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I am sure they have thought of the ways to get the shelf increased before selling 100s of millions of shares that don’t exist yet . If they can’t deliver those shares , then the company is done . Moreover investors won’t have shelled out millions of dollars without having some foolproof plans to get the shelf increased .
So it may be probable that we see the share raise in April?
I disagree, I don't believe it's priced in. There is no guarantee share increase will be approved.
I do agree that with good news, we run hard!
I thought there was a 6 month wait to exercise them.
That’s exactly what I said . I wrote the upcoming dilution is already priced in .... meaning I don’t expect SP to drop because of pending dilution .
And of course it will go up with good news
However the reason it may go down is if there is no meaningful news
What is the purpose of blinded publication...we already know this information...just doesn’t make sense to publish blinded data.
How can you be sure?
I think the price will be much higher once good news comes. Hopefully that happens before shares vote. If share price does dip, I'll buy more.
Aren’t we expecting a share raise before all these expectations? I can’t imagine the so liking another raise before anything else happens in April if we are looking at May...and beyond.
Even further when the increase takes placed though
Presumably, but LP expects it to take the same "three months" it always takes.
the most important "something" released .... patients are living longer than anticipated... I bought 10k more today
IMO this is all coming soon ... UCLA says " it is better than we thought... PUB says better than we thought... at ASCO LP say better than we thought... AF says I was wrong!"
OK maybe it is a stretch for AF... but what we do know is patients are living longer and DCVAX is being asked for by name... will NWBO shoot to the moon??? maybe... but a mountaintop is not out of sight for this year!
This vaccine is a winner and so is LL... very bumpy road for many longs ... hang tough don't get talked out of your shares before the party starts!
all jmho...tony
Dilution is already priced in IMhO
Anybody here thinking to unload their shares before June if no publication or any good announcement since increased in authorized shares will take place and will dilute us again?
Price held up pretty good considering 8-k.
Presumably the spring refresh would become easier each year because some poor individuals will have passed, leaving less queries to deal with.
I agree...I just lightened holdings by 10k...don’t like vote for shelf increase and lack of clarity at this point. There is absolutely no reason they can’t update on conferences and awaiting publication, something...
Thanks point worth noting
ASCO 2015, I anxiously await.
If topline were to be released around ASCO, it is possible they will follow it up, as even large pharma have on occasion, at ASCO's industry theater because they are so dang secretive, because ASCO blew confidentiality on all companies last year, and because we have Cofer. You can even restrict/define your audience at that venue. If they do that, I'd think they'd be buttressed by having prior publication on the phase III. So I won't discount the possibility of Phase III topline around ASCO solely on not submitting an abstract. If they do not submit one. JMHO.
Back to 20's, are we crazy thinking Linda powers can actually get a manuscript published??
She is 0 for her entire career.
Worst ceo in history.
I hope you are right. Of all the variable possibilities on how this plays out my personal favourite is to unblind PFS and leave OS blinded (I have read this posted several times on this board by a number of posters) I am sure PFS data must be adequately ripe by now and has been modelled (Bohsie et al) demonstrating a successful outcome, it can also be argued it was also endorsed by NWBO (by virtue of the fact they referenced this modelling in their filing). Linda's ASM statements aside I do feel the spring refresh should coincide with data lock leading to top line PFS (minimum) being announced at ASCO, going further beyond ASCO raises serious questions IMO GLTA
Hmmm...will be behind 8 ball soon!
Phase 3 randomized, controlled registration trial with TSC and SOC chemotherapy and radiation, compared with SOC alone in 236 patients newly diagnosed with inoperable glioblastoma multiforme (GBM), a type of brain cancer, is underway. A Phase 2 clinical program was completed in the second quarter of 2015 and evaluated 59 patients with newly diagnosed GBM. This open-label, historically controlled study demonstrated a favorable safety and efficacy profile for TSC combined with SOC, including a 37% improvement in overall survival compared with the control group at two years. A particularly strong efficacy signal was seen in the subset of inoperable patients where survival of TSC-treated patients at two years was nearly four-fold higher compared with the controls. Due to its novel mechanism of action, TSC has safely re-oxygenated a range of tumor types in preclinical and clinical studies. Diffusion believes the therapeutic potential of TSC is not limited to specific tumors, thereby making it potentially useful to improve SOC treatments of other life-threatening cancers. Additional studies under consideration include Phase 2 trials in pancreatic cancer and brain metastases, with study initiation subject to receipt of additional funding or collaborative partnering. The Company also believes that TSC has potential application in other indications involving hypoxia including stroke, where the Company recently announced its PHAST-TSC study which will be conducted in co-operation with the University of California Los Angeles (UCLA) and the University of Virginia (UVA) to test TSC in stroke patients in an in-ambulance clinical trial setting.
It as unbelievable that she would choose such an ambiguous language this late in the game when she knows very well investors are awaiting end of the trial. What does “ there might be similar cycle this year “ imply ? That there is a reasonable chance that there may not be data refresh this year and we may just skip this year . And then they are surprised why is there so much lack of trust in them and why shorts take advantage of them ....
I think it's not Linda's call. I think the DMC is telling (recommending) people exactly what to do at this point. AVII has provided some pretty interesting reading/dialogue from DMC trial control. One would be ill advised to dismiss their direction late in the trial.
Besides. Unless there was a mid-trial trial manufacturing (aka: efficacy) improvement, imo, there are likely no more original placebo patients left to PFS event, and likely only six (give or take) original placebo patients alive (regardless if they crossed over or not.) How on earth could unblinding have any impact on trial integrity under such circumstances at this late stage in the trial? Remember me....I'm the one that went on for years about preserving trial integrity. They can still collect data after unblinding.
On the other hand, if there was mid-trial improvement, hopefully the single arm whole trial analysis will capture its impact in a front to back style analysis. It might actually be more dramatic if this occurred.
JMHO.
hankmanhub,
I thought I made myself clear in my original post but if not the point I was trying to make was that I am excited about what I have found but am not willing to get into too much detail. You want the details spelled out and those who want to do harm to NWBO might also want those details spelled out. I had to point out to Pyrrhonian when he went negative on NWBO something about certain cell types that he confessed he was not well informed about. The import of those cell types was later affirmed by a doctor that has been cited several times by posters on this board. The reason I am sometimes obtuse in my comments is that there are those who express concerns about NWBO products that turn out to be irrelevant to this trial at this point in time. They may have been early concerns that were taken care of but are deliberately misleading when brought up bease they are called to our attention to create at least some temporary concern until we figure out that that concern was already dealt with. Does that sound like FUD? Pyrrhonian expressed concerns about DCs matured and processed with freeze thawed lysate being unable to create a significant immune response. Then flipper44 showed him and all of us the DC trains created by low dose administration and reminded him that Dr. Linda Liau and the doctors at NWBO knew more about how to create DC mobility than he did. Another example is when I asked AVII77 to use the data points we have to create a graph comparing 1st half event rates based on PFS, and standard time to death after recurrence, to second half event rates based on the enrollment curve data and data points given. I do not have his expertise in this area or I would attempt it. I did look at the numbers and saw a trend but lack the skills in statistics to clarify with certainty what I was seeing. Linda Powers essentially confirmed that second half event rates had slowed when she spoke at the ASM and I believe AVII77 could demonstrate this in graph form if he wanted to. Do you see where I am going with this? I hope so because I agree with several posters that have already responded to your posts that personal due diligence is key to your understanding and confidence in your investment. Your due diligence may also end up helping others with theirs.
By the way, I will share one observation about the Phase 1 Direct trial that I knew absolutely had to be corrected for any next phase trial. The spacing of treatments is bioligically critical. I knew they had to get initial treatment spacings down to about 2 weeks for full effect. They announced they would do this in their next trial after I had commented on this publicly already. Best wishes.
Well Linda has potentially forewarned us of further trial extension. At the ASM she is quoted as saying that we (investors) should want to wait for the long tail and that it is now a judgement call from her when the trial finishes.She also made it very clear that the endpoints once reached are only the earliest point at which they could end the trial. I am totally 100% sure after this next spring refresh both endpoints will have been surpassed I am not however convinced that the trial will end anytime soon. Hoping ASCO but not holding my breath.
I don't think she mentioned DMC once at the ASM. Anybody remember the very last time she mentioned DMC?
I don't recall him "feeling bad." I don't know what he felt.
The only positive that came from such a reveal which to me disappointed many longs is the fact that they chose to reveal this information this year.
IMO this means that this spring is the end and turning point of this trial.
Publication of interim blinded results will be the start of a very exciting journey for all investors and believers of this science.
Yours and our disappointment will be short lived.
I didn't mean overlooked over the years, I meant overlooked by many after the recent ASM. I had a similar reaction to yours.
Absolutely why not? the whole conference is about brain cancer. And DCVaxL is their baby too. UCLA is such a prestigious institution and when they move it from March to May, it is going to happen certainly no doubt about it. They are doing it so that they can talk freely about their L trial, recall how bad that young surgeon felt when he switched to present general topic instead of GBM trials recently in the CA conference. So we are going to see the publication before May or may be some FDA approval by then who knows.
Good questions. I tend to think the process starts before spring and ends mid May or earlier. Dr. Bosch needed time before his ASCO presentation. IMO. Someone here made that last point a while back. Can't say if they'll have a data lock or not in the process. They have done it three times before, and one would assume they (independent statisticians) either did a blinded or unblinded analyses (with a soft data lock). There is not much question, for me personally, that they could turn this fourth "spring refresh" into topline results if they so chose. AVII points out that topline analysis is the easiest part after data lock (if it is to occur).
Wasn't overlooked by me.
After being invested for over 4 years this was kind of shocking to me when Linda said this and that this information never was known before.
If I had known this, I would not have stayed invested from back when I initially did and continually add to my position. I would have waited, knowing that final data wouldn't come until now.
This one piece of information felt like a betrayal to me as there was never any chance of this stock taking off until the final data collection.
This is the carrot in front the horse kind of sh*t that irritates me about management. No worries... 4-6 weeks all our questions will be answered (and free beer tomorrow).
To accomodate the publications and the ripple effect it has on such things as new trials, future therapy options and UCLA direction in research. IMO. There is a fork in the road.
Flipper44, thank you for this post. IYHO, will the process begin in this Spring, or will the process be finished this Spring?
I am hoping it will be completed by the Spring of 2018 and then the paper can be published and then the data locked and then the top-line real statistics can be un-blinded and reviewed at ASCO.
What is your time-line? I always read and contemplate your opinions and the facts you dig out and post. Thank you.
Peace, Reg2015
flip are you saying that the whole conference was possibly moved out 2 months to accommodate NWBO publication?
Come on, Flipper, share!!! It’s the only fair way to do this. Then we can all give you credit when it happens. Writing it on a piece of paper doesn’t count.
I thought this portion from the ASM was somewhat overlooked, so I decided to post it again with some highlighting.
Senti,I wish I had an answer, the data is all over the place and definitely above my pay grade, check this out!
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4772393/
Glad the warrant holders aren't selling now. Wouldn't mind picking up more shares but I'd rather the price not drop anymore.
Wonder no longer. He's very purposeful in how he approaches his coverage of NWBO - it will always be negative.
The real key piece of information is the answer to why is he always so negative.
I was reading AFs latest article about DCVax being delayed. Nowhere in it did he mention that the principal investigator in the trial said two years ago that “the longer the trial goes, the better the anticipated results should be”. I wonder why he’d leave this key piece of information out?
Do you think that 59 weeks from the VB-111 P2 study was likely from progression forward - so around 14 months from progression?
Linda Powers explained at the ASM they can't talk about anything in a journal article that is being submitted, lest the journal reject it. I've become accustomed, but not fond of, their writing that almost always allows at least two interpretations, but I would agree that once they were in the process of submitting, they needed to be quiet until it came out. Prior to that, as Les pointed out at the ASM, on June 5, 2017, at least Dr. Bosch gave us the enrollment curve and an overall survival update.
Sentiment sniffed out all these journal embargo issues far earlier than me. We also needed people with either good knowledge of publication timing in their experience, and or additional people that due diligenced it, and of course each individual's own due diligence. Eventually all these things happened. I believe Jimmy James might have started the cold shower on the board when he pointed out the wait we might be in store for.
I think the problem was, NWBO kept making it seem (intentionally or not) like maybe the article was about to be published because they had all these intervening appearances and then pulled out at the last minute. Remember the Florida one? It looked like the whole team was going. Or Dr. Boynton in San Diego? Last minute pullout there as well. Of course it started with the London pullout, but that one made more sense. It was the ones that kept being announced then withdrawn from at the last minute that kept making it seem the publication was about to be released.
Jeez, remember the Seattle conference recently? They were going to discuss Autologous vaccines, and at the last minute, the speaker, an investigator on the trial, changed his topic literally minutes before giving an alternate presentation.
Intentional or not, these little moments have their impact on everyone's psyche. Now we have UCLA moving their very patient oriented brain cancer presentations for the public two months out to the middle of May. Every bone in my body says they expect the publication before then, and delayed the public meetings apparently so that they can give patients more informed answers at the presentations. Remember when Senti went to a presentation a year ago and talked about Dr. Cloughesy not being being able to give precise answers about when the combination trial might start? I suspect they'd rather go with more available answers about DCVax-L by the middle of May, and thus why they moved it.
Because that also addressed expectations that the data would be unblinded in the very near term. They were revealing that it was their plan to publish the blinded data before they would reveal anything about the unblinded top line data. They could have been a lot more clear but then maybe they were not sure of which way the would go, or maybe wanted to retain the maximum flexibility. And as usual we're evaluating them in hindsight and we can never be sure if they are trying to release the minimum possible info; if they were simply unsure; if they had a clue about the actual timing or not. Basically, it's always impossible to know for sure if they were being reasonably informative given what they knew or being either evasive and/or just being super pathetic communicators and/or all of the above.
Will you post this on IV aswell? Haven't heard you use the word bullish before!
Quote AVII77:
It does seem bullish that an "unaffiliated institutional investor" still held (up to) 18.5 million warrants excercisable at 17 cents considering the pps is almost double that now. No?
I mean, they could have excercised them and realized (up to) a $3 million profit. But they held instead.
curious.
I've also had a change with my impression of the rGBM combination trial. I think UCLA moved it out (for the fifth time) to June 1, 2018 (apparently a pivotal date for many things), in order that their trial design can take into account any and all new information gathered from the "spring refresh." They might or might not do some last minute tinkering to the combination trial design. Of course, it appears they are also likely waiting to see topline in the phase III for obvious pragmatic reasons at this point. I'm less inclined to believe, as I once more did, that the rGBM might be used for confirmation. The continued timing delays for the combination trial seem to emphatically reject that proposition. Of course, this then can be spun either way. It could mean UCLA anticipates the phase III trial will prove ultimately fully approvable for DCVax-L on its own merits, or they have enough knowledge about their unmasked adjuvant and monotherapy armed trial that they think they already have confirmation in the bag in case it is needed, or, on the bearish side, that they don't expect much from the Phase III trial. I doubt it's the latter.
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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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