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troc not saying I know the answer but feel like, saying if I were Linda Powers I would like to wait until FDA nod for approval or at least semi-official approval nod via positive conversation/response which could come in various ways and forms. It's nuts to argue whether NWBio has been unblinded or not and whether NWBio has communicated with FDA with unblinded data. Of course NWBio has been unblinded and FDA must have been briefed with the results!
In doing that, it's Linda's way to better look after the interests of NWBio investors, partly and strictly on investment front, by saving the most loyal investors from premature selling when the price is on its way up incrementally while delivering a dead blow to those who short, or to lessor extend who constantly swing trades.
Look a lot of investors would think of selling some if not significant portion to "de-risk," or to "diversify" when stock price "finally" breaks the band and appreciates to $1.7, $1.8, $2, $2.5, etc., while some investors after holding for years averaging down and up would finally feel "enough is enough" losing the last shred of patience and sell all the shares.
Instead, Linda would like to give you a substantially high share price by holding long enough getting the right time to release the big news, for example $5 versus incremental share price increases from the current $1.4 and up by incremental releases of some good news [the cost of doing so may not be worthy of it in long run].
Linda and all directors (in general insiders) who own the majority of shares have been aiming at the big prize, not day to day price fluctuation or message box chatters. So far we have not seen any insiders selling; instead they have collectively suspended their warrants and options until the end of this month.
As long as when the big news will hit is IMHO still any day now and as long as it must take to get there. For me it's no difference though I would prefer it to hit tomorrow because as the same as Linda and directors I also am aiming at the big prize.
Only thing I can do in the meantime is to keep up with new development if any, buy more shares to continually average up or simply just sit and watch, waiting for the news.
This is my last post for today. GL!
Exactly iwasadiver. The only SAP whether it's called original or revised SAP is the SAP the sponsor uses to analyze UNBLINDED data. So in essence, there is only one SAP which is the one used in analyzing unblinded data. Or one can call other previous ones draft SAP.
I guess you may be somewhat confused on several issues:
The SAP and the endpoints the analyses will use when data is unblinded will be the revised reordered SAP and endpoints therewithin, ie, the primary endpoint is
"The primary objective of this study is to compare overall survival (OS) between patients randomized to DCVax-L and control patients from comparable, contemporaneous trials who received standard of care therapy only, in patients with newly diagnosed glioblastoma. This endpoint will be assessed using 3 different analyses"
and the first secondary endpoint is
"The first secondary objective is to compare overall survival (OS) between patients randomized to placebo who received DCVax-L treatment following disease recurrence and control patients from
comparable, contemporaneous clinical trials, in patients with recurrent GBM."
Source: https://www.clinicaltrialsregister.eu/ctr-search/trial/2011-001977-13/GB
As we all know, part of the reason for revising SAP (endpoints are part of it) is pseudo-progression wreaking havoc on "original" primary PFS endpoint and cross-over confoundment on "original" secondary endpoint OS."
Nonetheless, sponsors of trials may revise respective SAPs while they remain blinded according to FDA guideline, and it's exactly that NWBio revised its SAP while remained blinded. NWBio would be (has been) for the first time using this SAP to analyze unblinded data.
After all, since well more than five years have passed after the last patient in the trial was enrolled and treated, any data/analyses on PFS will be truly secondary, which may be used as an evidence support. The focus is now and should be now squarely on OS, in particular long-term survival.
It should be stressed NWBio revising SAP and endpoints are conducted to have more accurate and up-to-date metrics used to measure efficacy of the trial data, not to make up for "a failed trial" so it is not only necessary but essential.
One other reason for revising SAP is obviously as of today it is understood any immuno-therapeutic trials must be conducted longer enough to fully capture the effectiveness of the underlying immuno-therapeutic agents/vaccines due to normally delayed effects. For this reason, long-term OS is most important relative to the median OS, or the now obsolete surrogate endpoints such as PFS. Not only has NWBio exactly done that but it has acquired unprecedent rich and extensive data for all patients in the trial.
With Dr. Liau's presentation slides, particular those comparable, contemporaneous prior trial curves as well as the blinded data of Phase 3 DCVax-L trial as of 2017 (published in 2018) and its subsequent update data in 2018, plus the information arm data presented, it should be no difficult to conclude both the primary endpoint and the first secondary endpoint will be significant when analyses of unblinded data are announced in the near future.
GL
it's better pay attention to the OS after median for long term OS where curves get wider in difference to reflect on the nature of immunotherapy.
That's great information. Thank you always for your diligence, and specifically providing Dr. Liau's presentation slides this time.
It's great information because despite obvious absence of any Phase 3 DCVax-L trial mentioning, the whole thought process of Dr. Liau in the form of her presentation slides is actually what we are expecting for the analyses of DCVax-L trial presentation in the near future. [anybody can draw the curves of DCVax-L and fit it in the slide graphs. Wow beautifully superior!]
There are some specifics on how to present the control patients from comparable, contemporaneous trials as comparison with DCVax-L treatment from the presentation.
Once again, it's almost 100% certain at least both the primary endpoint and the first secondary endpoint of DCVax-L trial will be significant, and people will be able to understand how these comparative curves are prepared from what sorts of comparable representative data.
Highly informative and positively suggestive. Thanks again.
Buyout grinding machine marches on with one more evidence to chew around. Why has the company faced with high probability of DCVax-L approvals at least in UK, Germany, EU as of now (it's also possible FDA beast may finally act like a leopard to first approve DCVax-L, which nobody knows really, but Linda's paranoid on anything or everything FDA such as having yet to simple updating CT.gov site is a clue of such possibility IMHO) not yet expanded its team, which is definitely required and a normal practice for any other companies in such situation at this stage, unless one thinks the company will be broke soon. You may think well these (see below) boilerplate languages are in last year's 10k as well, well we are one more year closer to success, and in effect success is only days or weeks away, so definitely an urgency to expand NWBio team! So why no, unless there is a buyout.
See below Item in the Risk Section of 2020 10K, page 8:
"We will need to expand our management and technical personnel as our operations progress, and we may not be able to recruit such additional personnel and/or retain existing personnel.
As of December 31, 2020, we had 18 full-time employees in the US, and one full-time employee in Europe. Of this group, only four employees are considered Management. Other personnel are retained on a consulting or contractor basis. Many biotech companies would typically have a larger number of employees by the time they reach late stage clinical trials. Such trials and other programs require extensive management capabilities, activities and skill sets, including scientific, medical, regulatory (for FDA and foreign regulatory counterparts), manufacturing, distribution and logistics, site management, reimbursement, business, financial, legal, public relations outreach to both the patient community and physician community, intellectual property, administrative, regulatory (SEC), investor relations and other.
In order to fully perform all these diverse functions, at many sites across the U.S. and in Europe, we may need to expand our management, technical and other personnel. However, with respect to management and technical personal, the pool of such personnel with expertise and experience with living cell products, such as our DCVax immune cell product, is very limited. In addition, we are a small company with limited resources, our business prospects are uncertain and our stock price is volatile. For some or all of such reasons, we may not be able to recruit all the management, technical and other personnel we need, and/or we may not be able to retain all of our existing personnel. In such event, we may have to continue our operations with a small team of personnel, and our business and financial results may suffer.
We rely at present on third-party contract manufacturers. As a result, we may be at risk for issues with manufacturing agreements, capacity limitations and/or supply disruptions, and/or issues with product equivalency.
We rely upon specialized contract manufacturers, operating in specialized GMP (clean room) manufacturing facilities, to produce all of our DCVax products. We have worked with several such manufacturers, in several different locations, during various periods of our clinical trials and our compassionate treatment programs, including Advent BioServices, Cognate BioServices and the Fraunhofer Institute.
We will need to enter into new contractual agreements for manufacturing at our Sawston, U.K. facility and new agreements for commercial production in any locations. We may encounter difficulties reaching such agreements, or the terms of such agreements may not be favorable. Following negotiations, if it is necessary or desirable to change our facility design and development arrangements or our manufacturing arrangements, that could involve increased facility costs and/or increased costs related to manufacturing of our products, and could result in delays in our programs or applications for various regulatory approvals. In addition, after such contracts are in place, the third party contractors may have capacity limitations and/or supply disruptions, and as a client we may not be able to prevent such limitations or disruptions, and not be able to control or mitigate the impact on our programs.
We have been in breach of the services agreements with our contract manufacturers on numerous occasions, primarily for untimely or non-payment. Our breaches of the services agreements may not be tolerated in the future as they have been in the past, and if we continue to breach the services agreements, for non-payment or otherwise, the contract manufacturers could cease providing services and/or terminate these agreements.
Our intention is for the U.K. facility to manufacture DCVax products for both the UK and other regions. However, this may not turn out to be feasible, for regulatory, operational and/or logistical reasons. It is also unclear whether or how Brexit will affect or interfere with these plans in regard to Europe.
8
Table of Contents
Problems with the manufacturing facilities, processes or operations of our contract manufacturer(s) could result in a failure to produce, or a delay in producing adequate supplies of our DCVax product candidates. A number of factors could cause interruptions or delays, including the inability of a supplier to provide raw materials, equipment malfunctions or failures, damage to a facility due to natural disasters or otherwise, changes in FDA, U.K. or European regulatory requirements or standards that require modifications to our manufacturing processes, action by the FDA, U.K. or European regulators, or by us that results in the halting or slowdown of production of components or finished products due to regulatory issues, our manufacturers going out of business or failing to produce product as contractually required, insufficient technical personnel and/or specialized facilities to produce sufficient products, and/or other factors. A number of factors could also cause possible issues about the equivalency of DCVax product produced in different facilities or locations, which could make it necessary for us to perform additional studies and incur additional costs and delays. Because manufacturing processes for our DCVax product candidates are highly complex, require specialized facilities (dedicated exclusively to DCVax production) and personnel that are not widely available in the industry, involve equipment and training with long lead times, and are subject to lengthy regulatory approval processes, alternative qualified production capacity may not be available on a timely basis or at all. Also, as noted above, our contract manufacturer(s) could choose to terminate their agreements with us if we are in breach, or if we undergo a change of control. Difficulties, delays or interruptions in the manufacturing and supply and delivery of our DCVax product candidates could require us to stop enrolling new patients into clinical trials, and/or require us to stop the trials or other programs, stop the treatment of patients in the trials or other programs, increase our costs, damage our reputation and, if our product candidates are approved for sale, cause us to lose revenue or market share if our manufacturers are unable to timely meet market demands."
It's typical boilerplate languages in both 10K. No companies on earth would have absolute certainty on things like this. At least it shows the company has not received definite no from FDA in both case re endpoints.
The market will try patiently absorb those shares bought last Thursday for a few pennies swing trade today, after that we move higher if not soon later today.
I believe marzan not only has the company applied to FDA for FT but we are now waiting for decision of FDA any day.
And yes the company might also apply for FT before, but this time things are fundamentally different because the unblinded data is available for FDA to review.
I guess any day now we may hear the new about Fast Track.
Potential buyers can have a look/review of trial data with NDA. On the other hand, the buyout or some arrangement to that effect can be milestone based.
Anyhow it's just a deduction based on the missed item in this year's 10K.
Could it be really a buyout which has been done but yet to be announced? In the past many investors have provided that the average age of the management, Duffy's mysterious short employment with the company, Cognate's management buyout, forced preferred shares conversion, etc, etc, as factors contributing to the speculation of a buyout deal with Merck, or other major pharmaceutical companies.
Now perhaps one more provision for the buyout fuel to ignite/materialize:
I compare Risk Factor section of this year's 10k and last year's 10k under Risks Related to our Common Stock and find the following (within quotation marks) exists in last year's 10k but missing in this year's 10k.
It's quite interesting in last year's 10k discussing Linda's material influence: This influence could have the effect of delaying, deferring or preventing a change in control, or impeding a merger or consolidation, takeover or other business combination or action that could be favorable to investors (see below), as if this influence no longer exists, despite Linda still being a material significant shareholder?
"Linda Powers and Cognate BioServices, each have beneficial ownership of material amounts of our securities, and this concentration of ownership may have a negative effect on the Company and/or the market price of our common stock.
As of December 31, 2019, Linda Powers, our Chief Executive Officer and Chairperson of the Board of Directors, beneficially owned a material percentage of our outstanding securities. This concentration of ownership could involve conflicts of interest, and may adversely affect the trading price of our common stock because investors may perceive disadvantages in owning stock of companies with stockholders who could have conflicts of interest. Ms. Powers’ holdings of our securities could enable her to exert some material influence upon matters requiring approval by our stockholders, including the election and removal of directors and any proposed merger, consolidation or sale of all or substantially all of our assets, as well as over our business plans, strategies or operations. This influence could have the effect of delaying, deferring or preventing a change in control, or impeding a merger or consolidation, takeover or other business combination or action that could be favorable to investors. Cognate BioServices also beneficially owned and/or had a contractual claim to receive a material percentage of our outstanding securities as of December 31, 2019. Since the management buyout of Cognate BioServices in February 2018, Cognate BioServices is no longer a related party; however, Cognate’s continued beneficial ownership of a material percentage of our outstanding securities could adversely affect the Company and/or our stock, for example if perceived adversely by investors, and could enable Cognate to exert influence over matters requiring approval by our stockholders, as well as over our business plans, strategies or operations."
Last year's 10k (page 17):
https://sec.report/Document/0001104659-20-034145/#a_002
This year's 10k (the item is missing):
https://sec.report/Document/0001104659-21-044832/#ITEM1A
I share the same concern pgsd, but I think NWBIO should just continually ignore him at this stage. He will always come up with some new slanders/allegations it's in his nature. Fortunately his influence (gained from his collaborators otherwise he is a nobody) has been continually dwelling, to a point now it's almost nothing burger.
If there is a time for NWBIO to directly deal with him it would be sometimes after DCVax-L is approved.
In regard to his lying as he was falsely stating that the endpoints had been changed after unblinding, it's easy for any serious investors or potential investors to verify from NWBIO's various SEC filings that he is plainly wrong.
Have a wonderful Easter!
[this is my last post for today]
To add to this fwiw, I don't think whether the ct.gov site is updated or not has anything to do with publication in a first tier journal. The site is not in the guideline for editors to make any decision. Normally, there is Introduction of manuscript which will be enough to answer any questions that may arise from editors/readers/practicing doctors, etc. In most time, a footnote is suffice enough.
I also think strongly this trial is already successful and will be approved by all RAs involved because DCVax-L is safe and efficacious to readily exceed the Benefit-Risk requirement weighed by RAs to make decision. No companies with any clinical trials in the history have shown such persuasive long-term survival data as obtained from DCVax-L trial. None.
So I think investing in NWBIO is indeed de-risked at the current market cap of roughly 1.2billion considering its post-approval blockbuster potential and gigantic commercial implication.
But rest assured, there will continual be ups and downs in all aspects, let alone stock price.
Nonetheless, I will see that as some entertaining episode of a life changing grandeur success story.
GL
Fwiw, my email exchange with DI, cc LP and LG (this is my first direct exchange with NWBIO for months, as I have been confident enough to average up regardless, unless something fundamentally changes in the future. Honestly I am ok whether or not NWBIO updates the site):
Re Time to Update Endpoints on clinicaltrials.gov Site Now to Foil Misinformation
Dave Innes <dinnes@nwbio.com>
To:dan
Thu., Apr. 1 at 5:28 p.m.
I plan on it. !
Dave
Sent from my iPhone
On Apr 1, 2021, at 5:28 PM, danxx <danxx@yahoo.com> wrote:
Thanks Dave. Have a good Easter!
On Thursday, April 1, 2021, 4:57:12 p.m. EDT, Dave Innes <dinnes@nwbio.com> wrote:
Dan
Thanks for your continued support. Will pass along your comments.
Best
Dave Innes
Sent from my iPhone
On Apr 1, 2021, at 4:25 PM, danxx <danxx@yahoo.com> wrote:
Dear NWBIO management:
Now 10k is filed. NWBIO is once again attacked with misinformation mostly centered on revised SAP, spearheaded by AF via his tweet and probably collaborated with some collaborators trading/shorting in the market.
I think updating the site will serve NWBIO well as we are close to reveal TLD.
Thank you all very much for your hardworking and attention to investors concern.
Dan
My projection is DCVax-L data will be published in a first tier medical journal. The gov clinical site will be updated soon, followed by publication, as it is now officially made public of the revised SAP and endpoints from the 10k.
The only possibility for the data not published in a first tier medical journal is NWBIO cannot wait for additional months asked or requested by the journal, so instead they choose the one which can publish the data timely.
We shall see what will happen soon.
That's why one needs to have dry powder ready all the time for occasion (manipulation) like this.
LOL and be quick.
Manipulation on a decent 10k filed on time is laughable:
Shareholders have increased from 16,000 last time reporting to 40,000 as of 30 December 2020;
NWBIO intentionally omitted subsequent events section to presumably avoid revealing anything regarding unblinded data for some more substantial announcement at the right time;
NWBIO confirmed it submitted the same SAP of which both primary and secondary endpoints were revised to the four RAs;
About $13 million received from exercising of warrants in 2020;
NWBIO has secured some loans at outrageously low interest rate of about 6.5%; and
About all insiders and directors warrants and options for a total of about 260 million potentially dilutive shares have been suspected twice, now until end of April 2021.
Reported from practicing doctors that NWBIO's Expanded Used program in UK is once again accepting new patients.
Exactly. On the other hand re 10k etc,. some prolific posters are once again injecting self-inflicted wounds questing deadlines and exactly day or whether it's delay or not.
Man, they seems having not understood as of now the most important thing is not those but TLD, or how to better present trial results!
Anything pivots on unblinded trial data, no matter in what form.
And somebody even think it's impossible to manipulate price in a thin volume (instead it makes it much easier to manipulate).
Wow what's a bunch of impatient investors/traders.
[I have reached my 3 a day limits so this is for Flipper: so you think because price unchanged means no manipulation, which makes me speechless, genius!]
Now yes I take it. Linda has her plan and is in control of timing.
This morning at the beginning of trading, the pair Jane and Cdel probably naked shorts somewhere around a measly one hundred thousand shares to pain the floor as if telling potential retail buyers: not buy anything above we specified price range.
Those are just some of cheap wishful MMs wet delusions, because most retails are smarter than those delusional MM punks.
Buy as many as you can afford, or as much as the manipulators can afford to lose
Yes Merck has come up with a hefty price tags for acquiring NWBIO based on milestones such as as it was, obtaining designations from RAs, approval from one or all RAs, etc, but Linda Powers smiles and said then wait until I am ready for both time and price tag.
Just for conceptual discussion purpose:
Merck would offer $3 billions when and around Dr.Duffy's short stay at NWBIO, and signed a NDA. Linda said wait.
Linda worked damn hard. NWBIO acquired Flaskswork to add value.
Merck would offer $8 billions after a sneak review of unblinded data and signed a new NDA, and Linda said wait.
Sawston facility is expanded and ready for certification. While values added, it's a necessary step for RA, in particular in this case UK approval.
Merck asked how long are we going to wait? Linda said pretty soon, perhaps in coming months.
The story continues. So we wait.
Above all if the price tags are not to the satisfaction of NWBIO and its shareholders, the beauty is NWBIO with everything it has built so far can go it alone.
So it's a win win situation for shareholders unless you have sold.
In the meanwhile we continually watch the pair of MMs: Jane and Cdel who are in cahoots to manipulate price, most likely via naked shorting.
It seems people are either failed to understand NWBO is a de-risked stock at this market cap with huge upside potential when results are confirmed from TLD/publication;
People seems readily forget scientific evidence and RAs' updated and accommodated policies and support for revised SAP, including better measures of primary and secondary endpoints.
When it comes to a few pennies/dimes shakeup/swing/raid, the solid ground has shaken to the point of knee jerking and insomnia leading to constant whining.
Today's $1.5 is yesterdays' $0.15, and tomorrow's $15 or $30 or even $100 if indeed hundreds of millions of naked short shares exist.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=162860917
Easy to decide, isn't it?
We may well see hundreds of millions naked shorted shares when and after TLD/publication comes out, which will accelerate and overshoot price in an epic price appreciation we have never seen before.
Archegos's blow out margin call (https://markets.businessinsider.com/news/stocks/credit-suisse-market-capitalization-archegos-hwang-margin-call-stock-sales-2021-3-1030253684) will look elementary if nwbo did trap naked short wolfpack with hundreds of millions naked short shares.
And Smith's Could There Have Been Hundreds of Millions or Even More Than a Billion Counterfeit Shares of Northwest Biotherapeutics Created Through Illegal Naked Shorting? (https://smithonstocks.com/could-there-have-been-hundreds-of-millions-or-even-more-than-a-billion-counterfeit-shares-of-northwest-biotherapeutics-created-through-illegal-naked-shorting/)
If there are hedge funds who believe DCVax-L is at best grapefruit juice;
if there are hedge funds who believe DCVax-L has no chance of FDA approval because it's a failed trial, and Linda has hidden the results for years; and
if there are hedge funds who believe the best results for NWBIO is to run a confirmation trial;
then why not sell unlimited, non-borrowed naked shares for no interests needing to be paid, nobody would locate and notice the selling with collaborate banks and market makers -- it will be easy money.
I know hedge funds are good at drinking, drugging, and fantasies, and they are real stubborn boys' club when it comes to recognize mistake, let alone major mistake.
When warrants stop being exercised, and knee jerking retails stop selling to diversity, it seems there are still plenty of shares sold in the market.
Where those damned shares come from?
I have no complain at this moment. My sight is fixed to when TLD/publication and future approvals from RAs, and beyound, but I am eager to see justice served to those bastard naked short wolfpack!
People have taken that term of "in coming months" too seriously as if it was a specific SEC filing.
So you forget TLD announcement and/or publication.
And who knows what else will be revealed as well.
There has been rocket solid floor of price around $1.5-$1.6 despite we are trading at the lower band now because we are so close to the major revelation.
FOMO is in play, and rightly so.
Does the chart no longer tell? My brain tells me it's up, steady after breaking the narrow band of $1.5-$1.6.
MMs and collaborators have been able to maintain price in this range as of now. Things could change very quickly.
As I said months ago keep eyes on Jane and Cdel, the couple in cahoots to manipulate.
They are close to be done.
News will break officially declare the primary and some if not all secondary endpoints are met.
You didn't check the link I attached didn't you.
Yes the Ohio State University Hospital is a participant in the DCVax trial.
https://clinicaltrials.gov/ct2/show/NCT00045968?term=dcvax&draw=2&rank=4
Locations
Hide Hide 86 study locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
Sutter East Bay Neuroscience Institute-Eden Medical Center
Castro Valley, California, United States, 94546
City of Hope
Duarte, California, United States, 91010
UCSD Moores Cancer Center
La Jolla, California, United States, 93093
Kaiser Permanente - Los Angeles
Los Angeles, California, United States, 90027
UCLA Medical Center
Los Angeles, California, United States, 90095
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92663
St. Joseph Hospital of Orange
Orange, California, United States, 92868
University of California, Irvine Medical Center
Orange, California, United States, 92868
Kaiser Permanente - Redwood City
Redwood City, California, United States, 94063
Sutter Institute for Medical Research
Sacramento, California, United States, 95816
United States, Colorado
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
Colorado Neurological Institute
Englewood, Colorado, United States, 80113
United States, District of Columbia
Georgetown University Medical Center
Washington, District of Columbia, United States, 20057
United States, Florida
University of Florida
Gainesville, Florida, United States, 32611
Memorial Cancer Institute
Hollywood, Florida, United States, 33021
Mount Sinai Community Clinical Oncology Program
Miami Beach, Florida, United States, 33140
Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Georgia
Piedmont Atlanta Hospital
Atlanta, Georgia, United States, 30309
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Illinois Cancer Care
Peoria, Illinois, United States, 61615
Cadence Cancer Center
Warrenville, Illinois, United States, 60555
United States, Indiana
IU Simon Cancer Center
Indianapolis, Indiana, United States, 46202
United States, Kansas
University of Kansas Cancer Center
Westwood, Kansas, United States, 66205
United States, Kentucky
Markey Cancer Center/University of Kentucky
Lexington, Kentucky, United States, 40536
Norton Cancer Institute
Louisville, Kentucky, United States, 40202
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Michigan
University of Michigan Cancer Center
Ann Arbor, Michigan, United States, 48109
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Spectrum Health
Grand Rapids, Michigan, United States, 49503
United States, Minnesota
John Nasseff Neuroscience Institute at Abbott Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
United States, Missouri
St. Luke's Hospital
Kansas City, Missouri, United States, 64111
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, New Jersey
The Brain Tumor Center at JFK Medical Center
Edison, New Jersey, United States, 08818
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
The Valley Hospital
Ridgewood, New Jersey, United States, 07450
Overlook Hospital
Summit, New Jersey, United States, 07902
Capital Health Regional Medical Center
Trenton, New Jersey, United States, 08638
United States, New York
Long Island Brain Tumor Center at Neurological Surgery, P.C.
Lake Success, New York, United States, 11042
North Shore University Hospital
Manhasset, New York, United States, 11030
New York University Clinical Cancer Center
New York, New York, United States, 10016
Mount Sinai Medical Center
New York, New York, United States, 10029-6574
Columbia University Medical Center
New York, New York, United States, 10032
University of Rochester Medical Center
Rochester, New York, United States, 14642
Stony Brook Medicine
Stony Brook, New York, United States, 11794
Brain and Spine Surgeons of New York and Northern Westchester Hospital
White Plains, New York, United States, 10604
United States, North Carolina
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, United States, 27514
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
University of Cincinnati Cancer Institute
Cincinnati, Ohio, United States, 45267
University Hospitals Seidman Cancer Center
Cleveland, Ohio, United States, 44106
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Ohio State University
Columbus, Ohio, United States, 43210
OhioHealth
Columbus, Ohio, United States, 43214
United States, Oklahoma
Oklahoma University Health Science Center
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Jefferson Hospital for Neuroscience
Philadelphia, Pennsylvania, United States, 19107
Temple University School of Medicine
Philadelphia, Pennsylvania, United States, 19140
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, South Carolina
Medical University of South Carolina Hospitals and Clinics
Charleston, South Carolina, United States, 29425
United States, Tennessee
Saint Thomas Research Institute
Nashville, Tennessee, United States, 37205
Vanderbilt Ingram Cancer Center
Nashville, Tennessee, United States, 37232
United States, Texas
Baylor Research Institute
Dallas, Texas, United States, 75246
The Methodist Hospital
Houston, Texas, United States, 77030
University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Cancer Therapy & Research at University of Texas Health Science Center San Antonio
San Antonio, Texas, United States, 78229
United States, Washington
Benaroya Research Institute at Virginia Mason
Seattle, Washington, United States, 98101
Swedish Hospital Neuroscience Research
Seattle, Washington, United States, 98122
United States, Wisconsin
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, United States, 23215
Canada, Quebec
Montreal Neurological Institute, McGill University
Montreal, Quebec, Canada, H3A 2B4
CHUS - Hôpital Fleurimont
Sherbrooke, Quebec, Canada, J1H 5N4
Germany
Universitätsklinikum Heidelberg Neurochirurgische Klinik
Heidelberg, Baden-Württemberg, Germany, 69120
Katharinenhospital
Stuttgart, Baden-Württemberg, Germany, 70174
Universitätsklinikum FrankfurtKlinik und Poliklinik für Neurochirurgie
Frankfurt, Hesse, Germany, 60528
Universitätsklinikum Bonn Nervenklinik (Zentrum), Klinik und Poliklinik für Neurochirurgie
Bonn, North Rhine-Westphalia, Germany, 53105
Universitätsklinikum Klinik für allgemeine Neurochirurgie
Köln, North Rhine-Westphalia, Germany, 50924
BG-Kliniken Bergmannstrost, Klinik für Neurochirurgie
Halle, Saxony-Anhalt, Germany, 06112
Klinik für Neurochirurgie, Klinikum Chemnitz gGmbH
Chemnitz, Saxony, Germany, 09116
Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
Dresden, Saxony, Germany, 01307
Neurochirurgische Klinik
Hamburg, Germany, 20246
United Kingdom
Addenbrookes NHS Trust
Cambridge, Cambridgeshire, East Anglia, United Kingdom, CB2 2QQ
Kings College Hosital NHS Foundation Trust
London, Greater London, United Kingdom, SE5 9RS
University College Hospital London
London, Greater London, United Kingdom, WC1E 6BT
University Hospital of Birmingham NHS Foundation Trust
Birmingham, West Midlands, United Kingdom, N15 2WB
yes Ohio State University (at Columbus, Ohio, United States, 43210) is a participating university for DCVax-L trial.
https://clinicaltrials.gov/ct2/show/NCT00045968?term=dcvax&draw=2&rank=4
President Biden may have heard.
I have to concur tctrader38. I have a very large asymmetrical nwbo portfolio as well. Never ever happened to me in the decades of my investment. I have bought shares averaging up at a price as high as in $1.80s because
I believe the floor has set -- the foundation has been building with the development of DCVax platform.
We are now up and running with DCVax heading toward a much more deeper and expansive land of fighting cancers.
The floor has set for price as well, fortified with the known data which is strong, with SAP and RAs which have adapted to the more accurate and better measures on how well immunotherapy unleashes its cancer fighting power.
For that we know it's highly probable the primary endpoint of DCVax-L trial for GBM will be readily met in a statistically significant way, so will some if not all secondary endpoints. Imaging as this first step completed, a significant portion of GBM patients (may be as high as 20-25%) can have a chance of living over five years and beyond with or without progression, which is unprecedented and unheard of.
From the bottom of my heart and the inside of my brain, I know the first stage of declaring DCVax-L a success is upcoming, and we will soon move to the next stages at a lightening speed to combat more cancers, expand efficacy, and eventually find a cure, either alone or with combination.
With that, our investments will grow exponentially in value as well.
Deepest sympathy for your loss GBMwife! It's once again a reminder our investments in nwbio is not only for monetary gains but in a great sense our collective fight with cancers.
And we believe the floor has set -- the foundation has been building with the development of DCVax platform.
We are now up and running with DCVax heading toward a much more deeper and expansive land of fighting cancers.
The floor has set for price as well, fortified with the known data which is strong, with SAP and RAs which have adapted to the more accurate and better measures on how well immunotherapy unleashes its cancer fighting power.
For that we know it's highly probable the primary endpoint of DCVax-L trial for GBM will be readily met in a statistically significant way, so will some if not all secondary endpoints. Imaging as this first step completed, a significant portion of GBM patients (may be as high as 20-25%) can have a chance of living over five years and beyond with or without progression, which is unprecedented and unheard of.
From the bottom of my heart and the inside of my brain, I know the first stage of declaring DCVax-L a success is upcoming, and we will soon move to the next stages at a lightening speed to combat more cancers, expand efficacy, and eventually find a cure, either alone or with combination.
With that, our investments will grow exponentially in value as well.
God bless you and your family!
yes sukus it's amazing how far we have achieved manufacturing wise as a small biotech company. Kudos to Linda.
At least initially we will absolutely no problem in terms of manufacturing, and marketing as well despite no dedicated market team as of now.
Because the eighty something sites who participated in the trial in the four countries have been more than understanding of how the vaccine works and how to administer its use.
That alone will keep initial commercialization process going in a very profitable way.
Thank you for your contribution and GL.
Yes I agree, but make no mistake I actually enjoy very much Sojo's technical analysis which is to the point and off the chart. After all he/she is not chart predicting appl or tsla.
So I enjoy his/her brilliant TA with a lightened mood.
I thought I am a person who doesn't care about a few pennies of difference, when I am in accumulation mood for a company like NWBIO which I think will change the world of cancer treatment.
I thank Linda for painstakingly making sure the first step is right and to the maximal effect: to approve the concept of DCVax-L in treating cancers with positive trial data for GBM.
After that, I have not doubt things will move in a lighting speed.
It's useless to guess price movement. A major seller or buyer would change all patterns right away on a daily basis, involving measly hundreds of thousand shares.
The shares have been accumulated, but it seems not in a big way. there have been no forms 4, and it seems there would not be any before data announcement or any other major news.
Smith is truly "independent" analyst because he has no collaborators in the support of each and every his analytic report, even not a single son/daughter/grandson/daughter of his are buying a single shares at the release of his report, let alone any collaborating funds.
So in short term, he is nobody in terms of share price movement, and if he by chance draws some retails into buying nwbo shares, it's easy for manipulators to quell quickly.
MMs want everybody to think the price in this range ($1.5-$1.6) is reasonable as of now.
It all sounds a little depress for anyone who cares about every day's price movement, but for those who set their sights on the big prize, it's actually good opportunities to accumulate.
Everybody is now waiting and something will be revealing, either from quarterly, annually, or share holder meeting, if not the big one everybody has been waiting since early October.
As I said before we have been well past pure TLD stage, when news comes, it will be plural in a short span and much more significant, despite TLD still the first to come.
I suspect accumulation is indeed going on or has been going on for a while. Definitely somebody (a market maker or two) may involve. They don't want to report some of their trades for a reason during trading hours and preferred to lump them up after hours in the form of a T-trade. MMs may not want to give signal prematurely before they get it done. It is legal though under the FINRA rules of the OTC Markets as long as MMs report all trades of the day on that day either when it happens or after it happens.
Guess it's clear to everybody the trial will readily meet its primary endpoint and some if not all secondary endpoints, with long-term survival data unprecedented or unheard of.
It becomes increasingly hard for MMs to operate by stealth as time goes by.
GL
IMHO, definitely positive despite somebody may spin negatively otherwise. My simple interpretation of the quote from Bill Malloy interview with LL below is 1) it's impossible to design a trial without giving chance to patients the real shots after their GBMs progress [it's true in the past and it's true today. FDA has to adapt to it because the sponsors designing and running the trial have no way to change this situation;] 2)FDA has to catch up with the nature of immunotherapy for accepting appropriate measures for its efficacy. As a result, today we know FDA has exactly caught up and come up with this guidance:
Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products Guidance for Industry (https://www.fda.gov/media/133660/download)
And specifically, NWBIO has received Regulatory Agencies' acceptance of NWBIO's adapted reordered endpoints (https://www.clinicaltrialsregister.eu/ctr-search/trial/2011-001977-13/GB, and https://www.clinicaltrialsregister.eu/ctr-search/trial/2011-001977-13/DE)
"Q: Can you explain more about the difficulties in designing the trials to do what’s best for the patient?
A: For instance, I’ll just take what happened with the DCVax. You really want to get clean data. We’ve never allowed for patients to get the vaccine once they failed, because they will. You enrolled in the trial. You had a recurrence, and now you’ll have to try something else.
I could tell you patients are fighting to get the vaccine. And even if you tell them, “Well, there’s no proof that this works. This is the whole reason we have to do the trial. I can’t tell you that there’s any benefit.” But I guess the counterargument that I hear quite often is, “well, the side-effects aren’t bad.” And they’re not. So, it’s like, “Well, if it’s not going to hurt me why can’t I have it? Why can’t I try it?”
Because of that it’s hard to prove something based on what the FDA requirements are without being a little cold-hearted and saying, “Well, no, you’re not allowed to try that.”
So, a part of it is having the FDA think a little bit differently about what constitutes approval. On the converse, like the Optune device, that Novocure device, is FDA-approved. But I must say a lot of patients are like, “Well, I don’t really like it.” And I think on the physician side, we just don’t understand how it works and there are a lot of problems with the clinical trial design.
There was no true placebo arm, but they did design it in a way that met the FDA checkboxes. So, it was approved, but a lot of us don’t really believe that it works. I think it’s one of these things where if your ultimate goal is to cure GBM, it’s hard to reconcile all these different factors; the regulatory factors, the financial factors, as well as the science and the biology of the tumor itself, which is very complex.
Q: Got it. Sounds like we have our work cut out for us.
A: Yeah, but if your smart people can figure this out, I think it could be done. It’s been done in other fields, but I think it just takes a different way of thinking about it, and it’s not the “Eureka!” moment of, “oh, I discovered something in the lab. I’m going to take it to clinical trial, launch my startup company, and charge ABM.”"
Maybe he just wanted to signal to you to sell and hoped you would no longer bombard him via email/phone constantly.
Yes I have added about 100,000 shares to my wife's accounts;
yes I am a believer of big prize in the horizon, regardless what that term "in coming months" mean; for me it means nothing but accumulation. Not even a single one form 4 has reported recently;
yes, I don't think the company can "hide" any longer, let alone in coming months, for annually, quarterly, and shareholder meeting, just a few quickly coming to mind;
yes, I am in line with Linda Powers in terms of getting it right, and for much bigger the prize at any means the law allows, and if it needs to take longer, so be it;
yes, I do think we are already derisked. Why lightening shares but not adding more?;
Thank God, I can see the primary endpoint be readily met, and patients will have a chance to live long term; for some cancer free for years to come. This is something the current SOC and FDA approved optune device cannot afford, and the very reason why RAs will and must approve it.
Yes I appreciate your sharing your encounter with DI on this board. Maybe next time you can share it timely so other retails who wants to lighten can lighten with you together.
GL to you for whatever you choose to do.
Regardless what you do, rambling, grudging, whining or pumping or just vicious attacks despite having no position long or short whatever;
Regardless how you read and analyze the data available to day about DCVax-L trial, the SOC, and the commercially available Optune device, and the conclusion you may draw from;
Regardless how you rate LP, and the management team, their strategy and what they have done today;
As least we all agree GMB is a deadest kind of cancer with unmet need in real life.
And the market agrees DCVax-L will get approved by four RAs by assigning a market cap of about $1.3 billion before TLD.
First step, confirm the market is right with positive tld of which it's almost certain the primary endpoint will be readily met with some unheard data showing long term survivals of three, four, five years.
Then, ten fold MC increase will be in the card (around $13 billion)for job well done and speculation of hefty revenue
Then, reasonable multiple will be given (up to $20 billion MC) considering other indications with now approved MOA.
In sequel or parallel, money will fly wilder and higher as DCVax-D comes to mind....
Not many retail investors will have the gut, wit and experience to hold for the big prize. They are born for pennies. I have seen this happening no end, and that's the nature of it.
When we see that accelerate we are real close regardless the term of in coming month or days or years. when it comes it arrives! Ladies and gentlemen, market is forward looking, it acts most times out of expectation!
Have I mentioned now I have been also adding shares to my wife accounts, about 100,000 now.
End of my rambling.
[Just realize this post is not intended in reply to RobotDroid. Sorry for that]
Newbies understanding of "in coming months":
= TLD announcement and/or publication spaced in days
My understanding and also those who have done their DD right:
= TLD, publication, an approval at least in UK spaced in days. And perhaps in between some other news such as partnership, or buyout chat/revelation (not just speculation)
There is no contradiction between Linda going alone and NWBIO being bought out with the news of manufacturing rapping up in UK, or elsewhere, the only difference is the suitor will have to pay more;
Technically and practically, Linda can go alone judged by things have been done so far.
You don't need a dedicated market team initially. The manufacturing may have a hard time to keep up!
As I said yesterday, the market yesterday was heavily and plainly manipulated to the news.
Maybe the recent acquisition of Cognate by CRL is the result of a tip-off that Cognate was preparing for FDA inspection just like Advent's which is in preparation for UK MHRA inspection soon.
Why in a hurry for an "overpriced" manufacturer?
NWBIO may be soon its predominant customer again.
Have a good evening (this is my last one for today)
this is actually what has been happening, confirmed by today's PR. MHAR would not inspect a manufacturing facility for readiness and then issue a certificate unless it has reviewed application/request or at least TLD
The same will be true for other RAs.
The market pretends otherwise today. It will change in due course.
Doc where have you been. I see Fudsters have succeeded somewhat in their FUD, now it seems that even you a long investor has had some doubt or uncertainty on whether TLD has been possessed/known by the company.
WOW, now I did see the use of those nonsense short narratives. When one reads them all, one may get drag along one day.
The reality is it has never been clearer from today's PR that the company has not only possessed TLD, but submitted/requested to UK MHRA for approval (probably FDA as well despite not explicitly indicated in this pr): the certification of manufacturing readiness is the last step for approval, which has never changed for any company who requests RA approval for its product, which usually comes after TLD, submission of NDA/BLA.
As far as price is concerned, it can be up and down on any news or no news for various reasons, depending on which one you pick, but any manipulation regardless of which way the price goes, it will settle down to the level commensurate to the true meaning of the news.
Today's news is super positive. It's just that the market fails to appropriately respond, as a result of manipulation.
I see steady price appreciation in the days ahead because partly of today's news (delayed effect just like immunotherapy LOL)
Come on what's the point to bring that pseudo "biotech" analyst up to life again on this board.
Not enough and useless already.
He has had nothing to offer, only being pull to act [by some body] behind the stage. You know that, don't you?
Not enough data to chew and gain enough confidence?
Save some energy to fight those Adams and plain village idiots who will soon come onboard again after Zoom meeting.
They are all on my ignore so I can only see them from you fighting them with your replying posts.
Charts are beautiful but only entertaining in small biotech land; the tailwind is the fundamental nobody can change.
You use a wrong word deceit. It's best for NWBIO to reveal as minimally as possible in a critically important period of time of approving the concept of DCVax for its first indication.
As you know the naked short wolfpack is relentless, evil and maybe capable as history has evidenced.
So why broadcast everything in planning or under development or trivial (compared with TLD or the ultimate success or failure, anything else may be deemed as trivial in my opinion). Instead only reveal information as legally required, such as the recent $11 million loan.
Any only reveal the information which has materialized or been accomplished. What's wrong with it?
Yes, the company has repeatedly moved its goal post, but at the time it did there must be enough reason of why it did so.
Things have been changing in multiple fronts in multiple ways we cannot staunchly ask the company to stubbornly stick to its goal as it requires adjustment, change when things change.
I feel comfortable despite impatience sometimes with how the company has been conducting its business, because I have basic trust in the company to take care of its investors, not focusing on the time being, but in a long term prospective.
Anytime I am impatient or weighing on whether buy more or not, I re-assess if the interests of the company (Linda's) are aligned with mine. So far I have not come out with a negative conclusion.
Maybe Linda gets a bigger piece of pie relative to mine but that's life I can accept.