NWBO: Once In A Decade Best Stock Investment -- Regulatory Approvals Coming! [Dec10, 2022 在第一页加了中文简述]

For those who believe in the science of DCVax-L and have done their DD. The recent days' shaking up may pose a good entry point because fundamentally nothing has changed:

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Now Germany is also confirmed: [just for my record: bought four batches of shares this morning ranging from $0.958 - $1.02.



KaOsiris Wednesday, 10/28/20 04:41:55 AM
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Revised endpoints now also updated by PEI on german part of the EU Clinical Trials Register:

clinicaltrialsregister.eu

Quote:
A. Protocol Information
A.1 Member State Concerned Germany - PEI

.....

E.5 End points
E.5.1 Primary end point(s)
The primary endpoint of this study is overall survival (OS) compared between patients randomized to DCVax-L and control patients from comparable, contemporaneous trials who received standard of care therapy only, in patients with newly diagnosed glioblastoma.
E.5.1.1 Timepoint(s) of evaluation of this end point
October 2020
E.5.2 Secondary end point(s)
The first secondary endpoint is overall survival (OS) compared between patients randomized to placebo who received DCVax-L treatment following disease recurrence, and control patients from comparable, contemporaneous clinical trials, in patients with recurrent GBM.
The second secondary endpoint, confirmed progression-free survival (cPFS), is confirmed disease progression (cPD) compared between subjects randomized to DCVax®-L and those randomized to Placebo within Study 020221.
The third secondary endpoint, PFS, is progression-free survival compared between subjects randomized to DCVax®-L and those randomized to Placebo within Study 020221.
The fourth secondary objective, OS, is overall survival compared between subjects randomized to DCVax®-L and those randomized to Placebo within Study 020221.
The fifth secondary objective is tumor response compared between subjects randomized to DCVax®-L and those randomized to Placebo within Study 020221.
E.5.2.1 Timepoint(s) of evaluation of this end point
October 2020
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GlobeCitizen, 你講的很抽象，我需要一點時間研究。

One more question, when apply DCVax-L to other operable solid tumors, can we expect the OS numbers higher than current GBM OS number.
 
No problem. Take your time.

The comparison needs to be done for the same indication (cancer). Glioblastoma multiform (GBM) (also called glioblastoma) is the deadest, most widespread form of brain cancer (account for about 52% of all brain cancers). The current DCVax-L trial is designed to compare both safety and efficacy using DCVax-L + Standard of Care in treating GBM patients with that using Standard of Care alone.

 
再請教一下。DCVax-L 用在GBM以外的其他operable solid tumor, 要如何推廣，都會是will be part of SOC，還是有可能replace part of SOC (ie replacing chemo).
 
If DCVax-L is confirmed both safe and effective in treating GBM, then the concept of DCVax-L (autologous dendritic cells pulsed with autologous whole tumor lysate) in treating various solid tumors will be approved to be both practical and feasible. To be used in treating other tumors, label extension is required which requires much less time with much higher odds of success. With some common biomarkers, some trials may take even less time to conduct, for example arouind one year.

At the time being, DCVax-L is used as an adjuvant to the current Standard of Care, and it will become part of the new Standard of Care if successful. In future, trials will be conducted to compare DCVax-L alone with the current Standard of Care (surgery followed by chemotherapy and/or radiotherapy) and the future Standard of Care (the current Standard of Care plus DCVax-L), if DCVax-L alone fares better in terms of both safety and efficacy, then DCVax-L alone will become the Standard of Care for GBM.

The above concept applies to other types of cancers as well. So it is possible that DCVax-L may become part of SOC and /or it can replace the existing SOC and become new SOC for various types of cancers.
 
Dan88 Saturday, 10/31/20 12:57:06 PM
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If you reason anything NWBO for a few minutes, it would be very clear that investing in NWBO in the next few weeks should be quite an easy and pleasant thing:

Investors should not be focused on the known unknowns: 1) whether warrants and how many will exercise and sell onto the market or not in the near future; 2) would the naked short wolfpack take advantage of such an anxiety to make thing worse, and I bet they will but there will also be buy pressure from who I don't know; and how the stock price would react on the above and beyond, will it increase or decline by how much? and 3) in the near future when exactly will top line data be released, and are there any other news which could also be released before the top line data or shortly thereafter?

In other words, the stock price may either increase or decrease with unknown intensity? Which nobody know for certain, and why anyone should exhaust own time and energy on that?

Instead, we should be focused on the knows: 1) fundamentally nothing has changed, if not better, because we have now known for sure that the whole EU is onboard with the company for its adapted SAP and endpoints; 2) despite that the share price has been halved in recent days from around $2.5 to today's $1.1 (with an equivalent market cap from about $2 billion to today's $1 billon); 3) tens or twenties of millions of warrants have exercised, sold and added to the float (now about 808 million shares outstanding), and it would be reasonable to believe that roughly the equal number of shares may have sold short by some warrant holders with their future warrants as hedge; 3) top line data will be released probably before 20 Nov, but it could happen any day before that; 4) it's most likely there may be other possible news around 20 Nov;

Most importantly 5) we now know almost for certain that the top line data will be positive -- at least the primary OS endpoint and/or a few other secondary endpoints if not all will be med with statistically significant p values, and 6) for GBM alone DCVax-L is at least worthy of $10 billion if not $20 billion if approved by the four RAs (equivalent to about $10 to $20 per share).

At the market close last Friday, NWBO traded at about $1.1 per share or about $1 billion market cap. How confident do you believe we will reach $2 billion mc ($2.2 per share), $3 billion mc ($3 per share), $4 billion mc ($4 per share), … $10 billion mc ($10 per share), and $20 billion mc ($20 per share) after top line data release within the next two or three weeks? How much will be the factor considering other indications? How much will DCVax as a platform really worth?

I don't know what you think, nor your strategy and tactics in the next few weeks in terms of buying or selling or holding nwbo stock?

But for me, it's quite simple: as long as the fundamental has not changed as it is laid out above, $1 per share (about $1 billion mc) is a strong buy. As a matter of fact, I have added shares recently in the range from $1.87 all the way down to $0.958.

Ladies and gentlemen, stop torturing yourselves, and please look at the forest not the trees!

[Despite I don't think warrant holders are dumb enough to exercise prematurely for several dimes of profit instead of dollars, the above reasoning still applies]
 
Dan88 Sunday, 11/01/20 11:51:13 AM
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For newbies and potential investors from an old timer:

Nothing is 20/20 only the hindsight.

We were insulted as bagholders when price dropped drastically from dollar land, yet we were defiant, average down;

We were insulted as bagholders when price further declined into one half of a dollar, yet we were defiant, average down;

We were insulted as bagholders when price continually declined into $0.20s, yet we were defiant, again averaged down;

We were insulted as bagholders when the price drop into teens, yet we were defiant, continued average down;

Despite the repeated prediction/assertion for the demise of our company due to depleted financing and increasingly dire financial difficulties, and likening the brilliant science being no more than some grapefruit juice, yet we were defiant, accelerating our seemingly destined endless share price average down,

because we believe in the science, the management as a whole who can bring DCVax platform into full play in the market, and stock prices will be ultimately reflecting on its fundamental value.

Most of our old timers now have held shares probably ten or even twenty times what we were initially desired for with an average share price in the range from $0.20s to slightly more than $1 because of repeated averaging downs. Yes we are all in the black now with the share counts ten or twenty times what we initially planned to have, showing a huge profit (in paper of course) much more than we have anticipated at this stage before top line data announcement, or partnership, or buyout.

Newbies and potential investors, we had been in a much harsher and more difficult situation, yet we were defiant, continued average downs in the past, and now most of us have averaged up, repeatedly. For me I have bought a significant number of shares averaging up in the range from $0.3s to $1.8, and again averaging down from $1.87 to $0.958 recently.

Now the brilliant science behind DCVax platform is about to be confirmed, the outcome of the trial is as clear as day. What have you been waiting for!

Gook luck to all, have a good rest in this beautiful Sunday, and happy investing!
 
8-k filing today: NORTHWEST BIOTHERAPEUTICS INC (Form: 8-K, Received: 11/02/2020 14:16:52)

Item 8.01.Other Events.

On May 20, 2020, Northwest Biotherapeutics, Inc. (the “Company”) reported in a Form 8-K that 233 million warrants and options to purchase shares of the Company’s common stock had expired, would expire, or had been suspended through November 1, 2020. The Company has recently received questions concerning the status of those 233 million warrants and options and so provides the following updates:

Of the 233 million total, 62 million were warrants that had expired in May 2020 or were due to expire in June 2020. Approximately all 62 million such warrants have expired as of November 2020.

The remaining 171 million were warrants and options held by a group of significant long-term shareholders and the Company’s CEO, Linda Powers. The exercise of these 171 million warrants and options was previously suspended through November 1, 2020 as reported by the Company in May 2020. Approximately 157 million of those 171 million warrants and options have now been suspended through December 15, 2020.

Furthermore, the holders have agreed to suspend the exercise of approximately 21 million additional warrants through December 15, 2020 for a total of approximately 178 million new suspensions.

Consequently, approximately 274 million warrants and options are now suspended through December 15, 2020: the 178 million warrants and options as reported here plus approximately 96 million warrants suspended earlier in connection with new share purchases.

In consideration for the forgoing suspensions, the Company has agreed to extend the term of each suspended warrant by 45 days and issue approximately 5 million warrants to the holders of the 178 million suspended warrants and options.

No material number of warrants has expired since June 2020.
 
As huge-warrant exercising fearmongering ends and expectation builds up, supported by expected multiple news in the weeks ahead, share price is now on its way back up:

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NWBO = 自體樹突細胞免疫療法

NWBO 將是醫療史上第一個落實自體樹突細胞免疫療法的公司。
 
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