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And don’t forget there is a shelf life. I can’t remember exactly but it’s around a year. If they get conditional approval and start pulling in some money they can produce their product and get ahead on their schedule
Who needs the FDA?
Once UK gives the go ahead for conditional approval, were off to the races.
Europe will not stand by and watch its citizens cross the pond to get help.
When Europe gives the go ahead for their 140,000+ new cases each year, CVM will be maxed out on their capability to produce Multikine (20,000) till they build another facility. Depending on the agreements with UK and Europe, their looking at 1.5-2b yearly revenue.
2B in potential cancer drug sales is nothing to sneeze at and Big Pharma knows this. Especially with other cancers to follow.
There will be a buyout early on.
Nope. You can leave. Are you a member of the IHUB trash pickup? My can is overflowing with penny stock posters
Must we endure the rubbish discussed? (As the violins play in the background.)
I tripled by investing, holding and then selling when able to do so for a profit. At times I was stuck many years in between. I am slow because I can't time the market. Some people can do just that. They must have tips or some kind of heads up which I do not. Oh I stay away from all OTC stocks now and have done so for many years. Rule 115 did apply, but it was by accident on my part LOL.
Well, don't know how many years it took to triple but there is the rule 115.
I suggest the slow and steady method....and stay far from penny stocks.
Anytime and you are welcome. Glad you try to help others because I could certainly use some help. Not easy guessing stock picks all the time. I know there is a system and skill in some way. Took me many many years to work $600 into $15,000 by guessing - and of which was an initial investment of $5,000. Not very profitable considering the time spent. I only tripled my money before taxes.
Well I appreciate that. Surprisingly, you are correct about me. I try to help people, but apparently, being a "basher" is a thankless job. Even though I'm typically right.
That is funny. I know deep down you are a nice person. I give credit where it is deserved. I shoot straight. It's the way I am.
How dare you be complimentary to me!
Just hundreds in it. But actually it does matter to me because hundreds of dollars is alot of money for me. And believe it or not I do honestly know that you are a better stock trader than I will ever be. I am sure you know way more than I do. I do compliment you on your success, something I never picked up myself. A skill like yours is something I only can wish I knew. Some have it and most don't. I do not unfortunately.
So then, you don't have "thousands" in it?? So, does it really matter?
The reality of penny stocks is you don't want to put a lot of money into something so high risk, so why do it at all?
Unless I plan on holding a stock for no more than a couple days (because I'm expecting good earnings), I'm looking at it for the long haul, and that certainly wouldn't be a penny stock.
Enough for my wallet. Way more than I have in CVM. Many times more. If I had deeper pockets, I would have put $thousands into it. I got shares as low as $1.29. Still up even with the end of year profit taking from the day traders. I usually hold at least a year for long term gains of less taxes. Been holding CVM for almost two decades because I am stuck.
Humor me for a moment.....how many shares of FBIO did you buy?
Funny how a person claiming to ignore me, can't stop talking about me.
I think you should ALL put me on ignore. This way, if there ever was a newbie, I could talk to them without all the lies and static.
I haven't seen any of his dribble in MANY months. Ignore works great and I believe the worse thing for him is to be ignored either by function of just not replying to ANY of his posts.
I see that. Not sure why people focus on others opinions and contributions to a conversation to chastise.
he does tend to focus on the irrelevant almost exclusively
I only pointed out what you said because you focused on something that I said which was irrelevant in the first place. That is all. Not pumping anything. I don't care what people buy or sell. I don't need anyone to follow me or take any advice I may imply. All I know is that I am still down over 80% of my original investment into CVM since 2007. My FBIO shares are up well over 50% in a month. So you tell me what was the better buy?
First off, I said it was off topic.
Then I said...
Because you told me FBIO was tanking. MSFT is irrelevant. No different than saying $20.00 will get me on the subway.
No. Why would I?
Have you checked MSFT?
Have you checked FBIO lately ?
So between CVM and the rest, I should be good. FBIO chooching away. Also bought into EQ today that seems to be another that just got noticed and is at support levels and near 52 week lows. So the latter two are my tickets to ride.
No problem, glad to share.
Assuming nothing too choppy happens during early 2024 - I do think that CVM share prices 'only' rising to $8.40 might be a significant underestimate by end of H2 2024.
But we shall see and I ain't going anywhere in the meantime.
Cheers and thanks for sharing this!
https://www.webdisclosure.com/finance/stocks/cel-sci-corporation/news/1211815.html
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CEL-SCI CORPORATION Original-Research: CEL-SCI Corporation (von First Berlin Equity Research GmbH): Buy
Directive transparence : information réglementée
05/12/2023 15:46
Original-Research: CEL-SCI Corporation - von First Berlin Equity Research GmbH
Einstufung von First Berlin Equity Research GmbH zu CEL-SCI Corporation
Unternehmen: CEL-SCI Corporation
ISIN: US1508376076
Anlass der Studie: Initiation of coverage Empfehlung: Buy
seit: 05.12.2023
Kursziel: USD8.40
Kursziel auf Sicht von: 12 months
Letzte Ratingänderung: -
Analyst: Christian Orquera
First Berlin Equity Research has initiated coverage on CEL-SCI Corporation (ISIN: US1508376076). Analyst Christian Orquera's rating is BUY with a price target of USD 8.40 (€7.70).
Abstract:
CEL-SCI Corporation (CEL-SCI) is a biotech company with a development-stage immunotherapeutic product pipeline focused on cancer. The company's lead drug candidate, Multikine, is a biological product that contains a mixture of naturally derived and naturally occurring human proteins called cytokines, capable of activating a patient's immune system to fight and kill cancerous tumours. The drug candidate has been primarily developed as a neo-adjuvant (prior to standard therapy which mostly implies surgical removal of the tumour) immunotherapy for the treatment of various types of solid tumours, the lead indication, primary advanced head and neck squamous cell carcinoma (HNSCC). While Multikine did not meet the primary endpoint of the overall phase 3 trials in 923 patients, it demonstrated superior performance compared to standard of care in the pre-defined low-risk arm (n=380). Moreover, post-hoc data analysis of the whole study showed that the drug candidate achieves an even stronger performance in less sick locally advanced disease patients meeting certain criteria (No lymph node involvement - N0 - and low PD-L1 tumour expression). These patients showed a 73% 5-year survival rate vs 45% for the control group, a 28 percentage point overall survival advantage vs control (p=0.0015). Importantly, 38% of these patients saw pre-surgical responses with Multikine which led to a >32% 5-year absolute overall survival advantage vs control (p=0.0019). Based on this data, we believe CEL-SCI's lead drug candidate, Multikine, has a good chance of receiving conditional approval in Canada and the UK in H2 2024, followed by Europe and the US in 2025. Subject to approval, the company will be able to commercialise the drug while conducting a confirmatory study. We project sales potential for Multikine in these markets of >USD970m. We expect positive news flow from Multikine's approval process to add substantial value to CEL-SCI and positively impact the share price. We initiate coverage of CEL-SCI with a Buy rating and a USD8.40 (€7.70) price target.
First Berlin Equity Research hat die Coverage von CEL-SCI Corporation (ISIN: US1508376076) aufgenommen. Das Rating von Analyst Christian Orquera ist BUY bei einem Kursziel von USD 8,40 (€7,70).
IMO - if NICE does complete a review of Multikine and they say it belongs in the Great Britain SOC for head and neck cancer, then what the FDA choses to do is just a bonus in a lot of ways. The GB medical system - despite Brexit - still has close ties to what the rest of the EU does. And since H&N cancer is reportedly more abundant in Europe than in the US, that market is enough to drive share prices up to at least at the $25 level.
All I know is that we are likely in for an interesting, and positive, 2024 and beyond with CVM. I have been here in at least a small way since about 2009-10, but didn't really start adding much until after the Phase III trial results were revealed.
If the UK does approve Multikine as SOC would that really cause us to rise more then a little or does Multikine need to be approved by the FDA to bring us back to the $25+ again.
Been here a long time thru 2 R/S, hope we can see something finally.
Don't be sore. buy some more.
Now that is what I am talking about…keep the good news train rolling. We know that Multikine should be SOC. Let’s roll…
Wow.....interesting and I missed seeing the pop today and it came close to three bucks. My January $2 options are looking decent. Let's hope it is still there tomorrow ....and the next day...etc
Now I am only down 83%. So it is going in the right direction finally. Only have 50 shares. But used to only have 7 shares after that huge R/S. In 2007 or thereabouts I invested $900 into this pig and was down 99%. So I bought more a couple months back and hope you regain my initial investment soon.
I'm feeling pretty darned good about those shares that I have added during 2023 at around the $2.30 ranges,...
UKS National Institute for Health and Care Excellence (NICE) Selects CEL-SCIs Multikine as Potential New Standard of Care for Head
8:30 AM ET 12/4/23 | BusinessWire
VIENNA, Va.--(BUSINESS WIRE)--December 04, 2023--
CEL-SCI Corporation (NYSE American: CVM) today announced that the British National Institute for Health and Care Excellence (NICE) has selected Multikine* (Leukocyte Interleukin, Injection) to be evaluated as the potential new standard of care for squamous cell carcinoma of the head and neck (SCCHN) in the UK. NICE posted a detailed report from the UK's National Institute for Health and Care Research (NIHR) regarding Multikine, its clinical data, and its potential to become a better standard of care in treating newly diagnosed head and neck cancer in the UK. This published report informs UK doctors, patients, and other interested parties that NICE has started the review of Multikine and is soliciting public comment.
As stated on NICE's website (click here), the reason for selecting Multikine is the following:
"Anticipate the topic will be of importance to patients, carers, professionals, commissioners and the health of the public to ensure clinical benefit is realised, inequalities in use addressed, and help them make the best use of NHS resources"
A detailed Health Technology Briefing prepared by the NIHR posted on NICE's website (click here) titled "Leukocyte interleukin with cyclophosphamide, indomethacin, and zinc for neoadjuvant therapy of squamous cell carcinoma of the head and neck" can viewed in full HERE.
The NICE briefing includes the following statements:
-- "The current standard of care for locally advanced SCCHN is an
aggressive combined modality therapy. With current treatment the risk of
recurrence, distant metastases, and death (5-year survival rate) for
patients remains high."
-- "With current standard of care, most patients with SCCHN still
experience disease recurrence or develop distant metastases (spread to
distant organs or lymph nodes), therefore novel treatment options are
needed."
-- "The LI injection [Multikine] utilizes naturally occurring,
immune-regulating cytokines, and could be the first investigational
immunotherapeutic to be used in locally advanced SCCHN. Results from
phase III clinical trial (NCT01265849) indicated a statistically
significant 5-year survival benefit with LI immunotherapy produced in
patients receiving surgery plus radiotherapy, representing approximately
40% of the study population."
-- "If licensed, LI [Multikine] will offer the first-line neoadjuvant
treatment in previously untreated patients with SCCHN prior to standard
of care."
Dr. Mehmet Sen, MD, FRCR, one of Europe's leading head and neck oncologists treating patients for more than 30 years, and Consultant Clinical Oncologist and Honorary Senior Lecturer at the St. James Institute of Oncology in Leeds, UK, commented, "There is a clear and imperative need for a new treatment for newly diagnosed head and neck cancer patients in the UK and worldwide. Multikine's efficacy and safety data are clear and compelling. Moreover, because Multikine can be administered before the current standard of care of surgery and radiation, it has strong potential to be additive to survival at minimal additional risk, if any, to the patient."
"We are highly encouraged that NICE has selected Multikine for evaluation as a potential new standard of care for head and neck cancer. This is a big step forward in the UK," stated CEL-SCI CEO Geert Kersten.
NICE is an executive non-departmental public body of the Department of Health and Social Care in the UK. NICE publishes guidelines in four areas:
-- the use of health technologies within England's National Health Service
(NHS) and NHS Wales (such as the use of new and existing medicines,
treatments and procedures)
-- clinical practice (guidance on the appropriate treatment and care of
people with specific diseases and conditions)
-- guidance for public sector workers on health promotion and ill-health
avoidance
-- guidance for social care services and users.
These appraisals are based primarily on evidence-based evaluations of efficacy, safety and cost-effectiveness in various circumstances.
According to Cancer Research UK, an average of 12,400 cases of head and neck cancer are diagnosed each year in the UK.
About CEL-SCI Corporation
CEL-SCI is a clinical-stage biotechnology company focused on activating the immune system of cancer patients to fight cancer before surgery, radiation and chemotherapy have damaged it. The Company's lead investigational therapy Multikine completed a pivotal Phase 3 clinical trial involving head and neck cancer, for which the Company has received Orphan Drug Status from the FDA. The Company has operations in Vienna, Virginia, and near Baltimore, Maryland.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. When used in this press release, the words "intends," "believes," "anticipated," "plans" and "expects," and similar expressions, are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Such statements include, but are not limited to, statements about the terms, expected proceeds, use of proceeds and closing of the offering. Factors that could cause or contribute to such differences include an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products, inability to raise the necessary capital and the risk factors set forth from time to time in CEL-SCI's filings with the Securities and Exchange Commission, including but not limited to its report on Form 10-K for the year ended September 30, 2022. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
* Multikine (Leukocyte Interleukin, Injection) is the trademark that CEL-SCI has registered for this investigational therapy. This proprietary name is subject to FDA review in connection with the Company's future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by the FDA or any other regulatory agency. Similarly, its safety or efficacy has not been established for any use.
View source version on businesswire.com: https://www.businesswire.com/news/home/20231204232873/en/
CONTACT: Gavin de Windt
CEL-SCI Corporation
(703) 506-9460
SOURCE: CEL-SCI Corporation
Copyright Business Wire 2023
> Dow Jones Newswires
December 04, 2023 08:30 ET (13:30 GMT)
Patience is the buy (sic) word. Next news event liable to be very big
Not sure why dilution is assumed or thought of when the stock price declines…could be lack of interest from buyers because we don’t get regular updates from management. We all know that Gerry is terrible in this area and until that changes we will have share price fluctuations.
I was very appreciative of the shareholder letter a few weeks ago, but come on management, follow on with progress toward goals outlined. I think this is a reasonable request.
I remember that stock! I was in it about the year 2007 or so thereabouts. I lost almost all my money in penny stocks that were OTC. Never again. Took me 10 years to work my last $600 into $15,000 from my initial $5,000 investment. And NWBO was one of the culprits that stole my money !!!!!!!!!
Never , generational wealth in 2024 from NWBO
Jd shouldn't you be selling your nwbo shares that are tanking .
Hopefully CVM does as great as FBIO. I only have 50 shares of CVM, but am only down 87% now from 99% a couple months ago.
Glad I got in to FBIO at $1.29, $1.42, $1.54, $1.92 & $2.40. I am now up 25%. This made up for the CVM decline. Holding both stocks tight with FBIO being my ticket to a new car with only an investment of $700.
Look for company to meet the filing deadline at MHRA of Nov. 27 to qualify for a CHM meeting on2/22-2/23/24. The $5m from a private investor may very well be used for that purpose.
Stock should pop on the filing of the Marketing Authorization Application. Multikline will lead to Multi- Gain. Deal closes tomorrow and short will be covered. Watch volume numbers.
Why do you keep discussing off topic stuff here?
Considering the share price was around $2.80 a month ago and yesterday just jumped it back up to $1.90, I wouldn't be all that excited.
Are you here to pump it? That is quite a bit of volume today.
Perhaps you don't understand how issuing additional shares works?
It's ok to admit what you don't know.
FBIO - Tanking you say ???? LOL You should read the news more.
Cel-Sci Corporation (CVM)
https://www.youtube.com/watch?v=auAihG3rtC4
Multikine® (Leukocyte Interleukin, Injection) is the full name of this investigational therapy, which, for simplicity, is referred to in the remainder of this page as Multikine*.
Multikine, CEL-SCI's lead investigational immunotherapy, is an immunotherapeutic agent that is being developed as a potential first-line treatment for advanced primary head and neck cancer. If it were to be approved for use following completion of CEL-SCI's clinical development program, Multikine would be a different kind of therapy in the fight against cancer; one that appears to have the potential to work with the body's natural immune system in the fight against tumors.CANCER - MULTIKINE
Multikine may also have the potential to be a first in a new class of cancer immunotherapy drugs. It is the first investigational combination immunotherapy thought to have both passive and active immune properties. More...INFECTIOUS DISEASES - L.E.A.P.S.(TM)**
L.E.A.P.S is a patented, T-cell modulation, peptide epitope delivery technology that enables CEL-SCI to design and synthesize proprietary peptide immunogens. L.E.A.P.S. compounds consist of a small T-cell binding peptide ligand linked with a disease-associated peptide antigen.
This new technology has been shown the potential in several animal models to preferentially direct immune response to a cellular (e.g., T-cell), humoral (antibody) or mixed pathway. Diseases for which antigenic epitope sequences have been identified, such as some infectious diseases, cancer, autoimmune diseases, allergic asthma and allergy, and select CNS diseases (e.g., Alzheimer's) may be potential candidates for development using this technology platform. More...* Multikine is the trademark that CEL-SCI has registered for this investigational therapy, and this proprietary name is subject to FDA review in connection with our future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by the FDA or by any other regulatory agency. Similarly, its safety of efficacy has not been established for any use. Moreover, no definitive conclusions can be drawn from the early-phase, clinical-trials data summarized on this page or elsewhere on this website involving the investigational therapy Multikine (Leukocyte Interleukin, Injection). Further research is required, and early-phase clinical trial results must be confirmed in the well-controlled, Phase III clinical trial of this investigational therapy that is currently in progress.
** L.E.A.P.S. is the trademark of CEL-SCI for this investigational platform technology, and this proprietary name is subject to FDA review. No L.E.A.P.S. product has been approved for sale, barter or exchange by the FDA or any other regulatory agency for any use to treat disease in animals or humans. The safety or efficacy of these products has not been established for any use. Lastly, no definitive conclusions can be drawn from these early-phase, preclinical-trials data involving these investigational products
Partnering Philosophy & Corporate Partners
CEL-SCI's partnering philosophy is guided by the belief that any partnership entered into should serve the best interests of:
CEL-SCI is open to any reasonable partnership proposals that will accelerate its being able to bring its medicines to market.
Multikine (Leukocyte Interleukin, Injection) is the full name of this investigational therapy, which, for simplicity, is referred to in the remainder of this page as Multikine*.
CEL-SCI has a unique expertise in the development and manufacture of complex biologics. CEL-SCI is not a company that markets and sells drug products at the current time. Regardless, CEL-SCI believes it will be capable of marketing and selling Multikine on its own for head and neck cancer in both the United States and Europe if and once it is approved by the FDA (or EU regulators). Since its primary target is head & neck cancer surgeons, a rather small audience, CEL-SCI does not believe that a large sales force will be needed to commercialize Multikine, if and once it is approved by the FDA (or EU regulators) following the review of the total Multikine Biologics License Application.
Current Corporate Partners:
a. | Agreement Signed August 2008 | ||
b. | Territory - Israel, Turkey, expanded to also cover Serbia and Croatia in August 2011. | ||
c. | Revenue Share | ||
d. | Website - http://www.tevapharm.com/ |
a. | Agreement Signed November 2000 | ||
b. | Territory - Taiwan, Singapore, Hong Kong, Malaysia, expanded to also cover South Korea, the Philippines, Australia and New Zealand in the Fall of 2008. | ||
c. | Revenue Share | ||
d. | Website - http://www.oep.com.tw/ |
a. | Agreement signed August 2011 | ||
b. | Territory - Argentina and Venezuela | ||
c. | Revenue Share | ||
d. | Website - http://www.gp-pharm.com/ |
Based on the Company's L.E.A.P.S.TM** technology, as long as a disease epitope is available, CEL-SCI may be able to develop an effective treatment/vaccine using the L.E.A.P.S. technology. The two leading candidates derived from this technology are the H1N1 treatment being developed as a possible treatment option for hospitalized patients and the Rheumatoid Arthritis treatment vaccine currently being tested in animal models of the disease.
* Multikine is the trademark that CEL-SCI has registered for this investigational therapy, and this proprietary name is subject to FDA review in connection with our future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by the FDA or any other regulatory agency. Similarly, its safety or efficacy has not been established for any use. Moreover, no definitive conclusions can be drawn from the early-phase, clinical-trials data summarized on this page or elsewhere on this website involving the investigational therapy Multikine (Leukocyte Interleukin, Injection). Further research is required, and early-phase clinical trial results must be confirmed in the well-controlled, Phase III clinical trial of this investigational therapy that is currently in progress.
** L.E.A.P.S. is the trademark of CEL-SCI for this investigational platform technology, and this proprietary name is subject to FDA review. No L.E.A.P.S. product has been approved for sale, barter or exchange by the FDA or any other regulatory agency for any use to treat disease in animals or humans. The safety or efficacy of these products has not been established for any use. Lastly, no definitive conclusions can be drawn from these early-phase, preclinical-trials data involving these investigational products.
http://stockcharts.com/h-sc/ui?s=CVM&p=D&yr=3&mn=0&dy=0&id=p60195179833http://stockcharts.com/freecharts/gallery.html?CVM
http://finance.yahoo.com/q?s=cvm&ql=1
https://frugalnorwegian.com/cvm Insight into CVM P3 Trial Results
https://www.cvmresearch.com Insight into CVM P3 Trial Results & FDA Chances of Approval
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