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Non responsive to my post.
- anyone claiming NWBO has the compassionate right to sell DCVAXL other than GBM indication is spreading falsehoods.
- anyone claiming NWBO's HALTED and NON-CONTINUED in the past L or D trials will contribute to its valuation if NWBO is acquired is spreading falsehoods, and does not know what he is talking about
- all nonrevenue biotech are in possession of intellectual property, if they didn't they would be worth zilch. There is nothing special about a biotech owning IP/Patents. Immunomedics had plenty of IP/Patents before it was acquired.
- anyone claiming NWBO will be approved for other cancer indications outside GBM without additional trials, is spreading falsehoods. Immunomedics had 2 other P3 trials just before it was bought. MWBO has NON.
- Current combo DCVAX trials are sponsored by UCLA NOT NWBO although NWBO holds the IP.
- DCVAX is NOT a platform as long as NWBO has not conducted other trials for other cancer indications based on which outcome RA's will grant NWBO approval for those other indications.
In the future, we plan to conduct clinical trials of DCVax-L for other types of solid tumor cancers, beyond brain cancer, when resources permit.
After acceptance, we're looking at 3-4 months before approval, yes?
so your estimate of NWBO's acquiring value is based on cases where the total outstanding shares of the acquiring company could very well increase by 25% to purchase a new company? Those biotech companies that have been required by issuing 25% of O/S may very well have generated $300, $400 million in revenue prior to being bought.... Do you or anyone have an example of NONrevenue biotechs that were acquired above $ 25 billion with a single approved product? Ever?
But NWBO would be the first then? Not going to happen.
Keep in mind, NWBO's business model includes the potential for all solid tumors
Additional ongoing studies are evaluating the potential of Trodelvy as a treatment for non-small cell lung cancer and other solid tumor .
In the future, we plan to conduct clinical trials of DCVax-L for other types of solid tumor cancers, beyond brain cancer, when resources permit.
Hi Mionaer
I still stand by my previous estimate
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172048843
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I am expecting Merck to pay the same for NWBO as Gilead paid for Immunomedics so $21 billion but perhaps +$3 billion extra =24Billion
https://www.reuters.com/article/us-immunomedics-m-a-gilead-sciences-idUSKBN2640V8
In my view, Immunomedics can be very 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
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No argument there :)
100% agree
And what OTHER bio stock that you owned is/was attacked by MM like NWBO? Name ONE to this extent! Wagons are circled which is fine by me. The science is irrefutable, I’ll wait thank you!
Im more annoyed by NWBO zealots pushing fantasy fairytales than by the shorts/bears spreading nonsense. The latter is way less devastating for new longs than the first. Zealot fantasy fairytales completely out of touch with reality harvest great disappointment among longs that believe the out-of-touch stories.
You gave an accurate description of how future DCVAXL trials could be conducted.
Personally, I do not believe NWBO will and is capable of ever starting any new DCVAX L trial for new cancer indications. Merck will (after it bought NWBO after DCVAXL has been approved for GBM).
From NWBO's last 10Q:
In the future, we plan to conduct clinical trials of DCVax-L for other types of solid tumor cancers, beyond brain cancer, when resources permit.
But according to you, NWBO is lying and you know better than NWBO itself?
Perhaps you should send an email to NWBO that their 10Q contains a falsehood that there is no need for other DCVAXL clinical trials for other types of solid tumor cancers, beyond brain cancer, for surely the RA will provide NWBO approval for all solid tumors without the trails NWBO itself says it is panning.
BTW, you did see that tens of patients with various types of solid tumors had received DCVax-L.
You may ask those biotechs to see if they ever cured dogs.
Why not leave NWBO for those biotechs?
Additional ongoing studies are evaluating the potential of Trodelvy as a treatment for non-small cell lung cancer and other solid tumor ..
You're apparently not following the evolution of the regulations with regards to extending indications and getting coverage for other indications based on real world evidence, for drugs once they are approved for one indication.
In the future, we plan to conduct clinical trials of DCVax-L for other types of solid tumor cancers, beyond brain cancer, when resources permit.
The market for solid tumors
My friend has been assured that as well, as I have been saying here a few times already.
He said that there is not a clear time differential between submission and acceptance in these situations,
This innovative vaccine is undoubtedly promising; therefore, the methodological issues of the DCVax-L trial deserve our attention and, possibly, another confirmation trial.
The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and fill an unmet medical need based on a surrogate endpoint. A surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit but is not itself a measure of clinical benefit. The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval.
Drug companies are still required to conduct studies to confirm the anticipated clinical benefit. If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug. If the confirmatory trial does not show that the drug provides clinical benefit, FDA has regulatory procedures in place that could lead to removing the drug from the market.
Of course, no one knows for 100% but I'm convinced NWBO will be bought a few months after approval (FDA or MHRA). Its a fact that Direct is Bosch's life work and Im convinced he wants to continue working on it after NWBO has been acquired.
Why you think he would not want to move back to the US to continue his life work is a guess. If your provided reason is retirement in Europe then that is also true also for him yes or no working for NWBO as lead investigator/CTO for the Direct trial in the future. Why would that be any different? In other words, if you think Bosch will retire in Europe then you also think NWBO will be bought. I just happen to think Bosch wants to work for Merck after they bought NWBO.
Most cut and pasted from every 10Q.
The Company is now working on preparations for an application for regulatory approval of DCVax-L. The Company is working with teams of specialized consultants on pre-requisites for the application, and on portions of the application package itself. One of the pre-requisites — obtaining regulatory approval of a Pediatric Investigation Plan (PIP) — was completed during 2022 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 with the contract research organization (CRO) and specialized consultants on preparing the Trial Master File to be inspection-ready for regulators.
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.
If you want to know the reason why the application is taking so long then read page 23 of the last 10Q its right there is nothing mysterious about it
https://www.sec.gov/ix?doc=/Archives/edgar/data/1072379/000141057823000976/nwbo-20230331x10q.htm
Bosch was presenting himself to Merck as lead investigator for the DCVAX trials Merck will conduct after they bought NWBO 3-6 months after MHRA approval.
I think its safe to say they really dont want us to know what they will communicate: the submitting, acceptance or the approval itself.
lol
Northwest Biotherapeutics Announces Filing of Application for License for Commercial Manufacturing at Sawston, UK Facility
or
Northwest Biotherapeutics Announces Approval of Pediatric Investigation Plan (PIP) by MHRA: PIP Approval Is A Pre-Requisite for Application for Approval of A New Medicine for Adult Patients
or
Northwest Biotherapeutics Announces Filing of Application for License for Commercial Manufacturing at Sawston, UK Facility
or
Northwest Biotherapeutics Announces Commencement Of Cancer Vaccine Production At Its Sawston, UK Facility
Dave = USELESS
or
That LP doesn't know left from right wrt the regulatory process, is an absolute stubborn git and is in way, way over her head.
Did he guess JAMA right? Yes. But let's be honest, he had a 50/50 shot at that. It was always either going to be JAMA or NEJM. Maybe 33% if you throw Nature in there. But still not terrible odds.
He was talking about DCVAXL not DCVAXD
Anyway sure anything is possible in the future but the suggestion is being made that they are applying for approval for DCVAXL on Tissue Agnostic basis which will not happen without additional trials.
Again, as two weeks ago, false news is being spread. Two weeks ago it was NWBO has the right to sell compassioned use for all solid tumors now its they are applying for tissue agnostic
They are not applying for tissue agnostic. This is just more unwarranted optimism to explain the inexplicable delays.
so NWBO in its last 10Q was lying when it said this:
The Company has completed a Phase 3 clinical trial of its DCVax®-L product for glioblastoma braincancer , has publicly reported the results in a peer reviewed publication in a medical journal as well as at a medical conference, and is working on prerequisites and preparations for filing an application for regulatory approval of the product.
Your friend had the right idea to run away.
I'm glad to see NWBO get any press
I agree it's not that professional, but if it reaches an audience of hundreds of thousands
Come on. You never had a drink or know people that do?
DCVAX combats cancer and is a cancer treatment. The correlation between alcohol consumption and cancer has been proven in many scientific studies. An Alcohol bar environment is not the appropriate venue to promote DCVCAX.
Anyone calling that a fabricated narrative is narrow-minded.
Someone saying that its a laughable narrative that alcohol is a cause of great medical problems among others different types of cancer and also many social problems tells you everything you need to know about the character of that person.
Les in the big Vodka show is cheap and sleazy.
Also, I remind everyone that promoting DCVAX by Les in a room filled with alcohol (alcohol increases the risk of cancer dramatically) screams of poor taste, and an immense lack of knowledge of modern health issues associated with the use of alcohol.
For a biotech company combating cancer presenting itself in a bar surrounded by alcohol just demonstrates poor taste and a complete and utter lack of respect for medical doctors combating the health implications caused by alcohol every day.
https://biztalkwithscore.com/enjoying-people-through-beer-and-food
https://www.cdc.gov/cancer/alcohol/index.htm#:~:text=Why%20Does%20Alcohol%20Use%20Raise,cell's%20normal%20growth%20and%20function.
Some studies show that drinking three or more alcoholic drinks per day increases the risk of stomach and pancreatic cancers. There is also evidence that drinking alcohol increases the risk for prostate cancer. All alcoholic drinks, including red and white wine, beer, and liquor, are linked with cancer. The more you drink, the higher your cancer risk.
even SOS two moths prediction made on APR 11, 2023 to finalize the MAA has come and go
The MAA is a complex document which includes both clinical data and the MIA. NWBO stated last December that it was very far along in preparing the MAA and noted that there were around 1.5 million pages in the document, but it still had further work to do and also had to wait for the MIA approval. I expect that it will take additional time finalize the MAA.
We'll see. Sounds like everyone on the Thermo flowers train is expecting news early next week. Maybe it finally happens. Doubt it though.
Sloppy. Les is NWBO’s Kryptonite.
Les on the Bud Beer show screams of desperation. They have nothing to show for, we are in for a long wait still.