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Right, thanks LIghtRock
Very good cure ratio
Interesting, they are using a beta blocker and a NSAID to prevent inhibitors of the immune system
while Cel Sci is boosting the immune system with Cytokines
Results is similar : micro-metastasis are more efficiently fought by the immune system
I guess in the future a combination of all those technics will be proven most efficient.
Very good find Biobonic, thank you !
I published this on Yahoo MB :
New study to confirm Multikine injection protocol in this clinical trial is legit
==============================================================
Last year, somewhere around June 2019, I gave a call to Dr Talor, chief scientist for CEl SCI corporation
I published the transcript of this conversation on this message board.
A section of this transcript was the following :
"On the question on why this Science would work while every research seems to focus on Treg inhibidors : he [Dr Talor] simply said because he saw it work on more than 200 cases in prior studies ! He said that the fact that they treat prior SoC on an intact immune system without delaying SoC is a key point in the success of the drug that is being considered seriously now by some research oncologist and should be an eye opening if CT is successful."
A recent study, (credit Biobonic from iHub), shows that injecting immunotherapy prior (and after) surgery is key to eliminating metastasis.
Wow, hats off Dr Talor
Thinking that this study is only from July 2020 and that Cel SCI has been doing the right thing for the last 20 years proves how slowly science sometimes advances
Cytokines science is not new, but still, if Cel SCI is successful, this clinical trial will be an eye opening as mechanism of action of cytokines cocktail prior surgery is only being understood in 2020.
They have been right since the beginning
Good luck all, this trial will be successful
Fosco
Study
Inhibitors are very toxic
Yet they are efficient
That's what makes their current fortune
Now we have immunotherapy candidates compounds which are non toxic
Yet they still have to be proven efficient
This is not a done deal
But a promising one. If trials are significant, no doubt they will be block busters
I am thinking about NWBO and also CVM
GL All
Fosco
thanks !
c@sab and al
You said "Geert does want more money on hand". Well, I think the latest move, or more exactly the latest lack of move on expiring warrants, is a clear sign that Geert does not want more money.
This is very good news !
1) This prevents additional dilution for the large majority of shareholders (Bit more than 1M shares) : the "little and unconnected people" who have helped sustain this company for years and bought theirs on open markets.
2) Geert think he has enough money with $20.1 M end of June, so count about $15m in bank by end of September (from memory if I am not wrong). 15M is enough for 3 quarters, but as Geert is a careful money manager he will want back $10m when TLD is released. So we'll expect TLD to be released between now and the end of the year.
I hear your mentioning my latter sentence : "Indeed, Geert is a careful money manager, so why doesn't he take as much money as he can from expiring warrants" .
I will be tempted to answer "Because he cares as well of the little people"
I will not.
I think, more pragmatically that the answer is "Because he thinks he can raise money easily, and before he reaches his $10m money cushion".
Now I hear you say "But, Fosco, Geert is blinded, how, Geert being Geert, could he take the risk of not taking additional easy $ 10/20 M before TLD is released ? "
And this is the moment that I answer to you :
"Indeed, Geert is blinded, but as data is being reviewed and reviewed and cleaned and cleaned, still he is not deaf"
So to me, this latest news is extremely positive, it means that Cel SCI think they will be able to raise as much money as they require in less than a quarter
JMO of course
Fosco
@sentiment_stocks
Thanks for your posts. I have read your pathways and they seem reasonable, although I think communication by the company will be key if both endpoints significance is not reached.
I am impressed by the level of DD performed on this stock by the posters of this board. I hope this bodes well for the future. Such skills might be welcome once you are successful and look for other bios in the future. I might help a little if required.
(I myself have a small few k$ stake bought around 35c, but I personally know people that came in with a much larger position)
GL to all NWBO followers !
Thanks Eagle
Very informative post
GL too
Fosco
Nice run up for NWBO
Actually, there shall be a big Bump as I will invest all my profits on Cel SCI
@marzan
Thanks a lot for your reply and this fantastic recap : you brought me additional details I did not have.
Fosco
@skitahoe
Ah, at last some intelligent posters in this board, much better than yahoo's !
Guy I fully agree with your statements.
Recently on the stock, I made some DD and here are my conclusions so far, not sure I am 100% right but I am sharing with you
Just to speak about correct data :
===================================
Please keep in mind the 2018 data : Median OS for the 100 best responders was of 58.4 months with 95% confidence interval (from KM) : 45.9 – 94.5 months
The 40.4 months figure comes from 2017 data. In 2018 more patients recruited in the latest years made it through more years in survival than the previous median, hence 2018 median is higher than 2017.
Therefore 50 patients (half of 100) made it likely between the various points in time in the KM derived confidence interval.
.... Overall survival is at least of 15% (50/331) between month 45.6 (year 3.8) and month 94.5 (year 7.8), average months 58,4 (4.86 years)
We can therefore state with 95% confidence than 15% OS stands between year 3.8 and year 7.8, most likely around year 5.
That was 2018 figure. There are probably better data from 2019 and 2020 as more and more patients (those who were recruited in the later years) ,as Guy stated, are not censored anymore in the KM analysis and survived above the previous median (more than 5 years). This will have as an effect to right offset the confidence interval :
For instance 15% on the overall trial population might conservatively have survived between year 4 and year 8, average year 5.5
Now, please have a look at my extract from SEER Glioblastoma survival database, courtesy SEER
SEER SURVIVAL FOR GBM 2000-2017
For instance 2012 data has shown 10.9% survival at month 36, 7.9% at month 48 and 5.7% at month 60 for the standard population
We can therefore state that this population is surviving longer, including in the low range of the confidence interval.
Conclusion :
============
Will overall better survival than expected be enough for approval ?
We do not know for sure because of the SAP changes uncertainties and the crossover design which might make difficult to compare test VS control.
However it is looking obvious that this population is surviving longer and that might be the effect of the drug.
GL all
Fosco
"Tesla is currently the besting-selling electric car brand in China"
That's why I assume they'll ban Tesla...why wouldn't they ? I will hurt the US, wouldn't it ?
Currently in its chinese models, tsla is putting NMC batteries from LG Chem (a korean company). Nothing prevents chinese manufacturers to either buy LG Chem batteries too or use chinese technology which is not so bad after billions invested by PRC.
jmo but w&s
Exactly, I was always convinced of AMAZON success as soon as a partner from the US in the consulting firm I was working for told me in the mid 90's "you don't know Amazon ? You'll hear from it one day", frustration was that it went public very late, and when it did I thought the IPO price tag (I think it was 800$) was too high. Same for Google, IT guys I was working with where early adopters, but went public when the opportunity seemed behind !
Now regarding TSLA, beware China. China is talking about banning Apple, it could very well do so for TSLA, (I am sure it will as a matter of fact), and this will knock the valuation (imo of course, but on these matters of high valuation, I am often wrong)
btw, congrat Robot for tsla
Never would have bet on it, I remember @ 300$, I was finding it too expensive
No rationale in those valuations, just speculation and short squeeze "spring" effect. Hopefully we get such effect one day
@sab
Bold statement Sab, hope you being right
(Your credibility at stake lol)
grazie mille signore sab, sentimenti e rispetto condiviso
Truth is that I cannot stand conflict or confrontations, makes me sleep bad. I'd rather flee away
Right George
Sorry for my late response to Remit and You.
I factored in a 86% overall survival at year 1 in my models through an ofsett of normal patients survival for this condition, so that you "only" have 14% of patients dying at year 1, including those who die of other causes, this should hopefully fix this concern, we have no certainty on how the physicians decided to select their patients (fragilness, comorbidities) so that they do not die while taking the drug and being treated by SOC.
sorry, duplicate
GD: regarding Vical's IDMC meetings recommendations, I do not know the specifics but
Usually IDMC meet at 50%, 75% of # of events, interim endpoints
This might be not enough to stop for futility, 25% being still far away from the full power of the study. It might be enough for efficacy if p<0.05 (meaning large effect size).
HR (which is a mean measure) might not be very meaningful, if the confindence interval includes the "1" value : was the Confidence Interval provided in the study you mentionned ?
In the case of Cel SCI , we are talking about a meeting held in April 2020, may be 1% away from final event. The october'19 meeting, likely 4% away from endpoint. This is very close from the trial design power, so I would say that if IDMC run a conditional power analysis, they have either seen futility or efficacy as a 99% outcome when trial finishes, or were still in the grey undecidable zone (around 10% benefit, but may-be with a 5% probability).
Thanks for interesting link
I think Soxrate is asking good questions, but lacks a bit of knowledge of the trial. Furthermore he is striking a sensitive nerve in Geert who has been attacked by false arguments put forward by shorts for years.
1) As for why not attack the Mestastatic cancer field, is very relevant question, as the trial would have been much faster. I guess that CEl SCI did not chose the long way for pure masochistic reasons. Inhibitors have chosen this way, but inhibitor work very differently (removing barriers that prevent to kill the tumor) whereas MK stimulates the immune system. Not being a scientist on this field I speculate that it is likely that stimulating a weak system will not improve the outcome, wherease removing barriers still offer better survival, even for a weak immune system
2) I do not agree with the IDMC comment. "IDMC advise not to stop your trail well after the expected median survival doesn’t necessarily mean that you’ve got much better survival from your drug. It purely means there is not enough survival signal of benefit or toxicity to be sure either way of benefit or futility" : IDMC had the means to stop the trial in April, and probably in October (see my blog in SA). Soxrate ignores this for lack of DD.
3) It is likely that inclusion criteria implies better than SEER survival in SOC group. How much better is the key question, doubling median survival would be very surprising
Fosco
@GD and Sab
I have read many explanations, but no satisfactory one, explaining why they would do so (wait for complete analysis rather than publish early results such as primary endpoint).
So my own explaination is that :
- In case primary endpoint is reached, I believe Geert will jump to the PR machine straight away. He won't be able to keep it to himself, and in anyway it will be good for the pps, and those who have expiring warrants and option calls will worship him for such announcement ! nobody will blame him for early divulgation
- In case primary endpoint is not reached, Geert will wait till the complete analysis is finalized, there might be some good news on the secondary endpoint sides.
His lawyer's wording is a precautionary measure in case some would be tempted to accuse him of non disclosing promised results. In the meantime,we will have no news for datalock as I was expecting (it might already have happened... or not)
JMO
Fosco
Those who sold want it to drop
Those who buy want it to climb
That's a mankind constant
Fact is that :
1- There is always a initial drop when a R/S is announced, in this case weak hands of small investors.
2- R/S appropriately performed tend to recover if fundamentals are good. And fundamental, in this case are good. Money manager will look at the market cap and the pipeline. Compounds are promissing, pipeline is good and newsflow will come this quarter.
IPO_Dude
I fully agree with your statements
A R/S can be bad for companies that are light-years away from any results and keep diluting to fund themselves and stay listed.
This is not the case for ATNM, they have a short term plan, just needed a solid pps and solid float before the big thing.
It has gone down due to small retail investors panicking and this was predictable (I had asked the question prior on this board with no valid answer). It will go up with the institutions and larger investors once valid results are published.
Guys
Thanks a lot for reading this into details, I do not find the strength to do it right now, so am looking forward to your return.
The thing that I (think) I understood is that they are still in the Datalock process that will be followed by a blinded (to Cel SCI) Analysis.
Plus some updates on warrants (looking forward to Sushi updated Sheet as well)
And a rather comfortable cash position
Fosco
ohh ! Well, nobody's perfect, my father had a big ego too because he had a height complex (5'5'')
@Hebrew
Re-HR (the guy you mention), he was indeed very smart and called for many things that happened. However his "speciality" was also to twist others speech to fit his narrative, and when proven wrong, deny it or vanish for a while (he was wrong many times as well like all of us). I think I announced leaps news before him, and on this very board.
As for latest covid news, the fact that it works well on animal is worth mentioning, right ? The news itself is not using a so "pumping" tone, it is just stating facts, and to be honest there is nothing spectacular, we do not have yet an IND or pre-IND announcement or a roadmap provided, or a promise of a grant. This is a bit disapointing for someone who would expect a big pumping game, but may-be such news will come later. They could have pumped much more, so I do not think they are building from this to fund further Cel SCI : Cel SCI has enough cash and we will have Ph III news before any worthy Leaps news.
Thanks for your wishes and GL to you. So Geert is the only one not selling? May be he believes, or may-be he is less blinded than we are !
Fosco
NWBO annoucement describes the process that is waiting for CVM data :
As Sushi mentionned : Database lock (not in July !), hopefully in August and then data analysis :
@GD / Biobonic
I Agree with your remarks as well on NWBO and how it compares to Cel SCI.
The following is my understanding from the back of my head :
NWBO protocol is much more complex than Cel SCI, furthermore primary endpoint is PFS with such problems as how to discard pseudo-progression not as simple as CVM's binary events. In addition their trial design is complex (2/3 - 1/3 in arms) with placebo arm taking drug in the end because of compassionate use or some sort. They had to modify SAP once due to the existance of a marker that might change the conclusions and I believe still in discussion with the FDA as you state to modify the SAP so that some sort of sub-set analysis can be extracted and prove efficacy on some patients with specific markers.... For locking data they need proper analysis of patients samples so that they can identify specific markers and so on and so on... *
Nevertheless : They have 300 or so patients and Cel SCI 3 times more in many locations on the other hand, so Cel SCI timing should not be significantly shorter.
So in conclusion locking db must have been complex and timeline might be a bit more than Cel SCI, 5 months is a hell long, so I am hoping DB Lock will happen in August for Cel SCI (4 months) and they early conclusions (and essential = p value for primary endpoint) from the independant analyst (Cel SCI still blinded) to happen a few weeks after : end of august till mid September.
* This complex and chaotic trial and SAP from NWBO design does not preclude the fact of some expert saying that science is extremely robust and, while bearing some risks , does not preclude of a potential success. I expect NWBO share price to rise from yesterday's low as datalock is announced in 2 weeks time and prior final analysis and a lot of course afterwards if results are conclusive.
you are very welcome Stephen
And thanks to you to your perpetual good humour and civility. I think you earnt the prize of nicest poster on the web
Hope your familly is safe and OK
(Not posting much because busy outside and nothing much to share. Waiting like everyone else. Hoping for August and if not September)
Take care
Fosco
ww Ergomed is paid in shares by Cel SCI
As per their contract with Cel SCI (don't have the link here so do not remember ex), they are limited to a certain % of stock to sell in a given day to limit dilution and they can only sell enough stock to payoff debt. All remaining/unused stock is "returned" Thus, there is NO BENEFIT for ergo to hold these shares. They can not make money on these
However they can make money out of their 12M$ participation in Cel SCI. They can make up to 48M $
Please read this excellent link
KILL THE SHORTS
yeah, reverse split would not be a good thing, I can talk by experience, lol
Knowing the only valuable news will come from interim analysis (Q4), they might want to wait till then, as they have 32 M in cash in bank ok for 15 Months of operations if I not wrong
But then what can explain current momentum ? Any idea ? sorry, new to the stock and thanks for insight !
Fosco
Thanks for the advice Sab and Tarius
I think we are not in datalock yet,
Then you will need several weeks for data analysis, done by and independant statician (Cel SCI still blinded).
I do believe those will be two separate announcements, for the simple reason that :
- 1) Cel SCI Will be blinded throughout the process
- 2) There are still $16.75 warrants out there expiring October that could bring additional $11M to Cel SCI, so why not playing the speculation between the two announcements ? Those will always be $11M for Cel SCI whatever the outcome : better have $11M in bank whatever the final outcome than 0$ and a (even highly unlikely) negative outcome.
3) Smart money might wait for the very last minute before the binary event, so what not give it what it wants
Thanks for the TA !
Fosco
Sushi
I had no basis at first point but time it should take and wishful thinking
I made a subtile change to my stance to "Datalock to happen by 14th of July" in a lately yahoo post, that's still wishful thinking or premonition, we'll see soon enough
take care
Fosco
I don't know DYAI
I knew NVAX and INO because of previous SARS crisis
Fact is that in the week of the 21st jan, all those three broke their resistances,
CVM 's was at 10$ and it blew to 14+, NVAX from 4 to 9, INO from 3 to 5 and probably others
So I Believe a smart fund invested a blend of ex-known SARS stock
Anything that will get significant funds or a phase I announcement will be a ten bagger given the current climate imo. "Animal model", is still not sufficient !
So, since this post NVAX has improved tenfold b/C of funding and phase I announcement and INO is following following a recent 76M$ Grant.
Trickshot
I saw your post and agree totally
I don't believe we are right at 10%, it would be too big coincidence with a number that was not set from clinical results but as a minimum threshold to be triggered by a sample size of 298 events, and probably a number which, if reached, would satisfy the FDA that the cure can be used as a standard of care because it shows enough benefit. Those 10% have no "clinical" justification, it is just a reasonable "acceptation threshold" that can be highlighted by a reasonable sample size (not too big to avoid too costly trial).
Therefore, if efficient, the drug must have been proven so (through significance analysis) in the last IDMC meeting, because it is likely more efficient than those 10% and did not need the whole sample (298) to reach enough power.
Thanks Biobonic
Predetermined efficacy analysis can allow to stop the trial for efficacy, or stop the trial for futility as that has happened for Pfizer trial. Usually, predetermined, or interim, analysis are set at at least 50% Of the required events. With less events, it is very likely that any futility analysis will not detect with enough certainty that the trial will be futile in the end or reversely that the drug is efficient (lack of power). To stop early for efficacy, the effect size has to be much greater than anticipated.
In Cel SCI's case there is not such predetermined study planned, because the power of the study is set at design by the protocol. There have been many convincing and well documented explanations as to why this study could not be ended early for efficacy. However it could very well have been ended earlier for futility because of the conditional power analysis they are doing.
Conditional power also allowed to increase the sample size if required (eg compensate dropouts and enroll more), meaning that there won't be enough people/events in a timely manner. In CEl SCI's case, with 298 events needed, 928 recruited, I do not see really how more enrollment would have been required, either than to accelerate the number of events, because 298 can always be reached with 928.
The fact that there is not such predetermined stop points, does not mean that significance cannot be calculated early by the IDMC. In fact, significance has to be calculated when they do conduct the "conditional power and sample size". It is not only intended at determining if more enrollment is required, is it vitally aimed at simulating a "best case scenario" (for instance if all the events left fall into the control arm), and see if significance will be shown in the end. If significance will not be shown in the best case scenario, then it will not be shown whatever happens and the study should be shut down. On the other hand, they can simulate a "worse case scenario" and see what happens if all the remaining events fall into the test arm. If significance is reached still, that means that the effect size is likely above the 10% from the study design, that the study can continue and will be successful.
The in-between scenario, when significance is shown in the best case scenario and not in the worse case scenario happens throughout the IDMC meeting. That's the standard scenario, however when it comes to the very end, with 10 events left, or even five events left, there is little probably that the effect size is right at 10%. It should be either close to 0 or close to the phII observed 30%+
Therefore, with this in mind, thinking that the IDMC only had 1 or 2 events left last time that they met, for me it is mathematically highly unlikely that they have not seen significance in both scenarios : the best and the worse. If IDMC has done its job of course.
Fosco