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That certainly is very interesting
If they managed to get blinded interim data published in any journal of that caliber, that would b a Christmas miracle! Only way I can see that happening is if they managed to turn the blinded outcome data into some mechanistically-relevant study that is not dependent on knowing treatment condition (e.g., immune changes as predictors of PFS or OS).
Chinatown1980, I don't think you and I are on the same page. If I remember your positions correctly, you think LP is a crook and NWBO is a scam. I don't. I think the science is legitimate and give Linda (who I hold in high esteem) credit for getting us this far. Furthermore, I think she is taking what she thinks is the safest/easiest route to the finish line. I really support her and the company. I want to approve an increase of authorized shares but that requires additional info as I laid out previously.
No creditable manager/shareholder would approve this, imho, without this info.
Volume is unconvincing and not sure if we close in the green, but I'll take this any day over closing near LOD! At least there is clear sign of buying demand to at least equal the random attrition sellers who have to sell for xmas presents etc.
I'm cautious but hopeful that we get some positive news and don't have to sit around this level for a long time just hoping that nobody decides to test how far they can push this down.
Look, if you (pretend you are a company) told me today, a material report would be ready in 10 days, but in 5 days you had a different investor sign an NDA and told him the material report would not be ready for 100 days.,..there is a problem. IMO.
Not saying that was done here.
RegFD is about fair disclosure, and there is an NDA exception. I'm asking if you're asserting an exception to that exception because you have researched this technical/legal question or because you have personal experience to know this or is it only because by your own common sense you have concluded that case should be an exception to the exception that allows "unfair" disclosure to specific limited investors as long as they have signed NDAs.
VuBru, SAGE jumped 70% today on release of some positive news on their trial data. Publication of interim blinded data might be possible tomorrow, imo.
Point taken. I already planned to write to the company and have started a draft. I'll have it done within a few days and will e- and snail- mail it directly there after. I don't think it will matter but I do think its my/our responsibility to let them know.
The web is a very dark place
The Lancet has an eight week holding period before publication. New England only four. Just sayin
Fair disclosure. People right now are buying and selling shares based upon previous public info shared about approximately when data lock should occur. If that plan for data lock changed by company decision, it should be shared/corrected for the public, particularly if it was shared with other preferred investors. IMHO. Again, not saying that scenario happened here.
Ah, thanks for the interpretation of your interpretation. Reminds me of Rodney Dangerfield in ‘Back to School” where he hires Kurt Vonnegut to write a book report on one of Kurt’s books and the professor gives Rodney a F grade, telling him that whoever wrote the paper doesn't know the first thing about Kurt Vonnegut! That was hilarious. But in this case, I would give your interpretation of what you wrote an A! I like your thought process much better.
Where did you get that idea?
No, you are missing the point. Material information can be relayed via NDA, what I don't think you can do is continue to let knowingly old incorrect information (since modified) sit out there for the common retail, if you've just given opposite info to preferred investors. You see the difference? Not saying they did that.
Found on the dark net?
Tilt - Isn't Friday a common day for releasing new journal issues?
Flipper, I think you're making an incorrect assumption. Material information CAN be disclosed under an NDA in connection with an offering. This question seems to keep coming up here. RegFD prevents disclosure to one group of investors and not to all, but the NDA sets up an exception. Here's one reference that seems to be very clear on this.
https://www.wsgr.com/PDFs/regulation-FD.pdf
How does Regulation FD work?
• Intentional Disclosures: If the company discloses material, non-public
information to investors and securities market professionals, the company
must make simultaneous disclosure by press release, previously announced
public conference call or webcast or by an 8-K.
Exceptions to Regulation FD
• Regulation FD does NOT cover communications to:
– Customers and suppliers if ordinary course
– Employees and consultants if ordinary course
– Press, if broadly disseminated (although best practice is to observe
same practices with news media as with analysts and investors)
– People who owe a duty of trust – outside bankers working on a
transaction, lawyers and accountants
– People who expressly agree (written or verbal NDA) to maintain the
disclosure in confidence
– Communications in connection with offerings of registered securities
– Credit rating agencies, if results are publicly available
Ha ha - Exactly! That did the trick.
Smokey - I am sure you are correct as far as you go. However, I further suspect the NDA covers them showing the investors the blinded data results and the presumably in press publication we are all waiting on. I think that is the only thing that would convince them it is worth investing, and I look forward to seeing it. When I have worked with pharma companies under an NDA, they have been pretty open about everything going on that was relevant.
Exactly. Well put.
Or were they given a particular body of writing?
I suspect that the NDA was more around the plans for increase in authorized shares, possibility of splitting, or both. Since that is not public knowledge and the plans there would have factored in to the decision to purchase the preferred or not, I think they would have had to NDA something like that. I don't believe they were given any insight to the trial results in that NDA. Maybe a few nods and winks, or reassurance of what the publicly available information portends.
Holy JC! I think we are on the same page for once. Is this an alternate reality. Where the hell am I?
Please communicate your last paragraph directly to the company. Posting on MB might make you feel better for an hour or for a day but such an ultimatum means absolutely nothing unless you communicate that directly to management. Don't rely on their reading your demand on the MB and only consider your msg delivered after you have voted no. Just as a practical matter how are they supposed to know what the bottom line is when everybody has a different demand? Now, I don't really think they will think about negotiating with us if they don't have to, but as a practical matter, and also a matter of principle, writing any demands on the MB is not reasonable communication to the company of what you want, imo.
No, what I'm saying is that if NWBO changed their mind to go more than a deminimus amount beyond OS 233, they could not, imo, share that with a preferred investor, and leave another common retail investor at the same time with incorrect info. I don't think they'd do that. Thus I assume things have moved forward. They are no longer talking about maturing "data sets." This is near where the rubber is supposed to hit the road.
The word "minimum" does not shield a company to go to 331 events. That might never occur in decades. You see? So they clearly did not mean minimum, as in whatever number fancies us. They qualified minimum by stating approximately July to mid summer, and they also arguably qualified it due to patient follow up. Again, my assumption is they stayed relatively confined to these parameters. I don't think they would leave those out there and then tell a seperate preferred group of investors something else. That would mean old investors were living on info known to be defunct. I don't think they'd do that, and thus I believe things must be moving forward. There is no reference, no matter how opaque, as to data "maturing" anymore. It will be interesting to see if your anticipation of regulator feedback before eoy pans out.
So you’re saying
If the preferred investors were told of data lock and common investors were not then analyzing this further I would say preferred investors were told of data lock to get them on board for needed funding by assuring the trial won’t go on forever with subsequent significant dilution of their investment OR preferred investors were told of data lock to get more shares in (very) friendly hands since if common shareholders also knew perhaps the SP would start to rise and the shares would be in less friendly hands? Or perhaps a combination of both thoughts? But in either case, the clock would be ticking on releasing top-line data.
At least that’s what I think I read behind the lines.
You did the best explaining the situation that whichever way the logic flows, it comes down to waiting on FDA that we can see. If they say 233 reached, then it means they must have turned in data to FDA. If they say 233 not reached, it is really good and still it is possible interim blinded data could have been turned in at FDA. Whichever way they speak, the leading indicator then would come down to FDA submissions. Your logic makes sense and the timing also is quite possible. Thanks for your analysis.
Please - those daily Reg SHO figures have nothing to do with short volume. It's just another tool to brain fog retail with.
I am not familiar with the Wells case but the Chardan case seems quite defined and I don't think an announcement should have an effect. I am thinking and hoping they want the vote for share auth. expansion to be conducted post positive news, which makes it much easier. I try to remain balanced but FDA can beef up their 2017 approval numbers with this monumental (risk free) approval. I see Gottlieb holding his staff much more accountable than prior management/administration. I would not want to the be lead investigator on DCVax-L if FDA has been the cause of any delay. If on the other hand all delay has been NWBO's choice to strengthen their data, I believe they have all they need now for approval and reimbursement and can still concurrently gather more. This should be in the new FDA sweet spot now. I think the company is focusing on reimbursement specifics. It is also a candidate for a rolling submission, which I think started a few months ago, when they hit the expected 233rd event, regardless of whether it happened. The company has final say to end the study and not FDA regarding a positive effect. I think it is coming together between NWBO and FDA.
Non-disclosure agreement
No, it isn't too much to ask. Furthermore, do not let others say/imply that by voting to NOT increase the number of authorized shares, you are voting for the demise of the company. Absolute bullshit!
LP & co raised darn near a $ billion over the past 10 years and have a mc of less than $72 million! We have little insight to where the funds went or if they were used efficiently. They told us in February we can expect to meet the P3 trail OS threshold within several months, based on previous 8-month pattern of OS events. In the same PR they communicated they had began a multi-month process to move toward datalock, analysis and then the unblinding of data. Now 10 months later, where are we? Who the fuck knows? Some smart posters believe the trial has been informally extended for another year while others think we will be getting FDA approval in days! All the while NWBO says nothing, or even worst, they referenced an analysis of an unknown MB poster in a profession presentation and, later, provide some vague bullshit about producing an interim blended report. and now they what more stock to give their buddies without being accountable for the last billion. PLEEEEEEEASE!!!!
Shareholders have a responsibility to hold management accountable. We have stood by management and gave them the benefit of the doubt. The fact the some of us "old-timers" are still holding strong despite the phase5 report, mysterious screening-halt and the so-called 90-day internal investigation that has been ongoing for almost 3 years is proof positive that we wholeheartedly and uncompromisingly support NWBO and its management DESPITE A 95% LOST!
I will vote against issuing more shares until management communicates where we are wrt:
(1) Phase3 OS threshold,
(2) status of the unblinding process-- specifically (i) are we still in the data audit, (ii) did we lock the data, (iii) performing the data analysis or (iii) ready to communicate top line data? Additionally, we need (3) an update on the internal "governance" investigation. Don't we need to know that there are no governance issues going forward? Without the above, we would be giving LP & Company a blank check to use as they see fit with no transparency or accountability.
Just my .02.
I will be doing basically the same thing this week. I also want to know and if they cannot update me I believe that is actually a good thing.
Flipper44, I cannot see a downside to informing the public of the 233rd event occurring. And, I do not think they can state something different to new or NDA covered investors than they informed public shareholders without then communicating the same to the public shareholders. But, they did use the term "minimum" and I don't think they specifically committed to informing us when the 233rd event occurred but that they would keep us posted on progress. If all is true, then either they:
- are continuing the study blinded because the 233rd event has not occurred (not likely but wouldn't that be wonderful for all)
- are continuing the study blinded beyond the 233rd event to reach another statistical endpt, since they used the word "minimum" when talking about the 233rd event (possible but if so I don't believe they can give more info to some investors that has not been publicly shared)
- have engaged immediately in a regulatory process with FDA and will not communicate until it is completed as they have stated before regarding regulatory processes
Remember, companies try not to be put in positions where they either have to lie or reveal info they do not want to reveal, which is why quiet periods are self-applied. When in that situation they have to say "no comment" and then the interpretations are wide open. So, they keep their people at the office and the phones channeled to IR.
I think that if the 233rd event has not been reached they would communicate that, it is a very bullish sign but one that makes sense to divulge, and, not a reason to cancel presentations. They would communicate this unless they are working with FDA in the approval pathway.
I think that if they are pursuing data beyond the 233rd event that they would have communicated the 233rd event occurred and then stated again that the data examination and review period will continue for a bit longer, which would all be true, and, data lock would occur once all is ok'd. This however could preclude their presence at conferences as once the 233rd event has occurred everyone knows that they know the blinded and blended results if nothing more. But, that can be telling. But, I think they would communicate that because that would be bullish given the timing of the study and it would explain the quiet period, unless they are in FDA discussions about an imminent regulatory pathway.
I think that if FDA discussed filing with them (whether the 233rd event occurred or not, but, assuming it did) that they would commence immediately and we would not hear until a final approval ruling was taken by FDA. Their reasoning would be that they were into a regulatory process and decided not to talk about it. Given the market need for GBM therapeutic alternatives and the absolute lack of safety issues with DCVax-L, this is the only logical thought. I am going to go far out on a limb here and state they are hoping for a positive FDA response by EOY and want to hold the ASM until they know that is their news. Otherwise they have a very convoluted situation to explain and I would love to hear that live. But, then again, I would prefer to hear a positive FDA decision, whether live or not. Bottom line for me, sorry for so many words, is that I see no reason to not communicate whether the 233rd event has been reached unless they are into the regulatory approval pathway with FDA and we know they do not discuss such things.
Thanks, Sojo, and if recent history is any kind of indicator, the rally we've all been waiting for should be getting under way any time now.
non disclosure agreement
50 % to BP ? ! !
have you had this thought the last few days? LP could have given BP 50% of the company "free for charge" if they just paid costs .. and we would have been better off economically plus we would have had a BP to back us with expatice and people who knew about FDA better that LP + we would not need further dilution .. But then LP and Cognate wouldn't have so many shares.. just saying..
Thank you vnda and etrf, I just keep buying.
What is an nda?
It's better giving than receiving. Hope whatever you have will more than make up by Christmas.
There was another document posted to the Chardan case on December 4th. I was busy the past couple days but don't think it was ever posted here.
https://www.pacermonitor.com/public/case/21771510/Chardan_Capital_Markets,_LLC_v_Northwest_Biotherapeutics,_Inc
Theoretically, the remaining legal cases should all be complete (Chardan and Wells) by January 3. With the exception that Wells can be reopened, I think, later if any terms are violated. IMHO.
Wish I could play the same game but I am heading in the other direction ... had to sell 5K shares today to fund Christmas
I believe one annual meeting is a legal requirement and there is a stipulation around timing post the fiscal year. While quarterly reports are a legal requirement quarterly meetings are not. We know they will respect all legal requirements for communication, though not much more. I would personally take a late annual meeting as a good thing since we know NWBO mgmt. has a burning need to vote on expansion of authorization of share count. I would believe any delay would more than likely to provide some positive news along with the recommendation to increase the authorized share count. I am hoping the meeting gets delayed into Jan and maybe more shareholders would be able to make it.
This is what most people here should do including myself rather than speculating on everything about the trial
monentum2 please post the e-mail address for all to see/use.tia
I did that too after watching how fast the dip was.
Just will your shares to your kids and grandkids. You can't leave a better legacy than a cure for cancer.
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Moderators XenaLives 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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