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What there any mention of a pre-BLA meeting with the FDA?
44.42% daily short volume but PPS up 6.57%!
33.15% institutional ownership
44.42% daily short volume on Monday!
9.08 million shares (21.8% of the float) currently shorted
Current borrow fee: 100.6%
Shares available to borrow: 35'000
44.42% of the daily volume has been shorted on Monday but the PPS went up 6.57%!! Only 35'000 shares are currently available for shorting (iborrowdesk) and the borrow fee is 100.6%! Any day from now we might get some more news and the manipulation by the shorts will finally come to an end! And this is all for a drug with a median extended life expectancy of more than 4 years and zero toxicity!! Let us hope that many cancer patients can soon profit from this revolutionary treatment! GLTAL! Tick tock, tick tock ...
Wasn’t pointing to you
Ummm, ok, I didn’t assume otherwise.
Page 19 says
WE ARE TALKING W FDA
THIS MEANS MULTIPLE PRE BLA MEETINGS
ASSUMING OTHERWISE IS TOTALLY WRONG
https://cel-sci.com/wp-content/uploads/2022/06/CEL-SC_Corporate_Presentationwebsite_June2022.pdf
Kpauliukonis, thanks for the meeting synopsis. That was the tipping point of deciding not to drive to Northern VA for the meeting, ie, no advanced PR.
On the heels of a positive response @ ASCO, then Geert’s presentation at last week’s LD Micro Conference, I was looking for/expecting a PR by last Friday (or at the latest premarket today), and absent either, figured I wait on a post-ASM PR.
How often do the fda get a ten year study w near a thousand patients? Anyone have that perspective?
How many times do they gotta say it’s complicated and this causes delay
The original post has no merit. Nobody knows what it’s saying or referring to
Nobody cares about the term “pre-bla”
He said they’ve talked
Total mislead to suggest they haven’t
Upshot of todays shareholder meeting. Abstract was very well received at ASCO with lots of very encouraging feedback. Articles have already been submitted to peer review journals for publication so could happen literally any time. Fresh data will also be revealed on the clinical trials.gov website once a few corrections are made. Validation of the manufacturing plant is ongoing. Geert is constrained from saying more until data is either published in journals or released on the website. It sounds like there's a PR written and ready to go as soon as the data comes out. He said it's long, complicated and more like a white paper than a PR. The company has enough money on hand until the end of 2023. Principals at the company remain very optimistic.
Wow... they ran another study somewhere using a placebo ? News to me.
So, it appears that Mr. Market is quite happy with CVM on a day where the broader market is seriously down.
Good to see. The shareholders' meeting appears to have gone over well.
Sounds like I’m glad I decided not to go to the Annual Meeting, even though it was only a 20 min drive away … wasting my time would’ve only added to my already significant frustration …
You are 100% correct!
Where is the pre-BLA meeting they were supposed to have last year and now it’s 2022?
Cheers
Shareholder mtg, as I said, would be a big nothing burger. Again everybody was so excited that they had rented a big hotel room and that there was going to be big news
Cheers
"CEL-SCI intends to file a BLA with the FDA for approval."
So what are they waiting for?
They've had the data for going on a year now, they have FDA people consulting, and they've done ASCO. Supposedly, the data is irrefutable.
These applications should have been done months ago and ready to submit.
Do they have to wait till the data is posted on ClinicalTrials.gov?
Do they have to wait till a medical journal decides to do an article?
If so, we are screwed, cause these journals report to higher powers.
Do they have to beg the FDA for a pre-BLA meeting first? Again, higher powers.
As an investor I just want to know why the word 'intends' is being used.
It's not like they haven't been INTENDING to do this for years.
How about 'By End of Month, or 'Next Week' or better yet 'Tomorrow'.
It's just so frustrating to see them act as if they're in no big hurry after so many years.
You’ve talked about delusion bullish confirmation bias. Do you ever worry that confirmation bias isn’t a 2 way street? Eventually the shift will come without asking for your timeline
Look for a live feed of a donut shop. They may patch us in
Does anyone have info on how to virtually attend today’s Annual Meeting? Thanks!
Great find. It's a shame some people's integrity can be bought.......
All You Have to Know About Adam Feuerstein
This article tells you all you have to know about Adam Feuerstein's "alternative facts". Tick tock, tick tock...
https://insiderfinancial.com/feuersteins-flab-on-northwest-bio-nwbo-dives-stock-on-meritless-claims-after-nailing-primary-endpoint/183278/
I love it when you say zero chance of pre approval buyout
Makes me think there’s 100% likelihood of it
While I’ve been very clear that Cvm has a decent chance for approval, approval won’t come until early 2024
I remember Geert talking about a pre-BLA meeting happening last year, whatever happened to that?
Bla filing late 2022 or early 2023
Zero chance of buyout before approval
However I will swing trade this ‘cause they’ll be some ups and downs in the stock but I don’t expect this stock to hit more than five dollars anytime soon
$2s this week.
Cheers
“Subset” and “thin” for 300 subjects?
Misleading
You can 'see things' in statistics, like if you do just a big SOC and divide it in half one half will come out better than the other, most often.
That's why details matter :)
You sound pretty sure of yourself, Last time you were that sure, it was 95 percent that Cel Sci was going to be approved according to your website, Strange thing is that someone? took the website down.
Shareholder Meeting On Monday...
Will be UNEVENTFUL and a big NOTHINGBURGER
Cheers!
Short "volume"s meaningless. Just MMs doing their job filling orders during the day. Short INTEREST are open short positions needing to be bought back at some point in the future.
61.98% daily short volume on Friday!
33.15% institutional ownership
61.98% daily short volume on Friday!
9.08 million shares (21.8% of the float) currently shorted
Current borrow fee: 72.9%
Shares available to borrow: 65'000
61.98% of the daily volume has been shorted on Friday!! Only 65'000 shares are currently available for shorting (iborrowdesk) and the borrow fee is 72.9%! Any day from now we might get some more news (let's see what the yearly shareholder meeting on Monday will bring) and the manipulation by the shorts will finally come to an end! And this is all for a drug with a median extended life expectancy of more than 4 years and zero toxicity!! Let us hope that many cancer patients can soon profit from this revolutionary treatment! GLTAL! Tick tock, tick tock ...
Alternatives are alternatives
I wouldn’t have stayed invested if it wasn’t for the non-toxic and 60 year drought of treatment alternatives
If there were 10million studied and 9M showed improvement but the overall didn’t, the math heads would still churn the 10 perspectives
Most shorts, if it was the same amount over the survival improvement as is worse as shown overall now, then the shorts would say “barely over doesn’t count for nothing.” In other words, you couldn’t prove chemo superior x<10% as mush as inferior to the alternative in the overall.
The reality is and always has been, we don’t know exactly why all died. But the study with 300 subject without chemo, if they did a study just with those people, shorts would have NOTHING. That’s why 100s of doctors are still working on it and thank God it’ll help people in the right situation
THANKS FOR REMINDING US, and God help anyone thirsting for this failure
I called Gavin about the .gov. He said it’s the same bs they keep referring to as if some freak doesn’t describe the problem/solution well. Typical hell called ‘government.’ This government watches people die every chance it gets
Cheers!
I was surprised overall, patients on multikine were worse off than soc. I expected some OS increase. But it was worse!
Cheers!
Lightrock
WOW! Nice to see you
Yup, primary end-point failed with SOC better than MK was a shock.
Cheers!
So many real other companies out there when Covid hit that a fortune could have been made on....MRNA....LLY just two examples. CVM has been brutal over the last year and a half. Brutal!
ASCO Open Comment:
https://www.asco.org/practice-patients/guidelines/open-comment-guidelines
Interesting information - thanks for compiling this and sharing it.
So it's a distribution with a fairly short average time to review data and get it accepted, but with a very long tail to that distribution. With as big a data set as CVM has generated, we can obviously expect it to be longer than average, and it already appears to be longer than average.
So how long does Clinical Trials.gov typically take to approve trial results for posting? Out of the 273 carcinoma squamous cell "Completed Trials" and "With Results", I tabulated how long from "Results 1st Submitted" to "Results 1st Posted" of 50 trials.
14% were posted same month they were submitted. then
26% took 1 month
26% took 2 months
12% 3 months
4% 4 months
2% 5 months
6% 6 months
So 78% of the completed trials took 3 months to post the results and 90% were done within 6 months.
What about the other 10%?.... 1 took 8 months, 1 took 10 months, 1 took 13 months, 1 took 16 months and 1 took ....get ready for it.....21 months.
Geerts next task :
Buy meth for whoever the heck is involved w approval
To the point about anyone caring about the algorithm, there’s still patient choice. It’s not unethical to try once approved. Post algorithm it’ll just be more refined
Useless concern
“YOU’RE NOT ALLOWED TO DELAY SURGERY.”
Until now
I wish they’d express that second part is what’s coming w approval
It doesn’t matter what his thesis is
So what if CVM sucks, it’s still buyable w ease
If you own a piece of wood and sell it on the street, if someone knows how to make a cabinet - they buy the wood and make the cabinet. This opened a terrific doorway. Nobody cares if some freak doesn’t like the wood. The wood guy still makes money and a lot more than $3
DR.....Don't give him the time of day..he has issue's being a man...go with your gut feeling it has saved me many times......The street....stinking alfa...and other rags BS
GLTY...You seem like a decent person
GO CVM
First....AF is Cramer's lapdog....don't pay any attention to him.
He probably plays in the sand box with that susushi person.
I was in CVM many moons ago...got out now back in........
I trade with Vanguard which has the best fund managers around.
And invested in CVM.....that says's alot
I beat bladder cancer with an excellent doctor here in Turkey.
GlTA I'm buying in the morning
I'm not sure where Mr. Feurstein's expertise in matters of immunotherapy are derived. Several here and in other spaces have reported that he has a B.S. in Political Science. I've read a few of his pieces, and have never been impressed. His conclusions tend to be poorly formed, with large holes in his logic. In fact, I've never read anything by him, or heard of any piece he's written, that has ever painted any target of his work in a positive light.
Agree. I don't see how this doesn't get approved. I'm an old insitutional buy side equity research analyst, biotech/rx on long and long/short funds, CFA charter etc etc...I may be a little rusty, but this would have had my attention front and center back in the day.
I want to know what AF's bear thesis is. The presentation was pretty straight forward. Is it the "small" increase in benefit, or what exactly is his problem with CVM at this point? I'd love to get a recap of his version of his meeting with GK, which is apparently on his website.
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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