lindas have a posse
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This is the way.
I have spoken with Dave regarding issuing guidance on regulatory approval. I don't know if it will be forthcoming. Regardless the worst case scenario of an application submitted this month or May then approval by July or August isn't concerning to me since I will own this stock for another 5 years at a minimum. The consternation regarding this period we are in now makes zero sense as management have had nothing but success.
Have they not earned our trust?
You have no evidence supporting your assertion that management are behind schedule.
Shareholders are not served by arguing that management are late nor are patients. In reality at every step of this process management have executed flawlessly with zero rebuke from regulators. So what's the problem, really, when Sawston has cold storage for $50 billion in DCVax doses? That isn't going idle once we get approval this year.
None of this matters for long-term shareholder.
SEC does not require companies disclose the submission of a new drug application. Linda Powers isn't verbose in her strategy. It has been nothing but flawless execution. I trust in their judgment of the process.
Dave can say whatever he wants in reality the courts and SEC do not find a new drug application to be a material event given the substance of the application must have feedback from regulators before being a consequential occurrence affecting the revenue of said applicant. Companies must PR any negative response in correspondence with regulators not simply submission.
You have no basis to claim they're unprepared. In reality they could have already filed. That submission isn't a required material disclosure.
I don't care how many pages are within the application or what page they're on this Friday because I know the outcome will be approval.
Longs should keep their eye on the ball as the outcome matters not the mundane details.
Stop devaluing the immense effort management have put forward to get us to this derisked outcome!
Those who simplify the approval process without any comparative baseline should own companies which manufacture pedestrian analgesics not the autologous platform for all solid tumors.
Those who claim we are running behind should remember that DCVax isn't Viagra or whatever other pharmaceutical products they typically consume.
Unique intricacies are present in this product thus process!
You don't know Linda Powers the genius facilitator of DCVax CEO who will save millions of lives.
https://www.c-span.org/video/?c5017935/user-clip-linda-powers-testifying-congress-july-17-1990
Buy now or cry later!
https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847
https://www.researchsquare.com/article/rs-2591941/v1
https://nwbio.com/glioblastoma-drug-development-summit/
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=169815671
Submission isn't material as it doesn't tell us what regulators have to say about the application. Only once feedback has been received would management need to disclose that material event. This happens to be what the SEC and courts have to say about filings before drug regulators. Most companies do PR submission of applications but that's company preference not a legal requirement.
Linda Powers may decide it makes sense to PR once feedback has been received by MHRA et al. Submission really may not benefit our share price as we are on low volume OTC. So perhaps they're waiting for more concrete feedback? I don't know. There's only one destination in my personal opinion. The journey to that place isn't as important to me given we are derisked.
What variables are at play?
We have:
Proven cure for the most deadly cancer
Fordist manufacturing process
MIA approval
PIP approval
Widespread support from patient advocates
Nearly universal support from oncologists
No side effects
These are all strong signs of approval!
My 400K shares will be worth 30 million in the next few years if management are able to execute on this platform treatment. I see regulators as being facilitators of that outcome but the application itself must be complete before it can be submitted for review. I can wait for that to occur knowing it's simply a formality in my personal opinion.
Why would regulators impede such an amazing blockbuster treatment for the deadliest cancer which took John McCain, Beau Biden, and Teddy Kennedy?
We all want the stock to be at $50 instead of $0.50.
In my personal opinion it has been derisked. I don't know everything because I am not an insider. Management remain heavily invested in the outcome while meeting all milestones. For that reason I have no concerns.
Management are not going slow. What comparative autologous therapy was approved sooner?
If you are unhappy with owning the platform for all solid tumors then there's a solution to that problem.
Absurd to suggest that Linda Powers who owns about 100 million common shares isn't aligned with common shareholders.
Absurd to suggest that Les Goldman, who isn't part of Toucan, as well as the board, would sit idly by while Linda Powers dilutes them on behalf of Toucan.
These are conspiracy theories bereft of any evidence.
Have contractors submitted regulatory applications for personalized autologous dendritic cell based cancer vaccine before?
No!
Nothing's running behind schedule.
Your expectations are wrong.
Novocure has no product that works. That's why their management constantly dump their stock.
Once DCVax achieves worldwide approval shorts will argue Northwest Biotherapeutics isn't worth that much as a cure to cancer since there won't be any more patients left to treat. Their arguments are that ridiculous.
Long term investors don't care which month in 2023 blockbuster oncology platform gets approved.
All of this are useless distractions.
Northwest Biotherapeutics are seeking to reach a greenfield market worth trillions. Proper execution matters not satisfying the timelines of those without patience.
They reach every milestone. Maybe not when we expect but they get it done.
Bringing DCVax to market with such little debt as well as the ability to access many billions in global sales will bring Linda Powers accolades as one of the most effective CEOs in history yet you act like she's worse than Jeffrey Immelt!
Anyone who's upset with the world-class Northwest Biotherapeutics management should find another company with a platform for all solid tumors as well as Fordist manufacturing process which could scale to hundreds of billions on global annual sales.
I don't know or care if he's right on timing. The most substantive part of his article was clearly focused on manufacturing and the intricacies of how DCVax works. My takeaway was that zero barriers exist between the global rGBM and nGBM market except a large MAA application. If it's 1 million pages, 750K, 1.5, or 3 million in length really does not matter in any way as PIP and MIA clearly tell us it will be approved. If approval happens in June, July, October, September, October, November, or December of 2023 I will be very happy regardless. A few months means nothing to my investment timeline as I have no plans to sell my shares.
NWBO have been risk off since PIP. All of the banter on this forum amounts to hot air. Complete waste of time and energy. DCVax will be bigger than Keytruda yet chicken little always thinks meteorites incoming.
Northwest Biotherapeutics management delivered what no other firm has been able to achieve. They developed the platform for all solid tumors as well as Fordist manufacturing processes to scale up for global demand. This means being able to access hundreds of billions in global sales. If realized that translates to a trillion dollar market cap.
I can wait a month or two for that possible outcome. I can wait a couple of years in fact. I will never sell my NWBO shares. If some are so impatient then perhaps they shouldn't be invested in this company. An FDIC-backed CD at 5% might be their cup of tea.
For those others:
Buy Now Or Cry Later!
https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847
https://www.researchsquare.com/article/rs-2591941/v1
https://nwbio.com/glioblastoma-drug-development-summit/
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=169815671
Shorts are rabid seeking to drive the price down as they know, like longs are well aware, that MAA news should be coming soon.
Well said
They suffer from self-serving bias as their research efforts will be completely negated once DCVax achieves approval. That doesn't mean they're stupid or unable to see the value of the Phase III trial.
There's no guessing the trajectory of Northwest Biotheraputics.
The sturm und drang on social media as well as this forum are in no way representative of the unending efforts put forward every day by management.
Linda Powers seeks synergies for Northwest Bio. There are complementary technologies which may benefit us down the road. It's great to see that our world-class leadership are tireless in their pursuit of novel approaches.
That's why Swaston has the ability to store 50 billion USD of DCVax in cold storage.
That would be required for a facility producing 40 billion of vaccine in a single year.
If this comes to fruition will be more profitable than US Steel.
Great job Hoffman.
I wonder if all of the shorts do such rigorous comparative analysis before spreading lies about Northwest Bio?
Allen Turner helped develop the manufacturing process for DCVax Direct!
@AllenTurner206 You have not gone unnoticed! Your contributions as an inventor of the #DCVax-Direct TTL device are important, so thank you! @NorthwestBio $NWBOhttps://t.co/7GiYnlDFNG https://t.co/m4jxcyyoNX pic.twitter.com/kZom9tzI58
— Henry (@HenryMuney) June 8, 2022
Nobel Prize!
Time Magazine!
Presidential Medal of Freedom!
Are you ready?
https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847
https://www.researchsquare.com/article/rs-2591941/v1
https://nwbio.com/glioblastoma-drug-development-summit/
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=169815671