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Chuck
Too funny
What a clown show !
It was TONY on yahoo posting it, fool!
I hope you are enjoying the $3s, Charles
LMAO!
Cheers!
Looks like someone that said they "talked to codfather yesterday" was lying
How rich!
Cheers!
Another Trial Is Needed
I believe that another trial is needed to CONFIRM the post ad hoc Algorithm
You will recall that this ALGO was created AFTER the trial was done as part of the data mining process. This ALGO determines who gets RADIATION and who gets CHEMO
Another confirmatory trial will be needed, IMO
IS THIS WHY CODFATHER_59 SOLD ALL HIS SHARES AFTER 20 YEARS?
Woof!
Cheers!
Codfather was very outspoken that he had a direct line into Geert.
Why would a 20 year+ plus investor sell his entire stake in CVM and then post “choice words for Geert” on Yahoo?
This is all coming from yahoo but it’s got to be concerning to fellow Longs to see one of their trusted peers bailing.
Question is: What did Geert tell Codfather that spooked him after 20 years+?
Maybe Cod heard that the reason for the delay in having the pre-BLA meeting (going on 15 months) is that a confirmatory trial is needed to prove out the new the algorithm! Regardless what it was, Cod bailed.
Cheers
HUGE NEWS IF TRUE
All of you know that CodFather has been on the yahoo boards for 10+ years and a CVM investor for nearly 20 years.
Apparently he posted last night that he sold his entire position yesterday and had parting words for Geert
Why is a 20 years+ investors ditching CVM? What does HE know?
Cheers!
Bezinga Article paid by Cvm!
This is a rehash of the Zacks coverage paid by CVm
15 months and still no pre bla meeting
Woof. Somethings not right here
Cheers
Clock says $3.
Woof !
Tarius
Geert memory
I did call $3s this week
Have a Geert weekend
Cheers
Q
You asked how about them $3
You tell me!
Have a Geert weekend
Cheers
Back to the $3s
Everyone said "When ASCO comes, BOOM"
Everyone said "When CT DATA comes, BOOM"
Dont see any booms....just a big BOMB!
Shabbat Shalom
Cheers!
Price Target Lowered to $13
Keep in mind that zacks is paid by CVM to promote their stock. The best they can do is $13?
Woof
100% agree.
This is fun
Take a look at the Yahoo board
Im a puppet master
Cheers!
ON JUNE 28, 2021 CVM REPORTED THEIR PHASE III STUDY FAILED
FROM THE PR DATE 6/28/21
"the study did not achieve its primary endpoint of a 10% improvement in overall survival"
https://www.bloomberg.com/press-releases/2021-06-28/cel-sci-s-multikine-immunotherapy-produces-significant-14-1-5-year-survival-benefit-62-7-vs-48-6-in-the-group-receiving
Um no, it was NOT an economic issue
The stock price dropped for one reason: on June 28, 2021 CVM reported it’s phase III study failed it’s primary endpoint
Cheers
When the stock dips into the $3s tomorrow, that’s good? Smart Money?
Cheers
So I guess that explains the stock price plummeting from $30 to $4?
Smart Money selling is good…. Lol.
Yup
Makes sense.
Cheer
But aren’t you supposed to follow the “smart money”?
You posted a few months back “follow the smart money” as they always “know before us retail investors”
I guess it only works one way
Woof!
@G8
No proof or support to your outlandish conspiracy theories.
You are grasping and you don’t see what’s right in your face.
Ask why SMART MONEY is dumping CVM. Ask why no pre-bla after 15 months. Ask why no time lines given from Geert for filing a BLA. Ask yourself if you want to wait until 2024 for an approval response from the FDA
There will be no buyout prior
If you can wait until the 2024 PDUFA date and be happy with a stock that trades between $3 and $5 for the next 24 months, then have at it
Cheers
It’s of my opinion that the market is unimpressed with the data and that smart money, like blackrock, is staying away
You will recall, blackrock dumped over 1M shares last quarter
I guess smart money is waiting for the 2024 PDUFA date.
Cheers
Huh? “CVM IS NOT SUBMITTING THE BAD CHEMO DATA”
This was posted on yahoo this morning
This is a lie and couldn’t be further from the truth
CVM must submit all the data from the trial. Fact. Call Gavin at (703) 506-9460 for confirmation
All data will be submitted. “Bad data” can not be withheld as all the data will be required
This shows the persons lack of respect understanding of how the BLA process works
Cheers
From yahoo.
I agree with this
“It's hard to state how badly Multikine failed its PhIII trial.
On the primary endpoint, median overall survival (OS), the Multikine arm was 46.3 months while the standard of care (SOC) only arm was 52.9 months. Multikine use LOWERED median OS by 6.6 months!
On a key secondary endpoint, Progression Free Survival (PFS), the Multikine arm had a median PFS of 32.4 months while in the SOC only arm median PFS was 45.5 months, or more than 13 months longer!
Multikine use harms patients!
Still Geerty blabbers on about a tremendous benefit for low-risk patients, those who don't require chemo, but that subgroup was specified only after the database had been locked and the huckster sliced and diced the data as many ways as he possibly could to find some random subgroup where it appeared that Multikine worked. Post hoc data mining at its most blatant!
And astonshingly, there were only 2 patients in the United States who participated in the trial, in the Multikine arm and the other in the SOC arm.
No wonder Geerty is delaying the BLA filing”
IMO
Cheers
It’s not going to be easy to get this approved, if at all
Given the likely tolerogenic nature of Multikine, CVM reported results from IT-MATTERS showing just that:
Median Overall Survival:
Multikine 46.3 months
SOC: 52.9 months.
SOC patients lived longer.
The middle arm, LI+SOC, was open label and not meant to be compared with SOC arm. Only LI+CIZ+SOC vs SOC alone count towards the primary endpoint. But even though the median was better in LI+SOC, the HR was worse in all Multikine treatment groups vs SOC.
They also enrolled a whopping 1 subject in the US (and none in SOC arm)
1!!! Let that sink in
Finally, from the CT data dump, “Low-risk assessment and data analysis was never performed during the study and was done only after database lock”
All verifiable and factual. Direct from the CT site
Woof
These are facts.
CVM ADMITS TO DATA MINING! OOPS
Data mining is a problem, especially when the Primary Endpoint Failed.
"OS was assessed using Kaplan-Meier life-table using a log rank test and confirmed further with tumor stage, tumor location, and geographic stratified log rank test. Both Stratified and unstratified log rank test are presented with the unstratified log rank test constituting the primary analysis. A two-sided p-value of 0.05 or less was considered statistically significant for comparing the two groups (i.e., Study comparator arms: LI+CIZ+SOC vs. SOC alone). Low-risk assessment and data analysis was never performed during the study and was done only after database lock.
https://clinicaltrials.gov/ct2/show/results/NCT01265849
Tough to see
Cheers!
Another Feuerstein post
“Also, $CVM incessant hand-waving about a Multikine benefit observed in lower-risk patients is a non-starter.
The analysis was post-hoc data mining and will be thrown out by any regulatory agency that sees it. If Cel-Sci actually files, ever...
Adam Feurstein On Twitter
"PLACEBO PATIENTS LIVED LONGER. THIS DRUG IS NOT GETTING APPROVED, ANYWHERE"
Another trial is needed, IMO
Woof!
Cheers!
Reasonable to Assume
If they dont need to do another trial, then the PDUFA date will be in 2024
pre-bla meeting: Q4 - 2022
File BLA: Q2 -2023
Acceptance of BLA: - Q3-2023
PDUFA Date Q2 2024
Cheers!
Congrats
Data is out
G8T
You are DEFLECTING
The issues are with CVM Management/Employees, not the Goverment. CVM is the ones making mistakes.
Let me explain:
From the CT site:
"The submitted information may not be available if it is pending Quality Control (QC) Review by the National Library of Medicine (NLM) or if issues identified during QC review are being addressed or corrected by the sponsor or investigator. NLM's limited QC review assesses for apparent errors, deficiencies, or inconsistencies. NLM staff do not verify the scientific validity or relevance of the submitted information."
Did you pay attention?
It says " NLM's limited QC review assesses for apparent errors, deficiencies, or inconsistencies."
So CVM's issues are 1) apparent errors 2) deficiencies and/or 3) inconsistencies. I dont see "formatting" btw
WHY CANT CVM do it right the 5th time? Its CVMs incompetence.
If you blame anyone, blame Geert He had 14 months to get this right!
HA!
IN SUMMARY
Trial Failed the Primary Endpoint: FACT
The Company has not released any data regarding SECONDARY ENDPOINTS: FACT
THE CT.GOV site has rejected CVMs data for a 5th time: FACT
Posters ASSUME the rejecting is related to "formatting" but no one on these boards know really why they are being rejected: FACT
No pre-BLA meeting in the 14 months since data has been released: FACT
CVM "HOPES" to have a pre-BLA meeting by Year End per GK's reddit: FACT
Many trials that FAIL their PRIMARY ENDPOINT need a second trial: FACT
Woof
Cheers!
Q
Who are these Shorts you refer to?
Im not short, nor do i have any plans to.
I have no options, stock, etc, nor do I have plans to
I know that doesnt fit your narrative...
Im just here giving my opinion, like ALL posters
Chers!
Here is the list of Secondary Endpoints From CT.Gov
Verifiable Links are important vs made-up posts. I have provided the link to the CT Site for you all to verify at the end of this post
As of 8/18/22, CVM has yet to share the success or failure of any Secondary Endpoint
Q's assertions should have verifiable facts behind them, dont ya think!?
Secondary Outcome Measures :
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.
Progression Free Survival (PFS) in LI + CIZ + SOC vs.SOC [ Time Frame: 3 year. ]
PFS will be assessed using Kaplan-Meier life-table and compared using a logrank test and confirmed further with stage location and geographic stratified log rank tests. The unstratified logrank test constitutes the primary analysis.A two sided p-value of 0.05 or less will be considered statistically significant in comparing the groups. The Holm closed-sequential procedure will be used to control type 1 error probability to at most 0.05
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 data will be assessed for change in QOL from baseline within and between treatment groups.Between group comparisons will be performed using ANOVA or Wilcoxon rank sum test. Within treatment group change from baseline will be performed using a paired t-test or a signed rank test. Two-sided t-test will be used with no adjustment for type I error. An exact binomial test of each treatment group will be used to assess a 10 point improvement between treatments. A Fisher Exact Test will be used for between group comparisons.
https://clinicaltrials.gov/ct2/show/study/NCT01265849
SUBGROUPS ARE NOT SECONDARY ENDPOINTS
I know this is confusing to people, but SUBGROUPS (like data mining) are not the same thing as Secondary Endpoints
CVM had Secondary Endpoints like Progression Free Survival
We still dont know the success of ANY SECONDARY ENDPOINTS
All we know is the subgroup
Cheers!
Show the verbiage that states "SECONDARY ENDPOINTS"
You cant because you are lying to the Board
What you are referring to is a SUBGROUP!
IE Data Mining!
Cheers!
THERE IS NO PR OR FILING FROM CVM THAT STATES SECONDARY ENDPOINTS WERE SUCCESSFUL
FAKE NEWS UNLESS YOU CAN PROVIDE VERIFABLE SOURCE
Cheers!
THE PHASE III STUDY FAILED ITS PRIMARY ENDPOINT
The study did not achieve its primary endpoint of a 10% improvement in overall survival.
That is from CVM's PR
https://www.businesswire.com/news/home/20210628005472/en/CEL-SCI%E2%80%99s-Multikine%C2%AE-Immunotherapy-Produces-Significant-14.1-5-Year-Survival-Benefit-62.7-Vs-48.6-in-the-Group-Receiving-Surgery-Plus-Radiotherapy-in-a-Landmark-Head-and-Neck-Cancer-Phase-3-Study
Cheers!
With this latest REJECTION, i see $2s coming!
So funny
Cheers!
So now that the CT site has rejected the data again, another 30 days until you get the data from a failed study
Cheers
CT Rejected Yesterday
Ha!
Told ya
“Blog”
Ha!
Good morning
I believe when a trial fails the primary endpoint, and OS at that, the odds of another trial being needed is very high. You will have a hard time finding examples that counter that.
Cheers