Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Me thinking i’m gonna stop investing in Biotechs and grow cotton ...
Btw, was a good pres. from Geert
ahaha
"I think most are wrong."
probably true
However the end date is directly predicted from the Taiwanese leak of 133 in feb 2017 and 208 in feb 2018 which showed low death rate. Not rocket science BUT if those figures are wrong then of course end point could happen anytime with same probability so one could base himself on Ergomed announcement for H1 '19.
If those figures are right... you will believe in XL
Yeah your right, the 3% is not the scientifically comparison of two kaplan meier life table using log rank test (by the way I am not sure that they will compare at year 3, I believe they will compare the whole curves and see if they match a theoretical model where MK improves by more than 10% every year)
The 3% is very approximate, eg the surviving people in both arms in Feb 2020 regardless of the how the curves behave in the middle. Gives a flavor
I am running various models too as some know
Latests one with drop outs, Soc still around 53% observed survival at Y5
One with 6% drop outs and 18% improvement survival in MK arm is saying October (18% is needed to match with Feb 17/18 figures we've got). Still if all remaining (18p) die in MK arm the MK benefit would be 9,3% in October 2019
The other with 10% dropouts and 18% improvement survival in MK arm is saying endpoint by Feb 2020. If all remaining (30p) die in MK arm the MK benefit would be 3% in Feb 2020
All this is compatible with IDMC decision to continue trial : good observed improvements so far (almost 20%) but still need to continue trial in case all remaining people to reach endpoint die in test arm.
hahaha Sushi
too funny
In case of success cash will pour in. As simple as that and dilution might not be the best option. (not talking about R/S either, ha ha ha what a joke !)
I would be Geert, I would just borrow from a bank. No need to add more shares. $ 100M borrowed at day 1 to fund operations would bring back $1B one year later in terms of revenue.
But he won't go through that. He will just ask a Big Pharma to pay BIG. This will be very fast, won't last for years or months
Btw : strange trading pattern indeed, looks like stock is boiling and pressure cooker cover will pop soon to the roof
Nice CV. Here are the bad guys
------------------------------
Hunter Adams, a member of the expert advisory board for The Street Sweeper, understands stock manipulation firsthand. Adams entered the securities industry 15 years ago with a focus on high-risk penny stocks. He quickly became an expert at establishing shell corporations, executing reverse mergers and selling both equity and convertible debt in speculative small-cap companies. His career ended in 2001, when government investigators accused him of manipulating worthless penny stocks. He pled guilty to two conspiracy charges — for securities fraud and money laundering — and served time in prison for his crimes. Years later, he pled guilty to racketeering charges, fully cooperated with the government and accepted full responsibility for his actions. Today, he has embraced a life of reform and now hopes to help protect the public by exposing the bad companies littering Wall Street.
@sab
ok understood : 7.5 and after "terra incognita" (in the positive sense of it)
Thx and GL today !
@Sab
Thanks a lot for the update, much appreciate
Does TA really says 8 resistance and then 13 / 14 ??? Nothing more precise ?
Regarding a buy-out, IF we get approval from FDA, I believe speculation will lift CVM till at least $ 10B, even if production capacity will not allow to generate such P/E ratio.
Then Big Pharmas will rush in and 10B the basis. 15 B is conservative estimate
----sorry duplicate ------
This study from Cotton is interesting, but not because it relates to black population as none of the clinical trial sites are in Africa.
It is interesting because basically it states that adjusted to socioeconomic and insurance status , survival in the white group and black group is more or less the same, while some minor differences (in stage occurrences, etc) can be observed.
This means that the large difference in OS that we see in SEER data between blacks and whites in the US is mainly due to socioeconomic / ability to pay for insurance reasons.
Other fact (Many links can be found on this topic) is that HPV related oscc has mainly developed in western countries, while is less spread in poorer countries or even countries like Italy :
hpv Italy
hpv Ghana
My personal conviction from all that I have read is that the real progresses in OS observed in North America is due mainly to the spread of the HPV related oscc in the white male population, while tobacco/alcool related oscc were occurrences were going down with healthier habits.
Therefore, the oscc observed in most of the sites of the study _ from which 62 out of 101 are in developing countries please see the list here :
List of dev. countries sites
_ are mostly not HPV related and mostly affecting a population which has low socioeconomic standards and poor ability to pay for insurances.
We have seen how disastrous survival was in Bulgaria : heavy smokers and drinkers, likely little HPV prevalence, less private insurances.
I do therefore believe that observed OS in the clinical trial treated by SOC only is far below the observed survival in North American statistics and closer from what Cel SCI states as an unchanged survival of near 50% OS @ Y5 in absolute numbers
Thanks
A worldwide heritage built 900 years ago which survived revolution, wwi, hitler
Religion is not that important, rather a marvel of medieval art and civilization
Purely accidental
Happy easter to all
Fosco
"Just trying to figure out why this is still going on when this committee who has all the data and so knows if it works or not. "
Likely people die in both arms of the study
Likely there is a difference between both arms which makes that IDMC did not close the study for futility reasons
Likely more people need to die to be able to assess statistical significance of this difference with 90% Certainty (Meaning you need more data to compute a "two-sided p-value of 0.05"). So that means that when IDMC met they had no 298 people, not even 290, likely less than 280
I am assuming all deaths counts in order to trigger 298, including those who die from other non related disease ("observed survival")
Then they will do further analysis to keep only oscc related data and compare both arms and compare "relative survival".
nobody died? Even in car accidents ??? hehe
Not likely, there were 75 deaths between feb 2017 and feb 2018 where the count was of 208. So it is not surprising we didn't see 298 deaths earlier , just as simple as that. Humans keep dying, unfortunately.
lightrock
sure, not sayin' there is no genetics differences too. Just think about skin cancer for which black people are highly protected against.
Was really thinking that socioeconomics consideration could be a factor.
May be HPV has a say in this equation as well. We know HPV related oscc is highly curable with modern SOCs and likely to increase overal survival stats. We know as well that HPV related are more and more the cause of oscc in western countries (may be also due to the relative decline in smoking) . I am expecting in developing countries of the study much more smoking/tobacco related oscc than HPV related which offer an a bad survival prognosis. Could increasing HPV-related cancer be the cause of a better soc os survival in the recent years in the US notably ? The exclusion criteria of the trial did not include HPV detection, therefore we shall expect some HPV related, but less in developping countries than in the US.
An interesting article on HPV (didn't read all yet) :
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5802923/
Abstract :
"Topographically restricted to the oropharynx, HPV-driven HNSCCs, which exhibit a survival benefit compared to HPV-unrelated tumors, have been increasing rapidly in several Western countries. Although to a lesser extent and following different patterns with respect to those observed in other Western countries, the trends in HNSCC incidence and survival rates at the different sites examined here suggest a potential increasing impact of HPV infection on oropharyngeal oncogenesis in Italy"
No african site
This said survival doesn't seem to be due only to genetics, as the socioeconomic factor seems to be playing a big role. I would tend to think that its the same reasons that make Bulgarians or Thaï having disastrous survival as well as we've seen lately.
"Much of the difference is because of lower socioeconomic status and less access to medical care. "
https://www.cancer.org/latest-news/gap-in-cancer-death-rates-between-blacks-and-whites-narrows.html
lightrock
Now I See what you mean
Hadn't looked well at the x axis (they followed people for 40 years !)
I agree with you : with 1973/2008 data, things looks good
@trustbaby
Same as lightrock
First a lot of enthusiasm due to the data, spreadsheet, time it takes to get the 298 event, additional leaks from clinical sites.
Then the doubts. What have I missed ? What could have a negative bias on the study ? When is best timing to invest ? What could be a positive bias ?
Currently, as we are heading into the month of May, the risk is getting lower, definitely better than 50% I would say as well. I could say much more if only I knew the real SOC overall survival in the 101 countries of the study, so we're reading stuff, studies, statistics etc...and things are looking rather positive but we cannot discard the risk of failure
Fosco
lightrock
Sorry I had not followed you, may be lack of time and concentration
According to me, the latest Seer database gave "too good" survival for white american population but I was confident this was not the population followed by Cel Sci
"From what I can see, it looks like the "signal of effectiveness" converges into year 5 (starts to fade into the background)"
I see more or less what you mean. (You have a very complex way of thinking, with kind of genius ideas. On my side I am very analytical, linear). I can hardly comprehend your conclusion.
My bottom line is that, based on 133/208, we should see something around October this year, and SoC survival and drop outs are key to success. I am hoping this 928 clinical trial won't be recorded in history as the clinical trial (funded by us) that has shown that survival in H&N cancer treated with SOC has increased dramatically worldwide over the years !
I will add a few thousands more soon
I wanted to add in May provided no events were announced (According to me, May was a threshold date in terms of risk), but as I am confident no results will be published before, I will anticipate a little bit as the technicals seem to open a window of opportunity.
For record
Need to update when I have the info
https://docs.google.com/spreadsheets/d/1ulpVesaigAtoU_rXoZ8t-A3sonbKHs6T8YV95lGMYBw/htmlview#
Fosco (from his phone)
Indeed
I had seen these figures
Some remarks to ponder :
- 65 relative is 56 observed
- How does this population compare with the trial population, 60% of them originary from developing countries ? Perhaps black-americans OS is comparable
lightrock
Quick remarks:
You considered OS from fig 6 but you'd better consider for fig 7 (stage III)
With fig 7 stage III, I do have a log curve that matches pretty well (except Y2 and Y3), and I do match ok feb figures with 36,5% benefit in survival arm. Way too much. Survival is probably better but let's not forget these are 2000-2010 figures
y = aln(x) + b
a = -19,26
b= 81
Good point Sab.
May be you are onto something.
A softer version of your scenario though might be that they had the "sense" last Friday that pps was going to go up from there and realized that they had a last window of opportunity to have options with strike price below 6$, and they granted themselves with full options packages
What made them "have the sense"?
May-be
- Are they doing some TA
- Are they seeing (more) dead people
- Have they access to some positive signs
good move warefaretrader, congratulions I envy you.
(This said, I wouldn't say aside a too long time given the momentum)
I would tend to think his effect is close to 0 with the following notice that his vocabulary matches 100% Johnny's on yahoo MB. He has never been credible with regards to his positive recommandations. His only audience was with the short side of the equation ... an easier game to play until his followers got badly burnt with some wrong prediction of failure ... Lol
We are seeing some strong profit taking within the close range allies, which we can't blame for.
Let's see if the forces of capital are superior to the sum of individual profit takers
Indeed my friend Lightrock thanks for the link
Got the same benchmark in head
.
That's why I think 500 M market cap is not an illusion and the range 200-800 possible (200 coming soon).
What's the float now ? 30M shares, pps could reach 20 some day before any data readout is published.
As for trading, I wish I knew this art, I would have managed 1000 more shares yesterday at no cost
Take care
Fosco
China, china, china
A boulevard for Multikine with all the smokers there
We wouldn't talk of a 10B market cap with China as a market, rather a 20B... At least.
Who knows, may be a Chinese mamoth Pharma will buy CEl SCI
Btw if anyone's interested, here's a link to cvm warrants table
https://docs.google.com/spreadsheets/d/1ulpVesaigAtoU_rXoZ8t-A3sonbKHs6T8YV95lGMYBw/edit#gid=369549476
Dear Sushi
===========
You can't know how happy I would be to be wrong today and you right !
Me think I should have listened to your advice and bought earlier. I wanted to wait month of May for safety, but pps might be much higher than I expected. I will have to cope with my mere 16000 shares when I should have had 30 000 easily.
With Cel SCI
Strong weeks are often followed by Weak Weeks
Let's see how this one goes. If strong, it could be an extremely bullish signal (Even a TA nerd like me can read this). It could mean that Cel SCI has at last become a "Normal PhIII biotech on the verge of issuing a successful product". Given the potential of the drug, this could lead, with speculation, until $ 1B market cap prior approval. May be I 'm dreaming, but I think $ 500M is reasonable.
I don't think/hope that last week activity can only be due to short covering but we should have a hint by tomorrow : if short interest has not decreased much then it will mean that it's "something else" and then the next key indicator will be institutional holding.
Good day to my fellow longs
Fosco
@Lightrock
Ok thanks. I guess will will have more info in the next institutional reports / short interest reports. When is that ?
On another topic, I went looking at the outstanding warrants table (in order to understand the float when PIII is done and to know if we can fund with this base of warrants) :
If I am not mistaken :
- There were 12M outsanding external warrants as of 12/31. I don't know how many have been excercised since 12/31, however of those 12M
- 10M are currently on the money (under 5$ exercice price)
- Net proceed for those warrants would fund Cel SCI with $ 22m in total
for those interested I can share the Xl
So I can conclude that
- we should fund enough till end of ph III, with warrants alone. A small additional dilution (private offering ?) of 1 or 2M shares should'nt be ruled out
- float at end of PIII shouldn't be more than 45M shares. That's the basis to compute pps if a Big Pharma makes a multi billion offer.
Of course, there will not be any R/S anymore. In the best case we will witness a split. In the worse, pps won't be worth doing a R/S.
Sorry for the nerdy question of the day
But does anyone know with certainty what is happening ?
Is it more the action of individual longs buying based on sudden attention due to latest news, institutional buying, naked short covering ?
Any possibility to know by reading stock exchange forms or whatever indicator ?
Thanks and congrats to all fellow longs
Hi
thanks for the link Sushi.
I do see 3 items of interest :
- all mails and contacts of doctors in case one of us wants to volunteer and ask them what they think about multikine
- "Sample Size from India=230" : that's a lot actually. There are 11 CT sites in India. I assumed that 62% of patients would be from developing countries... well we have 24% from India. I doubt soc OS survival is so good in India. So confirmation that a big chunk of CT patients have bad survival hopes as compared with US/CAD/UK benchmarks
- Confirmation that both S-RT and S-CRT will be used against tumor in India. S-CRT indeed increases survival
sushi,
u're doing a fantastic job in drying out the source of shares they can borrow to innocent an unaware long traders like us. (by the way, I thing we can set a GTC order to 195$ without much risk of missing something !)
Now let's not forget that short interest needs cheap shares (or warrants) to cover. While we can't do much on the warrants side, we can still prevent from short covering at a cheap pps by .... not selling anything before at least current price x 2.
Static
-------
Next week may be : 45/55.
Next May or June : 65/35. The 35 is the "cautious approach" of if you prefer negative CVM bias. I will buy more if pps not too high
This being said I strongly believe "it" will happen after this summer, and likely in October (repeating myself lol) because of the 208th event date. I will never rule out the risk factor even if it happens in 2020, so will never be "all in" till the end, may be will sell (in shares number)30% before results 70% after (And only at BP buyout)
Take care
Hi
Thanks
re random thoughts. Let me share mine
1) Being a nerd in trading still my guts feeling is to say that traders should stop trading and keep holding until this stabilizes as it seems that IDMC news has liberated the last brakes that let this stock undervalued. Fair value should be between 200 and 800 market cap
2) Models are models. The worse case models (good soc overall survival, bad drop outs) show no benefits from MK, the best case models show benefits. Always keep this in mind.
3)Related to 2), wise investors (not traders) will look for at least two profit taking points in time. 1 prior end of phIII and 1 when/if a big pharma buys out Cel Sci. A little frustration is always better than a huge disappointment. Wild investors who want to be "all in" until the end will need to make sure they are not betting the farm. I believe the publication of 298 th event will trigger a run upside even if no data is published. So there will be plenty of room for trading at this point in time. I hope though that we reach a fair valuation by then, eg at least a speculative $ 500M
Static mirror
1) Not for sure but in a post below I mentioned all the sites in developing countries. I counted 62 sites out of the 101 sites of the trial. Basically it looks as if each site would follow about 9 to 10 patients
2) Sure, I'll do this for you but feel free to download and play. (Folder 5 in this scenario efficacy should be around 19% as of today)
https://docs.google.com/spreadsheets/d/1qW36sMXgKvx2_76GPF3fjmXFYApgsOUq0vU1qlumz6w/edit#gid=2023843568
Hi
Ok so you provided the Canadian link, sorry I gave credit to static mirror. Believe me I have read it from A to Z and noticed the difference of survival in SOC when it passed to S-CRT from S-RT.
Bulgarian study is relatively recent and they themselves agree with the fact that they have bad survival and they compare to 62% ( necessarily S-CRT) in developing countries with their 30% (Thaïland is worse !) . Then I do expect those 30% to include S-CRT AND S-RT. That's why I would rather apply a 40% survival, knowing that they have worse prevention means, detection means, equiment etc... Now you can consider 45% instead of 40% if you feel more comfortable. Mean (pondered 60/40) survival would be around 52% still very acceptable from a "spreadsheet analysis point of view"
Of course once again this is speculation with some who can view the cup half empty or half full. I am just trying to highlight all the variables and provide a realistic view on figures and I think you too. SoC is one, the other key on is drop outs.
Regarding the company presentation, this sentence was added after I did expressed doubts on blindness of the study. So I agree now that we have written words from Cel SCI. This said, I am not sure they are blinded to events number.
"The study is an open label blinded study. Only the regulators, the Independent Data Monitoring Committee (IDMC) and select members of the CRO have unblinded information
Spidey
======
If you have a look at Keytruda, it extends median survival from 12months to 16 months. Which means that basically may-be 35% events happen at month 12 and 15% more 4 months later.
Assuming some patients whose cancer has become metastatic of this clinical trial are being treated with keytruda (which btw was only approved in Feb 2019), it should affect overall survival only marginally as most of them will extend life by a few months. And in any case they have not been treated by other experimental drugs, only approved drugs (eg soc) + MK
So odds that new approved drugs have been used and had an significant impact are very low.
This being said, considering the two and only variables which are likely to affect the clinical trial survival analysis going on are :
1- the number of drop outs that has happened
2- the soc survival statistics
My convictions is that one should not be blinded to the fact that drop-outs have happened in the trial and also that soc has improved over the years.
One can read this study kindly provided by Static mirror and will find interesting information :
https://www.ncbi.nlm.nih.gov/pubmed/23672952
This study will provide improvement of SOC over the years and also a good idea of drop outs in a developed country (Canada)
"Two and five year estimated overall survival was significantly higher in the S-CRT group at 77 and 58% (p < 0.05),versus S-RT with 55 and 40% rates(p < 0.05)"
In addition it gives and indication of how many drop outs can occur during treatment (see footnote calculation) : about 6% according to my calculation.
The other information that we have and is critical, is that at around 60% of patients are in developing countries (62 sites out of 101). One can read in the following link how bad Soc survival is in a developing country (or can refer as well as the Thailand study).
https://www.journal-imab-bg.org/issues-2016/issue4/vol22issue4p1385-1388.html
This sentence says it all "The overall 5-year survival rate is 62% in industrial countries, while in developing countries they hardly reached
the rate of 30% [12]. The presented results (27%)corresponded
to the survival rate in the developing countries. The
death rate associated with this cancer is particularly high not
because it is difficult to detect or diagnose, but due to the
cancer being routinely diagnosed late. Furthermore increased
vulnerability of existing old treatment modalities should be
considered, conferring a significant survival disadvantage."
Having considered all those parameters, one could assume that :
- Survival in the patient will be strong in developed countries (around 60% at Y5) and bad in developing countries (around 40%). Survival of overall population should therefore be in mid way (50% at Y5)
- Drops out should be around 6% of the enrolled patients.
Therefore with this in mind we can still conclude that MK is apparently increasing life of patients. If we consider drop outs, we should be closer to 10% than to 50% of efficacy of MK group. Hence one could understand :
1) Why IDMC did not urge yet FDA to approve the drug
2) Recommended the trial to continue till 298 events
Footnote : Drop out analysis:
==============================
“895 patients were diagnosed with OCSCC in Alberta from 1998 to 2010. Of these, 311 patients were found to have stage III or IV oral cavity tumors. 25 had palliative treatment, 15 refused any form of treatment, and 7 had therapy outside of Alberta.
A total of 16 patients did not undergo planned adjuvant RT or CRT treatment with 2 patients deemed medically unfit and 14 refusing the supplemental treatment.
This group was excluded from the study as they were deemed not compliant to the
treatment. 12 patients that were planned to receive postoperative RT or CRT had metastasis or a second primary cancer during or prior to starting adjuvant therapies.
They were excluded because their goal of treatment had become palliative since the discovery of distant metastasis or the second cancer. 6 patients with only surgical resection were excluded owing to down-staging based on their pathology report. 3 had misclassified tumours, and 5 had incomplete data. As a result, 222 patients were included in the final analysis.”
Am I wrong if I can conclude that 6,7% of patients dropped out of the chemo treatment ? Can we consider therefore , that 6% is not an illegitimate figure as we will assume that patient undergoing the clinical trial do have more incentive to follow the full treatment ? So in the following example we have 222+16 enrolled, from which 16 dropped out.
(sorry the following table does paste too good)
Elligible p Screening Drop Outs Reasons for discarting
895
311 584 Stage III and IV selection
286 25 Palliative treatment
271 15 Refusal for treatment prior treatment
264 7 Therapy outside of geography
262 2 Medically unfit during treatment
248 14 Refusing supplemental treatment during treatment
236 12 Metastasis or other cancer
230 6 Downstaging
227 3 Misqualified tumor
222 5 Incomplete data
TOTAL 657 16
"Enrolled" 238
Drop outs 16
Drop out % 6,7%