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Time to add, $240 M of Market Cap. is a terrific bargain, after the partnerships we'll easly go above a Billion.
Why are the insiders so poorly invested in CVM? Geert salary is $629,000 per year,but he owns about only $500k of shares.
No real indications about the P3 trial from the previous test ( P2 not clearly controlled). On the contrary in 2016 the CEO Geert asked to FDA to lower the overall survival to be able to approve Multikine from 10% to 6.5% and to increase the number of patients to 1200 from 928,and started to enroll more patients without permission.
This was an huge warning about the effectiveness of MKine
The FDA reacted very badly and halted the P3 until Geert accepted the previously agreed rules.
The CRO wanted more patients enrolled and a lower survival difference
vs placebo arm because they observed a higher survival than expected
Again, Geert is poorly invested in his company vs his enormous salary.
This company and this CEO not be trusted, stay away.
Reverse merger by eoy.
CVM is a worthless company, without real assets unless the millions of shares bought by unwary retail investors.
Geert a con man , shareholders the pushovers.
The harsh reality for many longs
Arbitration has taken 4.5 years, Multikine 20+ years , Leaps 10 years.
Geert strategy is clear, dilution and dilution for years and years, until OTC, BK or reverse merger.
I can't see anything of relevant before Q3. We float around 10 for a while.
Just my opinion.
Remember 3 months ago reading the Geert PRs the arbi and the MK end appeared imminent_The same 6 month ago, the same 1 year ago, 3 years ago.. .....
He is riding the nothingness for years.There is a void below
Aironite P2 data soon.
Top Line Results From Aironite Phase 2 Clinical Trial for the Treatment of HFpEF to Be Presented at American College of Cardiology 67th Annual Scientific Sessions & Expo on March 11th.
Heart Failure with preserved ejection fraction is an important disease with poor drug options, it is a market of several billion $
http://savarapharma.com/investors/press-releases/release/?id=2332998
I bought this stock in 2008 or 2009 when there was a spike to $2, it was before the 2 splits, on the news that they got a possible "cure" for the pandemic flu, a drug named LEAPS !
These were the days when pandemic flu appeared to be imminent, and only 2 or 3 companies had something against it.
Before, in 1999, they had a drug for HIV AIDS that showed evidence of activation,a drug named MULTIKINE!
These 2 drugs are still on the scene, years after years they are presented for different diseases, and, obviously, heavily finaced with retail SH money.
It was a continual recycling of the same things, but finally this year should be the final year,that can no longer postponed because so close to BK or lawsuits, and Mr.Watson IMO is the man that has the right skill for an exit strategy.
http://www.evaluategroup.com/Universal/View.aspx?type=Story&id=114921
https://www.fiercebiotech.com/biotech/cel-sci-to-conduct-first-clinical-study-of-investigational-leaps-h1n1-treatment-for
I 'm saying this since the Watson's hiring. Mr. Watson is here to close CVM business in the best painless possible way, especially for Geert.
IMO something like a reverse merger should happen in months.
Watson must avoid lawsuit with SH, SEC investigation and other risky situations accumulated in these 20 yrs of strange manipulations.
Also the arbitration is an attempt to reverse the responsibilities of 20 yrs of dilutions and RS
Could Molgradex help in pneumonia and lethal influenza?
Some studies are extremely interesting
https://www.ncbi.nlm.nih.gov/pubmed/21474645
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4414562/
that looks really bad is this lack of clarity and so many complications about everything: finances, number of shares, number of warrants, trial management, CRO, IDMC opinions and effectiveness, FDA warning, very long arbitration, trials disappeared, big shareholders that want to sell large amount...
a total mess, what is it hiding?
last PR about molgradex , 2 case reports
"Both of our patients had a long history of M. abscessus infection that we had not been successful in treating, and both were experiencing a decline in their clinical condition, but when started on inhaled GM-CSF treatment, both demonstrated rapid microbiological response and clinical improvement."
The PR gives us insight that also other lung infections could be treated with Molgarex especially in combo with antibiotics.
http://savarapharma.com/investors/press-releases/release/?id=2330507
Target $35+
we'll see, but not so easy that MK can help cancer, tested for 30 yrs is a vintage drug. Fortunately current immuno-oncology is light-years ahead of interleukines
Explain me the S1. Please.
Per S1 Ergomed and the biggest shareholders put their shares up for sale.
http://filings.irdirect.net/data/725363/000165495418000147/cvm_s1.pdf
pag.8
2018 year of trials and results.
P3 Molgradex in PAP ends in Q1 and results in Q4.
P3 Aerovanc in MRSA in Cystic Fibrosis continues.
P2 Molgradex in antibiotic-resistant NTM lung infection starts in Q1
P2 Aironite in Heart Failure pEF results Q1-Q2.
P2 Aironite in Heart Failure continues.
P2 Aironite in Cystic Fibrosis and P. aeruginosa infection results in Q1
if Aironite will show effectiveness as expected the target price can easily double due to very large market of heart failure.
Agenus and AgenTus shareholders. Garo should clarify the position of the AGEN's shareholders in the newco AgenTus.
How many shares have they? in what proportion ? Where does AgenTus get the money to grow up?
geert invested only $500.000 of his money despite he has a compensation of $650.000/year as CEO, and he is the CEO since 1995!!!!
Tens of million dollars of wage from the pocket of shareholders !
No insiders are really invested in their company.
Interleukin 2 is the most active compound of Multikine and it is used and approved as injection for cancer since 90's, checkpoints modulators like ipi (anti-CTLA4) and the anti PD1-PDL1 just like a lot of others in development are another matter.
Anything like that. Why did Mr. Geert appoint an experienced business man like Mr. Watson before the results? I think for a not easy operation.
Remember that Multikine is an interleukin mixture, but interleukine 2,the most active, is already approved and marketed for cancer since 1992! (es, Novartis Aldesleukin). Nothing of revolutionary then, only a specific application and a new dosing method. This explain the indifference of the big pharma and the current low market capitalization.
Does Multikine work? I think yes, how good is more difficult to say, my guess is more than 5% but less than 10.
Approvable? I think not easily for FDA , easier for other agencies in other countries.
Interesting in this stock is the good risk/reward ratio, and the tiny capitalization that is roughly the values of the assets.
My scenario is that geert wins the arbitration but know that multikine it's not so easy or so fast approvable,in this case with a merger (also a reverse merger with a larger private Co.) he can transfer all the cash and all the assets intact through,say, a 50%-50% merger, reviving the combined and more reliable company.
I think rather a reverse merger after multikine data (unlikely enough good to pass FDA ,IMO) above all if Geert will win the arbitration, a merger can bank the cash and erase the past. Already seen several times.
he seems perfect to lead a merger or a R/M ,a bit less for an approval
At Clinicaltrial they don't say 10% of OS improvement but only the more usual P-Value between the 2 group less than 0.05.
Not a little difference.
Primary Outcome Measures:
Overall Survival (OS) in LI + CIZ + SOC vs. SOC [ Time Frame: 3 year ]
OS will be assessed using Kaplan-Meier life-table and compared using a logrank test and confirmed further with tumor stage location and geographic stratified log rank tests. The unstratified logrank test constitutes the primary analysis. A two-sided p-value of 0.05 or less will be considered statistically significant for comparing the two groups. Interim analyses will be performed throughout the study to assess safety, sample size and futility.
Thank you Montana, I agree with the article, and it's less clear why they want to stop the trial now with hundreds of patients not tested for 3 year yet..
It could be because Multikine works better in the first year vs SOC or because of cash problem. No clue.
Again, I find Geert very repetitive and shallow with the story of SOC of hundred year old(X-ray or I WW chemo).
There are companies that survive on trials for years, with dilutions and dilutions...
At this point, if there will be an early data readout(early compared to 2016 enrollment), all is possible,
I'd repeat my opinion: something in between pass and not pass. In this case very important are the talks with FDA.
My warning was that they said in August 2016, when they wanted to lower the OS percentage to 6.5% from 10% and to raise the enrollment to 1,200 patients, already in accordance with non-USA regulatory agencies.
The FDA took it pretty hard and on September 26 2016 placed the trial on clinical hold.......
Just IMO.
let's get serious, Geert always perfectly knew the development of the trial.
what is strange is this phrase on Clinicaltrials Multikine page : "Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)"
They won't wait the 3 years follow up
A Company behavior not easy to be understood. Until a year ago they tried with the FDA to reduce the percentage of survivals to a 6% and to raise the number of patients to 1200. Clear signals of not exceptional data. Then they seemed a little late to reach the trial end.
Strange. IMO I though something as mixed results with some kind of the agreement with the FDA
Very interesting is that the mixture of Leucocyte interleukins are synergic with checkpoint modulators (as the anti CTLA4,anti PD1 and many others)that are largely developed by several pharma and big pharma companies in a very promising multi billions market.
The new immuno-oncology is based on checkpoints modulators, as I already said , Geert should immediately go down this road with pharma partners,because, in any case, Multikine can have a real future ad adjuvant in combo therapies.
Wake-up Geert!
likely not rocket science here, but Interleukins are natural compound strongly involved in immuno-response against tumors and in past trials as single agents they showed some effectiveness.
Leukocyte Interleukin injection are also tested in H&N in a P2 by another Co, IRX Therapeutics and showed effectiveness:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5300054/figure/F6/
This trial and this drug is a pretty perfect copy of the CVM trial and of Multikine, and they spent several tens of million for the Co and for the trials, which prove that there is something of interesting in this choice.
https://clinicaltrials.gov/ct2/show/NCT02609386
Obviously it's extremely hard to know how close is CVM trial to 10% of reduction, by inference, it seems that they would be safe with a 6% ,having regard to their request submitted to the FDA. How conservative was it?
IMO: I hope that also a reduction around 6-9% (that is not a poor result in cancer!) could lead to a negotiation with FDA.
the IDCM should be neutral,they always use standard and professional phrases in a report. This 2 lines are very typical to indicate a normal development of a trial. they never can report any kind of results,unless in case of serious troubles. Maybe the CEO can say something. Next week the E.R.
recommends continuing the study: it means that it is not futile.
In other words they are seeing that multikine is somewhat effective.
I'm speaking of partnerships with pharma companies. Sabby is a notorious manipulator of weak Co. typically trough warrants. But because they entered low, probably they want to speculate on arbitration,pumping the event. Most likely after that they will dump, shorting and holding only the warrants,just a little bet in case of trial success. That's the classic Sabby move.
Geert needs some sort of partnership to develop LEAPS and Multikine. If the trial was positive, above all for the marketing and even if the trial wasn't entirely 'yes' ,multikine should be still great in combo with new immunologic drug as Keytruda ,Ipilumab and other checkpoints modulators.
I'm surprised that they didn't do any test with these combos, nowadays so popular in cancer immuno-oncology and in bio-stocks. The results should be extremely attractive for funding and partnership.
Could be the restatement linked to the arbitration? How could they indeed claim a compensation for tort in an amount that is much bigger than the asset ?
If arbitration will be won or if ,more likely, there will be a settlement, every million are roughly $0.1 of cash per share.