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65$ per share looks to me like Science Fiction and wishful thinking.
This being said given the price I bought this , I can wait and whatever price above 1$ will be a good to take.
We need a few scientific voices to talk here, not just Geert and Dr Talor
There seem to be real proven benefit out there, with significance, and enough matter and data for articles and scientific community to have a look and talk.
In the same manner BP will move when their scientists assess this and once they compute chances of approval and expected sales
At this point it is premature to say anything
Good questions for Geert at ASM : Total responders, special markers, significance in this sub-group, number of patients in significant group,revised target population
Henkel
Appologies. I had read too quickly the initial publication. Thought significance was there for the whole population. That was my reading and I was in shock when I understood I was wrong.
Unfortunately cup is half empty. My initial reading was wrong, significance is here but only for a subgroup, those who do not go under chemo
That's half of the target population if I am not wrong : overall, there is no reason the drug not to be approved, but the market will have to weight this as overall primary endpoint was not reached. The results are interesting and should be sufficient in my opinion (no need for further study) to allow approval.
This should end positive, one year time from here we will be laughing, first time immunotherapy works prior surgery on non metastatic patients
Market need to digest the half victory
I removed my article
Need to read more the news
Significance is here but.... OS at year 3 no as expected
Plan trader
George
Hope you are doing well,
Andy is French like I am
Extremely strong analyst profile, working in M&A for world class insurance company
We communicate, currently seems he has more time than I do
Best
Fosco
Hi All and George
I liked your explanation George, until I had a look at the latest 10Q
Cash and liquid assets (Treasuries) by 03/31 were around $ 17.5M
Facility upgrade costs were mostly behind ($ 9.5 M out of the required $ 10.6M already engaged and accounted for), so there was no urgent and desperate need of cash, that's for sure
I do see some reasons though for this timely cash raise, others than Feuerstein's version of "raising before the doom"
1- Geerts to present a solid company after data readout :
- Rock solid data and data analysis
- Rock solid upgraded facility
- Solid balance sheet (I presume around 45M$)
that's not for the FDA etc... that's for any eventual Co that would want to buy-out CEl SCI : no defect in the shield.
"Be decent or pass your way"
2- Geerts friends where so happy to give him away $ 22M, and then even more : $ 32M, so why refuse it ? It costs Geert nothing as he can mitigate the effect of dilution on him and his board of directors by granting himself more options (And, well, he does it for our own good as well as we'll see when there is a buy-out although we do not know it yet). In addition, he might need more capital after results, so let's have them happy giving away millions. By the way, spending $ 32M on the casino is quite a high figure,unless he has been pretty convincing in his conference that the casino's roulette would fall on the right colour
3- There might have been some extra costs as well on the facility. Delays mean extra costs
Finally, I see as very positive the fact that Feueurstein had been previously warnt by Kingswood capital that Geert was not so sure of significance back in May. This makes me really think they wanted to manipulate this parrot, to keep price per share down. Why would they have changed their mind, then ? Why offering now to Geert more than he ever wanted ? ($ 32M instead of $ 22M)
Hope you are all well and GL for data readout
Fosco
Nope
That's a fellow Frenchman
A high level profile (with majors in stats and engineering) working in corporate finance and M&As
Best
Fosco
Now watch and learn what tactics China is using to undermine Tesla advance
USA is sending 300B$ every year to China and China just want to be sure 0$ will be sent back to the US
Here’s and illarious comment from Chinese regulator. China was not known for quality products until it challenged Tesla
“ Late on Wednesday, China's market regulator urged Tesla to ensure product quality in the country, while the official Xinhua news agency said that Tesla's apology was "not sincere".
"The arrogant and overbearing stance the company exhibited in front of the public is repugnant and unacceptable, which could inflict serious damage on its reputation and customer base in the Chinese market," the Global Times write.”
May be we should ask for an apology for every low quality Chinese product we buy ?
" it will tank to $5. "
I doubt it will ... this would be the stupidest move and a fantastic buying opportunity
Read better
I said data in April and will stick to it
(for now)
: - )
Hi Guys
Hope you are doing well
Not reading everything now, just waiting like everyone else
I published this on Yahoo, in case you missed :
Seer Data proof points
Followers of this stock know how predicting the success of this Phase 3 trial is dependant on our knowledge of the survival pattern of patients with similar conditions. This can be predicted using SEER database.
Somebody kindly shared with me the link to a new drug for Head and Neck cancer
Link
(ongoing Ph III clinical trial started in October 2020will probably will be delayed some years due to Covid)
Link
It's a bit different from Cel SCI by the inclusion criteria (Oropharynx, Hypopharynx, Larynx + stage IVb patients), but as they excluded HP + patients, survival should be very similar as per my SEER stats that I have put in the second tab of this sheet which is included in the following article in SA.
Expected survival in Seer is about 55% at year 3, probably lower if we exclude HPV + patients.
Link
link
Now the interesting thing is the Phase II they conducted : Overal survival in the SOC arm was measured at 51%. No miracle, no better survival than Seer database. Debio 1143 improved 3Y OS to 66%
link
My Sheet is saying that with 298 events in April, the expected survival should be a wooping 74.4% in the Multikine arm at year 3 (VS 59.8% in SoC)
Now, naysayers, please don't state what I did not. This drug is of no competition with MK. First the trial will not complete before years and years, including with Covid effect AND its mecanism of action makes it 100% compatible with immunotherapies increasing defenses of the body. Patients will have great chances of survival in the future...
Things are looking good guys. Don't look at the pps now, look it through your July 2021 telescope.
Hi Jim
Looks great improvement of Fosco's sheet
I would review the dropouts rate, I think it should be higher, in particular in the early years
Cheers from French Alps where we cannot ski because of Covid !
Fosco
hey you might very well be right .... If so, I 'll send you a bottle of Whiskey*
*French whiskey if P3 fails primary endpoints otherwise I 'll let you chose the brand and add a Cuban cigar as well, not sure you are allowed to smoke Cuban in the US
Hi all,
I published two new articles
One is an update of previous article that I had written in Seeking Alpha
https://seekingalpha.com/instablog/10921081-fosco-research/5552324-update-from-previous-cvm-article
The other is a new analysis on a new stock, for those who want to diversify a bit their profits taken on CVM, which I wish you all had.
I believe the chances of approval for FT218 are above 90% and the upside in the next 2 - 3 years is tremendous as well (with expected ups and downs)
https://seekingalpha.com/instablog/10921081-fosco-research/5552294-avadel-pharmaceuticals-looking-good-for-investors-and-patients-narcolepsy
Happy week end,
Fosco
Exactly Biobonic
Alternatively, you can go to Fosco's latest sheet Here !
Select cell B24 till B49 : look at total at the bottom : 670... jeezz... missed date for about 10 patients, no big thing
Thanks GD, I am not always following twitter,
(While some investors find this attitude unprofessional, Frankly speaking, I do not see any bad : I mean people betting against companies aiming at curing terminal diseases are clearly on the evil side of my system of values. Just hoping his reactions are rather guided by his knowledge of the CT outcome than his emotions.)
I am not sure what you are hinting at us but I do like very much this document : this is perfect synthesis of a successful trial, well presented, concise and clear.
The part of interest might be that database lock was achieved as of April 2020 and the publication of the "victorious" interim analysis seems to have been only done by August 2020, so 4 full months after.
Eg it took them 4 months from Datalock to publish the final Analysis summary. It seems a lot but then the FDA approved it in October 2020 ! (not in the document but in this link)
So in summary : Analysis took long, (4 months) after data lock but then the FDA approved right away. Worth noting that the sponsor wanted it to be approved as of Standard of Care, hence they seem to have particularly allowed themselves enough time and no shortcuts to produce a perfect analysis.
Geert told that he wanted a complete analysis because he wants to prove that MK is suitable for Standard of Care. So , although, as someone who is used to people working on data (not on the medical field though), I would tend to think Analysis Time, or at least an undeniable proof of success, should be fast, the shown example study is consistent with what CVM is saying. What I can tell
Okay,
As expected (and explained in previous post) we did not have an early termination for efficacy.
The good thing is that we did not have either early termination by the IDMC for lack of power. This was a possible outcome.
So the phase III trial will continue till 150 patients are recruited. This is the best possible outcome, the other and only one, as we explained in previous post, was for the trial to stop for futility in the control arm
The market does not like the news but the market was expecting something that could not happen.... what a shame and a waste of money : people just do not want to listen to things that don't please them ... In any case I would wait a little bit before buying back, the end of phase III is no way near with covid around
GL All
Fosco
Good to hear from you guys
Fosco
Like everyone else, at first my reptilian brain reaction was "why prior TLD release" and "why so low while its climbing ?"
Then, fortunately, I began to think.
First, there is not really new dilution as some options calls that expired in October had the same diluting factor
Than, when you look at stocks that recently raised cash on the verge of disclosing important new :
Novavax raised 200m at 44$, then there was a huge spike till 170 $
NWBO raised 8M$ at 0.35, look where it is now
One can put itself in the shoes of the company that raises cash at this moment, cash that is needed to fund operations : salaries, facility expansion to prepare for the best, BLA preparation etc... of course, that's obvious and there is no optimum secure timing due to uncertainties.
But, overall, one can put itself in the shoes of the investor who buys at little premium (Monday price) with no Warrant, no edge. He must be pretty confident it will go higher such as NVAX or NWBO investors where pretty confident it would go higher. So this offering at 14.XX $ is just a good trade-off for the seller and the buyer of an optimum moment to sell and buy.
And while idiots on twitter are shouting "Hahaha. $CVM is such garbage" , I am chanting Hahaha at all the past and present idiots who were claiming Hahaha when I was recommending this stock while it was at 4$
Fosco
I am listening to you amico mio
with all this liquidity, no wonder it will go somewhere, but where ?
MB the biotech sector as a whole is worth it, I wonder what is its weighted average roi, but I believe, intuitively, that it is still undervalued. there is no such thing as a GAFA in the biotech sector : there should be !
Dear Friends
Just to say that I am going to publish an article in SA, behind the paywall if they accept it
It will not be "new" news for old timers, but it is a compilation and the latest about my thoughts.
May-be will it be useful for newcomers, those who will invest in the 14s to make a 10 to 20 bagger
Anyway I have been away for a while during this wait time, confident about the outcome. The quality of this board's discussion, who used to be premium, has be going down.
It is our collective falt : lack of new items, impatience, frustration, other occupations.
I am missing old timers such as Lightrock or Cotton, wxshouqs (whatever his/her name) I hope they are all OK. We did not always agree (sometimes LR gave me headaches) but at least there was some creativity and discussion.
Vegas party being not so far away, I hope you are all safe with your family, so that we can enjoy it-all when this is over,
Fosco
They do have something good indeed,
Just wondering how the market will react when they will announce delay b/c they need go talk with the FDA regarding Iomab-b trial redesign,
PS : Will stop a bit posting here, I hate sounding negative
Fosco
ok timber
you can still state trial arm is effective
but how can you state it is effective if you do not have anything to compare with
you need to compare to standard of care arm. but if your standard of care arm only has few patients to compare with, it is very difficult to state objectively that your trial are is "better". Better to what ?
You can compare with historical data from litterature, but then that's not the original design of the trial. You need to negociate with FDA to demonstrate effectiveness
I guess we just have to wait and see how this comes out
I regard those results as spectacular on a small population
Now, goal of a phase III is to replicate in larger population what is seen in a phase II, large enough to become mathematically and statistically significant (eg with p<0.05)
Is this goal achieved ? It does not seem to be at the 75% interim otherwise they would have stopped for early benefit, it does not seem it will be at 100% as well. The reason is not the compound, the reason is the design of the Ph III : it needs to be redesigned either by changing the SAP (for instance allowing historical control) and this will require talks with the FDA (lengthy : again with such results my assumption should be that the FDA should say YES product is good and historical control is enough) or by doing a new phase III trial. I am guessing they are waiting to see if this trial can finish till completion (results of conditional power analysis) prior talking to the FDA as they might suspect this talk will be longer than completing the trial as designed initially.
Reading between the lines as this company does not seem to be willing to communicate things as they are.
I am sorry, but that's my view right now.
NB : I hope I will be proven wrong by end of year, in the meantime I sold my shares and wait for this next PhIII news
Fosco
While clinical trials results seem encouraging
Let us focus on Phase III Iomab-B Sierra trial and answer simple questions.
Will latest analysis performed on 75% of the population result in early termination for efficacy ?
The answer is NO, otherwise the company would have said so. Let us be clear on this.
So here comes the next question. What will be the outcome of the ad'hoc interim going forward for this 75% population ?
There can be two :
- Either the trial will continue till completion
- Either the IDMC will recommend the trial to stop
Can the IDMC recommend the trial to stop and for which reason ?
The answer is YES it can, for lack of power in the control arm
Let's look at the control arm
There were 5 patients evaluable (for primary endpoint) in the control arm at 50% interim VS 29 in the TEST arm (N=37+38)
There were 7 patients evaluable in the control arm VS 44 in the TEST arm at the 75% interim (N=53+53) => This is clearly not enough to terminate this trial at this point
How many evaluable patients will there when all 150 patients achieve treatment ? That is the outcome of the incoming ad'hoc meeting, it might be something like this :
N=75 TEST N=75 CONTROL
around 60- 62 patients evaluable in TEST and around 10 in Control
Clearly the IDMC might conclude through a conditional power analysis that there will never be enough evaluable patients in the control arm and recommend the study to be terminated for futility as designed as such. It might also recommend to continue till completion, but still the trial could complete without achieving enough power because of the control arm.
Thus Actinium management will need to talk to FDA to amend this trial and change the SAP (for instance to use historical survival instead of a control arm) or redo another better designed trial. I see this as very likely despite the encouraging results showed so far, whose gibberish language for the average investor is not showing clearly this reality. Talk to the FDA will take a lot of time and will delay things. The market will not accept this phase III news as good news
Sorry, but this is my understanding of the facts regarding Sierra Phase III Trial, but I guess we will know soon enough what is the outcome before the end of the year.
Fosco
Oh yes
I am 80% sure, looking at IOMAB b results, that the FDA would accept change of the SAP plan, given the new orientations of FDA, you are citing OMER, and I have in mind as well NWBO and few others that might make it as well.
The only thing is I am not sure of the timing, so this Ph III might be delayed. Is it better to wait till completion with 100% of data or ask for early termination ? I am not sure what the company prefers, looks like the first option which makes me think they would prefer a normal completion to a lengthy talk. Company is not clear enough. I do not like lack of clarity and we know time is money while cash is burnt.
Control arm being futile is not necesarily the worse thing that can happen, given the fact that the difference between Iomab-B treatment and control is already very clear, because the patients can switch arms and the treatment works successfully for almost all patients who have switched. Continuing the comparison with an untreated control group is therefore relatively useless..
However what is happening, in my view, is not in the initial SAP that would have allowed an early termination for showing benefit. So here are the alternative of the trial :
1) continue the trial till completion as they believe the control arm will finally show enough patients to compare with (mid 2021)
2) continuing the comparison with an untreated control group is relatively useless.. : therefeore there will be discussion with the FDA, as everything that is not is the initial SAP needs discussion and this shall "take time". Discussion meaning ask for early termination as TEST is behaving very well, compared with.... litterature
Interesting to know what IR would say regarding this scenario, for what I have seen of changing a control to historical data this can take many months... but for sure what has been removed for the 10Q that was in the original PR is that the study stop for early benefit during this interim.
now I think I know what it means, quite precisely now. You can check with IR if you wish,
The drug is good, I have little doubts about it, as shown in PII and also in Test arm in Ph III
The problem is the design. The design makes that many patients in the control arm can't be elligible, because they fail engraftment or so. So they are left with very few patients in Standard of Care to compare TEST arm too. If you look at what they say, there is probably around 45 patients in Test arm and 7 elligible in control in this 75% interim. That's too few for significance comparing, for a p value below 0.05.
The way out for them in this Ph III is to talk to FDA and ask for historical control rather than a placebo arm ... or re-design the trial ... I am not expert.... from my experience it can take a bit of time to change SAP and primary outcome measures so that you do not compare to a control arm.
This can work out, and I believe drug is good enough for it and can show sufficient benefits.
However, this will take time in my opinion, in the meantime, in best case, Ph III will be stuck in time and cash will burn, in worse they will pronounce futility... so may be come back later would be a good option
Sorry for my final rather negative conclusion on this Ph III Iomab trial, but the wording in 10Q made things hard to read. Let's see now what happens in Q4 regarding this trial.
There is one thing in the wording that is striking me now on the Iomab-B PhIII trial.
I thought initially they had missed a comma between "early termination" and "for futility" as in the previous PRs like this one from April: "Actinium plans to exercise an ad-hoc analysis that could generate topline data for the primary endpoint in late 2020 and early termination of the trial if positive".
Does someone know where this has gone ?
Another thing unknown in my vocabulary is "futility in the control arm" from the 10Q.
By definition, control arm being control, futility (if demonstrated) should be shown in the test arm vs the control. I do not fully comprehend this wording.
One interpretation could be that they failed significance in this interim and are waiting for further analysis to determine whether they do have enough eligible patients in the control arm.
Does someone read like me ?
Excellent Anders, thank you
So :
This is recent and still needs to be announced in the incoming days imho as this is material info
In my opinion PPS will pop fairly once they announce officially the good news
Why haven't they update CT site and announced that the FDA had agreed for the change ? There are deadlines to follow
Interesting Alexander
Eli Lilly announced those changes, this was important news for investors. In your opinion,why did NWBO NOT announce such critical change ? This is a material event.
regards
Fosco
A game changer
===============
I would like to congratulate some longs in this board such as sentiment_stocks or Marzan (sorry for those I did forget) who knew those changes on SAP where not only likely but approved by regulators.
I was sceptical myself, I think there are still open questions (see in the end)
Unless bad faith, there is no possible bear arguments against those changes.
1) OS is the gold standard for clinical trial so is irrefutable proof of effectiveness of a drug whereas PFS is only a surrogate. Length of trial allows to use OS instead of pfs. So no wonder why this SAP has been ammended and approved using OS as primary endpoint.
2) Changing control to historical both increases the power of the trial (more patients to be compared to historical data) allowing to measure smaller effect sizes and like hood of success. We knew from blinded analysis that this population was surviving longer than it should have, we knew the compound was administrated to most of the patients, so the sample size is bigger and the effect to be measured against historical is already visible.
3) There are still open questions. Why EU regulator only and not the FDA (No change in CT database) ? Why was the SAP change not a material news. This is a huge news for investors, this is a game changer. So has the FDA not approved the SAP Changes ? Yes or No ? And why no company press release on the matter ?
GL All and congratulations
Fosco
Wow
That s great news
I did not forsee success if they did not implement this change, and they did it !
There was no other way for success
Fosco
Interesting, not sure though what you mean by "mind blowing"
True that incidence has been growing over the years
Taïwan healthcare has always shown superior survival, so no surprise it is superior to what we have in other countries (including USA)
This being said, as compared to SEER:
I have used their definition of Oral Cavity (not exactly the same as Cel SCI) to retrieve survival from Seer
click for survival table here
Taïwan relative survival at year 5 is :
Stage III 57.1 (54.7–59.5)
Stage IV 38.9 (37.6–40.1)
Versus SEER's :
Stage III 53.6 (51.3–55.9)
Stage IVa 38.7 (37.1–40.2)
Observed survival for this Taïwan population might be 5 points below in ST III and 4 below in ST IV there fore around 52% resp 35%. So that looks about 4% above what is seen in SEER.
This is still very far away from what is observed in this trial population and in any case under my conservative assumption for SOC
Sure, but still looks like a hint eg I am pretty confident and hopeful we will have news by 31 Dec latest or
before,
In the meantime :
- pps is getting cheaper, last opportunity to buy more
- nwbo is flying due to imminent release of data (this month likely. It took them months as well to lock the data with only 331 patients)
Thanks !
Well there is a date in there : Dec 31
Looks like a latest date