Replies to post #340830 on NorthWest Biotherapeutics Inc (NWBO)

[anders2211]

Thank you so much VuBru for your extensive and elaborate feedback and answer to my question. I could not have asked for more.

Your timeline coincidence exactly with what I already estimated myself
Mid-February.

You see NWBO (LG) in the process of moving the warrants extended the warrants first to March 1 and midway in that process of moving April one. This moving again during the negotiations with warrant holders tells me that they encountered an obstruction for a new delay 2 - 3 weeks ago. This was, is what I am thinking, a delay in the publication (rejection of top tier journal?).

So that piece of info I have (moving the warrants first to March 1 then 2 weeks later to April 1) coincides with your well thought and much-appreciated timeline.

Mid-February it is (IMO)

Thanks!

Ps according to Senti the whole moving of warrants is off the table now.

[StonkMaster]

Wow fantastic detail, thank you.

[ATLnsider]

VuBru, thank you for the additional context & information. I value your firsthand experience & knowledge

[Dr Bala]

Good analytical reply. It would represent a rare success indeed in the world of vaccines, as you say. In addition, it would hopefully lead to a very effective therapy in prolonging life against this extremely deadly form of cancer.

[skitahoe]

VuBru,

While I can accept the fact that they may hold TLD till peer review will occur practically simultaneously, I can't say that I'm certain that will be the case. There are a number of major brokerage conferences early in the New Year beginning with the J.P. Morgan Healthcare Conference. If TLD were announced, I believe there is a good chance that they'd receive invitations to those conferences.

WRT upgrading to the Nasdaq or other major exchange, if results are what we believe them to be, TLD alone should see us at the $4 level or higher prior to further information from a peer reviewed article or presentation. I suspect that we'll have some issues due to not issuing financials on time, but it's possible that so much interest may exist in the company after TLD is issued that a major exchange might make an exception to their rules.

I'm not saying this would happen, if I remember correctly we've been late on the last two quarterlies. If the SEC has accepted the reasoning behind it, perhaps it's not as big a problem as I believe it could be, but I would expect the major exchanges would want at least a couple financials to be issued on time. Frankly, I believe that Institutions will invest regardless of the exchange that we're on, though some may be playing games in doing so.

What do I mean by playing games. With a MM's cooperation they can purchase shares beginning the first day of a quarter, then sell them back to the MM on the very last day of the quarter and nothing needs to be reported. They can repeat this quarter after quarter until such time as the stock meets the qualifications for that specific Institution. If the Nasdaq or NYSE were a requirement, when the stock listed on the exchange, they'd maintain ownership over the quarter, and it would be reported.

I don't know that you'd have a chance at an invitation to J.P. Morgan with news after the first of the year, but I suspect that TLD anytime before the first would at least create the possibility. As I remember it, their are at least a few others that occur early in the year. It's my belief that TLD will move us to a range between $5 and $10 and if I'm right about that, we could make presentations at several of these conferences. As they're investors, not scientific conferences, I believe that LP would be the primary presenter.

It's up to the company, we know they have the data, if they wished they could have a TLD statement out on Monday, it's all about their strategy for unveiling information. I believe the TLD could provide plenty of information that's worthy of discussion with investors and Institutions, but of course the details will be peer reviewed before they're discussed.

Remember, a potential partner or buyer would have full access to everything under confidentiality agreement. Nothing matters wrt either exchange or peer review to a potential partner or purchaser, all that matters is what they see in the trial.

Gary

[martyDg]

How many month/s left before next financing? They can't keep going for months not telling us anything and then issue dilution, or maybe they can?

[HappyLibrarian]

This is a pretty ugly scenario both on when we get TLD abs describes a trial failure being whitewashed with a journal article (hence why NEJM or the Lancet would have issues) and so I hope you’re wrong. It certainly puts paid to the idea of DCVax-L being the next SOC. Really hope you’re wrong.

[juslin]

Thanks VuBru. Makes more sense now why it's taking the company so long to PR

[juslin]

If results are as spectacular as some on here are suggesting then there is no reason for the company to continue holding onto TLD. Suggesting that they are waiting for a publication while holding onto spectacular results make so sense. Now if the results are mixed or did not meet expectations then I can see where you think waiting for a publication might make sense to calm investors.

[Jimcal22]

VuBru, thank you for sharing your expertise on the potential timeline!

[snoopycomic]

Such a depressing timeline for us longs who have waited 8+years

[reg2015]

VuBru. Thank you for this excellent explanation of the process and timeline for getting a paper published in the real world.

I think this article should be "stickied". I sure appreciate your considerable efforts. Peace Reg 2015

[Pablosrv]

Thanks Vubru. Great insight. How do you reconcile this with the company saying they expected TLD in September...actually they said twice they expected TLD one month after data lock? And what about the placeholder for the conferences? Either they are improvising along the way or I don't understand their MO at all.

[biosectinvestor]

Thanks for the very carefully explained and thought through explanation for the delayed TLD and why it would be more complicated than your standard announcement.

Really excellent thought process around what they are very likely dealing with...not including the general healthcare emergency that entire world, and even particularly California, are dealing with now.

[IkeEsq]

VuBru: I like the way you think! :)

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=159422319

Although you have a lot more detail and specifics, this is exactly what I have been thinking will happen. The stock has closed over $1 every day since October 12, so by mid January it will have done so for three months. I think up-listing and journal publication will coincide and TLD and a conference spot will be around the same time. Maybe announcements about Sawston or other good news around the same time in a blitz.

I can't imagine releasing big news while still on OTC. All just my opinions.

[jammyjames]

"It may may have taken them some time to identify and agree on the right comparison trials and construct these survival curves (I'm not sure sure whether they had easy access to the raw patient-level trial data from other trials)."

yes i think that raw patient-level trial data from other trials is exactly what they need to be taken seriously. Hopefully they can do something like i did with the estimation but substituting the DCVax-L blended data with the real test-arm data (and obviously more stringent handling of the historical comparison and no need to generate a markov-model):

http://jammyjames.com/analysis.php

but as you say i don't know how easy it will be for them to extract these specific details from other trials.

"As I have said in prior posts, if their original planned PFS and OS outcomes (DCVAX vs. the internal placebo group) are not significant and the only significant findings are the comparisons to historical controls, getting this accepted by NEJM or Lancet may be challenging"

yep and exactly the same likely goes for approval.

"Once the company has an acceptance letter in hand, they could in theory announce TLD in a PR saying the paper has been accepted by XX journal, and provide some additional context in the PR based on what is written in the article."

exactly what i suspect. Though I don't think they'll wait for a preprint.

[greenJack]

Thanks for the info. It will be hard to avoid any leaks if so many people are involved. Could be a reason they are forced to put out TLD first.

[abeta]

Vu

Appreciate your thoughts

So sometime between Aug

The Company currently continues to anticipate reporting topline trial data in September, and anticipates providing further updates as the process progresses.

https://nwbio.com/nw-bio-announces-completion-of-further-data-gathering-for-phase-iii-trial/

and

October 5th -

https://nwbio.com/northwest-biotherapeutics-announces-data-lock-of-phase-iii-trial/

somebody had a cup of coffee with somebody

and decided that the journal route was the only way to go?

Avisol Capital Partner - (seeking alpha - 20th) is thinking along your lines -

FWIW

When can we see the data?
According to one reference, NWBO is taking a lot of time to analyse the data because, due to the long age of the trial, a lot of new developments have taken place in GBM science that has to be accounted for. For example, it's been discovered in the last few years that wild-type IDH is oncogenic, while mutant IDH genes have better prognosis in early stage gliomas, which, although they are relatively rare in glioblastoma, about 10%, is probably having to be factored into the NWBO data. These things are delaying the analysis. Several slots were booked in major conferences but later cancelled by the company. They also may publish the data in a journal first.

Thanks for both your posts

regards

[anders2211]

Hey Vubru,

Looks like NWBO indeed chose the torturous path to get the publication out, unfortunately.

So, there is a lot of guesswork in this, but considering all information available, I think the publication could come out by mid--January at the absolute earliest, and possibly as late as end of February if they end up on a torturous path to acceptance .

do you still think it will be the end of February for the publication?
Thanks for answering