My valuation estimate is for when NWBO has received MHRA approval and filed with the FDA, so not much difference, therefore my assumption and comparison are almost identical. Now a comparison can of course not be made for DCVAXL has not been approved yet.
In my comparison I did not state that NWBO will be bought before any approval, it will not.

There will be no bid on the UK alone. If the UK is approved and NWBO has filed with the FDA then the buying party will understand that FDA approval is near. However, the most likely scenario is AFTER FDA approval NWBO will be bought for around the same amount as Immunomedics was bought for.

I am expecting Merck to pay the same for NWBO as Gilead paid for Immunomedics so $21 billion but perhaps +$3 billion more
https://www.reuters.com/article/us-immunomedics-m-a-gilead-sciences-idUSKBN2640V8

In 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

so? they first have to in the future start planning the idea of going about conducting the first layout of the possibility of clinical trials of DCVax-L for other types of solid tumor cancers, beyond brain cancer, when and if resources permit.

NWBO will NEVER obtain approval for DCVax-L for other types of solid tumor cancers, beyond brain cancer for the simple reason that NWBO will not exist anymore after DCVAXL for GBM will be approved.

This is Dr. Bosch pitching to Merck that he wants to be employed by Merck and continue with all Direct, combo, and DCVAXL trials after Merck has bought NWBO at Merck.

same here even $10 bye CU lol

Les is busy selling his securities, Linda is busy with Advent and Bosch is enjoying Europe which leaves no one to day-to-day or heck week to week whipping the highly paid specialized consultants.

Im not happy about it either. But here we are.
They will get the application done just slow as mud,

no, we are in post Covid excuses era now ;)

hahaha my bad I mean the ATH from the last 3 years

Its really simple. If the MHRA approves DCVAXL, which I still expect to happen this year even before Oct 1 then the SP will reach new All-time Highs if not then you will be right

NWBO said exactly where they are in the MAA process 3 weeks ago in their last 10Q. If you want to know where they are in the MAA process read the 10Q with date 2023-05-10

https://www.sec.gov/ix?doc=/Archives/edgar/data/1072379/000141057823000976/nwbo-20230331x10q.htm

page 23

when did ANY of these events brought ANYTHING exciting or new ever? It never has ASCO won't be an exception.

Insiders may be sued civilly either by the Securities and Exchange Commission ("SEC") or by private litigants if they trade in securities while in possession of material nonpublic information concerning the issuer of the securities. They may also be charged with a criminal violation.

https://www.sec.gov/Archives/edgar/data/1164964/000101968715004168/globalfuture_8k-ex9904.htm#:~:text=Insiders%20may%20be%20sued%20civilly,charged%20with%20a%20criminal%20violation.

It would be absurd to suggest that a trade is not a trade when the securities are bought from the listed company itself.

You will be surprised how much and how many times Les spilled the beans. From who do you think Thermo got the Jama peanut butter? The only problem with Les is that he lies about timelines not so much about the events itself.

The trial is only successful when the RA's say it is and as long as NWBO does not put the test forward to the grand jury we will not be able to find out if its successful according to the RA's especially the FDA

Hahaha lol I am still chuckling and laughing love it !

I’m planning to work on preparations to get something done in the future if ofcourse the budget allows my planning to prepare.

Yours sincerely NWBO hahaha

Yup but I’m sure these patients and other cancer patients are happy to learn, just before they die, that Linda self enriched herself for the second time with a CDMO financed by shareholders but hey:

they will start In the future, to plan and conduct clinical trials of DCVax-L for other types of solid tumor cancers, beyond brain cancer and to plan to work on preparations for Phase II trials of DCVax-Direct


So there is that

Tomorrow tomorrow I love you tomorrow you are always an NWBO life time away

“It’s Easier to Fool People Than It Is to Convince Them That They Have Been Fooled.” – Mark TwaiN

If you think that simple ownership of company owning the shares of Advent legal logic and economics does not not apply to Advent or in the UK then you do you

what IP? What lease? what equipment? The property Advent leases is NOT owned by NWBO but by Huawei

America Airlines leases all its airplanes from a subsidiary (owned by Boeing) that specialized in leasing out airplanes.
America Airlines leases its real estate from large real estate investors' Pension funds.
AA uses complex software IP from Ramco systems

So Ramco/Boeing/Pension funds now somehow OWN AA?
This claim here that because some equipment is leased to Advent and paid for by NWBO, makes NWBO the owner of Advent Bio Ltd is laughable.

Linda had no problem selling Cognate for 700 million

LP will SELL Advent together with NWBO and its Toucan who will receive all benefits from Advents success.

No I dont blame him either. Everything that you just wrote is correct, and to make matters worse.

They enrich themselves with a sickening 20% of outstanding shares and have shareholders finance the CEO's own private CDMO. And then the hardcore fans praise and cheer because Advent is now "the most advanced CDMO in the UK, servicing $NWBO and now checking all license boxes for GMP Manufacturing: MIA, MIA(IMP), MS, HTA, and GMO" And you know what they are right Advent is one hell of an accomplishment. However, NWBO shareholders will hardly benefit from it and did pay for founding Advent. Lindas talent is clearly at starting running and selling CDMO's and having others pay for it.

He is still in the top 5 largest shareholders

I remember that and I sure as hell hope and really expect that this time its different. If not then we are F@@@.

One in my group had enough and is selling large portion (not me)

yup but they keep on calling it NWBO's CDMO whereas the owner is Toucan, not NWBO. If NWBO owned Advent we would now after MIA be at $ 3 a share.

The fantasy story now is its better for NWBO to start and fund a third-party CDMO from scratch than to contract an existing third-party CDMO with tens of years of experience 4 billion in revenue and 21000 employees because somewhere another biotech got rejected by the FDA.
hahahaha

desperate propaganda trying to explain why Toucan needed its own CDMO paid by NWBO shareholders.

no you really didnt explain anything with your Tesla example. Telsa is an eCAR manufacturer NWBO IS NOT a CDMO Do you understand the difference?

You stick with your opinion that CRL the go-to manufacturer for nonrevenue biotech with 21,400 employees 150 locations and $4 billion in revue is a loser and therefore its better to start your own CDMO from scratch, fine with me.

According to you, all biotech managers dont understand how to build a biotech except the brilliant LP. Heck, you have to justify something for the dilution that shareholders have been through in order to pay for Linda's private CDMO.

from Seeking Alpha article Oct 8, 2022

if this company did things the normal way, then this data would make for a superb investment. But they don't do anything in the normal way, so I don't know. I can interpret the data, I can understand that the people behind the data have excellent pedigree. I cannot for the life of me interpret what NWBO is going to do. And that, my friends, remains the problem.

That pretty much sums things up

https://clinicaltrials.gov/ct2/show/NCT00045968

and
https://www.prnewswire.com/news-releases/nw-bio-announces-settlement-with-cognate-bioservices-resolving-past-matters-and-providing-for-restart-of-dcvax-direct-production-300857384.html

If you believe that there is less risk in building a CDMO specialized in manufacturing and developing cell therapy from scratch then there is, at least until some years after approval, working together with Charles River Labs a company with 21,400 employees and highly specialized in products and services to help expedite the discovery, early-stage development and safe manufacture of novel cell therapy drugs and therapeutics. And if you believe CRL would have been eager to butch this up and mess up its reputation as the go-to partner for biotech companies, then you do you.

Also, you still have not explained to me why in 2023 CRL is good enough according to LP at the ASM but was not right after data lock?

And I dont know why ImmunityBio messed up their manufacturing with their third-party CDMO but there is no other nonrevenue biotech company in the world ever that finances the private CDMO for their CEO instate of outsourcing the drug production to a partner such as CRL.

There were no issues with CRL when they produced DCVAXL for the trial. Also if CRL is such a risk then why would LP state at the last ASM she plans to contract them for the US?

Besides Advent and CRL are BOTH third-party CDMOs to NWBO.
Building a CDMO is much more riskier then working together with CRL to get MIA

personally, I do not believe that management has stalled the request for approval because the regulatory agencies told them to wait for combo trial data. I think that data will have no influence on the RA's decision.

I am as I said convinced Linda hold up the submission for a request of approval to first build her own personal CDMO financed by shareholders and owned by Toucan which is exactly what happened and we know now as Advent Bio. So pure and simple greed at the expense of NWBO shareholders.

and no Im not selling any shares. I will sell after MHRA approval or FDA approval if submitted.

most of the core and important decisions NWBO management took over the years have never been put up for vote, but always were a fait accompli to shareholders. If NWBO had for example directly asked shareholders if they are ok with financing Advent Bio as a private Toucan CDMO holding then 90% would vote no.

Had Linda decided to stay with CRL and contract CRL from the beginning (as what she said at the ASM they are planning todo this year 2023 and perhaps and hopefully this already happened), then this would have cost far less. After the CRL contract, the RA's could have approved DCVAXL based on the manufacturing contract with CRL, and within a year after data lock stock price would go to $ 15-$20 then sell 100 million shares THEN build a CDMO OWNED by NWBO AND start new trials.

This would have been the best path forward after data lock.

The reason why she did not is that IF DCVAXL were to be disapproved by the RA's then at least she can keep her own CDMO and sell it exactly as she did with Cognate.

And THAT is the real uncomfortable truth.

The reason for this is that Linda had to build her own private CDMO with shareholders' money. Had Linda stayed with CRL and focused on approval after datalock then we would have already been approved 2 years ago.

agreed

NWBO will not exist anymore in 20230. NWBO will be bought this year or the next.
I hope and expect Merck will continue with Direct.

misinterpreted what the FDA means when it says you can't cherry-pick external trial(s) data and compare it to your own data. It’s to avoid bias. NWBO didn't do that

Also it is misinterpreted what SOC is, its NOT a trial. If a GBM patient now in any hospital gets treated for GBM with SOC he/she is not being treated with a trial treatment.

For you:

.

hahahahaha if its a trial data it can not be SOC hahahahahaha

Its EITHER a trial OR SOC cant be both





SOC data is NOT pre selected trial data

Everything you quote is the FDA trying to warn Sponsors to NOT select an externally controlled trial to compare its trial data with to prevent biased and cherry-picking. Jeez grammar school FDA regulations here ex. Do you really think that Dr Liau does not know that?

again NWBO did not compare the trial data against a completed trial whose outcomes are already known., you are making this up. NWBO compared its data against SOC.

First of all, you, as I have said, posted a falsehood when you said this:

That is not what the FDA Guideline says, the FDA Guideline says You turned seldom into never.

More important the Guideline also says this
A. Survival is considered the most reliable cancer endpoint, and when studies can be conducted to adequately assess survival, it is usually the preferred endpoint.
B. But NWBO did not compare its data to externally controlled trials. NWBO compared its data to present Standard Of Care SOC.

Third C. "Demonstration of a statistically significant improvement in overall survival can be considered to be clinically significant if the toxicity profile is acceptable <which in the case of DCVAXL is, being zero> and has often supported new drug approval and as The Danish Dude pointed out ."

Confirmatory evidence could include, for example, adequate and well-controlled clinical
investigations in a related disease area, certain types of real world evidence20

Real-world data are data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources. Examples of RWD include data derived from electronic health records, medical claims data, data from product or disease registries, and data gathered from other sources (such as digital health technologies) that can inform on health status.

Real-world evidence is the clinical evidence about the usage and potential benefits or risks of a medical product derived from analysis of RWD.


https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence

The FDA has never said that, thats a blunt falsehood. Its not for nothing that you never quote FDA regulations with a link. Why is that?

I do see that as well, but I do hope its for the reason of DCVAX production and not because they are starting to get other third-party clients assigning Adventbio to other cell therapy Development and Manufacturing contracts.

In other words I hope we are not seeing the same thing happening here as we did see with the hiring at Cognate.