lindas have a posse
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I am also leaning towards voting against the options. While management made a compelling case in 14A for their many accomplishments, we need to see substantial progress this year on partnership deal to launch new trials. I want to see BP take non dilutive position in the company and provide us resources to help get this product to as many cancer patients as possible.
It's true that with Les and Linda working so hard things take longer while we wouldn't be where we are today without their leadership. Yet it simply undeniable that we need more resources to get this product on the market. I feel we could end up seeing news before the ASM which may change my mind though it's hard for me to vote yes on this matter, yet again, when our share price sits near all time lows.
Put the C shares to good use! We know the majority remain unsold.
LFG LP & LG!
Unleash the platform for all solid tumors!
That statement was not in previous 2023 10Q either. 10Q are abbreviated and do not contain everything that's disclosed in the annual 10K report. I wouldn't assume we have or do not have a partnership based upon the Risk section of 10K or 10Q.
We know they're under discussion at this point. Any actual deal will be disclosed, within four days of being signed, in an 8K as well as Press Release. It's an obvious material event that fundamentally changes our company so it can't be left for shareholders to deduce from comparing 10Q to 10K.
Management own 300M shares so wouldn't want to hide such a deal.
They hate the current share price like everyone else who owns this company.
So we will all know about such a material event upon it occurring.
Berkshire has 400K employees so owners can focus on big picture while staff implement their goals. We are in the opposite situation as our CEO personally authors patents and reviews regulatory filings. Les is knee deep in the lawsuit.
The process as a result will be slower though so far with ZERO ERROR.
At this stage we are with this management until the end while they own over 300M shares. So let's stay patient for the process to play out as it will result in approval!
We will get there 💪!
I do not think reaching $10 will be difficult after an uplist which should occur after MHRA approval. Before the lawsuit I suspected NYSE though we may instead go back to NASDAQ since we're suing every NYSE Designated Market Maker (DMM) which will not be resolved before regulatory approval. IEX would be ideal but they're no longer in the listing business.
As we get closer to DCVax approval it's important to remember that this company, WE, own transformational technology.
As much as we all speculate arguing back and forth on timelines we know nontoxic life-saving treatments will be approved for orphan cancer patients. If MHRA deliver approval this week or next let's all congratulate the tens of thousands of patients which will live longer lives through DCVax.
When I was only 16 my mother nearly died from breast cancer which drew to this sector of investing as an adult. We all wish this was completed years ago but remember the average time to bring a run of the mill drug to market happens to be over a decade at an average cost of $2B!
[B]We do not own discretionary consumer goods with few barriers to market entry!
After JAMA, MIA, Nature, and endless patent approvals, now isn't the time to panic or be upset. Let regulators finalize their process however quickly or drawn out that may be the result will be approval. All longs regardless of their cost average will see immense upside.
Love to you and yours I hope they never suffer this terrible disease!
We stand united behind this paradigm-changing company.
Most difficult challenge with $NWBO's DCVax was manufacturing the personalized autologous vaccine in cost-effective manner at scale to meet global demand not whether regulators would approve nontoxic life-saving treatment for orphan Glioblastoma patients.
— autologous assassin 🇺🇸 🇺🇦 🇮🇱 (@flaskworks) May 18, 2024
100B company. When approval? It's happening.
Julia you run but nobody can hide!
Why does Phase V author @juliaskripkaser try to hide from $NWBO? https://t.co/Zn7O3zT96h
— autologous assassin 🇺🇸 🇺🇦 🇮🇱 (@flaskworks) May 16, 2024
She deleted the report but we know she's the author:https://t.co/ORUEEEjjGH
Could it be subpoenas or investigations from @DOJCrimDiv @FBI @INTERPOL_HQ?https://t.co/ADOuL0QBJy https://t.co/LDXUtnjfEk
Per section 12(g) of the Securities Exchange Act companies must give 40 day notification. However given our low net assets we are not subject to federal proxy rules as shown in our annual 10K reports. Delaware law in our articles of incorporation apply.
Thank you for the correction. It's not my intention to publish misinformation.
Approval possible anytime from now until June 18th as the last day for ASM would be Friday June 28th. In my opinion zero percent chance management call ASM without approval.
Les gave an ambiguous forward looking estimation as to when MHRA will approve DCVax. "By fall" would be the absolute longest amount of time MHRA could take to approve DCVax so it's technically correct. We will know by fall. Nothing untrue in this statement.
He can't front run regulators by saying "next week" though from my reading of the Q1 2024 10Q they have made it clear in my opinion we should expect a decision next week.
This coincides with both 40 day ASM notification requirement as well as conclusion of 150 day MHRA approval process assuming no 60 day RFI.
I could be wrong but I believe there's high degree of certainty as management likely do not want to waste limited resources on an ASM without approval.
Approval likely next week given time required for sending annual meeting notification.
https://www.skadden.com/-/media/Files/Publications/2007/08/Publications1302_0.pdf
As you all know PII approvals can happen on stellar data especially for those treatments which have no side effects treating orphan diseases. We know of CAR-T approvals for example as a comparison though these are being restricted now due to sometimes fatal side effects. For DCVax with PolyICLC regulators could simply require a confirmation trial post approval which would be easy to recruit given the amazing PII data.
The PIP includes non GBM patients therefore it seems like we are applying for all brain tumors in the UK not simply recurrent and newly diagnosed Glioblastoma patients. MHRA are not going to experiment on children with therapy not approved in adults.
In my estimation it makes sense that NWBO management would apply for approval with PolyICLC, not simply as a monotherapy alone, since they had this amazing data in hand well before December MAA submission.
They may not have disclosed this effort since they have no idea how the regulators would act therefore it could be misleading to inform the market of such an uncertain outcome. Regulators are most concerned about providing an honest perspective to the market while management may believe approval on PII a relative long shot given the smaller sample size verses PIII monotherapy trial.
Yet I firmly believe this was attempted in the MAA as it makes sense to leverage limited resources for one large effort at once as opposed to going back to regulators post DCVax monotherapy approval. With high confidence we can speculate the Mechanism of Action proteomic data was included in the MAA so I am fairly confident same for PII PolyICLC combination trial data.
Does anyone agree with this possibility?
Much credit to ATL who has been saying this for some time:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173058182
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173058318
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173061962
We will only hear about approval from Northwest Biotherapeutics. That's it. As you say anyone who suggests otherwise are ignorant about biotechnology investing, a short, a swing trader, a moron, or all of the above.
Cofer Black never sleeps!
Another day closer to approval!
Let us enjoy this sunrise as it could always be worse.
Congratulations on your many purchases of NWBO!
Popping bottles soon!
2023 loan did but previous loans did not have prepayment penalty. The lender believes company will be able to access financing on far better terms. Approval anytime!
Linda Powers would make an excellent Chairwoman Emeritus with newer C suite brought into run the company. We would obviously get some new board members. Based on my insights and instincts these are likely outcomes not a buyout.
Management would be in violation of their fiduciary duty if they sold the company now while it's under such manipulation. Majority of shareholders will not support a buyout at this time. Management wouldn't have engaged in a multi-year lawsuit against Wallstreet if they were planning on selling the company in 2024 or 2025. Newco with BP partnership seems most likely.
I do not believe we should expect a buyout at the current valuation or anywhere near. In my opinion management feel the pain we know as shareholders which should be lessened significantly after UK approval.
While some members of the board and management are certainly old, younger staff can be brought in to help run the company. In that scenario the terms outlined on 10KA I do not believe would be executed. These are boilerplate which must exist in the eventuality of a partnership or buyout. They do not signify an imminent deal though I wouldn't be angry if I am incorrect.
If management wanted to sell the company
now allocating limited resources suing Wall Street seems irrational. While Cohen Milstein took the case on contingency, Les and Linda are hard nosed hands on litigants not sitting back letting a third party determine the future of their company.
In a time of scarcity priorities must be determined. I do not believe management would endeavor on this undertaking if they wanted to sell the company. There are other short-term efforts that would facilitate that outcome better than a multi-year arduous yet groundbreaking lawsuit.
Another day closer to approval.
We ready.
Given the rigorous evaluation put into the MAA, nearly flawless MIA inspection, expedited PIP, and 10 years of compassionate use data known by MHRA, I do not expect RFI. Those who suggest otherwise are likely wrong. They're probably the same people harassing MHRA staff daily for material non public information.
The firm would never disclose RFI either way as the drug approval process isn't public. It's an exhaustive process without an RFI. Quiet period post submission are best practice as one does not front run regulators while loose lips sink ships according to RegFD. I expect 14A once we get news from MHRA. ASM takes back seat in my opinion until approval.
NWBO at $25 soon. Are you ready?
Unlimited potential
$NWBO patent application published on April 18, 2024 - US17/766,904: "In vitro methods and compositions for enhancing the activation of dendritic cells and t cells, and for inducing a Th-1 immune response"#DCVax could have more applications. Pending examination. pic.twitter.com/bjrz7kV24l
— Henry (@HenryMuney) April 24, 2024
Guaranteed in my opinion. Anytime. MHRA are not giving an unapproved treatment to children in the post-approval PIP trial.
Approval anytime!
News anytime.
I agree that time to settle trades isn't the issue with naked shorting but blackbox self regulated institutions like DTCC and FINRA.
Baker Brothers sitting on lots of cash. I wonder how many shares they will acquire after MHRA approval?
https://www.wsj.com/finance/investing/two-brothers-a-big-biotech-bet-and-an-8-billion-payout-8b829af2
12K patients per year under the approved clean room method per Dr Bosch @ ASCO 2022.
100 bagger at a minimum.
Regulators do not disclose every back and forth correspondence with applicants. In fact they disclose nothing. Gven that you suggest they do means you are certainly not a master of this stock. Drug approvals are private. A lot going on behind the scenes with MHRA, NICE, and NWBO. Approval by MHRA will happen anytime with concurrent NICE reimbursement.
Submission of FDA applications are not required to be disclosed under SEC rules as submitting an application says nothing about what the regulator will do with the application. Denials and approvals must be disclosed however as they are material for investors. The majority of applications are in fact disclosed but this isn't a legal requirement.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6547098/
Amazing ATL thank you!
Approval coming!
Another day closer to approval. It will happen anytime. Get ready.
Approval will happen anytime. They know it. We know it.
Yes indeed
Says the guy who thought we would never see MAA submission in 2023 who holds solidarity with the team of degenerates which claimed our journal would be Readers Digest!
When you have a nontoxic cure for large proportion of the most deadly cancer known to man checkbooks tend to open. This is a law of nature and finance.
As I sit here now on my wonderful teak backyard furniture looking upon my azure pool as well as constellations and galaxies above it seems evident we will be celebrating NWBO in the coming days, weeks, and months this year 2024.
Those who disagree ignore management success at their financial peril!
FDA will rapidly approve DCVax as our data are far more robust than toxic yet approved CAR-T. NWBO applied to UK because first they're very familiar with DCVax via the Specials Program. If US had similar innovations more than a decade ago we could have applied here before the UK.
Under Orbis MHRA can refer our application to all other regulatory authorities (RAs) without need for NWBO to submit separate applications to other RAs.
The notion that FDA prefers mRNA over DCVax isn't true. mRNA simply has greater awareness due to Covid-19. We have superior technology by far. It will be approved without issue.
DCVax:
- nontoxic
- efficacious
- cost effective
Take that to the bank.
Median not equal to average yet you keep posting misleading timelines which suggest approvals take over 150 days. They do not. 50% take less than that as median is midpoint in distribution. MHRA Performance Reports use median because there's wide variation in time to approval. If the distribution was uniform they would use an average. It isn't so they do not. Moreover these metrics change annually. They are NOT designed to forecast a single drug approval but allow us to know how busy MHRA are as an organization! They give us little insight into the merits of each application which determines approval timeline not these metrics!
Never felt better about owning Northwest Biotherapeutics.
Please tell me how much you think $NWBO will be worth after #DCVax-L is approved for nGBM & rGBM patients around the world. Then add worldwide tissue agnostic approvals for all or most solid tumor cancers for both DCVax-L & DCVax Direct, both operable & inoperable. Here’s a clue: pic.twitter.com/MuZAePlGyp
— ATLnsider (@ATLnsider) July 30, 2023
News right around the corner!
Another day closer to NWBO approval.
As with MAA submission, and the journal, the anticipation will be met with news.
Don't let yourself be gaslit by negative sentiment from the peanut gallery.
Since I began buying in 2020 naysayers have been wrong about this company at every milestone.
Let's get ready to pop the champagne and pass the grey poupon!