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You never know
;)
Yet without him, Tesla, Space X and Starlink would not exist.
He only became hated when he took over Twitter and went against the narrative.
Sounds like political bias is getting in the way.
— Ida Bogac (@albtur_mnymkrs) January 12, 2023
“Merck is counting on partnerships and licensing deals to diversify its oncology portfolio and limit its reliance on the blockbuster Keytruda (pembrolizumab) as patent expirations loom.”$nwbo solves all of your Keytruda concerns. Bring a checkbook. https://t.co/09CJJR3YhZ
— Ida Bogac (@albtur_mnymkrs) January 12, 2023
I think NWBO accidentally uploaded all 1 million copies into the NOTAM system. Explains why flights were grounded this morning.
They stack them in one of those off site rental storage units that you drive by from time to time.
To be extra careful, they file each individual piece of paper in its own folder labeled “Page 1, Page 2…”
Interesting if true.
Why go with MRNA technology when DCVax-L is available?
Perhaps Moderna has a lot of political sway with politicians and BP's.
I sense a slight bit of sarcasm somewhere
News:
https://www.prnewswire.com/news-releases/northwest-biotherapeutics-announces-positive-votes-at-annual-meeting-reviews-2022-progress-and-looks-forward-to-strong-2023-301715484.html
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Northwest Biotherapeutics Announces Positive Votes At Annual Meeting; Reviews 2022 Progress and Looks Forward to Strong 2023
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NEWS PROVIDED BY
Northwest Biotherapeutics
Jan 06, 2023, 09:15 ET
78% Of All Shares Were Voted; Proposals Received ≥90% of Votes Cast
BETHESDA, Md., Jan. 6, 2023 /PRNewswire/ -- Northwest Biotherapeutics (OTCQB: NWBO) ("NW Bio"), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, reported positive results of voting at the Annual Shareholders Meeting on December 30, 2022, and discussion at the Meeting (which was publicly available) about achievements in 2022 and anticipated activities in 2023.
Annual Meeting Results
There was a strong vote turnout at the Annual Meeting, with votes cast for 78% of all common and preferred shares that were outstanding as of the record date (841,223,911 votes cast).
There were 6 Proposals for shareholders to decide, and all of them were approved by shareholders with ≥90% of the votes cast. The votes were as follows:
Proposal 1: Re-Election of Class III Directors for a new 3-year term
Ms. Linda Powers was re-elected with 97.20% of the votes cast.
Dr. Navid Malik was re-elected with 97.51% of the votes cast.
Proposal 2: Appointment of Auditors – Cherry Bekaert
Ratified with 98.81% of the votes cast.
Proposal 3: Ratification of Stock Options awarded to Management in 2020.
Ratified with 90% of the votes cast.
Proposal 4: Advisory vote on 2021 Management compensation.
Approved, on an advisory basis, with 91.9% of the votes cast.
Proposal 5: Approval of Stock Options awarded to the independent directors in 2020.
Approved with 90.42% of the votes cast.
Proposal 6: Amendment of the Company's Certificate of Incorporation to increase the number of authorized common shares by 500 million.
Approved with 95.09% of the votes cast (74.28% of the total outstanding) of common and preferred stock combined, voting together as a single class.
Approved with 94.96% of the votes cast (73.79% of the total outstanding) of common stock alone, voting as a separate class.
Review of 2022 Progress
During the Annual Meeting, the Company also conducted a Q & A session, which was publicly available by audio link. The Q&A included discussion of the Company's progress in 2022 and plans for 2023.
The Company believes that 2022 was one of its strongest years to date. Three major achievements included (i) reporting what the Company believes are strong positive results from its Phase 3 clinical trial of DCVax-L for Glioblastoma brain cancer, (ii) having the trial results published in JAMA Oncology, a top peer-reviewed medical/scientific journal, and (iii) commencing a major lawsuit to begin fighting back against what the Company believes has been manipulation of its stock.
The Company provided some additional examples of progress during 2022. These included work with teams of consultants on pre-requisites for an application for product approval, and on portions of the application package itself. One of the pre-requisites -- obtaining regulatory approval of a Pediatric Investigation Plan (PIP) -- was completed on an accelerated basis, including regulatory approval to use the same trial design with external controls as was used in the Company's Phase 3 trial. Additionally, substantial progress was made on preparing the Trial Master File to be inspection-ready for regulators.
Development continued at the Sawston facility during 2022, with the Phase 1A buildout previously completed and the Phase 1B buildout under way. Manufacturing of DCVax-L products for patients began in Q1 2022 after manufacturing licenses for Specials and clinical trials was obtained at the end of 2021. The application package for a commercial manufacturing license was submitted in June, the dual inspection for the commercial manufacturing license and review/renewal of the existing license took place in October, and post-inspection interactions with the regulator continued through year-end. In parallel, R&D work on the Flaskworks system also proceeded, with multiple versions of the system being evaluated, and with a test system established and operating at Sawston. In the US, the Company entered into contract discussions for resumption of manufacturing capacity there.
The Company also continued process and infrastructure improvements that will be needed for scale-up, including systems to avoid bottlenecks in quality control testing and product "release," and capacity for controlled cryostorage of millions of doses.
Plans for 2023
Building upon the achievements and progress in 2022, the Company believes that 2023 can be another very strong year. The first milestone in the New Year is anticipated to be obtaining the commercial manufacturing license, which is one of the pre-requisites for submission of an application for product approval. In parallel, the top priority and intensive focus will be continued preparation of an application package for product approval, as well as the supporting documentation. The Company already made substantial progress on the application package during 2022, and the Company plans to submit an application as soon as possible after the pre-requisites and preparations are completed.
During 2023, the Company anticipates that additional key areas of focus will include:
continued preparations for scale-up capability, with further implementation of streamlining product "release" processes;
expansion of the operation in Sawston following completion of the Phase 1B buildout;
continued development of the Flaskworks system, including choice of the system version to take forward;
commencing the pediatric clinical program required under the PIP;
as resources permit, pursuing clinical trials with combination treatment regimens.
Linda Powers, the Company's CEO, commented: "2022 has been a year of major accomplishments, and we look forward to an even stronger 2023. We are very grateful for the ongoing strong support from our shareholders, as reflected in the exceptional voting results of the Annual Meeting."
I'm willing to bet it's not as simple as "making a phone call to a local news outlet to run the story".
https://www.wpri.com/health/lifespan-to-announce-results-of-vaccine-trial-for-aggressive-brain-cancer/
"PROVIDENCE, R.I. (WPRI) — Researchers are announcing a major breakthrough in cancer research Friday morning at Rhode Island Hospital.
The Lifespan Cancer Institute will present results from a vaccine trial for an aggressive brain cancer at 10:30 a.m.
According to researchers, the Phase III clinical trial of the DCVax®-L cancer vaccine shows that it can expand the life of patients with both newly diagnosed and recurrent glioblastoma — the most common and lethal form of brain cancer.
During the trial, researchers said the median survival rate for newly diagnosed patients increased to 22.4 months and 5-year survival was 13%.
Patients normally survive for 15 to 17 months after they are diagnosed with a 5-year survival of only 5%, researchers noted.
Researchers say this is the first time in nearly 20 years that a Phase III trial of a systemic treatment has shown such survival extension in newly diagnosed glioblastoma."
A major breakthrough in cancer research, which will be announced this morning at @RIHospital.
— Dana Casullo (@DanaCasullo) January 6, 2023
Today the Lifespan Cancer Institute will present results from a vaccine trial for an aggressive brain cancer, the data showing it can expand the life for patients!
Details on @wpri12.
Linda stated that they still have a ways to go until their application is ready.
Is it my opinion that we won't file for MAA until early Q2 2023 (April), due to the sheer amount of work to prepare.
Assuming max review of 6 months, Oct 2023 is the earliest date for approval.
Hopefully it is much quicker than that, but we are on track for success.
Merry Christmas everyone!
Does NICE provide funding?
Well,
If you consider the "Additional Proxy Soliciting Materials" as news, then the rumors were correct.
;)
Yea, just not sure why they would wait so late in the week to announce anything, assuming news is being planned to drop.
If there was "big" news this week, you would think they would announce it EARLY in the week instead of later on.
The weekend is fast approaching.
On a scale from 1-10, with 10 being "BIG", what are your expectations for this news this week?
Merck to buy IMGO at $36 a share.
If there "is" a pending Partnership/BO with NWBO, I wonder if IMGO's purchase will postpone that.
No disagreement here.
TD Ameritrade just emailed me my proxy vote materials. Recommend checking your accounts/email.
Can you link it?
Able to share a crumb of your hypothesis?
Hence the phrase "I believe"
I believe the consensus is that privy information was shared that wasn't ready for the public yet.
Hopefully the ice cream machine is working this time.
Hopefully no deals were affected if there was privy deals in the webinar.
I agree. All indications point to a big development down the pipeline. I'm hoping it is sooner rather than later.
The fact that it's pumping, or the fact that there's something on the horizon?
Ok, I'm lead to believe that they still need to submit for approval then.
Two questions then:
1.) Can NWBO apply for regulatory approval before manufacturing approval is granted?
2.) Is NWBO required to PR the fact that they submitted an application for regulatory approval?
Good point. Now you got my head spinning.
One of the Board of Directors looks like:
https://www.linkedin.com/in/jerry-jasinowski-abb32b10
My gut wants me to believe that they are way farther in the approval process with the FDA than we previously anticipated.
At the same time, NWBO stated that they are making preparations, ie: haven't submitted for approval yet(?).
Don't know what to believe at the moment :D