging in community settings
Researchers study confluence of multidrug resistance and hypervirulence among Klebsiella pneumoniae."
https://www.nih.gov/news-events/news-releases/nih-investigates-multidrug-resistant-bacterium-emerging-community-settings
I forgot to mention that I got a phone call yesterday from Rep. Burgess' office in regards to the letter I sent him about the need for our EUA approval.
If I get a phone call from Dr. Burgess himself, I'll try to convince him of the need to rescind all discretionary authority from the FDA, but I will mainly try to convince him to speak to management about lenzilumab's potential.
I listened to the video several times. Something about it is off, in my opinion. I think it comes down to the speaker's charity in regarding the Pfizer and Moderna products as "vaccines." There was no distinction between mRNA and traditional vaccines, which is understandable, since Novavax has to subsist from table scraps in the US market.
https://www.facebook.com/sandy.reece.52/posts/pfbid08YGqxeS71QNLr8j9QxoMBS9RzEnN82raY5NMkVuX2Dyo8VEPVGxwjrqqzZrVnrG3l
But, like Humanigen, acceptance of our products may have to be forced on the US market by the fact that the current standard of care isn't working, and could actually be doing more harm than good. I think this could become even clearer as we develop our lenz/vaccine/anti-viral cocktail, and actually produce the world's first true covid vaccine, when lenz is administered with the Novavax or Janssen vaccines.
Janssen gave up on the US market, leaving Nuvaxovid as the sole traditional vaccine in the US market. Novavax stock has consistently had the highest short interest fee in the US. And now, they are reporting healthy gains is share price.
https://www.highshortinterest.com/
"Novavax shares have risen over 20% since the beginning of this month, tied to rising hospitalization and death levels witnessed in August due to a new COVID-19 wave."
https://www.benzinga.com/news/23/09/34252396/why-novavax-stock-traded-higher-today
Also, management has previously advised us that an increase in ICU utilization could prompt a partner into including lenz in a large platform study. It may even make the FDA, or MHRA, give us an EUA or approval, based on a resubmission of our EUA application with additional safety and efficacy data included.
In terms of taking the right steps to avoid disaster, what management and Baudax are doing is incredible. We'll probably see a "Notice of Effectiveness" from Baudax anytime time now, regarding the S-1 they filed yesterday.
I possibly can't even take the right steps to maintain my internet and phone service. Here's some of the chat text I had with the provider last night. The technician's name is Joemarie, and she thought I was talking about bandwidth problems, which I wasn't.
"Jay Booth: This is not a bandwidth problem, when it occurs. I have zero service, no dial tone on the phone, no browser access, no TV. That is what I expect may happen tomorrow, when my Direct TV service is discontinued."
"Joemarie D: At the moment, are home phone and internet both working?"
"Jay Booth: yes"
"Joemarie D: Thank you. Since service is still active, we recommend to wait once the DirecTV service has been completely discontinued and monitor the services by then."
"Jay Booth: I won't have any way of contacting you."
I am just tired of paying Direct TV charges when I seldom find anything they offer worth watching, so I end up on FOX news channel, which is a misnomer, because they have devolved into a series of talk shows.
On the plus side, if I have to wait for the internet service provider, I had two atherectomies done on the 17th, and I think I can walk without pain now. Maybe I can get some yard work done. I'll just have to pay attention to the 102-108 degree highs that are forecasted the next few days.
Thanks, Yooo. We figured that out already, but you're providing additional confirmation.
Basically, Durrant is waiting on Durrant. We need some meat on the bone in our 2Q23 10-Q. The tentative approval from Australia of lenz to treat CMML is likely what Durrant is waiting on. That will change everything for us, including the need to file a bankruptcy.
Otherwise, we won't see the 3Q23 10-Q until mid-November.
Once we get this validation of lenz, management can file to have the Class Action lawsuit dismissed, if it isn't voluntarily withdrawn, in my opinion. And they can re-open their communications with shareholders.
I seriously doubt that you will get behind what I just said, and express your hope for our regulatory success in Australia. But, that won't stop management from trying to get that success for you, and me, and all shareholders.