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The difference now is we are in the home stretch of a process that is now determined by the regulatory agencies more so than the company.
Also, I am not in the camp that the delays we have seen over the years were unwarranted.
Rather, I give management the benefit of the doubt that once we have all the information, the apparent delays will mostly be understood to have been due to logical decisions and external factors.
I could be wrong and it wouldn’t be the first time, however I have to go with my assessment of the public information and judgment of character of the management and the world class neurosurgeons running the trials!
TDD, Thanks for the summary! We are in Q4 now, at the final turn, and racing towards the breakout news.
I just spoke to my son about beginning to shift his dry powder in his IRA into an S&P500 fund over the next month, before the midterms and end of year holidays, since I think we’re closer to the bottom than a top.
I do have him in a small position in nwbo, figuring my position is large enough to float all our boats if and when it comes in!
I might discuss the risk-reward of adding a little more nwbo to his position, but ever since I enabled him as a kid to follow me into a beanie baby mania and stayed in it too long, I’ve felt badly that I let him take too much risk! Hence, the S&P500.
"I believe that looking at where we are today requires us to look back"
Don't let the rearview mirror be larger than the windshield!
Can't change the past (we can learn from it) so IMO, all the matters now is what is going to happen?
I'm positive and hopeful we learn something grand before Christmas (perhaps by Halloween)!
I believe that looking at where we are today requires us to look back at the choices made by the company over the last couple years. Going back to when the company first received the consolidated data from their contractors after the trial was locked they made a critical choice. They knew that a TLD statement without the backup of a peer review presentation of some sort would be the target of shorts, they clearly stated they be in a quiet period until they had peer reviewed data. They had the choice of having Dr. Liau present the trial at a major technical conference, then issue the official TLD statement, and being able to discuss the peer reviewed data, or they could wait longer, but have the data more comprehensively presented in a Journal, then announce the official TLD statement.
I believe that they knew that shorts would pounce on anything that wasn't fully explained in a short presentation, as they've been previously attacked by shorts, so the decision was to go for the Journal and go into a quiet period until it was issued.
At one year after their last Annual Meeting they knew the rules said an Annual Meeting should be set no more than a month later, but without the Journal they'd be unable to say practically anything, so they'd be facing hostile investors while asking for substantially more shares. I believe they knew that shareholders wouldn't vote against their best interests, but they also knew the audience would be hostile and the regulators would permit the delay, they chose to delay. Nothing changed by the end of the fiscal year and again the regulators aren't forcing the issue so once again they choose to delay.
I frankly don't know if the regulators would even accept delaying into the next year as long as shareholders don't sue forcing the issue. I would hope that no one does force the issue, with all the delay by management, I'd rather have a meeting where Investors were enthusiastic in attending because of the positive news rather than hostile because the company was standing on the quiet period all based on the initial decision nearly two years ago to go for the Journal.
Don't get me wrong, the decision to go for the Journal didn't slow down all the company needed to do for even a day. In fact, it's possible that management could spend more time on the development of the packages needed for regulatory approval, which must be considered their highest priority. Part of that effort was certainly qualified manufacturing capability, and again no time was being wasted in gaining approval of the FlaskWorks units and the rest of what's needed.
In short, management probably could have changed it's mind many times, but it hasn't, it's initial decision to go for the Journal is the choice that to this day has investors frustrated, but truly may result in the success all the longs are looking for in the long run. Others certainly would have handled this differently, but I believe the key is gaining regulatory approvals, and I don't believe that could have been accelerated at all, so their long term success would have been no greater. The short term prices will be forgotten once we have the approvals, just give it a chance to happen.
Gary
That’s remarkable trading by Biosect. Wished he had shared when he was selling, just to give everyone a heads up. But I guess that’s part of the game someone is better not sharing before putting in the sell order.
Biosect, congratulations on being up 60% a year on nwbo for 5 years (each year) that is remarkable trading. Clearly not just a buy and hold strategy as even had you purchased all your shares at 14 cents five years ago to average 60% per year nwbo would have to now be $1.50 a share. Nice trading!
Still wonder if you have examples of companies with 2 year 'quiet period' (next week is full 2 years) no quarterly conference calls and delays in ASM?
vator,
I get it. Everyone has their limits and venting has a way of helping some “make it through”. You have been here a long time and maybe your venting is an economic indicator that points more to the fact that the time is now more than than the time will be never. Taken as such, I believe that you are right; ). Best wishes.
Thanks for all the charts and observations...It certainly looks like its time to start a run...Hopefully this week.
jammy32,
It’s called lead with conviction and courage or get out of the way. Very few have a grasp on the potential of this platform because they don’t understand what the science represents. Those that do have bought and aren’t selling while those that don’t but trust others that do are following but not necessarily buying with utmost conviction. Those that like trading opportunities come and go and those that understand the science and the threat to their future are positioning for their next moves. Some moves in the past by some have led to unwanted consequences so those involved tend to tread more carefully. The May 10th attack on investor confidence could end up being a big problem though for those involved with the dirty work. Best wishes.
I'll be holding well past $2. I don't subscribe to these price ceilings no matter how often repeated.
Looking good. thanks judge
Different View and couple more Indicators telling interesting story:
1. Aroon Oscilator is STILL riding the CENTERLINE! Thas has now been @ 0 looking for direction since May 10 Apocalypse!! I have never seen anything like this. 21 WEEKS On Centerline! WOW..This is wild.
2. TSI(Similar to MACD) with nice Higher Lows Trend Line in tact.
3. Weekly Candle with the Standard Back Test after breakout. Thumbs up
4. CMF Chaikin Money Flow with the Outlier Topping Wedge May 10. Now we see the Inverse with the Bottoming Outlier Big Whiplash last couple weeks. Thumbs up
#3,
my investment is based off of the state of events in 2022. if someone wants to base investments off of 2011 forward looking statements that is up to them
have a good one buddy
The higher the better, but I own enough shares that $2 would guaranty me a bed and hot shower for life. That’s nothing to sneeze at, and I’m loathe to let that slip away again.
Poor Man, $2 a share right now sound pretty good, I may part with some shares there as well but still hoping for $5 or better for the bigger portion of my shares
Hoffman, think you missed the point- according to Linda Powers in 2011 we were on "the home stretch" turns out it was a long home stretch. Let's see what q4 of 2022 may bring
And they get the treatment in the doctor’s office, not hospitalized and with virtually no side-effects. I doubt regulators will look at it as you do.
Quality of life is improved, the potential for patients to live longer is established and has a compensatory value as well, some substantial patients will live many months longer than the few you indicated and that also has compensatory value, and then one looks at the alternatives, which is not “nothing” else.
I doubt very much that regulators are going to find reasons to say no on DCVax-L as part of the new standard of care and the new SOC for recurrent patients.
But you can argue in the abstract all that you’d like.
Shorts attacked the company and caused a meltdown of price and years worth of financing a few years ago. That had an ongoing and serious impact.
I think there is no denying what Adam Feierstein did in terms of false and disinformation efforts, false light posts and columns, this may, and it is doubtful that his fan boy collective of shorts did not take advantage of his generosity.
But nowhere have I posted that there is massive shorting keeping the price flat YTD. That would make no sense. In relation to the rest of the market and speculative bios generally, that is actually quite good for the year and doesn’t validate your claims.
The price has been flat YTD, the rest of the markets have collapsed. I am up at the current time approximately 60% per year for 5 years, so not seeing what you’re seeing.
The reality is social media direction is not valid. It just isn’t.
The regulators will analyze it properly, and so will the peer reviewed journal.
But your attempts here to imply fraud suggest a very unlikely set of facts, circumstances and conspiracies that are just highly unlikely.
Nonsensical statements. DCVax-L will be approved based on the outstanding results of the P3 trial. The helmet will be obsolete.
any idea what 20% of 0 is?
go nwbo!
:)
Horse, I’m coming to the noodle that broke the camel’s back scenario. Another Thanksgiving with nothing but ramen washed down with applejack might be my breaking point. The poor diet is affecting my liquidity and vision.
At today’s share price, I’ll probably keep 20% of my holdings just in case Linda and Les Clampett discover another oil well, i.e., Black Gold, Texas Tea, in their backyard.
Not it if was up to Dr. Ashkan who was stumping for funding DCVax-L batch spun up after each recurrence. Lots of future trials are coming up.
200k, by 5 years is 40k per year. Very very cheap. That is how NICE looks at things.
HyGro, I wonder why you don’t go over to the NVCR message board and post cherry-picked SEC disclosures from their February 24th 2022 SEC filing. Their risk disclosures start on page 26 of the NovoCure filing posted below. You stated that SEC filings are submitted under penalty of perjury and should be considered by investors. I tend to believe that the documents as a whole are important, but we could follow your lead and pluck out some interesting risk statements to publish in isolation. What do you think?
https://d18rn0p25nwr6d.cloudfront.net/CIK-0001645113/c5eca622-306f-417f-931b-c2ab018fa6b6.pdf#page25
And serious AEs specific to DCVAX? I don't believe so. Mono trials in the future will answer for sure.
Exactly. We'll said.
Blabbering? Hello kettle, this is pot calling...lol
I agree, great news for longs that a highly successful and enormous family fund is putting their money into nwbo!
have a great one pal! by.
Because that is NORMAL. Not exactly sure what “dilution” to which you refer, but all dilution is necessary to be commercially viable and not go bankrupt at the pre-revenue stage. No shareholder is in a position to manage the company from a billion miles high. That’s why we have people who actually manage companies and make such decisions.
I have an example just the other day of how reasonable it would be if the company got only 15,000 patients for GBM alone in the markets it is in only currently, and how that could easily generate a substantial price per share with 1.5 billions shares outstanding. If it extends the indications beyond GBM to new and recurrent cancers in various indications, and assuming the Flaskworks scaling works in terms of manufacturing, which I have no reason to not expect, in a few years it certainly could reach a very substantial market cap, engage in share buybacks and reach a substantial per share value.
Plus you can have irrational enthusiasm as we see with Tesla.
Nonsense. It is 2022. Not 2011. We now have a completed trial, nearly certified commercial manufacturing, an approved PIP and approvable data per the experts.
have a good one pal. by.
That should read up almost 60% per year for 5 years, not up 60% total, I was quoting the comment made to me about what I had said previously, to respond, but the reply mischaracterized what I had said in numerous instances.
Nope.
A huge difference between the science and the regulatory side of the issue.
I see nothing in LP';s bio that says she is any sort of an expert on the latter.
at least you’re on record now explicitly stating you think you know the science better than Linda Liau. This presentation is not by NWBO, but a prominent scientist—an important difference.
PM, I fear either you’re going through a ramen overdose reaction or I’m enjoying my daily red wine too much
You are obviously an intelligent person who has made it to the finest of the park bench neighborhood, and taking a profit of any size is better than a loss. So you do you and I respect you in any event.
As for me, I’m a sucker for a perceived bargain and a perma optimist, and although I have struck out several times before with bases loaded and two outs with the winning run being me at bat, I still like the opportunity of swinging for the fences!!!
This time we might be in the 18th inning but our team has managed to put three men on base and the pitcher is tired, and our home team is energized and awaiting the 3-2 pitch!
It’s at that moment I woke up
Checkmating after a highly successful P3 trial is an impossible task.
That, plus at this time there's not many other hideouts in the market. I think it will be another 3-4 weeks before we see a positive market shift. Hopefully be then we will have some news and maybe a small upward movement so people who have not yet de-risked their investment can get some of their cash out and have better overall market conditions to re-invest the money.
I’m in over 12 years, probably 13 or 14 by now.
The evolving timelines and minimal communication, at least since 2015, have required a lot of patience and faith, however all recent indications are that we are in the final stretch that will provide greater visibility and ultimate approvals of DCVax-L for GBM.
Especially knowing that the phase 3 trial primary and secondary endpoints have been met with ample statistical significance, and that follow on combination trials are indicating promising efficacy and outstanding OS outcomes for an unheard of percentage of combo treatment recipients!!!
I made my decision to stick it out to the end many years ago and to go big or go home. I weigh all the due diligence constantly and my logic keeps coming back as favorable, understanding that nothing is guaranteed and life is full of extremely questionable decisions that somehow get made despite the evidence.
All imho
They have been doing this for years.
The insiders at NVCR obviously know their company is over valued. No secret there. But NWBO’s lack of progress is not only offering them a longer runway to sell and capitalize at a higher share price, but also for insiders to receive additional bonus options, and I assume get past the vesting periods.
NVCR and their investors have made huge money with not much to show for it in terms of what they offer patients. I would say insiders at NVCR are laughing in the back of their limos on their long weekend drives to their homes in the Hamptons or the Vineyard — while I whistle my happy tunes on my park bench.
Weekly Chart Update:
RSI continues to ride the Support Trend Line from Dec. As long as this holds, hard to get overly bearish. Circled the very thin weak part of the cloud upcoming in Nov. That's when I'm also predicting 50/200 Daily Golden Cross to happen. Bottom Long Term MACD Histogram 65,90,12 showing inside 20 EMA and Nice Trend of Higher Lows.
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Moderators flipper44 sentiment_stocks CaptainObvious Poor Man - Doc logic JerryCampbell |
“Now this is not the end. It is not even the beginning of the end. But it is, perhaps, the end of the beginning.”
~ Winston Churchill
Stylized Dendritic Cell featured on NWBO board since 2015
- Dr. Linda Liau, PhD, MBA, Professor and Chair, Department of Neurosurgery, David Geffen School of Medicine at UCLA
Clinical Trials
DCVax®-L to Treat Newly Diagnosed GBM Brain Cancer (NCT00045968) - Phase III (Double Blind)
UK (MHRA): DCVax-L to Treat Newly Diagnosed GBM Brain Cancer (EudraCT#) 2011-001977-13
DE (Germany - PEI): DCVax-L to Treat Newly Diagnosed GBM Brain Cancer (EudraCT#) 2011-001977-13
Expanded Access Protocol for GBM Patients with Already Manufactured DCVax®-L Who Have Screen-Failed Protocol 020221 (NCT02146066) (Expanded Access)
Safety and Efficacy Study of DCVax-Direct in Solid Tumors (NCT01882946) - Phase I/Phase II (Open Label)
UK Clinical Trials - Study of a Drug (DCVax®-L) to Treat Newly Diagnosed GBM Brain Cancer
EU Clinical Trials for DCVax-L - Phase III
Dendritic Cell Vaccine for Patients with Brain Tumors (NCT01204684) - Phase II - at UCLA - Randomized (Open Label) testing DCVaccine with Resiquimod and DC Vaccination with Adjuvant polyICLC
Pembrolizumab and a Vaccine (ATL-DC) for the treatment of Surgically Accessible Recurrent Glioblastoma - Phase 1 (NCT04201873)
Dendritic Cell-Autologous Lung Tumor Vaccine (DCVax-L) and Nivolumab in Treating Patients with Recurrent Glioblastoma - Phase 2 (NCT03014804)
Dendritic Cell Therapy for Brain Metastases From Breast or Lung Cancer (NCT0368765) - Phase 1 - Collaborator: Mayo Clinic
Announcement of DCVax-L and Anti-PD-1 Monoclonal Antibody (Pembrolizumab) for Patients with Liver Metastases of Primary Colorectal Carcinoma Phase 2 Trial - November 17, 2016 - University Medical Center (UMC) of the Johannes Gutenberg University of Mainz
Cognate Bioservices - Owned by Charles River Labs
Website
Company Contact Info
Investor Relations:
Les Goldman (Company) (202) 841-7909 lgoldman@nwbio.com
Sign up for Northwest email list here (hit the subscribe to email list button in the lower right)
Company Headquarters
4800 Montgomery Lane, Suite 800, Bethesda, MD 20814 (240) 497-9024
NW Bio is developing cancer vaccines designed to treat a broad range of solid tumor cancers more effectively than current treatments, and without the side effects of chemotherapy drugs. NW Bio’s proprietary manufacturing technology enables them to produce its personalized vaccine in an efficient, cost-effective manner. NW Bio has a broad platform technology for DCVax dendritic cell-based vaccines.
Their lead product, DCVax-L, is currently in a 331-patient Phase III trial for patients with newly diagnosed Glioblastoma multiforme (GBM), the most aggressive and lethal brain cancer. This trial is currently underway at 69 locations thoughout the United States, Germany and the United Kingdom. NW Bio has also conducted a Phase I/II trial with DCVax-L for late stage ovarian cancer together with the University of Pennsylvania.
Their second product, DCVax-Direct, is currently in a 60-patient Phase I/II trial for direct injection into all types of inoperable solid tumor cancers, with trials currently being conducted at both MD Anderson Cancer Center in Texas, as well as Orlando Health in Florida.
They previously received clearance from the FDA for a 612-patient Phase III trial with its third product, DCVax-Prostate, for late stage prostate cancer.
DCVAX Survival Stories & Testimonials
Alice - Metastic Merkel Cell patient from Florida - ASCO 2018
Brad Silver - GBM patient from Huntington Beach, California - ASCO 2018
Sarah Rigby - GBM patient from Hong Kong - ASCO 2018
Kristyn Power - daughter of GBM patient from Canada - ASCO 2018
Kat Charles - GBM patients from UK - ASCO 2018 - as related by her husband Jason (Kat's Cure)
Prospective patients may contact NW Bio at patients@nwbio.com
UCLA Jamil Newirth DCVax-Patient Video - 2015
Allan Butler Video - National Geographic Vice President - DCVax-Direct patient from Phase 1 Trial with Pancreatic Cancer
NWBO - Patients Sunday Dennis and Jami Newirth - Enrolled at UCLA - Vimeo, Uploaded approx. May 2015
NWBO - Vaccine Helps Keep Brain Cancer Patient Alive (Jennifer Sugioka) - NBC Channel 4, Southern California, February 24, 2015
NWBO - National Geographic's Allan Butler Stage IV Pancreatic Patient using DCVax-Direct at MD Anderson
NWBO GBM Brain Cancer Survival Story of Mark Pace
Presentations
UCLA Agreements
Prostrate
DCVax-Phase II
DCVax-Booster
Upcoming Events
Videos
Linda M. Liau, MD, PhD, MBA - April 24, 2019 at University of Washington, Neurosciences Institute
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