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Q3 share holders update:
ACTIVE POSITIONS HOLDERS SHARES
Increased Positions 50 1,171,248
Decreased Positions 39 2,207,653
Held Positions 30 8,440,133
Total Institutional Shares 119 11,819,034
Net sell: 1.036405 M
https://www.nasdaq.com/market-activity/stocks/cvm/institutional-holdings
Very interesting DD from mastervp on stockwits:
" Attempts of direct administration of cytokine mixtures, known under
a name of “multikine”, leaded to the controversial results" inferring the "robust benefit".
Sentiment shows that multikine cytokine therapy had a "robust benefit only
in a subset of patients" -- this is similar to the aintree leak which
suggested it was 'difficult' to know which subset of patients would benefit from the drug.
https://stocktwits.com/message/256425578
To me, now it is 100% clear NWBO and CVM are in the same camp
the PIII results are data mined in strong subgroup data to fight
for FDA's approval, I am going to watch with no positions of NWBO
and CVM now to see what happens after results, good luck to CVM longs!!!
From my DNDN, SRPT and AMRN experience, FDA can do what ever it wants
with small biotech companies.
Since UK and Germany updated the SAP, I assume the final
SAP is set but FDA is not on board, NWBO may file BLA and
fight in advisor committee just like BIIB had last Friday.
Anyway, when NWBO release the topline data, CEO LP may have
to answer the question what is FDA's position.
And that is reason for LL's comments from yesterday's presentation:
1 FDA has rigid procedures.
2 How to push this to FDA for approval: good for patients.
NWBO longs should be prepared FDA has not agreed with the
new SAP, and but data dependent to file BLA, IMO.
Thanks for understanding and a bit of humor....
I delete it, it is about after learned this comments from a NWBO long,
I exited my CVM position right before the close, just do not
like NWBO's new developments regarding SNO and SITC, and especially
the reasons:
"they will NOT announce the nuance of the results in a secondary conference
if it would disrupt and/or negate getting published in a well established
peer reviewed journal."
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=159338409
Unfortunately, CVM's stock will be effected by NWBO's news,
in many ways now, CVM management is behaving like NWBO's,
endless of delays, full data set release to make sure street
understanding the efficacy(if OS primary end point P value
is 0.01 or better, no need for this, IMO)...I have a hard
time holding CVM after I bought in, but the potential is
so big, I jump in again when I feel safe...guess next time
I may buy in again when CVM release Q3 earnings report and
a better picture timing of results.
By the way, I am also in BCLI for ALS PIII results
by end of NOV and in ATNM for PIII interim results
by end of Dec, I feel good about CVM, BCLI and ATNM
PIII results, good luck!!!!!
NWBO longs, thinking hard what you want to do, my
opinion is the easy 500% gains are gone from $0.40
to $2.5, positive results, NWMO may be $2.5, negative
results, 10 to 15 cents, and neutral results, $0.75
to $1, IMO. I bought in again 0.5 and sold 2.05.
All in CVM now, CVM has better risk/reward, IMO.
Recent NWBO events regarding SNO and SITC presentations
are not confident actions, IMO.
We are going to have a very exciting NOV and DEC coming up,
have NWBO, CVM, BCLI and ATNM for PIII data with potential
for 300% to 500% gains.
Finish the trial is a good option, but FDA can give a conditional
approval first and ask ATNM to finish the trial to have the full
data for full approval, 100% success rate for BMT engraftment is
very strong efficacy for FDA to pass, IMO.
I agree with your #2 view, what I mean is the efficacy is clearly
strong for approval, but data can not be analyzed by SAP plan, FDA
has to see the data with open mind to save patients' lives. FDA
has agreed this with OMER's TMA trial with only 28 patients compare
with literature.
Agree 100% with your view of "they are expecting to ask the FDA for an
early termination and proceed to an NDA submission". In my view, "100
percent (31/31) of patients receiving a therapeutic dose of Iomab-B
achieved successful BMT engraftment with only a 6 percent (2/31) TRM rate
compared to the control arm where 18 percent (7/38) achieved engraftment
with a 29 percent (2/7) TRM rate." is a huge success, 84%(31/37) vs 18%
(7/38) chance for CURE intent BMT itself is FDA approvable data, IMO.
If that is case, all bullish. CVM valuation is mysterious
to longs, since the trial is open label which means trial
Drs and patients know which arm they are in, it is not very
hard to find out how is the trial doing from calling few trial
sites, IMO. Only concern I have is some one may try to sabotage
the trial again some where some how.
Yes, I think the patients still want to go through the SOC
to make sure they are cured, and that is why Geert says
the data is complicated and takes time to get complete
picture and now makes senses to me why Geert wants to release
the full data at first PR.
From Geert's tweet:
"What will be your next questions following success? How many people had
their tumor go away in 3 weeks? Was there any toxicity from Multikine?
What was the effect on the other treatments? If a MK patient dies, did
he/she die later? You cannot change the world with shortcuts."
Look at the bullish side, I take this comment of "How many people had
their tumor go away in 3 weeks ?" and it means to me CVM may be trying to
find out dropout patients live or dead as many as possible because there
may be many in the dropout group of tumor go away or tumor sides reduced in 3 weeks
to have a complete picture of Multikine true efficacy, and this may be the
reason of data lock delay, I am back in the very bullish side today, and
looking for results to come out late Nov to early Dec.
ASH late-abstract time line: deadline OCT 28, late-break title published
online on Nov 17, ATNM 2020 Annual Meeting of Stockholders, NOVEMBER 18,
2020. Interesting timing, I guess PR of PIII interim look to stop for
efficacy next week before OCT 28. Tomorrow's CC is unusual, why not
today? Is the interim news coming tomorrow too? I feel it is about
interim data to be presented at ASH as late-break abstract.
Why new cancer drugs are hot and worth of Billions?
From Pistol-Dollar To Petro-Dollar To Pharma-Dollar...
https://www.zerohedge.com/geopolitical/pistol-dollar-petro-dollar-pharma-dollar
US and China are on a race to find new treatments for cancer, NWBO
and CVM are leading at a brand new front to fight cancer, IMO.
NVCR's revenue is recurring every year if the patient is alive
and use NVCR's Optune, market gives a higher valuation for
recurring revenue.
If CVM is to present full data at ESMO, ESMO is going to start
releasing abstract titles 3:05 PM PST Sunday and Thursday 3:05
PM PST for late-breaks, so we will find out if CVM is in ESMO:
Publication schedule for accepted abstracts
1 Abstracts accepted for presentation at the ESMO Virtual Congress 2020 as Poster (suffix ‘P’, ‘TiP’) and EONS Poster (prefix ‘CN’) will be published online via the ESMO website at 00:05 CEST on Monday, 14 September 2020.
2 Abstracts and late-breaking abstracts accepted for presentation at the ESMO Virtual Congress 2020 as Mini Oral (suffix ‘MO’) will be published online via the ESMO website at 00:05 CEST on Friday, 18 September 2020.
Is CVM going to pull a trick on us like what NWBO has done:
NWBO trick:
SNO: Submit a final Late-Breaking abstract (with updated data) by September 1, 2020. If an updated abstract is not submitted by that date, the abstract will be automatically rejected.
DCVax-L Phase 3 clinical trial detailed results and analysis will be presented by Drs. Linda Liau & Marnix Bosch at the 2020 Society for Neuro-Oncology (SNO) on 11/20/2020:
https://www.eventscribe.com/2020/SNO/fsPopup.asp?efp=S0taQ1hBSFkxMTYzNQ&PresentationID=772799&rnd=0.2810788&query=Dcvax&mode=presinfo
If CVM is able to, CVM may submit the topline data as late-break to ESMO on Aug 17, and present the full data at ESMO, we will find out in two weeks
what is going on with CVM and ESMO, CVM and NWBO are in a race to report which company has the best immunotherapy for solid tumors, IMO.
SOC, does it matter to MK VS what ever?
I believe IT-MATTERS may be positive 10% to 12% OS advantage
range, my initial 25% home run results has a low chance now unless
MK arm KM cure is flattening after 4 year time mark and very high
% later events are from placebo arm. I just do not like Geert
talking down Walltreet at this late stage, they are powerful
when they are unified against CVM in terms of suppressing
CVM market cap even the trial is a success, IMO.
AMRN got the Huawei and Tiktok treatment, V's success may
be a threat to national security by a foreign company, if
a US BP owns V, this patent fight would not have happened,
too bad JT refused to sell for $42 last year, IMO.
Geert was out right lying on yesterday's presentation by
saying IDMC recommended to continue for last 9 years at
time mark 18 minute, the truth is On top of page 6 2016
annual report , FDA's issue b is the most serious one:
FDA recommend IT-MATTERS should be terminated for futility.
To me, at least in mid of 2016, the interim look data had
crossed the futility limit.
https://www.sec.gov/Archives/edgar/data/725363/000165495417003711/cvm_ars.pdf
One thing Geert does come through is his confidence(or arrogance?),
he better knows what he is talking about.....
Appreciate your DD, thank you!
Is "Horrible Amarin strategy once again" "Great for Amarin shareholders"?
I am confused.....
AMRN: 2018
June 28, last patient visit has occurred for REDUCE-IT
Aug 14, late-break deadline for AHA
Sept 24: topline PR and REDUCE-IT results have been accepted for presentation at the 2018 Scientific Sessions of the American Heart Association (AHA) on November 10, 2018 in Chicago, Illinois.
SWAV: 2020
April 6: finish enrollment for PIII trial DISRUPT-CAD-III
May 4: DISRUPT-CAD-III ends
AUG 11: Q2 earning CC, DISRUPT-CAD-III full data is presented
as late-break at TCT 2020, Sept 23-27.
What is CEO Geert's plan of PR the full data? ESMO???
Can AMRN copy's ABBV's strategy to file lots of new patents
to extend the patents' protection:
"The Initiative for Medicines, Access & Knowledge discovered through databases that AbbVie has filed 165 patents for Imbruvica, 88 of which have been granted. As a result, the company will now get an added nine years of patent exclusivity for the market it shares with Johnson & Johnson (JNJ)."
https://finance.yahoo.com/news/abbvie-proves-masterful-playing-drug-221146843.html
Do not want to misleading any one, I do not expect
any PR from CVM about ESMO today or tomorrow any more.
I may figure out what Geert plan may be, and
it is about ESMO, very similar to AMRN's plan
in 2018, it is positive for the final results,
IMO. I am going to change my view back to bullish
and act accordingly, since it is my speculation only,
no facts to back up my thinking, I do not want to confuse
CVM longs any more, good bye and good luck longs!
My speculation is CEO gets the last April's IDCM interim look
HR number, can you tell me is it legal or not to let him know
the HR since the trial is over? When he says he is still remaining
blinded, he means blinded to the final results not the interim HR, IMO.
I should stop this conversation here, because I just am speculating,
do not help any longs here, good luck longs!
As I posted before, I have no problem CVM wants complete
analysis data and err on the side of being conservative,
I have issue with Geert's plan to PR the complete data
to public at first time, which is not "err on the side
of being conservative", just the opposite, and means to
me the the results are borderline on efficacy, Soxrates
expresses this view much better than I do. I may be wrong on
this PR issue, but my instinct tells me something
changed from the CEO Geert I heard on many presentations.
Sorry my posts may confuse you, I really appreciate CVM longs
or any other biotech longs I follow posting their view to help
other like me. I have a small problem in writing as you notice.
I am trying to figure out why CEO Geert wants to PR the complete
data at first PR, which is against norms of biotech releasing
topline first and presenting full data at peer reviewed conference.
CVM can notify FDA right after receiving the data set, no conflict
of PR the complete data to the public too because CVM does not need
FDA's OK to PR the data, IMO. What ever the final results are set
in stone now, no matter of when and how the PR comes out, Good luck
CVM longs!
Yes, very interesting view of "You’ll get FDA approval because the bar is
so low these days. You’ll get snapped up by some big pharma mostly to
acquire the IP and bring development in house to avoid you getting lucky
and stumbling on something useful and profitable so they dont miss out
and avoid another AMGEN." Me too: "Come on Geert, shock the world......PLEASE!",
and prove my bullish case of PR presenting at ESMO is right next week!!!
His/her prediction "study might just show a small positive benefit." explains well why Geert wants to PR the complete data at the first PR
to fight the short attack of how useful in real setting and limited sales potential that sure will come after the data PR, IMO.
Soxrates:
in real life I’m a doctor that treats people with cancer. So thank you for that movie critic comment. It’s nice to see how you’ll treat your future potential customers.
I have no financial stake regardless of the outcome of your drug or company.
I wish you and the drug well. I hope for the sake of patients it is an absolutely wonderful drug that provides a cure. My point of questioning was to understand your trial. Not attack your company. But also have some counter points or other interpretations that (while we don’t know the data) might be equally valid. Hype in cancer medicine is a real problem and does harm. If your drug really really works. Feel free to hype to the hilt. I’m the first to wax lyrical about BCR-ABL inhibitors for CML. But the reality is most cancer drugs benefit these days are much much more modest. Yes there is improvement but the industry and acts and prices these drugs like they are hugely transformative when looking at things that truly matter to patients like living longer and better the absolute benefits are often, unfortunately, small.
regarding the comment on “doing what has never been done before” and “will improve you chance of being cured”.
What exactly do you mean that’s entirely novel. I’ll agree your exact mix of cytokines to perk up the immune system might not have been tried. But we have tried drugs and cytokines in cancer to turn on the immune system including interferons, checkpoint inhibitors, CAR-T, cancer vaccines.
If successful will improve chances of being cured. The main word there is if. You don’t know the data yet. Like I said I hope you do get a positive result.
Also improved cure rates in adjuvant setting have been achieved before is why addition of radiotherapy and those concurrent chemoradiotherapy regimes are standard of care.
I’ll admit I haven’t read all of your preclinical science. But what I have read is huge numbers of clinical trials in oncology. And it’s littered with trails that are negative that had solid pre clinical science behind them. This space is hard, and to come at people with valid concerns on clinical aspects of your trial and fob them off as just a short seller or uninformed is not helpful.
5) “ are you telling me that you prefer the activation of an immune system that has already been destroyed to one that is still fine”.
A. Obviously not. But that wasn’t my question and you know that. Nice bait and switch.
B. My question was why didn’t you trial this in a metastatic or relapse setting first before moving forward to neoadjuvant setting. All successful (neo)adjuvant therapies have activity in the metastatic setting. You could have run a relapsed metastatic trial the event rate would have been quicker to accrue as these patients are sicker. And if successful you have gone to market sooner and helped more patients sooner. You could then run your neoadjuvant trial safe in knowledge you have some market share, more information on likely toxicity and a better handle of likely effect size.
You might say yours is different due to novel mechanism of action and the immune system is “destroyed” by this point.
You must know that we have the option of nivolumab post chemotherapy, which despite being in a setting of a “destroyed immune system” still showed a survival benefit. Both that and your therapy will rely on some functioning immune system. The fact that you seem reluctant to test in this setting is red flag to me. For immunotherapy in head and neck Nivolumab is the bar and it has data in that setting. Why can’t you. Is it cause you expect it to not work, if so why? Is it that multikine isn’t as immunologically stimulating as nivolumab.
Comparing your results to the adjuvant nivolumab setting is going to pretty interesting. I’ll watch closely for the NIVOPOSTOP and IMSTAR-HN trials.
6) regarding your comment on the SEER data being from same tumour stage, obviosuly. that wasnt my issue. in the SEER data your going to get a group of people all say T3N0M0. but within that group is going to be some fit well people with T3N0M0 and some who have got comorbidities and maybe other problems. If you look at the median survival kf the SEER data its going to be derived from a mix of the fit and not fit ones.
now you have your trial. whose clinicaltrials.gov entry i found. And its not surprising your trial has to go on longer than the median OS for SEER. because you selected for people with good performance status, no immunosuppression and even explicitly selected for a life expectance longer than 6 months. Also depending on how you define functioning immune system and immunosupression in your trial protocol may exclude a large market share of patients with COPD who need steroid inhalers. if you excluded them you have a much fitter trial population than your average person in SEER with the same stage.
These are all valid points about your trial and trial design in general and will be key to interpreting the value of mutlkine or lack of depending on what the data show.
My prediction would be this. Your study might just show a small positive benefit. I persoanlly expect part of the reason it’s gone on so long is to see the LI relevance compared to your cyclophosphamide mix. You’ll get FDA approval because the bar is so low these days. You’ll get snapped up by some big pharma mostly to acquire the IP and bring development in house to avoid you getting lucky and stumbling on something useful and profitable so they dont miss out and avoid another AMGEN.
Depending on how you price things and the relevence of the cyclophopshamide you may struggle to go for the european market and you won’t like having the meet the QALY thresholds.
You’ll get a few years of market share in the US but alot of people will just use the zinc and cyclophosphamide mix. Then the nivolumab trials will publish. They’ll beat you, I’m sorry that just looks likey at this point. Your market share will shrink. but you wont care. you’ll have made lots of money by then.
https://www.reddit.com/r/IAmA/comments/i8hv6n/i_am_geert_r_kersten_i_have_been_working_in/?sort=new
Abstracts and late-breaking abstracts accepted for presentation at the ESMO Virtual Congress 2020 as Mini Oral (suffix ‘MO’) will be published online via the ESMO website at 00:05 CEST on Friday, 18 September 2020.
Late-breaking abstracts may be submitted for high quality, new research findings from randomised phase II or phase III trials with implications for clinical practice or understanding of disease processes.
I think CVM abstract is going to be a high quality, new research findings
from randomised phase III trial with implications for clinical practice
like SOC. Any way, I know it is a huge gamble to bet on CVM making the
ESMO, and it is a speculation I can think of CVM PR the results by Aug
18.
My speculation is CVM may receive the full data last Thur
Or Friday, finish the submission by this weekend or Monday,
issue a PR Tuesday morning.
Submission instructions
The deadline for the submission of finalised late-breaking abstracts is 21:00hrs Central European Summer Time (local Swiss time) on
Monday, 17 August 2020.
Abstracts, with the exception of Trial in Progress (TiP abstracts, see below), should be structured in such a way as to include
the following four (4) sections:
- Background: A short introduction indicating the rationale of the study
- Methods: A brief description of pertinent methodological procedures
- Results: A summary of the results of the research
- Conclusions: A statement of the main conclusions
https://www.esmo.org/content/download/260708/5029247/1/ESMO-Congress-2020-Abstract-Submission-Regulations.pdf
I love FOSCO's DD on OS spread sheets too, but I do not
agree 100% on FOSCO's view of IDMC interims looks, I give
you a most recent example of CLSN, as long as the HR value
does not cross over pre-set bounds which is always higher
than the final HR set for success in SAP, IT-MATTERS's HR
is 0.9, with no issue with safety, IDMC will advise the trial
to continue. Believe me, FOSCO mentioned VICL's PIII for
Melanoma too which I followed years, VICL CEO said the same
thing about DMC's advise to continue on every earnings CC
during the 1.5+ years delay, the final result is HR is 1,
if I remember correctly, the treatment arm OS is little
bid worst than placebo arm. Not trying to change your
mind on CVM, just do not like you calling me a CVM short,
we need good luck with CVM final results, it is truly
a binary event, IMO.