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Every punch they throw is pulled somehow
I don’t think $NWBO is expecting approval to be imminent; I believe the reason for the ASM in June is because the Nature publication is out and a partnership between Oncovir & NWBO seems highly likely. They might announce it at the ASM. That being said investors will be happy and will vote FOR whatever they demand on ASM.
Excellent comment, George. AND, I love decision makers that have millions in the deal! Hell !!! If it wasn't for Linda Powers steppin up in 2015, there wouldn't be company!!! AND for JFR, there you go again, "Play talkin" like you think you know something! Fact. is that you always seem to end up in 2nd place and we all know what 2nd place is, Yep!!! "First on a long list of losers!" Team Northwest is the only "First Place Finisher" in this deal!!!
Cheers,
BB
Good point. June ASM should be "that" meeting. And I believe May or June is timing for MHRA approval.
Flipper, I think what is more likely is given that the MAA submission was extremely large (1.7 Mil) and therefore the first phase of the MHRA analysis took longer than the normal time, and there was only one RFI without NWBO asking for an extension, and this can still be called "on the 150 day track" even though it took the MHRA a little longer to do the analysis. So everything is going well as per Les om Biz
I disagree. I would expect the ASM to be "that" meeting.
Still wondering why they chose June. I am under the belief that they expect a June decision.
Speculating here. I'm thinking “We’re on track for an accelerated approval and we’re thinking sometime in the fall we’ll have something to say about that" refers to talking openly about the whole 1.7M page application. By that time, the regulatory approval will have been obtained and it is ok to talk about it. Fall timing maybe refers to an investor meeting to coincide with a Quarter End report. All this because approval means NWBO starts a new chapter, a commercial focused company and there needs to be a meeting to discuss the vision then.
Why are so many videos going around about short squeezing this company?
The quarterly report was made at day 140 if you go by submission, and roughly day 110 if you use the January date. While the report was for first quarter financials, comments made in the report should be up to the minute. All indications are that the UK should issue RFI's well before either of the above times. I'm not saying that at day 149 they can't do it, but that's not the way they plan to do things, if they wanted, or needed more information, I believe it would have been far earlier in the process.
In truth, I believe the UK regulators have been watching the development of DCVax-L for many years, they've seen the demand for it in their compassionate use program and frankly they also have done a rolling review of the filing. I believe that for the most part they knew what they needed to know by the time of the submission, reviewing it just validated what they already knew.
I may be the only one who still believes we'll have a decision in no more than about 6 weeks or less, and possibly by this time next week.
Gary
Good point. 🥴
TJ,
How do you feel if it is approved before the end of the first week of June? Not only from UK. But from FDA and EU too. You know as a symbol of international collaboration against cancer.
I did see it sometime ago. Survival over three years is the most critical point. Recall that polio trial that was even on CBS 60 mins. It was promising in the beginning. But none of the patients became long-term survivors. You can see those what those mainstream media are doing.They hailed the results from some trials still in early stages as breakthroughs and they reported them in a big rush. But the truly real breakthrough has been published several days on Nature. They choose to ignore it.
They don’t have to read 1.7 million pages, they only need to read the summary of the Journal Article. They are government workers probably working remotely.
Wow, stunning actually
Contrary to what many believe I think a RFI is likely.
I think everything discussed to this point (January 24, March 7 & no changes to the MAA) has been about validation, not the technical assessment.
I don't think we've gotten any guarantee that a RFI hasn't or will not occur.
Either way, approval before the end of 2024 is very likely, and I'm ok with that.
Just my opinion, no need to get hasty.
Ok you take July and on. I’ll stick with prior to that date. After approval, it’s a beer is that friendly enough?
What justifies the +60 RFI when it's clear that there was no RFI I have no idea. A company doesn't request 60 more days when they're not needed. Without them, August 3rd would be your date if based on the March 7th date. While I believe the date should be December 20th or January 24th, without a +60 RFI when no information is requested, we'd be no later than about June 24th.
I'm still hoping all this goes away by next week because we've gotten the answer, but I may be the only one left on the board that believes it.
Gary
I won’t yell at you. Contact MHRA. Like ChatHPT, they’ll tell you clock starts upon receipt of a valid maa. That was December 20, 2024.
Validation passed January 24. Validation confirmed March 7. They’ll tell you confirmation does not delay start of evaluation clock.
Bonus: one day before the 10q came out, Les said they’d talk about fall in May 10th 10q. They didn’t. Is Les stupid, or did something else happen?
May 9 when he spoke was exactly 80 + 60 days from December 21. It’s quite possible they thought about asking for a 60 day extension to further respond to an RFI, but instead, they got it in at first 60 day deadline. May 9, 2024.
People underplay what a time jump to fall (or even later fall depending on punctuation) Les laid upon a small audience in a semi-public beer soaked venue.
How the f could he not know a day ahead of time the 10q would not include that? Les is a mess. He knew time mattered, yet he confounded his audience. Why?
Where are fibs more likely, 10qs or fake bars?
Friendly wager.
I'll take July and on.
Australian Doctor Glioblastoma-free One Year After Immunotherapy. Has anyone else seen this?
https://www.bbc.com/news/world-australia-69006713
I’m no pumper. The goal is 150 days from acceptance of submission. End of June Max.
While you are it you can also add the usual multimonth delay because it’s NWBO
He is a Q man; he was thinking in his mind about the next 10Q that is due in the Fall.
End of June max would be a pumpers dream…..
That would be a short’s dream. Try end of June max and the price has already started to drift up.
he meant the next 10Q later in the Fall.
Putting this out there, don't yell at me.
Application submitted: December 20, 2023
Application accepted (receipt): January 24, 2024
Application validated (it's all here, it's all good, let's start the review): March 7, 2024
150 day assessment + 60 day RFI = 210 days from March 7, 2024 = October 3rd, 2024 (otherwise known as, the fall).
Les loves to drive the shorts nuts and loves to keep them in dark. He must have set a trap for them with the fall timing words. He said Accelerated filing too; on that token itself, approval could come any day. He did not say approval in Fall. There are so many things the Company could do associating with the MHRA process in the Fall and thereafter. He talked about the Nature paper, and what kind of short narrative that those Ex and Nemesis will now come up with when Les clearly refers to DcVaxL for ATL-DC used in the Nature paper. Les also bragged about their dendritic cell patents all over the world which is a fact and the future potentials of the DcVax platform. Shorts go f yourselves, hahaha.
I believe that her experience as a lawyer has obviously worked for her for several years but at the stage the company is at we need external advice from experienced bankers. The company is preparing to graduate to the major leagues and we need big guns to get through the next stages. The “BIG BIZ SHOW” has had its day.
Correct. Or perhaps LG and RFK Junior suffer from the same
"dead worms in the brain syndrome".
I'll agree that she has control, but I believe her past behaviour clearly demonstrates she's doesn't want to be in opposition to many individual stockholder at any time she's speaking to a group of us. I don't think any CEO wants to face law suits from investors, but there are law firms who openly seek running such suits. The Gross Law Group seems to be initiating suits against many companies, one of them is AVXL which I have stock in, their headline often shows up as news multiple times a week here on I-H.
I don't know that she can do anything without informing all shareholders even if she has control of over 50% of shares. That stated, I do believe the company can choose the format of an Annual Meeting, if they wish to minimize investor interference they can hold it in their offices and not webcast it and limit business to issues to be voted. They would simply post results and that would constitute the meeting.
In recent years most companies are doing webcast, or hybrid meetings, but I don't believe the regulators have established how such meetings must be done. Holding a meeting at a time when shareholders are happy with the direction a company is taking is a no brainer if a company has the ability to do it. Sometimes they do, and other times meetings are clearly adversarial with those attending live. Perhaps when we're on a major exchange the company won't have the freedom they've had on the OTC with doing, or not doing meetings in a timely way.
Gary
JFR - I want to make a distinction- I’ve worked with bankers and attorneys with executed engagement letters. I’ve also gotten advice without engagement due to strength of relationship. So I won’t re engage until the prior professional opinion has gone stale.
That’s what I think LP does….she waits to engage until she knows she needs that help.
Alternatively, LG may have tried to say that during the coming fall we may
be receiving information concerning the pending accelerated approvals of
a number of MAAs that were submitted to various jurisdictions (e.g. FDA)
and it was not his intention to mention the upcoming MHRA approval time.
Hmm
Interview was recorded May 9 as he says in the interview Nature article published “yesterday” so that would mean May 8th
If Mar 4 was the start of clock RFI had to be issued in 60 days if I understand the process right , and consensus here is calendar days , so that will be before May 9.
Nice try though !!!
So you are saying a T worm was controlling his mind?🪱
I am guessing that LG simply did not convey the information in the right
sequence. His reference to accelerated approval most likely referred
to the MAA already submitted to the MHRA whereas additional
approved MAAs or more likely pending approvals will be a subject
of discussion during the coming fall season.
Drs. Robert Prins, Linda Liau, Richard Everson, & team investigated the effectiveness of adding TLR agonists to autologous tumor lysatepulsed dendritic cell (ATL-DC) vaccination in patients with newly-diagnosed or recurrent #gliomas. Read the article here: https://t.co/RbeQ8GAl7X pic.twitter.com/o7Hk1wZHGp
— UCLA Neurosurgery 🧠 (@UCLANsgy) May 13, 2024
By the way, there was nothing a day later in the 10q about “Later, in the fall.” Even though Les thought the 10q would have something about later in the fall on the May 10th. It did not.
Makes you wonder if they didn’t need to file for an extension after all.
May 9 was exactly 80 + 60 days from December 21. Les interviewed on May 9.
May 10 was 10q after hours.
this is not aging well :)
LG said: "We're thinking sometime later in the fall we'll have something to say about that in the Q we file probably tomorrow."
Clearly LG is talking about waiting until the fall to travel back in time to May 10th to not say anything about what happened in the interim in the Q that he was not certain would be filed by the May 10th deadline. Of course then you have to wonder how he wasn't already aware on the 9th that the Q had been timely filed on the 10th.
You are reading it wrong.
Here is what he said. I separated the two thoughts for clarity.
NWBO has the big biz show that has little reach and with Les who sounds boring and not to mention old. The investor base is filled with hopium and buyin from the company that spoofing is the reason they suck.
The Meme stocks are on every major network financial show, have a great online presence and have investors that are passionate yet realistic. They told the shorts they were better and won and they are about to win again.
Typical NWBO. Don’t be upfront. Shady as shit. Just like Less and LP.
He lied. Again. There can be something wrong that requires an RFI that is not considered material and would not be disclosed. Just like the futility recommendation.
And RFI with requesting extension on top of that will not be considered -on track for accelerated approval , at least a lawyer won’t be saying that publicly when they already had a complain to MHRA few months ago as someone posted on X.
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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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