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yes building Advent, unless you call the certification of Advent for the Sawston production facilities not building up, out?
Northwest Biotherapeutics Announces Development Completed for Initial Production Capacity of Sawston, UK Facility
Advent is a new business and as I said, their value is in their contracts and employees.
They have no real value at this time except through meaningful contracts that generate actual current revenues.
Is it also possible that at some point in time, Northwest would want to acquire Advent?
Advent would have little value right now if it lost it’s main customer, NWBO
Maybe it's a language problem.
My point was merely that Advent is not the end all be all for NWBO as you seem to suggest
Taking tiny profits but let losses run is the road to the poorhouse
Since the stock hanged around the 1.1 to 1.22 area for weeks a lot of investors had a lot of time to buy a lot of shares for trading. A great deal of these shares are probably on offer at 1.3+. Time is needed to eat through that offered volume
lol wasn't it Freud that uttered the famous words what is on a man's mind?
I dont blame you, I would say they will call you as soon as there is news but you probably are rested and mega woke long before.
here are not a lot of leaks coming from the NWBO team.
thanks sojo
I am very glad that Linda Powers and Toucan started and help fund Cognate and Advent Bioservices.
didnt even think off that you are right. That's why they were rewarded with hundreds of millions of warrants and options so late in the game, so they had not to undergo dilution after dilution over the last 12 years.
ha
most senior management when hired after starting a startup get their option pool at the beginning they got them almost at the end like 1-2 years ago.
ha clever
What many don’t understand, just a clinical description of management and how they’ve handled the business would turn off the vast majority of professional investors. The bet has to be entirely on the belief that the trial is a success; then most things takes care of itself.
again what has Advent got to do with Charles River Laboratories (cognate) , you asked me a question about CRL
So you don't believe CRL can produce DCVax for NWBO?
No IMO LP is aiming at selling Advent and NWBO as a one package deal for one is worthless without the other.
You didn't post this
You got me confused.
One minute you say NWBO is worthless without Advent, the next minute you say they are not?
sure they can.
Can Siemens produce 1 million vacuum cleaners if so ordered? Absolutely
Are they withholding 1000 staff at home sitting on their couch turning thumbs for such order which may come in the future? Nope.
to answer this one has to ask, in how far is Advent/ the Sawston facility run by Advent only equipped to produce GBM L? If only L then Advent for a large part would be worthless if L were not to be approved.
No IMO LP is aiming at selling Advent and NWBO as a one package deal for one is worthless without the other. This is very different from Cognate, although some here still believe that CRL is holding dozens of highly trained staff back in reserve for when L is approved.
Yet, virtually every public company PR's TLD on a material P3 well before the paper
Yup. I will sell after TLD and move on. Marzan can have the big pie after buy out :)
As you know Im a bit into legislation in The Netherlands and the EU. Now the UK is not in the EU anymore. But this construction Advent being paid by NWBO to be built up, NWBO being led by the CEO in possession of Advent (at least partially) would in most EU countries lead to legal charges... Thats why I find it remarkable.
what I think LP is aiming for is to sell NWBO and Advent as a 1 deal package to Merck or similar BP... One cant do without the other. BP has to buy both one is worthless without the other kaching
she is going to swim in a lot of money clever bird.
Im up till my ears in NWBO shares. :)
We don't know how much NWBO and thus its shareholders are paying to get Advent running and how much Toucan. Do we? I do know that the equipment and licenses are being provided to Cognate, how much is Advent paying us NWBO for that?
it would have been fair to have NWBO owned at least own a good part of both production facilities together with Toucan if indeed Toucan has put in money as well.
Hopefully this isn't thing going to become Cognate 2.0, as some bears here have stated. Don't know any good reason why NWBO and Advent aren't the same entity, as I've always believed should have been the case with Cognate.
yes so what I later added (apology) is that it then would "only" take in that example theoretically a new lease and new equipment for the license if they want to prevent the license to be revoked by the MHRA from Advent. In theory of course.
I thought that was already established here. I just read some posts here lately from some suggesting otherwise. And I must say the March 16 PR from NWBO leaves this issue in the middle so that did not help.
And yes I can assure you its true, a call has been made with the MHRA (not by me) and then one must provide a company name right. So thats how I know for 100%
do you think that the license provided by the MHRA to Advent would be revoked by the MHRA if NWBO (in theory) would provide another licensed company the assignment to produce DCVAX L? I think not
Of course if that were theoretically the case, the MHRA would demand that Advent must find a new facility (if NWBO would theoretically also revoke the lease) and purchase new equipment.
if a license is submitted to the MHRA then that license request can only be made in name of a business with a chamber of commerce registration and a VAT number. Ok, then what is the name of that business requesting a license? That's Advent Bioservices. Not Northwest.
So it will be Advent in possession of that production license for the facility as described here
https://nwbio.com/northwest-biotherapeutics-announces-development-completed-for-initial-production-capacity-of-sawston-uk-facility/
and NOT NWBO
That license in and by itself is worth a lot of money.
The increase in value for licensing of Advent will not be to any beneficiary of NWBO. As we know Advent is owned by LP/Toucan/LG, not NWBO
The benefit for NWBO is of course that L can in great numbers be produced in the UK for the market EU and UK, which is needed for approval.
Just to be clear
just for anyone so there is no misunderstanding
It is Advent Biotech that will be licensed not Northwest itself.
There has been some confusion about that here which is not all to strange since the Mar 16 2021 PR from Northwest about the licensing was not that clear altogether about this.
its not about the trial end date its this:
primary completion date of the DCVAX L trial
The final rule in 42 CFR 11.10(a) defines "[primary] completion date" for a clinical trial as the "date that the final subject was examined or received an intervention for the purposes of final collection of data for the primary outcome, whether the clinical trial concluded according to the pre-specified protocol or was terminated….
source: https://clinicaltrials.gov/ct2/manage-recs/faq
In other words when the last NWBO patient was examined for the purposes of the final collection of data.
I have asked.
I dont think I have said that you said that we get news this year. I said I hope we will which we all do.
I can assure you that NWBO has passed up on the option to get an extension to submit trial results.
An extension for good cause may be requested under conditions specified in 42 CFR 11.44(e) (the request for extension clause). The preamble of the final rule explains that such requests will be granted in limited circumstances. (81 FR 65076-79)
and they are already in violation of that rule. And yes that rule is almost toothless.
that is the question that is being discussed and I hope you are right it will be this year.
If this still will take months the NWBO starts to really drift far, far away from this
In general, for applicable clinical trials subject to § 11.42, clinical trial results information specified in sections 402(j)(3)(C) and 402(j)(3)(I) of the Public Health Service Act (42 U.S.C. 282(j)(3)(C) and 42 U.S.C. 282(j)(3)(I)) or in § 11.48, as applicable, must be submitted no later than 1 year after the primary completion date of the applicable clinical trial.
In general, pending publication would not be considered good cause for an extension.
ha thank you, a small bit of good news then
thanks
any poster daring to refute this news sent by Red Right Hand will be blocked and digitally cursed let me have this one please lol ;)
I just can’t fathom why CVM is used as an example not to release TLD.
CVM is an awful example, because their results were ambiguous at best. It was obvious that CVM had to shift to a slower lane. Hopefully that’s not the case with NWBO.
1. Can’t say if journal articles submitted or no
do you or anyone know if before submitting an article if it's normal to haveing it first peer reviewed?
He mentioned that they can’t just call these scientists and doctors and ask them to rush or give updates/timelines because their investors would like to know. This makes me think the authoring of the paper is complete and it is in review/approval stages.
sorry computer euh LP says no lol
again I find your perception of the medical industry incredible cynical
No, i have never seen real funds holding anyone to “account”.
I'm betting maybe 2 or 3 actually had anything more than minimal input and 50+ did nothing more than read it.
When they finally get their data out, it will probably be a base hit or "C", definitely not a Grand Slam or "A+"
Similar to AMRN.
This is what he said on the subject
Someone will always be slow to take care of these requirements, and with 60+ co-authors, I can see this taking up to a couple of weeks between submission and actually being sent out for review. So my guess is that they by today would have gotten to the point of having an article submitted. 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. However, I assume they would want to try one or both of these top journals first. These high end journals do an internal editorial board review of submissions before the paper is sent out for peer-review.