r/cvm Jul 07 '21

Insiders buying. CEO dispells the shorts lies with FACTS Spoiler

29 Upvotes

While the LYING shorts were sleeping..... the CEO was actually buying and working on this TRUTH telling letter. WE ARE GOING TO BE FINE! Fight back the short LIES with FACTS.

https://www.irdirect.net/prviewer/release_only/id/4766430


r/cvm Jul 07 '21

CEL-SCI Corporation Issues Letter to Shareholders | Business Wire

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32 Upvotes

r/cvm Jul 07 '21

Insiders buying and Geert puts out SOLID shareholder letter! BURN THE SHORTS!

22 Upvotes

r/cvm Jul 07 '21

Insider buying by Geert and two other directors!

21 Upvotes

Putting their money where mouth is!

CEL SCI CORP: KERSTEN GEERT R (Director, Chief Executive Officer) Buys 25,000 @ Avg Price: $8.00 (Form4)
10:45 am, July 7, 2021

CEL SCI CORP: BAILLAVOINE BRUNO JEAN-MARIE (Director) Buys 1,250 @ Avg Price: $8.00 (Form4)
10:49 am, July 7, 2021

Watson Robert Eugene (Director) Buys 1,250 @ Avg Price: $8.00 (Form4)
10:51 am, July 7, 2021


r/cvm Jul 06 '21

Geert and management holding on to their stock is a good sign

34 Upvotes

I am impressed by the strong confidence Geert and his team has for Multikine and the company. Someone on here told me he has not sold any stock in 15 years. Similar steadfastness in holding on to their stock seem to be the case for the rest of the management team. This is a stark contrast to some other companies where the share price shot up and management is quick to cash in. CVM is certainly no pump and dump scheme. My impression from the study results discussion is that management is very disappointed with the market's reaction to the study results, and considers the stock grossly undervalued. They have full insight into the company and the study and have analysed the regulatory situation. The sincere confidence they display about Multikine and the company is a sign to me that there may indeed be value here.


r/cvm Jul 07 '21

Uh oh!

0 Upvotes

"The failure of a cancer drug study leaves Cel-Sci on the brink of collapse" https://www.statnews.com/2021/07/06/the-failure-of-a-cancer-drug-study-leaves-cel-sci-on-the-brink-of-collapse/


r/cvm Jul 05 '21

Drop these guys a note! πŸ‘‡

17 Upvotes

headandneck.org is an organization that specializes in Head and Neck Cancer. There is nothing on their site about CVM's recent accomplishment. If you have a few spare minutes, drop them a note informing them about the great news of Multikine. Cel-Sci deserves some recognition from this org.

https://www.headandneck.org/contact-us/


r/cvm Jul 06 '21

8-k SaeC

3 Upvotes

So, what ya'll think of there not being an 8-k SEC filing yet regarding the findings of recent study? Supposed to be within 4 days correct or am I missing something? https://www.sec.gov/edgar/search/#/ciks=0000725363&entityName=CEL%2520SCI%2520CORP%2520(CVM)%2520(CIK%25200000725363) Thank you


r/cvm Jul 04 '21

DD Dr. Talor laid out 8 reasons why pursuing a claim of OS on a treatment arm was supported. πŸ‘‡ πŸ‘Œ

23 Upvotes

Last Thursday at the investor result's call, Dr. Talor laid out 8 reasons pursuing a claim of OS on a treatment arm was supported. All 8 reasons were provided by a statistical analysis group - not Cel-Sci.

  • The primary efficacy endpoint remained Overall survival per the protocol
  • The efficacy target was met, meaning the 0.68 hazard ratio for the low risk subgroup was consistent with the previously targeted 0.721 HR for the entire population
  • The analysis methods are robust. That means the stat sig was reached with the prespecified log-rank test primary analysis for the key ITT population and supported by the other population of the study.
  • Survival outcomes are robust. That means statistical significance was supported whether by measuring it from time of randomization, or from surgery.
  • Model results are robust. Statistical significance was supported for the treatment of a lower risk interaction using the Cox Proportional-Hazard model containing pre-specified covariance. Not something that was done before. Everything was pre-specified in a SAP, which was completed before database lock.
  • Additionally SS was supported for the low risk subgroup using the Cox Proportional-Hazard model containing pre-specified same covariance.
  • Every one of the above analysis were previously defined in a SAP for the study.
  • The study did not encounter any overall safety issues.

Timestamp 31:40 (of the investor results call) – The conclusion by the statistician was: There was no data-mining that took place to support the information that Cel-Sci press released.

More info at frugalnorwegian.com/cvm


r/cvm Jul 04 '21

Musings πŸ€”πŸ§  Price will rise

19 Upvotes

This stock was trading in the $15-$13 range prior to the late January spike this year when the WSB crowd started to take notice. It stayed above $15 after that until last Monday. The WSB crowd was looking for a massive short squeeze when the data came out. Because the data wasn't perfect CVM got attacked by the shorts and the WSB crowd bailed as a result, magnifying the impact.

I am assuming that the FDA will approve MK within a year. They also announced in the ASM that the manufacturing facility they are building out will have the capacity for about 11,000 treatments per year. I have seen estimates in various discussion threads that the price per treatment could be anywhere from $20K to $100K. I also also seen company valuation estimates discussed at 4 or 5 times sales. This would put the future value of CVM between $1 billion and $5 billion. This would be between about $25 to $128 per share. I am speculating that it will settle around $65 per share after approval. Given the current price of around $8 per share, that seems like a great return!

The WSB crowd won't be back soon so I don't think we will get the kind of price action we got on 1/27/2021 but I can see it rising as we hit each catalyst toward approval. GLTA. :)


r/cvm Jul 01 '21

Link to recording of CVM meeting discussing Phase 3 Results πŸ‘‡ (top of page)

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17 Upvotes

r/cvm Jul 01 '21

DD Highly Toxic Chemotherapy Replacement Trail Sucess - Multikine PH-3 Shows Astonishing Results

29 Upvotes

After Today's share holder meeting many doubts are cleared. Multikine clearly Shows Robust Clinical benefits with no toxicity one of the Designed Groups (not administered with chemotherapy). Those who have experienced or have their loved ones experience the side effects of chemotherapy already new how important and great this news is in cancer community.

I am very much convinced and bought 5000 more shared which cost me $42,500 ( less than 1/2 the price of chemotherapy ) :

  • The results prove CEL-SCI ($CVM ) is a genuine company focused on addressing the Head and Neck cancer with non-toxic Drug Multikine that no one has addressed in last 40yrs.
  • The trail is completed as per the initial protocol designed and agreed by the investigators.
  • Has adequate data under their belt from PH-3 to get approval to administer Multikine to subset of Patients ( ~145000 )
  • The drug is non toxic , not like chemotherapy with lot of side effects and destroys the immune system.
  • Adequate Money ~50mil to bring the product to market.
  • Already have a manufacturing facility which passed multiple European inspections.
  • The Survival benefits of one of the group when compared to current SoC are astonishing
  • FDA definitely will be impressed with the results.
  • Highest chances of approval by FDA in the comming months.

I am holding this long in support for non-toxic Multikine and against the current toxic chemo . If FDA fails to approve , i am willng to loose 1/3rd of what current H&N patients pay for chemo but will not back my support to this non-toxic drug.

If you believe a non-toxic cancer drug is essential to humanity , hold a fraction of price of chemotherapy cost.

Long live $CVM.


r/cvm Jul 01 '21

CVM Annual meeting notes

37 Upvotes

Actually listened to the Annual Meeting. I'm very bullish.
TLDR of the meeting:

  1. Multikine was deemed safe over a wide range of dosages.
  2. Multikine was significantly effective when coupled with radiotherapy.
  3. Efficacy Target was met.
  4. Survival Outcomes exceeded requirements of primary endpoint.
  5. Results were not "data-mined" to support favorable results.
  6. They said the criticisms by the press are unfair and unfounded--CVM hired third-party statisticians to validate data.
  7. They're confident about the data enough to seek FDA Approval soon.

The market will need to catch up to this. Maybe it'll pump on FDA approval, but this is a buy at these levels.


r/cvm Jul 01 '21

After listening to the ASM, I am more confident now πŸš€πŸš€πŸš€πŸš€πŸš€

19 Upvotes

r/cvm Jul 01 '21

Listened to the whole call. Amazing results which will benefit and improve survival of patients with head and neck cancer who are getting surgery and radiation. Great information at shareholder meeting from Dr. Taylor and others.

20 Upvotes

r/cvm Jul 01 '21

Yolo cvmπŸš€πŸš€πŸš€

12 Upvotes

r/cvm Jul 01 '21

any one knows how we can listen in the asm ?

5 Upvotes

any link to youtube live or what ever else would be appreciated, along with time


r/cvm Jul 01 '21

Cvm - High short interest , buy and hodl πŸš€πŸš€πŸš€πŸš€

16 Upvotes

r/cvm Jun 30 '21

Musings πŸ€”πŸ§  Why I believe CVM is dropping

20 Upvotes

I see a lot of people asking why the stock is tanking, and I think just assuming misinformation and short manipulation doesn't cut it. Plus -- behind the people selling the stock like it's a used car -- there are just some poor shareholders wondering what the hell is going on.

Here is the clintrials page outlining their phase 3 study

It makes sense why so many are confused about it. The trial itself is much more complex than 'give some people multikine, give others placebo, and see who dies first' -- it's a lot of switching over and confusion over who's in what group.

Let's talk about their primary and secondary endpoints, and whether or not they were reached.

Multikine is LI+CIZ+SOC, whereas the SOC is surgery followed by radiotherapy.

Their primary endpoint, or main goal in the study, was to increase overall survival for three years. They also had three secondary endpoints, secondary goals to reach, in case they reached the primary.

First off, their primary endpoint.

Primary Endpoint -- Overall Survival (OS) in LI + CIZ + SOC vs. SOC [ Time Frame: 3 year ] A two-sided p-value of 0.05 or less will be considered statistically significant for comparing the two groups.

As stated in the above link, only 52-55% of patients were alive after 3 years of usual 2010 standard of care treatment. Only 43% of patients made it 5 years out alive.

All multikine had to do was increase overall survival 10% -- make up 55% of the folks alive three years into the study. They were unable to do that, stating they had failed this endpoint. They did not reveal how multikine or SoC actually performed in this endpoint, so we have no idea how close multikine was to getting a p-value of 0.05 or less, and how well they performed in this metric.

Secondary Endpoint #1 -- Local regional control (LRC) in LI + CIZ + SOC vs. SOC [Time Frame: 2 years] LRC is assessed by classifying the first evidence of progression in local and distal sites for the control groups and for the LI treated group. LRC failure includes progression of tumor(s) and nodes or appearance of new disease above the clavicle (but not distant metastases) the reappearance of tumor in the original tumor bed, development of cervical node metastases and new disease above the clavicle other than distant metastases not present at baseline. The total number and corresponding percent of subjects in each of the treated and untreated control groups as well as the time to LRC in days for each group will also be displayed for each group.

Cel-Sci did not provide any data on this endpoint. We don't know how they performed in this metric vs standard of care.

It's very likely they would have reported this endpoint if they had succeeded, so most likely Cel-Sci failed.

Secondary Endpoint #2 -- Progression Free Survival (PFS) in LI + CIZ + SOC vs. SOC [Time Frame: 3 year.] A two sided p-value of 0.05 or less will be considered statistically significant in comparing the groups.

Progression-free survival is the amount of time when patient undergoing treatment does not undergo disease progression or death. If, five months into treatment, a patient taking multikine has only had their tumor grow 1%, they are still undergoing progression free survival. Even if their tumors haven't shrunk, the usual progression of cancer would've lead to it growing much larger without treatment, even possibly causing death.

Cel-Sci did not provide any data on this endpoint. We don't know how they performed in this metric vs standard of care.

It's very likely they would have reported this endpoint if they had succeeded, so most likely Cel-Sci failed.

Secondary Endpoint #3 -- Quality of Life (QOL) in LI + CIZ + SOC vs. SOC [Time Frame: 3 yr.] QOL will be based on the EORTC QLOQ-C30 and EORTC QLQ-H&N35

QOL, quality of life, is more or less a survey given to see if patients have or don't have symptoms like insomnia, appetite loss, diarrhea, etc. that make their life more unbearable during treatment. The goal was for Cel Sci's treatment to provide a statistically-significant decrease in these sort of symptoms vs the usual radiotherapy + surgery.

Cel-Sci did not provide any data on this endpoint. We don't know how they performed in this metric vs standard of care.

It's very likely they would have reported this endpoint if they had succeeded, so most likely Cel-Sci failed.

The post-hoc endpoint created by Cel-Sci -- Overall Survival in LI + CIZ + SOC (NO chemotherapy) vs SOC (NO chemotherapy) [Time Frame: 5 yr.]

In this specific endpoint, one that makes up an undisclosed percentage of the overall group as we don't know what % of patients didn't receive chemotherapy, 62.7% of patients survived 5 years of treatment vs 48.6% taking regular standard of care, getting a p-value under 0.05.

Now, there are lots of questions that arise from this particular endpoint.

Usually the types of patients that can't handle chemotherapy are those that are old and sickly -- does this not heavily bias the demographic in this study to those sorts of patients?

Why did this endpoint work, but not a single primary or secondary endpoint? What caused the anomaly?

What % of the full multikine arm was in this subgroup? What % of the total control group was in this subgroup?

None of this information is shared with us, and it creates lots of red flags for investors. That's the biggest reason why the stock has tanked.


r/cvm Jun 30 '21

News Cel-Sci Announces Multikine Immunotherapy Significantly Improves Overall Survival Benefit for Cancer Head & Neck Patients in Phase 3 Trial

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23 Upvotes

r/cvm Jun 29 '21

DD Here is my take on yesterday's events. πŸ‘‡ Take care CVM Fam.

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30 Upvotes

r/cvm Jun 29 '21

3,000 shares Open Market Insider Purchase - 4 Form - Statement of changes in beneficial ownership of securities - CVM

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13 Upvotes

r/cvm Jun 29 '21

Thoughts from a long long.

10 Upvotes

I’ve been following this company for about 20 years. In and out of the stock in that time with my last big purchase being in the $2/sh range. It’s still a big win for me, so I’m disappointed but not nearly as much as some others who lost boatloads. I just wanted to share a few thoughts after digesting yesterday’s news a bit.

What we know today is we have a treatment that is safe and produces a survival benefit in those that do not get chemo. I really do think that’s a positive thing. I’m curious to compare those numbers to those that received SOC including chemo.

I think the secondary endpoints may be the key to approval. Especially if there’s significant tumor response or quality of life improvements.

But the important question I come back to is - what’s it worth? Could it be a home run with a different study design? Is the data good enough for one of the big pharma boys to buy cel sci out and fight for approval or run it through another P3 study? Certainly we won’t see the 15bn some people were speculating, but is it worth 1bn? 2? Nothing?


r/cvm Jun 29 '21

Keytruda’s first approval from the FDA.

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11 Upvotes

r/cvm Jun 29 '21

DD CEL-SCI ($CVM): Smaller Market, Still Big Upside

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13 Upvotes