LC, their virtual booth at SNO included the following:

“The trial has been completed, the trial database has been locked, and independent statisticians are analyzing the data”

Now, this isn’t an 8-K, but it was visible on the SNO 2020 website in the virtual exhibit hall.

All this said, wouldn’t it be great to have something official from the company. A 10-Q, an 8-K, anything really. I understand the risk with this investment but I’m never quite sure why so many people are content with the lack of communication, but I don’t need to tell you this! I’m sure I’ll get bashed for saying this...

Any thoughts on when they’ll need to do a financing? It’s been a while since the last one and I had been hoping we might get TLD first.

Has anyone found any breadcrumbs in any of LL’s posters at SNO?

I believe this board has confirmed that ATL DC is DCVax? There’s a poster here that mentions its usage in gliomas.

https://eventscribe.net/2020/SNO/searchGlobal.asp?mode=posters&SearchQuery=Prins

You can see the posters without registering.

Ahh got it. It’s not a case of lending today at the current PPS, it’s opening the door to lending if the PPS is significantly higher that is the problem??

Can someone explain in layman’s terms why they think lending their shares is bad? On one hand people talk about a short squeeze, but then on the other hand say don’t lend....?

Your post reminded me of this from 2017

https://www.sec.gov/Archives/edgar/data/1072379/000114420417003329/v457335_ex99-1.htm

Thanks for the responses Ex and Anders.

Ex, I hadn’t thought about a non-binding opinion. However, could there be an argument here that a disclosure would be appropriate to incorporate this specific item into the going concern assessment in the 10-k? Would an auditor not want this to be highlighted?

You and Anders clearly know a lot more around this subject that most here, so your input (and Anders’) would be appreciated. Sorry, I ask a lot more questions around here than provide any of my own useful input.

Does the 10-q override the 4 day window? If I’m the user of the financial statements, is it not reasonable to expect the subsequent event section to be representative of the companies position as of the filing date?

Subsequent event disclosure....

I know there’s been a lot of debate on here about whether or not a failed trial needs to be disclosed within a certain period.

Slightly related question - does the company need to disclose bad OR good results in the Subsequent Event section of the 10q. In my mind, this would certainly be material enough that I would hope for disclosure. And I would assume that any subsequent events would be up to and including the date the 10q is filed?

SNO exhibitor details:

https://eventscribe.net/2020/SNO/searchGlobal.asp?mode=exhibitors&SearchQuery=northwest

I think this has been added recently but I may be wrong.

Another DC trial, quite interesting. Apologies if already posted.

https://academic.oup.com/neuro-oncology/article-abstract/22/Supplement_2/ii38/5960554?redirectedFrom=fulltext

I often check the following website but haven’t seen anything in relation to Advent. I’m not knowledgeable on the process, but I would assume that once Sawston had been inspected for GMP certification it would be added to this database. I may well be wrong though.

http://eudragmdp.ema.europa.eu/inspections/displayWelcome.do

Could one of the accelerated vesting conditions be responsible for a change in the accounting of option awards? Just spitballing.

Is there anything stopping them giving us TLD as a paragraph under “subsequent events” in the 10-Q?

Not that I think this will happen, just wondering if it’s even possible.

Looks like Advent appointed a warehouse manager this month, based on my semi-regular LinkedIn searching.

It’s not TLD, I know.

Can you one you clever people critique AF’s response to Bigger’s tweet?

The tumor elimination slide is a massive all in directional commitment from Linda Liau. We know where her mind is at. Betting against that? Are you f....n kidding me. $NWBO #foundational

— Michael Bigger (@biggercapital) November 9, 2020

Also, when the company has received the analysis from the statisticians, can they raise new dilutive financing before they PR TLD? Maybe a stupid question, but I guess I’m wondering whether there’s any fiduciary duty here to shareholders as we’d obviously be diluted more at a lower share price?

If the TLD PR simply states whether or not the endpoints have been met, why would the company need two weeks to discuss this internally? Isn’t it a yes or no answer for each endpoint? I can understand detailed discussion about what to present at a conference, but for a TLD PR? Am I missing something?

I’m hopeful that we get TLD well in advance of the new warrant date in December, though not holding my breath. Even an update by way of a PR would be nice, as my emails to the company go unanswered. IMHO it’s not surprising that we all go looking for breadcrumbs (myself included).

The one positive I’m taking from the last few days is the reports from board members about LL’s comments about DCvax and Keytruda in combination.

Glioblastoma post-operative imaging in neuro-oncology: current UK practice

New journal article with KA as one of the authors. Includes discussion on pseudo-progression.

https://link.springer.com/article/10.1007/s00330-020-07387-3

It would have been nice if NWBO was an exhibitor. Maybe they were too late.

https://www.sitcancer.org/2020/support/sitc-2020-exhibitors

I find it interesting that the LBA appears to have been withdrawn on the same day that LBAs are required to be submitted for the ESMO Immuno-Oncology Virtual Congress in December.

Lykiri,

Have you looked anymore into Autolomous recently?

I was browsing their filings on the UK’s Companies house and made a few observations:

- A few days ago, they appointed a new director based in the US
- *conspiracy theory alert* they name a small firm of accountants in their annual financial statements. The same accountants are also listed in Advent’s and Aracaris’ filings. The firm seems quite small with only two employees profiled on their website that I can see.
- In August they made a filing with a modification to their Articles of Association.

I believe they’re heavily involved with Advent (who have just employed a Validation Lead), but wondering if there are any other connections or links to NWBO that you’re aware of?

Ex, you’ve put a lot of effort in here and saved a lot of folks time. Thank you.

Few questions for you. Assuming the new endpoints are being used in all 4 jurisdictions:

- do you anticipate a net positive PR for TLD?
- if yes, do you anticipate at least a short term rally in the PPS above where we are now?
- if yes, are you not tempted to take a position?

Looks like the meeting I previously posted about - SNO Clinical Trials Think Tank - is free to attend and there will be opportunities to ask questions.

https://www.soc-neuro-onc.org/WEB/About_Content/News_Pages/SNO_Think_Tank.aspx

Conference is on 11/6 and the FDA have a number of people attending/presenting. The session that caught my eye is “statistical considerations for the use of external control data in oncology trials”.

Could be a good opportunity to ask some questions, unless we have answers before next week...?

Yep. I was just wondering if there was anything in the agreement that hadn’t previously been discussed and/or could put to bed the bears argument that the facility was just being developed for Advent’s benefit. Unlikely, but thought it was worth posting.

If we have any lawyer types on here I’d be interested if there’s any juicy details in the charge document filed for the loan from the Cambridgeshire and Peterborough Combined Authority to Aracaris Capital (one of NWBO’s UK subsidiaries).

https://beta.companieshouse.gov.uk/company/09103328/filing-history

Document dated September 7th.

The timing has changed slightly (now 9:30am) but there’s still a 15 minute slot that is TBC.

Strange, as the conference is less than two weeks away.

2020 Think Tank on Neuro-Oncology Clinical Trials

Has this been posted?

https://www.soc-neuro-onc.org/WEB/About_Content/News_Pages/SNO_Think_Tank.aspx

9:50am on day 1 - Statistical Considerations for the Use of External Control Data in Oncology Trials.

The presenter is from the FDA.

2020 SNO educational objectives

I thought these were interesting objectives listed in connection with CME at the SNO conference:

Educational Objectives
After completing this activity, the participant should be better able to:
-Explain how to assess the mechanism of resistance to brain tumor therapy when determining strategies for novel therapeutic treatment options for patients.
-Indicate how to incorporate biomarkers as an important component when selecting optimal treatment strategies for patients with tumors.
-Explain how big data is gathered and the various algorithms used.
-Describe how to apply big data outcomes to optimal patient care in the clinical setting.
-Cite new advances in immunotherapy for brain tumor use.
-Summarize the best strategies for the care of brain tumor patients during the COVID-19 pandemic.

Outstanding shares are showing as 804,384,125 this morning on the OTC website. I believe this is an increase, albeit a small one. Flipper is normally good at keeping track and I’m happy to be corrected!

I still wonder whether we might see TLD before LL’s lecture on 11/6.

The topic of her lecture is “Brain Tumor Immunology & Immunotherapy” and while I assume she would save the juicy details for SNO, wouldn’t one expect the trial to be at least mentioned?

https://www.uab.edu/medicine/neurosurgery/education/continuing-medical-education/j-garber-galbraith-scientific-session-and-lecture

Senti, I’ve been lurking this board for a couple of years (first invested in 2017, I think) and I’ve always respected the posts from you, Doc, Flipper, Sojourner and even Ex

I do have a question for you - and anyone else who wants to chime in.

Over the past few weeks, the share price appears to be reflecting a greater possibility of success for NWBO. That said, I’m sure a lot of longs on this board would say that the price doesn’t accurately represent their outlook for the company.

I’m generally a pessimistic person but I am very hopeful. We can measure success in many ways, but an easy way is PPS (I use this as I imagine even the most positive data will be spun by some).

With all this in mind, what challenges/risks/obstacles do you think exist that would result in the PPS not increasing after TLD. Obviously a complete failure to meet any of the endpoints would not be ideal, but on a more granular basis, do you ever think about this?

This is awesome, thank you. I’d love to see the Twitter naysayers try to rebuke any of this. Though I’m guessing they wouldn’t try.

Flipper, it looks like the embargo on LBAs isn’t lifted until 11/20

https://www.eventscribe.com/2020/SNO/aaStatic.asp?SFP=TkNZV0tYR0dAMzIzNw

Edit: apologies, I think you were talking about a different abstract, not the LBA

I keep coming back to two things. All of the following is IMHO, clearly.

1. Soft lock. At least one of the PRs mentioned soft lock but the company never confirmed whether this happened. However, the acquisition of Flaskworks during the same window was a really bullish sign in my opinion.

2. SNO. While I get it that LL is kinda a rockstar in the Neuro-oncology space, the guidelines seem to be quite clear that the LBA required data - would they really waive this for anyone? Also, given the timing of TLD it seems like it might be a little bit of a rush to prepare for SNO. I understand that negative results could be discussed at SNO, but why would LL be so keen to discuss such in a rush, rather than waiting for another conference in a few months? The answer to this could be linked to 1. above.

I’m a finance guy, not a scientist, and these are just my own musings. I’d welcome any thoughts on the above, especially any counter arguments.

I change my price target all the time, but I’d love to see $7. That said, I want it to jump overnight as my wife thinks we should sell if it gets to $3.50.

Just my late night ramblings so feel free to ignore.

New Flaskworks employee? I was perusing LinkedIn and I noticed that someone started in the role of Principal Research Scientist in September. I’m struggling to post a clean link from my iPhone but should be easy to find on the google machine.

Advent are recruiting again.

https://adventbio.peoplehr.net/JobBoard/

From Advent’s LinkedIn page it looks like they want 2 GMP Production Specialists.

The job description specifically mentions “specials”. Do we know if Advent are manufacturing under the specials regime for anyone else?

SNO poster titles are up.

Is there any connection to DCVax here - LL is listed as an author

https://eventscribe.com/2020/SNO/fsPopup.asp?efp=S0taQ1hBSFkxMTYzNQ%20&PosterID=318908%20&rnd=0.475284&mode=posterinfo

Now, this isn’t dated so could be a holdover from a previous year...?

Hopefully someone brighter than me can enlighten the board as to the significance of this. It appears the options for trial status are the following (there’s a drop down selection box in the advanced search):

Completed
Not authorised
Ongoing
Prematurely ended
Prohibited by CA
Restarted
Suspended by CA
Temporarily halted