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The company has never released info that could be perceived as bad. And Less has flat out lied on the big booz show before. Less also never confirmed the IA was performed and we know from the JAMA paper it was. And the only reason to withhold that is if it was a futility rec.
Here’s LGs verbatim: “but if we as part of our dialogue with them we heard there was something wrong (29:14) we'd have to say so and that would be material so no news is good news we're on a track for an accelerated approval (29:21) we're thinking sometime later in the fall we'll have something to say about that in the quue we file probably (29:28) tomorrow.
Talking about something in the fall is not saying approval will be that time. Since when has the Co. ever tipped their hand about timelines publicly? He did not hint at which RA/RAs either… I still go with MHRA by July 1 and FDA/Canada/Australia through new pathway by election time, which is also in the fall.
skitahoe " I believe they'll want shareholders to feel comfortable with the share price at the time before voting on authorizing more shares."
OK lets get this BS out of the way that she wants share holders to feel comfortable with the share price. LP could not give a damn about share holders feelings when it comes to price/ amount of shares She is in the drivers seat with all the voting rights. Have to laugh when posters state they are going to vote against, additional shares. Go ahead if it makes you feel better, but Don't broadcast it cause you only look like a fool.
Least we not forget, Its her game and she has all the marbles.
DJPele thanks for bringing the partial transcript.
The very first sentence is “we’re getting all the approvals”. Then talks about the MHRA
Later Les says in reference to the nature article “that was published yesterday involving combo trials and L being the catalyst….”
“We’re on track for an accelerated approval and we’re thinking sometime in the fall we’ll have something to say about that”
Just looking at the quotes Above-
Les is intentionally vague, conflates facts, stretches the truth….
Example—Investors hoping to get all approvals is much different than “we’re getting all the approvals” I’m stopping here.
It just isn’t possible to rationally decide what should be relied on. So I’m not relying on anything Les said in this interview and future big biz interviews.
Toby Keith: I love this BAR
Me: I love this Board…….
Been invested since 2014, adding a long the way. If you know what you have don’t give a shit what happens till it does.
I work, workout, drink bourbon and enjoy every day.
I check in every couple of weeks for a few smiles.
I don’t give a fuck what happens until approval. When that happens I’m opening a very special Bottle of Bourbon. Then i work, workout, have some bourbon.
I’m taking my shares till it’s a shit ton or nothing. Probably going to be the first.
You guys need to just things run their course..
Crash you have got to be the worst pumper I have seen. Most of us want the stock to move up but, good grief
BMS filed FDA approval for subcutaneous nivolumab and PUDFA is on February 28, 2025. Don't recall Merck has released its Top-line data on its SC keytruda.
U.S. Food and Drug Administration Accepts Bristol Myers Squibb’s Application for Subcutaneous Nivolumab (nivolumab and hyaluronidase)
https://news.bms.com/news/corporate-financial/2024/U.S.-Food-and-Drug-Administration-Accepts-Bristol-Myers-Squibbs-Application-for-Subcutaneous-Nivolumab-nivolumab-and-hyaluronidase/default.aspx
Crash, apparently you weren’t assigned to watch Les today.
But he wandered off the premises and accidentally found himself in a TV studio somewhere.
Out of curiosity Flipper, do you know when UCLA was working on the Phase 3 Trial, which clearly was sponsored by NWBO, if patients being treated right at UCLA were receiving vaccine made by the company through Sawston or Cognant, or did they make it themselves. I would think that NWBO was responsible for supplying it, but don't know that to be a fact.
Gary
He said, “sometime later, in the fall”
JFR,
I believe that if you look at LP's background there is no shortage of bankers she could be speaking with. I know I'll sound like a believe the company is going after the shorts, the MM's, etc. but Posner's efforts are already saying that. What better way of getting these people than to allow them to think they have time, and suddenly spring approval on them. I don't know this is happening, but whether it's by next week, or by the middle of next month barring a major change in the share price before, indicating they're clearing out of their short position, we could see the mother of all short squeezes.
As I understand it, we're just a few weeks from also knowing that the MM's have no more MTD available to them, if they don't get a dismissal they'll either be going to trial, or they'll settle. I know none of this happens quickly unless they determine they want it behind them with a quick settlement rather than having it hanging over their heads for years.
I know I sound like a conspiracy theorist in saying, this, that's okay. If I'm wrong, no harm done, if I'm right, we'll all be far better off quickly. I know that DI wouldn't say, you're right, or your wrong, he just doesn't work that way. Frankly I don't believe that DI is aware of all the company is planning so that he does have deniability for not providing false information. He could very well be planning a PR campaign for after approval, or for the release of new information on the EDEN or other things without having any knowledge of when events were anticipated to happen. I know that DI has told other investors that the company plans to roll out more than just approval, once they have approval, I'm sure he's working on that, but the timing is clearly an unknown, at least to him, and I doubt if the company knows much about it.
Gary
I’m guessing 90% here did not know that inspections are not typically conducted in Phase I (80 days) of 150 day accelerated review. When conducted, they are conducted the last 70 days of the total 150 days.
He said by fall , not in fall if I remember right . So it can mean anything from June onwards
Just speaking my mind. In over a decade, I don’t recall a time when Les ever overestimated the time something would take. Therefore, I don’t think he thinks he is overestimating now. One could hold out the hope Les isn’t told everything.
Yes that's true that doesn't take us to fall.
GB, thanks for your message but if I say they don’t have a banker advising them it’s because I know for sure. I’m not in the “guessing game business”.
NWBO is probably the best investment opportunity I’ve seen in +35y.
I trust the science & the scientists immensely.
As an investor I would be more comfortable knowing that they not only have access to high level advice but also access to “smart” capital.
You must have missed Les’s interview. God knows I missed it until days after reading the 10q.
That doesn’t take you to fall.
Yes, try to understand what he said though.
He says if MHRA had informed NWBO of any bad news then NWBO would have to disclose. As NWBO has disclosed no bad news, there was no bad news from the MHRA.
So taking those two answers together, the phase 1 activities sound a lot like the kind of activities that could conclude with an RFI or with a confirmation of validation/acceptance (no RFI at the end of phase 1; such as, perhaps, the Notice that was received on March 7th), and are also consistent with statements indicating that the inspections (which happen during phase 2 and happen only if and to the extent deemed required based on the circumstances of each individual application), had not yet taken place as of March 31st, which could have been a date that was three weeks or so into phase 2.
Sure, 1% chance. Talk to the company
You're correct, I do speculate all the time, I believe others here do much the same. Based on experience, the company has waited on having something positive to say before holding Annual Meetings, and in the past they've forecast dates and delayed until something they wished to discuss occurred. I believe establishing June, but not a specific date yet, indicates a belief they'll have approval before then, if not, something else of real substance, like acceptance of the EDEN unit. If nothing positive comes out prior to the Annual Meeting being formally announced, roughly 20 or more days before the meeting, I'd not be surprised to see a delay into July, or even later.
I'm of the belief that we'll get a proxy to vote on that will include the authority to raise the authorized shares again. I don't believe that's something they'd want to ask for at prices even close to current prices. Of course it's possible they won't ask for it now, they could also do it later in a special meeting, but I doubt if they can go to the 2025 Annual Meeting for asking for such action even if nearly all holding options hold on without taking stock. With approval the company will clearly need additional funds from somewhere, it could come from a partnership that didn't result in substantial share involvement, but it's likely they'll need more shares. I believe they'll want shareholders to feel comfortable with the share price at the time before voting on authorizing more shares.
Gary
Approval likely next week given time required for sending annual meeting notification.
https://www.skadden.com/-/media/Files/Publications/2007/08/Publications1302_0.pdf
He clearly meant news regarding MHRA , something that could be considered negative . It doesn’t take a rocket science to interpret that . But everyone is free to interpret the way one wants .
Sure there is certainly a possibility that RFI issued . Everyone is free to take whatever from that video
Wrong. Go back and listen 100 times to what he said.
Instead:
Les Goldman
“As part of our dialogue with them, if we heard there was something wrong, we’d have to say so, and that would be material, so no news is good news.”
No, the "no news" was saying that NWBO has released no news. We know as a fact that MHRA has disclosed news to NWBO, so clearly he did not mean no news was provided to NWBO from the MHRA.
Also, there is the timeline. If the clock start was March 4, then the RFI would have been expected just a few days ago, After the interview was recorded.
Can you please give ChatGBTs answer to the same question wrt to phase 1?
He also did not say that they received RFI . One can take it either way based on their bias . However he did say no news . I doubt as a lawyer , receiving RFI would be considered No News , it may not be material news . Anyone is open to interpret what he said according to their rational and bias . No one’s opinion is any better than other’s .
JFR no one knows if they’ve had a banker advising them. But, I think there is zero chance, she has not received banking advice.
Next thought is why then hasn’t there been a notification in a 10Q that a banker has been engaged ? Because she’s not raising a chunk of money at these stock prices. So, banking advice yes, engaged a banker, no.
Less never said they did not receive an RFI. He implied they did not receive any bad material news because they would be forced to disclose it.
An RFI would be considered normal, not any sort of material news in need of disclosure. That posters around here fail to understand the process does not matter,
The expected timeline is March 4 (the submission slot reset after the MHRA certified any clarifications + 150 + 60. That would be Oct., leaves will be turning colors.
Gary, I agree approval is the key.
In the mean time, it would have been in the best interest of the shareholders to have a banker advising the company. I made my points clear about that.
I have no doubt about the efficacy of the science and once approved, I also expect corporate developments.
Small snippet of what I transcribed from the Biz Show. There's still some before and after this:
Every time we start to gain a little momentum management always screws something up. Finally get a good QT report with good news and Les screws it up.
Kap10jak They could try but their asses could land them in jail.
Ok. Whatever makes you feel better mate .
I hope they aren't holding the MAA decision up until after they see that last chapter in Nemesis' book.
NWBO has not received an RFI. No news is good news as Les said. However Les, NWBO anyone can not exclude that an RFI still may come at any day. If that's the case we will see the outcome of the approval process from the MHRA in late fall as what Les was referring to. Hopefully, we will never see an RFI.
And yes if the MHRA would send an RFI tomorrow then that would mean a flagrant violation of their timeline approval process..
Again, no audible available for posts on this board.
I have stopped listening to you years ago Thank goodness
“Maybe a rare case of LG underpromising in order to set expections.”
⛔️
JFR, I'll agree, but after approval don't you suspect that many brokers will want to become associated with NWBO over time.
I believe that LP is well connected, but those connections are meaningless until success changes the way the investment public is looking at NWBO. The MM's may have largely been controlling what's happening up to now, but post approval I really don't believe they'll be able to keep the share price down and the short squeeze will be a thing of beauty for all who're long. Once the short position is largely cleared we'll be a very different company.
Many who've spoken with DI have been assured the news won't end when an approval is announced. I suspect that once we get that approval a month won't go by without some meaningful release will come out of the company, at least for awhile. Perhaps some things could be said before approval, but holding them until after may greatly increase their impact. Other things frankly are keyed to at least the initial approval, so that's when we'll start to get word of them.
I think we all know that the company will have many choices as to the direction they want to take after approval. They may have already decided, or they could be waiting. Personally I still believe that CRL could play a major role, but it's not impossible to do it completely without them. I suspect that CRL already knows what NWBO will be doing, but no one can say anything until the time is right and that could be dependent on acceptance of the EDEN unit as well. Of course if CRL is purely intended to support the US it could all be dependent on an FDA submission as well.
Gary
We cant do this Attila, that would make yourself, from your own words, a FUDster, or a short. See my reply and timeframe to you accusing me of it. Then see your second reply.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173517970
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“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
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Investor Relations:
Les Goldman (Company) (202) 841-7909 lgoldman@nwbio.com
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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
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Linda M. Liau, MD, PhD, MBA - April 24, 2019 at University of Washington, Neurosciences Institute
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