Replies to post #425650 on NorthWest Biotherapeutics Inc (NWBO)

[Idunno]

Thoughtful post, Umibe. (Not surprisingly, followed by noise.)

[pgsd]

Totally agree, well said.

[kabunushi]

Kudos on a hyper-comprehensive and wise answer! I appreciate especially that you go well beyond the simplistic and foolish way-too-often seen blame and hate LP game of '(love LL) hate LP (and LG)'. FWIW, I hardly love either LP or LG, but if NWBO succeeds I know that they will deserve a lion's share of the credit for mostly having made it happen through their blood, sweat, and tears among a few other tireless workers.

Anybody who, like yourself, has served as corporate upper management would likely easily attest to the above paragraph. It's unfortunately all too easy for all and sundry to play the hate game and believe that LP is a wicked dictator who decides everything all on her own and willfully ignores the advice of her many expert advisors, which is a nonsensical caricature of reality. It's like the ignoranti who say that because NWBO explains little about what they are doing, that 'LP, LG, and everybody down the line at NWBO are sitting around doing nothing'. Of course, that is clueless idiocy.

As usual, you write thoroughly and eloquently which FWIW reminded me of the Japanese proverb 'chinmoku wa kin, yuuben wa gin' = silence is gold, eloquence is silver.

Be well, friend!

[Jack2479]

Good post…..

[MI Dendream]

LL is a USA physician, and thus cannot prescribe a drug in UK, Canada, or EU.

She presented the statical at Utah with external validation of positive and negative trials. She then went on in May and Mt.Sinai to presnt the model and SAP analysis overview with many forward looking statements about how to think about combing agents with DCVax with a couple case studies. In late summer, she told colleagues to save tissue at patient expense cryogenically frozen rather than paraffin as paraffin will make tissue unsable. Can pretty much guarantee the paper was submitted before this. So LL has seen data and continues to speak positively with expectations to have drug in the hands of other soon. PERIOD

UK and EMEA have approved these endpoints and production capability is ramping up. The 10Q alluded to Franhouffer still being in the mix and we all see Advent nearly done building out an workforce and should receive certification correcting after minor issues loke hiring a fre more people. This tells you 30-40% world revenue will soon be approve.

Flashworks per DI is preparing to do comparability studies with Flashworks which should be all that is necessary to get that to the finish line. This is not an efficacy comparison. My guess is they will need to show similar cytokine profiles on testing and safety of one or two doses in volunteers, probaly in the neighborhood of 20-30 GBM patients. Enrollment by AK et al in UK will be fast. That will not take long at all. That too is “coming soon”. UK/EU is in the bag and it certainly seems that submission there has begun due to the Swaton process for CGMP manufacturing approval.

This all creates revenue in 2022. So how then are we dropping like this. Serious money coming soon there.

On top of that, CRL is already approved for production in US & Canada. Ther is some questions of contracts here, but they too were alluded to as a manufacturer in a recent 10Q. After MT. SINAI, it was clear that the US application could be completed soon. People assume no news means they have not submitted the final data package. I think this is absolutely crazy and that the publication is a smokescreen for this, but absolutely real and on track to be ‘coming soon.’ This is all doubted based on CT.gov not getting updated, really? What of they drop that shoe before Cert and everything else?

Meanwhile they take out a full page add at ABTA which meets the limits of possible coming soon campaigns and remove their exhibit booths that would cross that line if not altered.

Your choice here is that everything is moving forward positively with regulators or that LL and UCLA are implicated in a criminal conspiracy case. Cases can be lost but this is what LL and LP would be conspiring to do along with others. The later is cuckoo bananas, bat $hit crazy.

This ‘bear raid’ is seen in many small biotech as big news is pending. I may have clarity on releasing my powder again soon and I love these prices.

That is how I see the present and near future worl which amounts to Orbis or Orbis like approval in the next several weeks.

FDA rushed to get SPINRAZA on Dec 23 to be ahead of Christmas holiday. That drug is different in many ways, like being a pediatric drug for an orphan disease, that is fatal and in some within months or others who melt away in fromt of their parents over years. They rushed to get er done in about four months.

Just what would they do here? Is what I call a coming soon campiagn happening bc that timeline project Jan-Feb approval in US.

[Mionaer1]

Outstanding post.

[hoffmann6383]

agree with everything you stated umbie

[CherryTree1]

GREAT Post Umibe
- Thanks for taking the time to share your well considered and thought through opinion based on the facts
GLTU

[sukus]

Thanks for outstanding post Umibe.

[Sojourner55]

Excellent post Umibe. Glad to know you’re still here.

[DavidW2]

Umibe, I have a question.

Some people, especially ATLister said, NWBO won't announce data lock unless all 4 RAs agree on new SAP, which OS is new primary endpoint. Is this true or false statement?

[FeMike]

Mostly well stated Umibe, and I agree with many of your points. Especially around the science. That is why I stay invested, in spite of management.

However, I must ask some questions with regards to things you state as facts.

For instance, you (and many others) say:

(naysayers say)…. it is not necessary to tie TLD to a journal publication. And if the data were so remarkable, a top tier journal would have accepted an article by now or at least it would have been written and submitted for peer review and this announced by now in conjunction with TLD.

The fact of the matter is that it is not quite that simple.

The bolder part claims that it is a fact that it is not that simple. But it is never explained why it isn’t that simple. I suppose your argument is that because they had to change endpoints and likely missed the initial primary, the data demands explanation in a journal. How, I ask, does releasing TLD prevent them from doing a data deep dive in a journal later? So I disagree, it is that simple.

If your counter is that they are protecting the market value…well, seeing as we are down 75%+ from the post data lock highs, that argument really doesn’t hold weight. If they had released TLD when they initially had it and the price was $2+, do you really think we’d be trudging down here in the $0.50’s right now? The only way that would happen is if the data were irrefutably failing, which doesn’t support the notion that we are still vying for approval. Those two realities are mutually exclusive.

Finally, science aside, let’s talk business. You mention that NWBO needs financing. Undoubtedly. You can’t honestly tell me they are more handcuffed for financing with TLD made public than they are if they have to negotiate NDA’s, quiet periods, and other massive communication restrictions while keeping the data from the public. They have so many more options if they disclose information. I guarantee our market price would be double what it is at now if data had already been released and a path to approval remained open. So even toxic financing would be twice as valuable if they needed to pursue that fundraising option.

So again, I concur with 90% of what you said, and you said it eloquently. But good science doesn’t mean good management. This management team has absolutely botched every step of the way for the past 2 years. All you need to see for that are their myriad missed timeline estimates.

[TheFollower]

Thanks for your insight and for taking the time to explain your view of this trial. I appreciate the effort.

[Nick119]

Couldn't agree more with the entirety of this post. Kudos.

[maverick_1]

UMIBE: Truly EXEMPLARY, as erudite as it get's without being an INSIDER and supercedes IMHO everything posted AND supports in greater detail, than I or the multitudes here could ever offer. Fortunately it is what I've espouseD and postED since 2015! Problem here for 99%: it has been beyond their closed mindset, AND Inexperience which the record here clearly has validated since 2015!

I take most all posters with a GRAIN of salt and have always marched to my own music versus the multitudes: As indicated I have consciously refrained from further contributions in last few years due to the rancor and vitriol ever present along with the grandstanding ring leaders who have been always BEHIND the eightball as it relates to the wrong roadmap from too many perspectives and clearly unproductive war of words typical of last four years.

A few weeks ago, in a Sunday hour, without interruptions, I devised ("For My Eyes Only")what I would do specifically in CEO Linda Powers shoes from a tactical and strategic perspective with her Game Plan on her FULL House of Cards and their highly critical, compacted and sequenced assemblage behind the heavy curtains including thoughts on an S1 and some voting directives for upcoming ASM: authorized shs, reverse stock split? ETC.

I have never waffled let alone had to revised my CEO nor Board member impressions.
That also applies to posters here! LotS of folks may have learned some very expensive investing 101 lessons.

ALL of us come with different viewpoints and perspectives based on our own set(S) of experience(S).

Too few posters are constructive or originators,let alone have the audacity of being bold, and being right for the right reasons.

Sadly, the preponderance has been clear, consistent errors of JUDGEMENT since 2015 compounded by the LOGICAL need for NWBO Corporate SILENCE(The Achilles Heels of investing in mine fields for Emerging BioTechs) after 2015's TWIN Hiroshima's: Neil Woodford's ONDRA Affair AND PHASE V ("Tome of Tombs"): pertinent here is: Hedge Funds Ensnared in Expansive DOJ Probe Into Short Selling https://www.bloomberg.com/news/articles/2021-12-10/hedge-funds-ensnared-in-expansive-doj-probe-into-short-selling

Especially the section: Mitts on 2010-2017 Big Short Targets: NWBO went from $1 Bln Mkt Cap to ~$20 Mln!

Fortunately I did not partake the technical advice proffered since late Nov courtesy of very high % of daily NWBO volume that was SHORT that was the harbinger of EROSION from $1.08 as well as too many leading, coincident and lagging technical indicators did NOT support the views posted.

Furthermore, I was early in indicating NWBO was at 52 week lows AND Tax Loss Selling Season was upon us! as the SNO event enthralled the multitudes.

AND I do not agree with the logic that late Friday detonation came from warrant holders.

Nevertheless:

THIS is still a PROCESS & The precursor of The Beginnings of a New Era for NWBO!

From more than TWICE near ASHES to The PHOENIX where The Legacies of Two Femme PHENOMS against Two Decades of INSURMOUNTABLES will be heralded for The Ages!

For the last 2+ years…Only allowed one NWBO post per day.

DIFFERENT STROKES FOR DIFFERENT FOLKS

[VikingInvest]

Very well stated, Sir.

[ae kusterer]

https://www.clinicaltrialsregister.eu/ctr-search/trial/2011-001977-13/DE

[danielboog2]

Thank you UMIBE

My point in explaining all of the above is that this is overall a complex process

Your reiteration of present moment perspectives and projections summarized....absolutely 1st Class

Patience and GLTA

[highwayman4life]

Great post and understanding of the broader picture Umibe!!

Thanks

[skitahoe]

Thank you Umibe, I believe the moderators should sticky this post.

There were several other great posts in the last day, one mentioned the possible roll of the MM's in yesterday's trading. I would suspect that the MM's are shaking the trees by selling to drop the price, then swooping in and buying far more shares than they sold for cheap. Why such a behavior, because they're anticipating good news and most important, they know they'll have great demand from some of their Institutional customers beginning January 3rd, the first trading day of next year.

Institutions purchasing after the New Year's can hold until the end of March, and sell by then and never report ownership at all. They also can buy with the hope that before the end of the quarter NWBO will be selling at a price, and perhaps on an exchange, which permits them to hold the shares through the quarter.

It's hard to say if the MM's got their fill on Friday, or if this trading action will continue. I would hope that no one here is panicked into selling, I look at it as a buying opportunity. Personally I felt I had all I wanted, my account is already concentrated on NWBO, but if it goes any lower, I almost certainly will make it even more concentrated.

Gary

[Doc logic]

Umibe5690,

Very, very well thought out post and the other reason that they are taking their time, even if data suggests a slam dunk or two, is explaining very carefully WHY everything in the data shows up as it does. This represents a scientific breakthrough that the progenitors want to explain to the very best of their ability to the scientific and medical communities without giving away trade secrets who will in turn explain it to patients on the level important to them with regard to best treatment options tailored to their cancer type. Best wishes.

[iwasadiver]

Great post Umibe. I’ve said this before; the FDA is not some vindictive punisher for not having foreseen issues that have never been an issue. PFS has been a controversial endpoint despite how often it’s been used in Cancer trials. Scientists love to fuck with one another in some intellectual bullshit sparring match and it’s all ego. If someone looked like they had progressed on DCVax and afterward ‘everyone appears to be living longer than expected’ (Dr. Liau) and subsequent MRIs show the “recurrence” has now cleared then it was not progression in the first place. Nothing else matters. That is NOT a “failure” of PFS no matter how someone wants to spin that. No one in their right mind, including the FDA, is going to dismiss reality and claim that ‘well, you counted it as a PFS event so we have to keep it at that’… and “fuck you”. That is not going to happen. Period. PFS is meant to be a marker so that a trial doesn’t have to go on for 12 years for OS, so PFS is insignificant at this stage. One needs no “marker” of survival if the survival itself is produced. However, the SAP more than likely used the marker of “confirmed progression” as a way to back up the efficacy because it was so long, and to avoid detractors claiming it was all just coincidence somehow. Wall Street can be fooled by such bunk, scientists and clinicians not so much. And as you imply, it’s us clinicians that matter the most in the end market. I believe NWBO has the home run, know it, and are in no hurry to allow a single crack to develop and leave an opening for the obvious bullshit that will flow once TLD is announced. Look no further than the last 2 years with COVID; once the crap hits the internet the conspiracy is on…

[biosectinvestor]

And that was a remarkably thorough and deep dive Umibe, not sure if I agree in every point but so thoroughly explained and discussed it really should be stickied and kept as a well thought out discussion for people to reference.

There were many points we do not often discuss. I have mentioned adaptive design frequently, but have not discussed Orphan status in a while and really it never comes up.

You really just did such a great job at covering so much ground. And the promise of the officers that they would certainly disclose a failure if it had occurred I think is meaningful even though I do not think that kind of complete, unambiguous failure was ever really in the cards given the blinded data and the revised SAP.

Really, so thorough! Thank you Umibe!

[eagle8]

Great post Umibe.
Thank you.

GLTU

[br8k0ut]

Great post, Umibe

[Flexroy]

Thank you for your welcome response. I'm also glad this has been stickied for any newbies.

Cheers

[The oNiOnHEAd]

Umibe, Thank you - I knew there was something that supported my thesis of NEW HIGHS SOON TO COME!

[Smokey21]

Great narrative with sound logic. Thanks for posting this Umibe5690.

[sentiment_stocks]

It's always good to see you show up again with many wise words to impart! Thank you for your comprehensive presentation of how things stand, at least from your POV, with Northwest management, MHRA, reason for a journal, RA approvals, and so on. It's much appreciated, and very soothing I'm sure for some shareholders after last Friday's... whatever it was.

:)

[iclight]

Utter nonsense.

[hankmanhub]

Within that context, LG has insisted in conversations with me and others I know that the “trial has not failed”. Even DI has indicated in certain conversations with MBers that if the trial had failed they would have had to reveal this and certainly by now.

I can confirm that I too had the same song from Les in my phone calls with him.

[maverick_1]

Re UMIBE's EXPOSE:Insights

IF one has NOT posted an intelligent & grateful response within 48 hours of UMIBE's post after the late Friday MASSACRE to 60 cts where ~8 Mln of it's 10 Mln daily traded... then it logically speaks VOLUMES about one's mindset atop their high horse.

IMHO what was evidenced in NWBO's late Friday MASSACRE was NOT CAPITUALIZATION nor that of a selling climax as it relates to Volume.

The entire sector was eviscerated having FAILED to exceed it's early Feb 2021 highs AND Failed it's significantly lower support level TWICE.

This amounted to a ~39% TUMBLE vs a ~76% SMASH for higher Beta NWBO.
The IWO ETF for comparison lost 17%!.

Unless NWBO get's a writeup or we get Big News,...... Since 2015,it has been FUTILE to make price (let alone Cloud NINE Potential Mkt capitalization) predictions. Without fail, those who did make those price predictions got a barriage of eggs on their face. Players and ConditionS CHANGE, most especially in Penny Stocks.PERIOD.

MOREOVER, maybe finally the reality has set in that there are DeepER Pocketed, Dark and Nefarious forces that I posted about since 2014 that very few knew about then!

Nevertheless:

THIS is still a PROCESS & The precursor of The Beginnings of a New Era for NWBO!

From more than TWICE near ASHES to The PHOENIX where The Legacies of Two Femme PHENOMS against Two Decades of INSURMOUNTABLES will be heralded for The Ages!

For the last 2+ years…Only allowed one NWBO post per day.

DIFFERENT STROKES FOR DIFFERENT FOLKS

[Know-Fear]

Also very cool and chill worthy.

[MI Dendream]

Umibe, I think most people assume that the originally randomized cohort comparison for survival is mOS. I believe this very well could be positive, but what if it is Hazards Ratio and includes the very long tail of data, or what if it is a proportional analysis?

IMO the original cohort survival analysis is positive. In which case, who gives a damn about the original PFS? It is a surrogate marker for death and it will be proven meaningless for personalized dendritic cell immune therapy for brain tumors. Know any drug that NWBO plans to market which meets that definition? Oh, there is just one?

So then, why still include it? Well, perhaps you want to prove to any and all that it is meaningless, but that the adjudicated PFS is not. That begs the question of order. If you believe that the most difficult hurdle is the one with likely much confounding issue that poorly correlates with survival which is all that really matters, then why third before such important 4th and 5th measures?

It seems to me to be a clue. One that may mean the order is completely irrelevant after the first and primary endpoint. Or, perhaps based on all that beyond study data that they possess, like watching vials from one pile disappear but the other pile slowly, then suddenly stops moving down. Maybe they already know that answer, but have an even better one. Who knows?

Linda and Linda, Max and Robert, Keymours and Timothy.

All I know is that LL was downright excited to talk to those outstanding neurosurgeons at another pinancle of medicine back in May, and she was quite confident in when she was leading them next. She was also quite confident when she told her colleagues to please start properly saving tissue, despite the out of pocket expense to vulnerable families.