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It always amazes me how the zealots know everything better than reality and the real world
https://www.investopedia.com/terms/a/activist-investor.asp
What Is an Activist Investor?
An activist investor, typically a specialized hedge fund, buys a significant minority stake in a publicly traded company in order to change how it is run.
https://www.thecorporategovernanceinstitute.com/insights/lexicon/what-is-an-activist-investor/
An activist investor is a person, or a hedge fund, who buys a significant stake in a publicly traded company to change how it is run and managed.
https://www.forbes.com/sites/emilywashburn/2023/02/03/whats-an-activist-investorand-how-do-they-exercise-so-much-control/
Activist investors, who purchase minority stakes in companies to change them for a number of possible reasons
But Bigger wants to change the way the company is run because he is happy as a puppy the way it is run.
exactly
Off course they want to slow down and enjoy their last years and not start hiring a sales team, designing new trials and so forth. All above demands a lot of work, doubt they want to do that.
the answer is rather simple.
The 1.7 million pages are much larger than the usual submission to the MHRA because its not just for the MHRA it is also for the FDA and EMA..
If it was only to request approval in the UK then the number of pages would be way less than what they are now.
Ofcourse Bigger is frustrated. If you say this "we will not hesitate to move to an activist position to unlock the value if required." Then you are frustrated and are considering becoming more vocal and outspoken after MAA has been submitted.
The zealots denying this, do not want to hear the reality and that this management is not capable of unlocking the value of NWBO. Thats why NWBO will be bought after FDA approval.
lol everyone would be selling their shares for 10$ faster than you can say Holiday on Hawaii
If Regeneron were to invest in NWBO then after the first investment they will buy the whole company probably after FDA approval. If they would first invest a small amount then that already will soar the stock price and I say let them buy NWBO asap.
Since Regeneron's market cap is $ 80 billion and they will not spend more than 25% of their present market cap with a max buyout price of $20 billion. I have always predicted NWBO would be bought for $24 billion.
In any case, I will be more than happy that Regeneron offers $14 per share rather today than tomorrow.
Question:
Mike, are you still bullish on $NWBO overall? The MAA seems to be taking longer than most thought. Have you spoken with management recently and do you have concerns? Or is it all in due time?
Answer:
Of course
Explanation:
- Still bullish on $NWBO overall: Of course
- Have you spoken with management recently? Of course
- do you have concerns? Of course
- Or is it all in due time? Of course
Why be involved with any now?
Legally when shares are added to the O/S by exercising warrants its dilution and not prior to that. Thats why the OTC will not count the number of warrants issued as O/S. Also it's very common for warrants (as with call options) to expire without shares being bought at the exercise price. In the case of NWBO that almost never happens since Les keeps extending the warrant time. There have been NWBO investors in the past who saw their warrants (which they bought at the open market) end worthless after their warrantdate had come to pass and thus did not buy the shares from NWBO's authorized shares stack which then thus did not increase the O/S.
"Market feeling wise" if you will the number of warrants is already incorporated into the number of O/S.
lol I know thats what I love todo hahaha If you state NWBO facts it makes you a short and bear hahaha
I was talking about the past and present :)
If I was NWBO CEO I would have already started a Tissue Agnostic Drug
Development trial 4 years ago.
anyone who thinks that NWBO has a shot to get approval for Tissue Agnostic should for 15 minutes stop pump nonsense and read the Tissue Agnostic Drug Development in Oncology Guidance for Industry
https://www.fda.gov/media/162346/download
It stands out that many here are fine with shadows of anomalies as evidence of nonsense speculation.
The Tissue Agnostic Drug Development in Oncology Guidance for Industry clearly stipulates that
"Sponsors should provide justification regarding prior therapies and the intended patient population prior to initiating studieS (plural) intending to support a tissue agnostic indication"
"sponsors should provide justification that an appropriate spectrum of specific cancer types and appropriate spectrum of biomarker-defined cancers (e.g., based on the different fusion partners) is included in clinical trialS and that the efficacy results are not heavily weighted towards a specific cancer type or specific biomarker-defined tumor."
"A tissue agnostic oncology drug indication should address the needs of patients of all ages therefore, sponsors should consider in their development plan how they will develop a drug to address the needs of children with the targeted molecular alteration."
I am not saying you’re a short,
Yes Im very bullish on NWBO apart from the never ending timeline it is taking.
Although some here think Im a short and a bear in cahoots with AF because I estimate NWBO being sold after FDA approval at "only" 24 billion which is a huge number for a nonrevenue biotech.
In any case the point is that I see all signs directed at NWBO being acquired, again after approval hopefully after MHRA approval but probably after FDA.
No I did not I based it on what Gilead paid for Immunomedics. Immunomedics as a biotech was very similar to NWBO's
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172048843;;
Saturday, June 03, 2023
n my view, Immunomedics can be well compared to NWBO
Just like NWBO Immunomedics was an almost zero (20 million) revenue biotech
Just like NWBO Immunomedics claimed to have a platform for solid tumors
Immunomedics catered to a much bigger market (Immunomedics Trodelvy is for breast cancer) than NWBO however with many more competitors.
Just like NWBO Immunomedics claimed Trodelvy can be used for all solid tumors
Just like NWBO Immunomedic had not started any meaningful P3 trial to provide evidence that Trodelvy is actually effective for all solid tumors
So with 1.5 billion shares O/S (1.1 now + 100 million max more dilution + 250 million for NWBO management) that would get us to around $ 16 per share buyout
what I find borderline insane laughable is that the zealots label you as a short and bear or worse in cahoots with AF if you predict NWBO will be sold for 24 billion.
Its hilarious
what is equally nuts is saying DCVAXL does not need the assistance of a large team to cater to over 30,000 GBM patients worldwide. Les can do all that by himself hahahahaha
You know why it would be good if NWBO were to be sold asap? Because that would mean many Zealots can start working their way back to sanity reality and have the money for a long recovery therapy.
No AF blocked me but you do realize that 24 billion is more money than $ 600 million.
You do know that right?
You understand 600 million is a lower number than 24 billion?
You understand that 24 billion is a higher market cap than 600 million you do get that?
mmm ok ask someone else to explain it to you then
risperidone (Risperdal), quetiapine (Seroquel), olanzapine (Zyprexa), ziprasidone (Zeldox), paliperidone (Invega), aripiprazole (Abilify) and clozapine (Clozaril).
10x a day each max dose
yes they will for $24 billion or around that number
Im not employed by NWBO neither are you. Non of us are on this board.
Here check this link every day
https://www.linkedin.com/company/northwest-biotherapeutics/about/
and as long as you are not on the employment list, you are not an NWBO employee.
And remember, check every day
Say it every day: Im not an NWBO employee. Get better soon.
You don’t need a sales force for that.
I have already previously provided what I think NWBO will be sold for. I never mentioned $3 per share thats your estimate.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172048843;
Saturday, June 03, 2023
"I am expecting Merck to pay the same for NWBO as Gilead paid for Immunomedics so $21 billion but perhaps +$3 billion more." There will be a serious number as soon as there is approval. That simple.
What's he supposed to say, "well, good question, we haven't gotten any serious offers, but we do have a company for sale sign listed,
https://www.uclahealth.org/providers/linda-liau
Meet Dr. Liau
Linda M. Liau, MD, PhD, MBA
Brain and Tumor Neurosurgery| Neurosurgery
Call Linda and tell her she is misinformed.
What does your post have to do with the contents of my post... ??
100% agree. As I have said before I dont want to be involved in any biotech anymore after this :)
They are struggling with the MHRA application they will get MHRA approval and let's see what the SP will do then. Could very well be I sell then.
There are so many flaws in the going after it alone story I can not even begin to tell you. The story foretold by Les that because they know 90 GBM surgeons/MDs in the US they can now somehow easily sell DCVAXL for GBM in the EU/US/Canada and the UK is right out laughable.
Just to give you an idea
There are 3,700 neurosurgeons who work in more than 5,700 hospitals in the U.S.
there are 13,146 oncologists engaged in active patient care in 1638 oncology practices in the US
There are 14,000 cases of GBM in the US
there are 16,837 oncologists engaged in active patient care in 2090 oncology practices in the EU
There are 13,200 neurosurgeons in the EU
There are 22,000 people per year in the EU diagnosed with GBM
Im not even going to mention Canada, Switzerland, and the UK.
But sure their network of 90 GBM surgeons/MDs in the US will suffice to cater to the US/EU/UK and Canada markets. Absurd. And no DCVAXL will not "sell" itself. No product does. And even if it would "sell itself" who will pick up to phone when Dr Schwarz from Frankfurt calls to get information for its 2 patients? Les? hahahaha come on
Look if they wanted to "go after it alone" they will need a marketing/sales/compliance/management/administration/patient care of at least 300 to 400 in specialized staff. It will cost them many years to have any kind of meaningful network and impact on thousands of hospitals and MDs. Not to mention that this specialized team will also have to negotiate with hundreds of insurance companies and dozens of EU countries to get DCVAXL reimbursement.
They have not even begun to plan to start thinking about this.
And even if NWBO would want to build a team of specialized staff then it would not only take them many years (three double that for this senior unexperienced dumb as a horse ars management) but hundreds of millions in USD per year. Such investment will never be earned back with one cancer treatment only. That is the reason why big pharma with existing networks and existing marketing/sales/compliance/management/administration/patient care teams and departments are able to launch new cancer treatments profitably. Their teams with hundreds of experienced staff are not just selling ONE cancer treatment but many, something Les already said they are not planning todo.
To sum it up.
One team of hundreds of marketing/sales/compliance/management/administration/patient carewill NOT be profitable to sell ONE cancer treatment. Let alone that NWBO is in no way shape or form capable todo so.
NWBO will be BOUGHT after FDA approval and hopefully before that.
Ofcourse he would never admit that they are going to get bought. It has always been NWBO's official policy that they are going to bring DCVAXL to market until of course they get an offer they cant refuse. This is common practice with every nonrevenue biotech they are going after it alone until they are being bought. As if NWBO would shout from the roves that they are for sale.
Also, bringing DCVAXL for GBM to the market would cost hundreds of millions which they dont have even after FDA approval. His notion that they have an "excellent" infrastructure to sell DCVAXL L is laughable they don't have that.
They will be bought after FDA approval.
What is interesting is that they are now double-checking everything before submitting phase. I expect the MAA to be submitted with the MHRA this month and accepted half of August.
exactly. this whole going after it alone is absurd and rediculous
All of this combined with the fact that they haven’t started hiring on the commercial front tells me that the MHRA approvals and reimbursements are at least 9-12 months out.
If they were really close to MAA submission and acceptance, I would rather wait a few weeks and then come to the show to add more visibility to that milestone.
when these "issues":
Post-COVID difficulties continue to impact the Company’s programs and operations, due to backlogs in the supply chain, at clinical trial sites, and at regulators. The supply chain backlogs include service firms and also vendors and suppliers of a wide variety of items, ranging from major equipment to particular reagents required for the manufacturing process. Shortages of certain key materials and supplies have also occurred. The clinical trial site backlogs involve delays for various clinical trial follow-up matters, such as queries and additional documentation. With regulators, committee processes and regulatory processes were focused on COVID matters during the pandemic, and a substantial backlog of non-COVID matters accumulated. The Company is hopeful that the various backlog circumstances will improve in 2023
"We are in the process of finalizing our applications. First one will be to the MHRA in the UK"
Can we finally put this other nonsense to bed? It's not Orbis. It's not already been submitted. It is just an application to the MHRA (the MAA) and nothing more, which is what I have been saying all along.
I never claimed it was. Stop putting words in my mouth
thats irrelevant flipper. You are misinformed. If the FDA will provide a biotech the green light to conduct a trial, pilot study or whatever experiment with drugs on living humans then also have the right to initiate/provide compassionate use for those indications. And those past compassionate use was what Bosch was referring to last ASCO.
NWBO does NOT have the right to compassionate SELL indications other than GBM n or r which was the subject.
Again know your RA regulation.
I already said previously that Bosch here is referring to NWBOs other now halted DCVAXL past phase 2 trials of many years ago. While these phase 2 trials were ongoing they were given the RA right to offer compassionate use for these other indications. NWBO left those trials by RA regulation the sponsor then also no longer has the right to SELL compassionate use for the cancer indications the sponsor halted the trial of.
Thermo's brother has been treated with DCVAXL for another indication than GBM years ago, while the DCVAXL phase 2 trials were ongoing.
Therefore the conclusion that NWBO NO LONGER has the RIGHT to sell DCVAXL for other indications than (r/n) GBM is CORRECT. That's common Biotech FDA/EMA/MHRA aka RA knowledge.
Also is it equally INcorrect that even IF NWBO would not have left/halted the Phase 2 trials for other DCVAXL trials they do NOT have the right to SELL compassionate use for other indications they are not running a trial for.
we will soon find it out be well
There were no DCVax-l phase ii trials on lung, liver, pancreatic, ovarian or liver cancer. You were misinformed.
and that is what Bosch was referring to among others.
These trials are all halted/stopped.
second one
https://immuno-oncologynews.com/dcvax/
DCVax-Prostate
DCVax-Prostate is designed to treat patients with late-stage prostate cancer that is not treatable with hormones. Because this type of cancer has spread beyond the prostate, there is no distinct tumor, cancer cells that can be harvested to make DCVax and DCVax cannot be injected directly into the tumor. To make DCVax-Prostate, prostate-specific membrane antigen (PSMA), a protein found in almost all advanced prostate cancers, is produced in the laboratory and used to “educate” the patient’s dendritic cells.
There were no DCVax-l phase ii trials on lung, liver, pancreatic, ovarian or liver cancer. You were misinformed.
Northwest Biotherapeutics Conducting Ovarian Cancer Clinical Trial With DCVax(R)-L at University of Pennsylvania First Patients Enrolled and Being Treated
There were no prior phase two trials for DCVax-l for lung, colon, pancreatic and liver cancer. You are misinformed.
I agree with your post however reality has shown that big pharma are NOT prepared to pay extra for could have perhaps in the future treatments. They base their businesses model, future cash flow and thus acquisition price on approved or nearly approved treatments.
After DCVAXL has been approved for n and r GBM treatment in a buy out it ONLY has DCVAXL for GBM to offer and nothing more. No ongoing trials no other approved treatments. It’s all in Linda’s watch. she should have kept the other L and D trials going like a normal biotech would have but she had othe priorities such as building CDMOs for personal gain.
However when all is said and done 23 billion buy out is just fine with me.