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Some minority shareholders want the upcoming stockholder vote to be disregarded or discounted because they believe that a "for" vote to the 2018 Stock Options awards will cause some type of harm to the "company" by the majority shareholders and the minority shareholders want said ownership to be diluted. It appears the board wants to maintain a specific share percentage of executive ownership (perhaps to ward off hostile investors). It is unknown what is the minority shareholder's true intent, if it's genuine or if they represent a malicious third party's interest
During the past 15 years the NWBO executive team has been working on behalf of shareholders to bring this PH3 trial and treatment to patients. No revenues except for financing. They have resisted hostile investors, bad financing deals, illegal spoofing, malicious lawsuits, FTD shorts with a bankrupt agenda, activist investors, and the Big Pharma Mafia. The NWBO board believes the stock options are warranted because of: “the extent of personal and professional risk [the] independent directors have endured in serving on our Board.”
They have now delivered a successful PH3 trial, prestigious JAMA peer Review. The company is now at a significantly de-risked junction. If you believe the current executive team can take the company to the revenue stage and unlock the stock price and the true company value... then proxy "for"
Dendritic Cell Vaccines "Work".
with NWBO's change of endpoints to adjust for progression the Data has a "high" probability to be successful. Have your popcorn ready
Dendritic cell vaccine (DCVAC) with chemotherapy (ct) in patients (pts) with recurrent epithelial ovarian carcinoma (EOC) after complete response (CR) to 1st-line platinum (Pt)-based ct: Primary analysis of a phase 2, open-label, randomized, multicenter trial.
"Increased immune response and reduced immune-suppressive factor secretion were also evident [103]. Another study compared autologous dendritic cell vaccine with chemotherapy to chemotherapy alone for recurrent platinum-sensitive ovarian cancers and demonstrated a trend toward improved ORR (87.5% vs. 62.5%, respectively) for the vaccine cohort (NCT02107950) [104]. A European multicenter, phase II study found that sequential administration of dendritic vaccines following primary cytoreductive surgery and chemotherapy had a trend of improved PFS compared with concomitant administration with adjuvant chemotherapy (24.3 vs. 18.3 months, p = 0.05) (NCT02107937) [105]
https://www.researchgate.net/publication/327450915_Dendritic_cell_vaccine_DCVAC_with_chemotherapy_ct_in_patients_pts_with_recurrent_epithelial_ovarian_carcinoma_EOC_after_complete_response_CR_to_1st-line_platinum_Pt-based_ct_Primary_analysis_of_a_phas
Dendritic cell-based immunotherapy (DCVAC/OvCa) with chemotherapy in patients with platinum-sensitive, relapsed, epithelial ovarian carcinoma: Survival analysis of a phase II, open-label, randomized, multicenter trial (study SOV02)
"A phase II study investigated the use of dendritic cell vaccine (DCVAC) with platinum-based chemotherapy vs. chemotherapy alone in patients with recurrent epithelial ovarian. DCVAC + chemotherapy decreased the risk of death by 62% which corresponds to 73% survival at 2 years, compared to 41% survival with chemotherapy alone
https://www.researchgate.net/publication/334266438_Dendritic_cellbased_immunotherapy_DCVACOvCa_with_chemotherapy_in_patients_with_platinumsensitive_relapsed_epithelial_ovarian_carcinoma_Survival_analysis_of_a_phase_II_open-label_randomized_multicent
A long-term survival analysis of patients with platinum-sensitive, relapsed epithelial ovarian carcinoma treated with dendritic cell vaccination immunotherapy in combination with chemotherapy showed a significant improvement in overall survival (OS; P =.0032) compared with chemotherapy alone. The improvement was not seen, however, in progression-free survival (PFS; P =.35). The findings from this open-label, multicenter, phase 2 study
https://www.cancertherapyadvisor.com/home/news/conference-coverage/society-of-gynecologic-oncology-sgo/sgo-2019/dendritic-cell-vaccine-ovarian-cancer-induce-anti/
CVM INCREASES PREVIOUSLY ANNOUNCED BOUGHT DEAL TO $31.7 MILLION
Some additional information to support a "projection" for Cel-Sci's FULL DATA release.
As previously projected by Fosco and Sushi and others who have stated that there is a high probability of an April 2021 "FULL DATA" Release date. That would be ANYTIME up until the end of April 2021 as that would mark a minimum 4 Month data analysis period (depending on the exact start date, Dec or Jan).
We can take the following ZYESAMI trial as an example to support the probable timeline required for "FULL" data readout
https://www.prnewswire.com/news-releases/neurorx-announces-zyesami-aviptadil-rlf-100-met-the-primary-endpoint-of-its-phase-2b3-clinical-trial-and-also-demonstrated-a-meaningful-benefit-in-survival-from-critical-covid-19-301257291.html
ZYESAMI™ met the primary endpoint for successful recovery from respiratory failure at days 28 (P = .014) and 60 (P = .013) and also demonstrated a meaningful benefit in survival (P = < .001) after controlling for ventilation status and treatment site.
This is transcribed from NeuroRX recent investor conference call delivered by Dr. Jonathan Javitt the chairman and CEO of NeuroRX
"This is the first clinical trial in my career in where it was impossible to have study monitors visit study sites and examine records in person because of the extraordinary measures taken to limit personnel in the hospital during the pandemic. Yet our monitors managed to improvise, to review medical records by video conference, and otherwise manage to uphold the FDA clinical standard of good practices in the midst of a public health catastrophe. In the case of this Clinical trial we are reporting topline data approximately 4 weeks after treating the last patient. I think you will note that most pharmaceutical companies' clinical trials report 2-4 months after treating the last patient. Therefore we ask that you not be influenced by those whose focus is on something other than scientific integrity, to believe that something is wrong or something is being hidden, if we take a month or two to make sure that we are doing our work thoroughly."
So armed with the possibility of an April 2021 FULL DATA release window, CVM investors have some decisions to make.
If you are a "long" investor and you don't have both "trading shares" and a "core position" you have to decide, do I risk selling my shares now and wake up tomorrow to positive data.
If you are a "short" investor do you continue to short shares, buy/sell options and do not close out your losing positions and wake up tomorrow to positive data.
It seems that the Shorts and the Longs have a similar dilemma.
Hedge funds would love to continue to short CVM shares and also get those options back down to Out of the Money range.
If they do continue to short CVM it would be "very risky" for any hedge fund in this current environment.
Retail investors have identified the hedge fund's stock and derivatives vulnerabilities and are exploiting it. no different from what they have done for decades.
According to Goldman Sachs Group Inc. " Hedge Funds continue to sell their long positions and covered shorts in every sector
Despite this active de-leveraging, hedge funds net and gross exposures on a mark-to-market basis both remain close to the highest levels on record, indicating ongoing risk of positioning-driven sell-offs."
I CAN'T SLEEP
LEAPS development is further ahead than most discern.
Pre-clinical: work has already been conducted at the Rush University Medical Center in Chicago.
2014: (Phase 1) CEL-SCI Received an NIH Grant for (Phase 1) proof of concept and "commercial potential" of LEAPS.
2017: (Phase 2) Two years later Cel-Sci received a SBIR grant for (Phase 2) Research to advanced the efforts achieved in the SBIR Phase 1.
2018: (Phase 2 Accelerator Program ) CEL-SCI was selected into the Commercialization Accelerator Program by the NIH. Only a select number of companies are awarded the SBIR (Phase 2) Commercialization Accelerator Program
LEAPS was specifically selected by the NIH for the Commercialization Transition Track, which provides technical assistance to awardee companies to move NIH-funded technologies towards commercialization and market readiness.
2020: (Phase 3) LEAPS is already on a commercialization path towards an IND application. (Phase 3) is here..."real patients" will soon be treated with LEAPS.
Static / Rogue,
I believe the study power would have been calculated with the total study population taken into account and if the Statistical Analysis Plan (SAP) contained survival censoring then the IDMC and their built in statisticians would have already calculated that, with survival censoring they would still be able to reach the 298 events. It would just take longer if there was high Multikine efficacy, hence "continue until the appropriate number of events".
The Trial's Statistical Analysis Plan details would not be publically available until the data unlock, so we can only "speculate" as to how or if the survival censoring is handled within the Multikine Study. This is why I say if you believe that survival censoring is a part of the study's SAP then this is very positive.
The censoring would be occurring in the randomized enrolled patients at 3 year follow up increments.
As a very crude example e.g. patient numbers being censored (3yr follow up - 30 patients - 14 survival censored) (3yr follow up - 20 patients - 8 survival censored) (3yr follow up - 110 patients - 51 survival censored)
If the Multikine treated patients are significantly outperforming the SOC patients, resulting in high survival censoring this behavior would have been anticipated upon the study design since Multikine received phase 3 go ahead by presenting data showing a 33% improvement in the Phase 2 study.
Since the Kaplan-Meier curve can easily handle these variables, there was no reason for the IDMC to make an amendment to the original SAP. They will continue to follow their charter and if we don't or cannot meet the 298 events then they will proceed to the 2nd stopping boundary in their charter.
Hi Q, that is "my" interpretation also.
Censored surviving patients have simply completed a "minimum" follow up period, an interval if you wish, but continue in the study and also continue to be followed for the "entire" duration of the study. The censoring is "statistical" they are still followed and continue to contribute to the remaining tail end of the KM curve. Patients with squamous cell carcinoma of the oral cavity have a median (3 years) survival. I believe this is what the trial intends to extend with the primary endpoint, the long term survival will be just as important to calculate the survival for the entire study population.
When the IDMC performs an interim analysis and review at a "future" date it includes the data from all previously censored patients. Data on if those patients have continued to survive or have died at some point since the last analysis and is then incorporated into the survival curve. This process is ongoing.
Hi Lightrock good to hear from you, it's been a while
I am not sure about your reference to drop outs. This article is "not" about drop outs.
Summary:
After 9 years, why has this Time to Event (TTE) study not yet arrived at 298 events?
-The longer than expected trial conclusion may be explained by better than expected patient "SURVIVAL" in the Multikine treated population.
-After a 3 year "minimum" follow-up time, if a patient is not an "event" and is still "alive" they are statistically “censored”, removed from the available patients that can be counted towards the 298 events.
-Similar to drop outs, "Surviving patients" are also "censored", but...differently because after they are censored they are still followed and continue to contribute to the remaining tail end of the KM survival curve
-If we accept the proposition that dropout rates have been reasonably contained within the study then the next logical assumption would be to replace the high dropout rates used in our models with high "survival censored" patients.
-Therefore, in a TTE study the more patients that survive the 3 year minimum follow-up time, then the fewer are available to contribute towards the 298 count. Resulting in a much longer time to meet the stopping boundary of 298.
-This is not a death study, but a "survival" study. Survival is the measurement. The longer study conclusion indicates increased median survival resulting in increased "survival censoring"
-Increased "censoring" over the years of the "surviving patients", therefore reducing the available patient population (sample size) necessary to achieve the predetermined 298 events, within the desired time.
-A plausible conclusion would be to consider that "survival censoring" is responsible for the longer trial duration.
Cel-Sci Survival Censoring
https://drive.google.com/file/d/1ScJBldrV9wNtTkaCE9_020UZx7xDWNxt/view?usp=sharing
From the Zacks (paid) research update:
"If we assume median OS in the SOC arm and a 10% improvement in OS in the Multikine arm, this suggests about 437 events in September 2019"
"assuming the control arm matches the SEER analysis and the Multikine arm demonstrates a 30% improvement in OS. We apply this to the upper bound (fewer deaths) of the confidence interval in Exhibit I and calculate a result of over 360 deaths as of September 2019."
Based on Zacks updated analysis we are WELL over 30% survival.
Fosco's "conservative" sheet is showing we have already met 26% survival improvement.
CVM's SEER survival sheet is showing 60% survival improvement.
Zacks has sourced much of the information from the company, including SEER data and inclusion criteria in order to make their assumptions. Since this is a paid research coverage I am going to assume this is how Cel-Sci views the overall survival numbers of the study.
It is now just a matter of time for others to "run the numbers" to realize that statistically the 10% survival improvement has already been met.
Multikine is administered to previously untreated, newly diagnosed head and neck cancer patients right after diagnosis for three weeks before the current standard of care treatments.
If this concept is wrong...then why are other companies taking the same approach.
Pembrolizumab as Neoadjuvant Therapy Before Surgery
Phase III, Randomized, Open-label Study to Evaluate Pembrolizumab as Neoadjuvant Therapy and in Combination With Standard of Care as Adjuvant Therapy for Stage III-IVA Resectable Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA HNSCC)
This is a randomized, active-controlled, open-label study of pembrolizumab (Pembro) given prior to surgery and pembrolizumab in combination with standard of care radiotherapy (with or without cisplatin), as post-surgical therapy in treatment naïve participants with newly diagnosed Stage III/IVA, resectable, locoregionally advanced, head and neck squamous cell carcinoma (LA-HNSCC). Efficacy outcomes will be stratified by programmed cell death ligand 1 (PD-L1) combined positive score (CPS) status. The primary hypothesis is that pembrolizumab given before surgery and after surgery in combination with radiotherapy (with or without cisplatin) improves major pathological response and event-free survival compared to radiotherapy (with or without cisplatin) given after surgery alone.
Durvalumab Before Surgery
This pilot clinical trial studies how well durvalumab before surgery works in treating patients with oral cavity or oropharynx cancer. Monoclonal antibodies, such as durvalumab, may interfere with the ability of tumor cells to grow and spread.
Patients receive durvalumab IV over approximately 60 minutes on day 1. Treatment repeats every 2 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Within 3-17 days after last dose administration of durvalumab, patients undergo surgery. Patients may receive an additional dose of durvalumab if time to surgery is longer than 30 days.
I Totally agree Lightrock,
"The overall survival (OS) data of immuno oncology therapies indicate a delay in treatment response, with a point of inflexion (or turning point) observed at some time following treatment initiation.
Since a subset of the patients in the study is no longer at risk of progression or death, this implies that the study duration could be substantially prolonged. In some occasions, delayed clinical effect and long term survival were present in the same study
Beyond the inflexion point, the Kaplan-Meier curve appears to plateau, meaning that patients who survive the initial period of delayed response experience an extended survival benefit compared to the standard of care (i.e., chemotherapy or targeted-cancer therapy) and could potentially be "cured"."
The main thing I found note worthy in the 10Q was the NEW deliberate wording of the study goal, which is now the "primary endpoint" and is no longer the 298.
Since there is no longer any dosing of Multikine the only thing they can do at this point is to continue to (track patient survival).
Very important...when 298 was the message Cel Sci was tracking "patient deaths" NOW they are tracking Patient "SURVIVAL" when you track survival ... death numbers are irrelevant
"continue to track patient survival until it can be determined if the primary endpoint of the study will be met"
The primary endpoint (survival) will be determined "AFTER" a total of 298 events (deaths) have occurred in the two main comparator arms of the study and have been recorded in the study database.
The pivot in new terminology and focus is on the "primary endpoint" which is: (10% improvement in overall survival of the Multikine treatment regimen plus Standard of Care (SOC) vs. SOC alone)
Order of operations says that you cannot evaluate if you have met the "primary endpoint" (survival) UNTIL (after) the final 298 events (deaths) occur.
Everyone who has been opining over the lack of coverage take a look at sushi ' s 13k filings reports.
There is the coverage. Follow the smart money.
Sushi the absence of a 5% filing could be due to exercised warrants changing the outstanding share count
looking forward to it, I've got my popcorn ready : )
Yes this news is worthy.
Important take away ... LEAPS has proven (independently) in a preclinical and Investigational environment to be "effective at modulating the inflammatory response and arresting (Stopping) the progression of arthritis"
LEAPS and MULTIKINE are based on the same immune modulating platform. They both direct the immune response.
Multikine is developed to modulate the immune response to break tumor tolerance and attack kill the cancer cells.
In preclinical we now know that LEAPS "stops" the progression of arthritis.
Is it logical to make the "leap" that if they are based on the same "platform" then Multikine ...
JUNE 3 2019 SAN DIEGO--(BUSINESS WIRE)--
Odonate Therapeutics, Inc. (ODT), a pharmaceutical company dedicated to the development of best-in-class therapeutics that improve and extend the lives of patients with cancer, today announced that the IDMC for CONTESSA, Odonate’s Phase 3 study investigating tesetaxel as a potential treatment for patients with HER2 negative, hormone receptor positive metastatic breast cancer, recommended that the study continue with no modifications following a planned interim efficacy futility analysis. The interim efficacy futility analysis was based on a pre-specified analysis of the first approximate 100 progression-free survival (PFS) events that occurred in the study. PFS is the primary endpoint of CONTESSA. The purpose of the interim efficacy futility analysis was to facilitate the early termination of the study if the IDMC determined that achieving a positive outcome on the primary endpoint would be futile. Odonate continues to expect to complete enrollment of CONTESSA in the second half of 2019 and to report topline results in 2020.
This notable quote is:
"The purpose of the interim efficacy futility analysis was to facilitate the early termination of the study if the IDMC determined that achieving a positive outcome on the primary endpoint would be futile."
There are some shorts that keep dismissing the importance of Cel Sci March 29 2019 IDMC recommendation:
"The IDMC recommendation is to continue the trial until the appropriate number of events have occurred"
No Futility observed on March 29 2019
The Russell Reconstitution on Friday June 28th 2019 is almost here.
In May 2019 At the recent Palisade Global Conference Geert stated that there are institution(s) that want him to do a deal with them so that they can get shares to COVER their short positions which is now in the losses of "Millions" of dollars. Geert refuses to do such a deal.
Geert presented as a sponsor at the Palisade Global Conference. They state that presenters at their conference are rigorously selected.
"Our companies are the cream of the crop, and have been vetted rigorously by the Palisade Global Team. These companies have world-class projects with even better management teams. An invite from us means we know the story and are confident in placing our name next to theirs.
Our attendees are high net worth, accredited, or institutional investors who are curious and diligent in their investment process. They believe in the fundamentals of the resource and precious metals space, and are always looking for investment opportunities."
We all understand that they are primarily resource and precious metals investors, but as stated that are always looking for investment opportunities."
Geert has made it publicly clear to savvy investors and to those that are about to take part in the Russell Rebalancing on Friday June 28th 2019 that Cel Sci is not only an excellent risk reward investment but it ALSO brings the added investment "growth" potential of a short squeeze. 4.6 million shares are shorted at well below the current stock price and Geert has made it VERY clear that these Shorts NEED his help in order to not lose millions. BUT Geert will "NOT" rescue them from their potential losses.
Will they be able to manipulate CVM the same way when new large institutions are also invested? So what's their NEXT move? ... Time and various options are running out. Russell Institutions that do their DD will be able to quickly see the implications of the "under water" 4.6 Million shares shorted and (hopefully) hint, hint, one or two institutions will want to take FULL advantage of it.
I have said it before... Coming to the end of this trial Cel Sci needs a BATTLE hardened, industry scorned, somewhat bitter, Resentful, looking to SETTLE a score, committed, CEO to take us to the finish line without selling out just before the prize....
This is Geert
Hi static thanks for sharing the highlights of your conversation.
We're you able to get a response regarding cel sci own statistical model?
Static, what were the answers to the other questions?
Geert has mentioned that institutions want share compensation before initiating coverage. If this is truly the case then it would explain the lack of coverage. You grease my hand and I will grease yours.
It would appear Geert is not willing to to give up any "easy" concessions this close to the end of the trial. If he is not giving his own insiders a discount then why should he give an institution...bullish. He did say if positive results he will have 100 new friends
The institutions would like warrant priced shares first BEFORE recommending this company to their clients or the general public. Are they looking for low priced shares to give to their clients? So are we just at an impasse with the institutions
My 3 Questions:
1)
I would like to ask/confirm,
Are institutions interested in the company and the Phase-3 results, but are they insisting on share compensation "before" initiating any coverage
2)
Other than the published SOC Survival percentages that the study is based on, Does Cel Sci have an actual "fluid" in house "statistical model" that (similar to Fosco/Lightrock) they are monitoring which has probable end dates and survival percentages
if "YES" (follow up question)
Does Geert share this "statistical model" and the "fluid" end date calculations with potential accredited investors?
(Otherwise without SOME kind of a statistical data model what is he asking them to invest in)
if "NO" (follow up question)
Is it mostly results from the Phase-1 and Phase-11 data that is presented to accredited investors?
3)
As Geert goes around to the investment community... What is his objective at this stage?
Is it to raise funds "without" Dilution?
Is it to get institutional coverage?
Is it to increase company awareness?
Is it to investigate / negotiate a "buyout"?
Geert is a "different" kinda guy. Over the years he has said what others want to hear and then do something differently. He has prioritized the Vulture funds over the everyday investor costing us great losses. He has not told the (whole) truth on many occasions. Would he have acted this way if he worked for a fortune 500 company? or is this the natural order of things when investing in a 30yr old biotech company with no revenues where the CEO has to make bad deals with vulture funds in order to keep the company afloat? is this behavior circumstantial.
Is he the best guy to take this company to the next level?... jury is still out.
But... with the earth quake that we just had (massive stock drop) where even the so called longs jumped ship, there was PANIC, FEAR, fear, second guessing. We asked ourselves were we wrong? did we trust the wrong man (Geert) , have we been steered in the wrong direction?. Should we cut our losses? These were all natural human reactions. And while this was all going on there was and insider buy and Geert jovially danced to "I am still standing".
Where this company is now, almost at the end of a 8yr trial, loaded with "potential", statistic leaning in our direction. with Vulture funds still in control of shares, shorts working with impunity, new institutions wanting shares in exchange for coverage.
Geert said his greatest strength is his "single focus" and his greatest weakness is his "single focus"
Coming to the end of this trial Cel Sci needs a BATTLE hardened, industry scorned, somewhat bitter, RESENTFUL of decisions he had to make, looking to SETTLE a score, committed, pit-bull CEO to take us to the finish line without selling out just before the prize....
This is Geert
HR I understand your concerns and partially agree.
Greet has recently repeated that nothing matters but the "DATA" ... he has referenced the 298 events as being significant in terms of the longer it takes to attain the number the greater the indication that something "outside" of standard of Care is responsible. You can make up your own minds in terms of what that something is...(Multikine)
as George stated the 298 Events had become significant because the trial is taking longer than expected. If it had ended earlier then the 298 would not have the same significance that is does now.
in previous months I would have categorize the 298 as "material" but I think as we progress further into the year without hitting the number this is why Cel Sci has pivoted on the 298 events going from being "material" to being "important" statistical news.
The longer we take to get to 298 makes it LESS "material" why ?... because if we reference the statistical models they will give us data about the projected efficacy based on the time it takes to achieve the 298 number.
So for example if today was Dec 15 2019, based on survival statistics, would the 298 number be of significance? probably not because it would just be a number signifying "when" the study will officially end and we would be focused on getting our hands on the un-blinded trial DATA to "confirm" outcome results that the Stats would already be pointing to showing a "very high" chance of success.
So Yes HR I think Greet has changed his tune but I think it's based on now looking "beyond" the 298 number to the Data which will vindicate him and the company.
He has stated that institutions want share compensation before initiating coverage, which he does not want to do. He has come this far why give away shares now when in a few months they will be writing coverage for free
He has also changed his tune from a drug with the intent to "extend" lives to a drug with the intent to "cure".
Why all of a sudden the changes in stance. They don't want outside financing, no more new warrants, analyst coverage without shares, more insider buys, stock option plans, less buyout talk...
I think what you are hearing from Greet is a confidence that we have already "past" a few important statistical thresholds for "probable" success, therefore the 298 is having less and less meaning to Cel Sci as the weeks move on(it's a bit convoluted but I hope you are following my reasoning)
Mark I agree that based on the way he speaks, with a dismissive tone his main intentions has not been relayed clearly.
Recent talk about achieving the final 298 deaths not being a material event.
As Fosco mentioned today when the 298 is reached the data results will be known "very soon" after.
CROs now utilize advanced software to manage their clients trial data, regulatory records, audits, inspections etc many of the new software even utilize artificial intelligence (AI) to predict safety and efficacy. So That being said the results will be available within a short window.
During the Shareholders meeting I believe Greet is making one thing clear to the investors.
When the final 298 event is achieved the company does NOT have to announce it right away because they have confirmed with the exchange that it is not considered a "material event". They can take a few days to calculate if they have met the primary outcome.
Following their calculations and legal consultations they will then most likely HALT trading and issue a news release.(imho)
Last count there is 2.4 million shares shorted that still need to be covered in the mid $4's to mid $5's. They will not relent until they can cover without a loss. whichever groups / Companies that shorted this stock it was coordinated. The recent SP drop began on heavy volumes the middle of last week (which is conveniently a settlement date) so on friday's report we wont be able to fully see the "recent" short details until June 11 2019. We won't know right away if the recent drop was their attempt to cover.
Cel Sci spoke silently to it's shareholders this week during the Share Price drop by making a $10,000 insider buy, even as the share price was tumbling downwards. Based on the date we have stats indications of probable success. This is the only way they can "speak" their belief directly to you so interpret it as you will.
I do not believe and I don't think it makes much sense that Cel Sci would first announce that the 298 events has been achieved and then allow days or a week of speculation to occur before releasing the primary outcome data.
Greet silently is not a fan of the Companies who are shorting this stock and holding down the share price.
Greet is making a statement:
When the final 298 event happens, don't be short, because Cel Sci will not give any warnings. It will be a binary event. The stock will be halted, the news of the 298 will be released at the SAME time the primary outcome (10% or greater) will be announced.
Then the HALT will be lifted
When trading resumes... Don't be short
Sushi thanks for adding that new tute to the website.
I was looking over their fund prospectus and interestingly Cel Sci is the ONLY U.S. stock in this German fund.
They state that the Fund's aim is to:
"The VM Long Term Value Fund strives for the highest possible long-term increase in value for below-average swings intensity. The fund invests in shares of listed companies with a long-term investment strategy. In particular is to be invested in shares of companies whose stock is lower than the intrinsic value of the target company"
German Investment companies pride themselves on doing in depth research.
They started last year with 70,000 share and increased it to 100,000.
The 298 events have NOT yet occured.
Also the 298 events did NOT occur in February 2019
On MARCH 29 2019 the IDMC stated that the 298 events have not occured by announcing that the study is "allowed" to continue until the APPROPRIATE number of events occur (which is 298)
On MAY 8 2019 (13 days ago ) Cel Sci in a public statement informed investors that the 298 events have NOT yet occured.
"We have not yet hit the primary endpoint of our 928 patient Phase 3 study with our investigational cancer immunotherapy drug Multikine. That endpoint will be reached when 298 events (deaths) have occurred and are recorded in the two main comparator arms of the study. Since the scientific literature does not suggest an improvement in the survival rates for oral head and neck cancer patients receiving standard of care only, we believe a delay in reaching these 298 events could be a good sign for the potential effectiveness of Multikine."
Geert has on many occasions made public statements that the primary endpoint of 298 events has NOT been met. He has done so in writing and in videos. He has been very forthcoming with this particular fact and has never avoided answering this question.
This is one detail of the study information that he is allowed to divulge publicly so let's stop speculation whether we have already reached the 298 months ago and have not been told. Every time he states that we have not yet reached the 298 it is a great treasure trove of statistical information regarding the endpoint data. Not reaching the endpoint is of great significance. Each time he publicly states this it's like saying the chances of success just went up a few more percentage points
Hi Sushi can you also add to the Tutes list:
BayernInvest Kapitalverwaltungsgesellschaft mbH who added 30,000 shares and owns 100,000 shares
https://money.cnn.com/quote/shareholders/shareholders.html?symb=CVM&subView=institutional
https://www.ampega.de/fileadmin/mediapool/fonds/Import/HJB/692_HJB_de.pdf
The purpose of the terrorist analogy is to make a comparison between the two different threats. I think it's appropriate because everyone can relate to the importance of identifying threats before they become more serious
This is one of his BEST interviews to date.
You can tell he has been speaking to a lot of people lately about the company. He is calm and his thoughts are well organized.
The interviewer did not ask great questions but he gave great answers
This is a re-post of a previous post on May 9
"Sushi thanks for the updated Short Interest numbers.
Based on the charts this new increase in Short interest would have been shorted between April 15 to April 30 and the share price would have been between $5.30 and $6.60.
So correct me if I am wrong ...they would be expecting the share price to go below $5.30. I guess they thought $6.60 was high?
We traded in the $6.60 ish range for a while and then Geert's letter came out and surprised them $7 to $8 plus +
So I assume they are currently under water and will attempt to push the price back into that range to cover."
Sushi I agree with your statement:
"Why can't they chew gum and walk? Many other companies do."
I think with the bad markets everyone missed the news details
Cel Sci first LEAPS product candidates are is CEL-2000 then they developed CEL-4000 and now we have:
"a NEWLY discovered LEAPS conjugate, DerG-PG275Cit"
I would call that some important NEWS.
LEAPS already has $1.5 million funding from the National Institutes of Health (NIH). Work is ongoing.
It seems we have at least one new German Institutional Holder that reported on 2019-03-31. This is an Investment Management company, Which would account for and explain the recent increased share buying from Germany.
Institution Name: Ampega Investment GMBH Inv Mgmt
%o/s: 0.3%
Shares Held: 0.10M
Reported Date: 2019-03-31
AmpegaGerling Investment GmbH is an Asset Management firm based in Cologne, Germany. AmpegaGerling Investment GmbH operates as a subsidiary of Talanx AG.
Sushi thanks for the updated Short Interest numbers.
Based on the charts this new increase in Short interest would have been shorted between April 15 to April 30 and the share price would have been between $5.30 and $6.60.
So correct me if I am wrong ...they would be expecting the share price to go below $5.30. I guess they thought $6.60 was high?
We traded in the $6.60 ish range for a while and then Geert's letter came out and surprised them $7 to $8 plus +
So I assume they are currently under water and will attempt to push the price back into that range to cover.
This is a VERY important line in the letter to shareholders:
"We are benefiting from renewed interest in CEL-SCI’s Multikine cancer immunotherapy by meeting with NEW investors WEEKLY."
interpret it how you like but what that tells me is every week that NEW investors (Accredited investors, not retail) are educated on the Phase 3 trial (A treatment for Cancer that is administered for ONLY 3 weeks) the potential for the share price to appreciate increases dramatically.
A few quick take aways from Cel Sci's presentation.
-Multikine is ultimately NOT JUST a Head and Neck cancer Drug
-Multikine has been proven effective in previous studies with Cervical Cancer, HIV and HPV Antiviral treatment, Prostate cancer and "Different Cancer tumors"
-224 Patients have been treated in previous studies which should have given Cel Sci a large amount of efficacy data to confirm that Multikine works.
-Multikine potentially may not be limited to only 3-4 weeks prior to SOC.
-If approved patients may be given Multikine for a LONGER period of time to maximize the benefits of tumor and micro metastases reduction
-Due to Multikine's excellent safety and toxicity profile it can be combine with virtually all the other existing Cancer treatment drugs.
I don't think the IDMC will stop the trial early for "ethical" reasons.
If the 298 events occur before the next meeting then they will review the data, if only 297 events have occurred by the next review they will recommend for the trial to continue until the appropriate events occur, just as they have been doing for the last few years.
They are very interested in the DATA. Is standard of care getting better? Is there something that we can add to SOC to make people live longer lives? If they even observed a 50% benefit during the last review, why would you stop the trail? I would want to know if the final number is even higher. What is the survival benefit. in order to prove a survival benefit patients have to LIVE.
This is the world largest and longest H&N trial. This data will be very valuable and I don't see them stopping early just before the finish line. Any early stoppage would open up potential doubt regarding the final efficacy number. Could it have been higher if we waited a few more months etc..
UNLESS there is also a HARD study END DATE that supersedes the 298 events number... we must meet the 298. No early endings
I think we have to realize that the spread sheets are constantly evolving (which i think is extremely valuable) as more data or new data is uncovered. For example the 133 and the 208 events required changes to the sheets, then the possibility of drop outs, varying SOC in different countries etc.
I think they are taking a "scientific" approach. If we can take all available data and create multiple scenarios and they all still point to varying levels of success ... then we can made a more educated investment decision.
Sushi that is great news. Your initiative to kill the shorts is amazing,
I love the passion. If we own a part of the company, (CVM shares) I think it's imperitive that we protect our investment. The shorts have demonstrated that they will go to GREAT lengths to secure "their" profits, some of them very questionable.
We as a CVM shareholder community with members from all across the world, who share this common interest must demonstrate the same resolve to protect the "facts" and give the share price a fair opportunity to increase without shorting manipulation.
I don't think that the shorts ever imagined that the retail shareholders (who they prey on) in this little penny stock would have rallied together, created an information website and vigilantly challenged anyone on a message board that thought of writing negative or fear mongering posts.
Yes there will be some newbies that will join the boards and post fearfull questions under the premise of ignorance and demand to be embraced. If they don't want to be accused a being a short that is trying to manipulate the share price then all they have to do is go to kill the shorts first before postings any misleading post. So yes your motives will be rightfully challenged.
We can now confirm that all the recent negative posts and legal tricks were the direct actions of the shorts covering.
They still have 1.9 million shares to cover so this is not over yet. Keep circling the wagons, force them to take their shorting to a stock with less organized retail investors
Trustbaby you were asking about the HIV studies.
you asked:
"But why didn't it work on HIV? Why the other studies that quietly faded away? Is it a drug that only works on solid tumors?"
I can't comment on the specifics of that study or the other investigated uses of Multikine. BUT I can opine that Multikine is ideal if not (perfect) for Head and Neck Cancer.
Here is a quote from one of the previous Phase-2 studies that outlines the reasons and support the theory that Multikine has a HIGH likely-hood of being successful in this trial and showing a survival improvement.
"There is increasing evidence that patients with head and neck cancer have immuno-depression and may, there-fore, benefit from immune-enhancing treatment **(for example a biologic like Multikine)** in terms of tumor containment and prognosis.1-3In 1993, Katz 2 was the first to suggest that head and neck cancers arise in the presence of underlying cellular immune deficiency. This assumption was later supported by the studies of Clark 4and Hadden.5,6 The specific defects in cellular immune functions reported in this patient population include altered effectiveness of tumor-infiltrating leukocytes, such as T lymphocytes and natural killer (NK)cells,7-9 decrease in T-lymphocyte number, macrophage and monocyte dysfunction, and anergy.10 Some researchers have implicated general immunosuppression and local immunosuppressive factors derived from the tumor itself in the immune-compromised state.
I think Cel Sci has chosen to pursue H&N cancer as their first approval for the above reasons.
It is just the RIGHT approach. Help the immune system to get out of it's depressive state and the body will be able to mount an anti tumor response to infiltrate the tumor.
Everyone else is trying to kill the cancer cells with other drugs, instead of addressing the real underlying issue of resolving the immunosuppressive factors.
By the way these same immunosuppressive factors will still exist even after SOC which is probably why we see the tumor re-occur.
My hope...if approved is to see Multikine administered "Before" and "after" SOC for the purpose of addressing the immunosuppressive state and perhaps extending the possibility of tumor regrowth.