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Exactly
Ooh no no silly me can you please send me the link with the top line results of the studies you mentioned? Thanks
Not so
I will not dare to contradict a member of the Kim Jong-un family Royal highness WE
lol
The number of authorized shares at present is 1.2 Billion which, except 50 million shares, are all spoken for via the Sweetener Warrants. Then there are the 250 million shares of common granted to NWBO management via Warrants and stock options.
Then there is the C prefs of I estimate 25 million in common have been sold.
Totalling 1.45B in common of shares that need to be bought off in a BO if a BO were to take place coming Monday. Now of course if they keep selling C prefs of which another 225 million common shares can be created the total number of common shares which need to be bought off would get to around 1.7 Billion common shares.
I believe the BO will be at around 25B so divided by around 1.7billion of common shares = $ 14 per share
I will you too horse have a wonderful weekend
Pies and skies are dreams of many. :)
I will take the Buy Out at $14 or a little less before that per share between now and 6 months which is still an incredible return :)
Retailers will not be the only ones buying NWBO, but its your prerogative to think that. Also, DCVAXL will be approved saying that it will not be approved as you assert is completely out of grasp with reality.
But go ahead keep shorting NWBO and see what happens.
there is/are (Nov 19, 2022) NO other P3 readout of (any) other DCVAX trials(s) on which a request for approval coud be submitted outside the successful GBM trial period.
second. There are NO active DCVAX trials at present.
Suggesting anything else would not be in balance with reality. The market/ BP acquiring NWBO judges NWBO valuation based on reality not on what perhaps may come.
the market only rewards reality and at present the prospect of an influx of near-future cash. The reality is that even for GBML L with solid evidence after 2 days of trading we still sit at only one billion in MC. Apparently mr Market wants to see the prospect of cash influx (BO, approval, royalty sales, JV whatever), thats how the market for biotech works these days. You dont need to be a "Doctor" to make that simple observation.
DCVAX has NOT provided ANY final evidence it works for other cancer indications outside GBM until then the market and a BP buying NWBO will NOT value it as such.
If what you said would hold any merit then we would not sit at 1 billion MC WITH overwhelming evidence for GBM. But here you dream of valuations with no evidence or approval of the outcome of nonexisting trials.
But hey if you want to value NWBO at 100 billion based on GBM approval alone because perhaps all solid tumors, its your dreamworld I will stay in reality.
I thought you repeatedly said you are a seasoned investor? yet here you paint unrealistic pictures,
As the famous trader Peter Brandt said "Im not looking for the bottom but the juicy 60% in the middle".
The future looks good for DCVAX and thus (what I think) will be Merck buying NWBO thus Merck reinitiating the other DCVAX trials. I believe all future DCVAX trials will start completely at new against new protocol ex-proof for safety (of course).
Yes I know about the other paused DCVAX trials I have been invested in NWBO for many years. What is your point? Have we seen Phase 3 read-out data from those other DCVAX trials from which approval COULD follow? No? Then it won't matter and my point remains.
ok agreed. Now about the valuation. DCVAX will not be worth more than the worth for GBM treatment until it has been proven to be efficient for other cancer indications and not before that. Heck Im sorry and regretful to say, since I have a boatload of NWBO shares, that apparently mr Market with JA in hand with evidence for an effective treatment for GBM, so far, does not appreciate DCVAXL more then where are we a little over $1 billion MC... Let alone without evidence for other cancer indications.
The reality of the markets is, as I have warned here about a few times and got scolded over here, is that the market for biotech has, since 3 years, started to care less about evidence of efficiency and much more about direct cash influx such as news of FDA approval, BO, royalty sales, etc. Im not making that up see the market in the known about the JA at close on Friday.
I other words ALLL longs here (including myself) could have better waited until AFTER JA and bought in Friday at close and be better of than years of waiting... Pfff
Im sorry but that's not how it works. Every MD will refer to the SOC when it comes to a cancer indication (for example Trodelvy for metastatic triple-negative breast cancer) since that's what protocol dictates and what medical literature refers to. Also all MDs especially oncologists will almost never refer to a nonproven treatment which in fact DCVAX L is for all other solid tumor indications outside GBM.
Second, the insurance companies will NOT reimburse alternative non-approved treatments. Yes some MDs may refer to medical trials with exciting new treatments but as long there is no running new P3 trial for DCVAX there will no be referring.
Btw from what I have understood. NWBO stopped producing DCVAX for other indications outside GBM so there is that.
40B buyout seems low considering the above
40B buyout seems low considering the above
NWBO is not lying in saying they were blinded, But that does not make the SAP change proper when it was based on knowledge the original primary endpoint probably failed.
LOL. Then when it get's approved. "Well it is approved, but it is too complicated, or too expensive, or patients will not want it"
yup. His last slider of hope is that somehow the FDA will dismiss the amended SAP submitted years ago (never mind that such would be a material event, if it had been dismissed by the FDA) based on a legal technicality that has nothing to do anymore with the science now its just a legal BS argumentation
yes but his last straw argument is now that IA showed that endpoints needed to be changed in order to get efficiency on new endpoints so they changed the endpoints, which will not be permitted by the FDA. If that was the reason, then still its absolute BS since the FDA permits endpoint changes ALL the time even if the reason is on blinded IA. Ex last hope is FDA will not approve the trial because the bases on which the endpoints were changed are corrupt. Complete nonsense.
There are many good articles on how to change endpoints in a medical trials.
Why do you keep fighting FDA regulation? The fact is the FDA permits endpoints to be changed prior to data lock and even after data lock. That's just reality why is that so difficult for you to grasp? I really dont get it. I can disagree with many regs and laws but what will that bring me nothing. I disagree with capital gain tax ok now so what, will that now somehow remove that rule for me?
A blinded IA does NOT legally prevent a biotech to change endpoints /to amend SAP. Where do you come up with this stuff?
serious question, hopefully, you will answer. Do you think you are smarter than the 50+ MDs signing off the JAMA article? Do you believe these MDs made some serious mistakes?
https://edhub.ama-assn.org/jn-learning/audio-player/18738384?resultClick=1
Linda Liau CONFIRMS changing of primary endpoint to mOS AND use of external controls was modified in the SAP BEFORE unblinding. End of story!
Who gives a flying ... if they got the hint from an IA in 2014 or 2015 to change endpoints. They changed the endpoints as how the FDA and EMA require endpoints should be changed and they, thus played it by the book. The amended SAP got accepted by the FDA something you never wanted to accept but something you have been proven wrong for as well so again who cares about IA you are reaching for straws.
In here there is
https://www.prnewswire.com/news-releases/northwest-biotherapeutics-reports-positive-top-line-results-from-phase-3-trial-of-dcvax-l-for-glioblastoma-301681901.html
Northwest Biotherapeutics Reports Positive Top-Line Results From Phase 3 Trial of DCVax®-L for Glioblastoma
Northwest Biotherapeutics Logo. (PRNewsFoto/Northwest Biotherapeutics, Inc.)
NEWS PROVIDED BY
Northwest Biotherapeutics
Nov 17, 2022, 12:36 ET
SHARE THIS ARTICLE
Both Median Survival and "Long Tail" of Extended Survival Were Increased In Both Newly Diagnosed and Recurrent Glioblastoma
Results Featured In JAMA Oncology Peer Reviewed Publication
BETHESDA, Md., Nov. 17, 2022 /PRNewswire/ -- Northwest Biotherapeutics (OTCQB: NWBO) ("NW Bio"), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, today reported that in its Phase III clinical trial both median survival and the "long tail" of extended survival were increased in both newly diagnosed and recurrent glioblastoma brain cancer patients treated with DCVax®-L. The trial has met both the primary and the secondary endpoint under the Statistical Analysis Plan for the trial.
The trial results were reported today in a featured publication co-authored by more than 70 physicians from leading institutions across the U.S., Canada, U.K. and Germany, in the peer reviewed cancer journal JAMA Oncology, entitled "Association of Autologous Tumor Lysate-Loaded Dendritic Cell Vaccination with Extension of Survival Among Patients with Newly Diagnosed and Recurrent Glioblastoma". https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847
The Company believes this is the first time in nearly 20 years that a Phase III trial of a systemic treatment has shown such survival extension in newly diagnosed glioblastoma, and the first time in nearly 30 years that a Phase III trial of any type of treatment has shown such survival extension in recurrent glioblastoma.
Ms. Powers, CEO of NW Bio, commented: "We are excited to see the meaningful survival extensions in glioblastoma patients treated with DCVax®-L in this trial – particularly in the "long tail" of the survival curve, where we see more than double the survival rates as with existing standard of care. With well over 400 clinical trials for glioblastoma having failed over the last 15 years, it is gratifying to be able to offer new hope to patients who face this devastating disease."
"It is especially encouraging to see these survival extensions with a treatment that has such a benign safety profile" Ms. Powers continued. "Over 2,100 doses of DCVax-L were administered during the trial, and we found that the adverse event profile was not meaningfully different than with standard of care alone. DCVax-L is also quite simple for the physician and patient: just an intradermal injection in the upper arm, 6 times over the course of year 1, and then twice a year for maintenance thereafter."
Glioblastoma is the most common and most lethal form of primary brain cancer. Standard of care (SOC) treatments have been virtually unchanged for nearly 20 years. With SOC treatments, patients typically survive for only about 15-17 months from diagnosis, with the tumor recurring at about 6-8 months from diagnosis and the patients typically surviving for about 7-9 months after recurrence. Five-year survival from diagnosis is only about 5%.
In the Phase III trial of DCVax®-L, median Overall Survival (mOS) for newly diagnosed GBM patients (n=232) was 19.3 months from randomization (22.4 months from surgery) with DCVax-L vs. 16.5 months from randomization in the controls (HR=0.80, p=0.002). Survival at 48 months from randomization was 15.7% vs. 9.9%, and at 60 months was 13% vs. 5.7%. For recurrent GBM (n=64), mOS was 13.2 months from relapse vs. 7.8 months (HR = 0.58, p<0.001). Survival at 24 and 30 months post-recurrence was 20.7% vs. 9.6%, and 11.1% vs 5.1%, respectively. In newly diagnosed GBM patients with methylated MGMT, mOS was 30.2 months from randomization (33 months from surgery) with DCVax-L (n=90) vs. 21.3 months in controls (n=199) (HR=0.74, p=0.027).
From a safety perspective, out of more than 2,100 doses of DCVax-L administered during the Phase III trial, there were only 5 serious adverse events that were deemed at least possibly related to the treatment. There were 3 cases of intracranial edema, 1 case of nausea and 1 case of lymph node infection.
DCVax-L is a fully personalized immune therapy made from a patient's own immune cells (dendritic cells) and antigens (biomarkers) from a sample of the patient's own tumor. A multi-year set of doses is produced in a single manufacturing batch, which takes 8 days. The product is then stored frozen in individual doses, and is "off the shelf" throughout the treatment regimen. The doses are stored centrally and simply taken out of the freezer and delivered to the physician when needed for the patient's next treatment.
Dr. Marnix Bosch, senior author on the publication, concluded "This DCVax-L trial, at 94 hospitals in 4 countries, involved the teamwork of a large number of dedicated investigators. Publication of the results in the prestigious, peer-reviewed journal JAMA Oncology honors this teamwork and demonstrates how the field can move forward with novel therapies and innovative clinical trial designs."
The Company is currently working on preparations for applications for regulatory approval of DCVax®-L.
Flaskworks certification ....
Yup
More laughable BS spread on Twitter and this website:
NWBO will get to the same market cap as Merck after TLD+JA+MHRA lol
NWBO will be granted approval for ALL solid cancer indications based on the GBM trial data right after GBM approval because murcidencel is a cool name and something about the science haha
NWBO will sue all shorts for billions
Misinformation
There are no 1.2B naked shorts.
what I disagree with you on is that the OFFICIAL TLD (yes a world first invented by NWBO), will green light new medium seized private equity institutions to start buying the stock. The reason being is that in that case, the DD department of those PE firms can tell the buying stock traders on another department that the biotech itself has confirmed Topline which thus then removes much more risk than before.
This will then of course increase SP for they will buy in large quantities.
I agree with what you are saying however a peer-reviewed journal means two things. Scientific validation and an incredible PR boost for the drug both are very important to BP.
I personally believe there will be a BO after MHRA has approved DCVAXL Murcidencel. After Murcidencel has been approved means that the production capacity has been approved for without a BP has nothing. Therefore Im, as I have said here a few times before, Toucan will sell Advent to that same BP as well. BP will buy NWBO and Advent in a package deal.
I’m still very confident we’re getting to a deal in a reasonable amount of time. That’s at least where my bet sits.
They also added another workstream to their prerequisites for application for approval.
I often disagree with you but you are correct here.
Its very very clear (and NWBO has for the first time laid this out in detail which I think is commendable) that its going to take many months before all of the 10 milestones are achieved before NWBO can submit a request for MAA.
It is, on the other hand, an outrage that we for the first time learn of this lengthy (and costly) production procedure
Have a great one Davey!
I understand. What I was saying is. Had they (Toucan) not sold Cognate (financed with NWBO shareholder's proceeds) then they could have added the evolving technology after 2014, and 2015 aka Flaskworks on existing production within Cognate. Now after Cogante was sold they decided to start all over which we call now Advent. Keeping Cognate and then adding new technology would have been faster than rebuilding from scratch aka Advent.
Lol they (Toucan) did put a lot of time and effort in production in the past sold and started all over again aka Advent. Brrrrrrr illlliant
I mean your post suggests that all of this is so easily done, why hasn't anybody else done it. Hint hint.
DD, respectfully did you think a team as small NWBO, would *not* hire consultants for huge tasks like the BLA?