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Is next news the 10K?
Likely. The usual suspects are suggesting NWBO is not going to say anything about the MAA status, so likely no news there. ASM is about out of math for happening prior to the 10-K.
So what might be in it?
. Eden milestones. So far only 1 of 4 has been paid. They are to be paid in stock so mandatory disclosures.
. The Advent MFG contracts. Why do they still pay $5M/year to manufacture at Kings when it is a fraction the capacity of Sawston?
. Revenue of course. The number itself ,matters little but why is it so low? It was way under even my estimates. Something is wrong there.
.
Other than that the usual mess of a balance sheet.
Oh, they probably have to disclose the BOD holdings (usually done in the ASM proxy but they forgot to have an ASM). Curious how they explain the disconnect on Malik's shares stated in him vs what NWBO states.
Have you contacted FINRA?
Why? You are correct Elios did not wait years for long term data on the early stage trials.
No bios do. Even NWBO launched the trial that became the P3 with very immature data in hand.
Another competitor but far behind us, using almost same approach as I understand it,
If Merck also installed similar freezers, I believe that is a big hint and that can be a key clue that Manufacturings of Dendritic Cells in the US are being prepared potentially by Merck.
Just an update. I'm waiting to hear back from Health Canada, FDA & EMA regarding their potential implementation of the IRP.
I like how you round up to 2B OS. Why not say 3 billion OS if you are going to make up random stuff?
If you check carefully, you can see that Merck has no vaccines in any form pending for approval. For Merck to start massive constructions of vaccine manufacturing facilities with crazy working hours and hire all high-caliber talents in the area of immunology, cell therapy, and cell manufacturing, Merck must have seen something definitive. There is nothing more definitive than DCVax-L. Period!
The deal with Daiichi which has the FDA approved oral CSF1R inhibitor, the only one on this planet also gives us the indication that Merck is aiming at including plx3397 in the further combination trial which has been going on for several years at UCLA.
Actually, I do recall any any articles by AF attacking IMGN in the periods I was invested. I do recall one where he had SGEN ahead of IMGN. Hard to say that was a bash when it was clearly correct.
Oh, I forget. You did not own SGEN so you think they are worthless.
OK, yes it was Roach (obviously, as they own Herceptin)
But now you say IMGN went downhill because their pipeline failed. Before you blamed it on shorts?
One can debate what clinical failure led to the long winter. For me, the Marrianne failure of T-DM1 in first line was the decision to leave. That was a P3, the rest of the pipeline had a ways to go.
Comparing IMGN and NWBO is bogus.
IMGN had a broad a broad platform and partnerships all over the place, They had Kadcyla approved a decade ago (OK, BMY had it approved).
I have no clue what was going on with it in the 90's. I do know what was going on in the 2005-present period though. The price rose nicely on the Kadcyla approval, but then fell with the first trial trial failure as that left them losing money and no reasonable prospect for over a decade.
I was one of those who sold out back then. I saw no reason to leave cash tied up for that long. Only got back in when they actually were close to real results a couple years ago.
I see no reason why the ,market was supposed to support IMGN.
BTW, congrats on selling back in the 90s. I am sure had there been a message board then you would have been posting "strong buy" as you sold.
Hi Hoff.
Are you suggesting they made a mistake in the SAP where it says the 5th secondary endpoint is OS between the 233 vs the 99 randomized to placebo?
Page 15 of the SAP:
Secondary Endpoint #4: Overall Survival (OS) – Comparison between subjects randomized to DCVax®-L and those randomized to Placebo within Study 020221.
learningcurve2020:Shares sold by Malik a month ago were less than 1% of his holdings.Had to do it for a tax bill.A.E.K.
Really? A 95% probability of approval DCVax-L by MHRA in the UK, according to Larry Smith (Smith on Stocks) and there's nothing to talk about???
You are correct on one point.
LP has negotiated some very good contracts for herself when doing business with NWBO.
And she also does a good job of getting most all those shares for nothing. The 25% true up on employees options was a very good deal she negotiated. Same with bonus warrants for having the loan extended at a penalty interest rate. And let us not forget how well she negotiated to have those warrants not expire.
So LP negotiated great terms with LP and made a loan that anybody would have made.
10% for an on demand loan. The demand feature made the loan virtually 100% safe against both default and market risk.
Plus it included 50% warrant coverage with warrants that basically never expire.
Plus it included a convert option that was priced below market.
That as just so nice and caring of LP.
Under IRP in the UK when DCVax-L gets marketing application approved, will Northwest Biotherapeutics then be able to get DCVax-L approved by regulators in Australia, Canada, Japan, Singapore, Switzerland and the USA, as well as the European Medicines Agency, individual EU member states and those in the EEA (European Economic Area) under IRP and witt new short Time horizons for authorisations, set at 60 to 110 days?
There s plenty of research with Poly-ICLC n GBM including DC vaccine combos.
https://jeccr.biomedcentral.com/articles/10.1186/s13046-021-02017-2
So you are left in the dark about MHRA approval under IRP?
WTF is "the patent"? That is not a hard question to understand.
FWIW, I strongly suspect the negotiations over a combo CI trial have to do with getting a BP to pay for the -L being manufactured for the trial. Especially if the trial is in the UK.
Do you agree or disagree with my assertion that UCLA had their ATL-DC prior to NWBO (as did many others)?
We all know NWBO themselves have asserted they did. Or did you not know that?
I am not sure what exactly you are talking about.
I general patents describe what exists in the field, not just their own inventions.
I would be glad to either debate and/or admit I am wrong if you prove a patent number or link. But just saying it is "their patent application" is not very specific.,
Just to hear your point. Why wouldn't NWBO PR this combo trial? Is it that UCLA as co-developer gets to market their vaccine that they created royalty free?
You mean the combo trial that the company themselves has never mentioned?
The completed date for the combo trial is 1/31/24 and so we may get news in February!
Most of the time, I've found that Fidelity actually fills most orders below my offering price, but only by tenths or hundredths of a cent.
Don't place your order AON (all or nothing).
Yeah, it is a bit iffy,
I assume you are looking at this link.
It looks like the CHM meetings tend to be published moderately regularly (within a few months). The others are sketchy. I am unsure if they sometimes update after the fact and that makes the dates look very late.
It will be published when it is published. And for once, not even I will blame LP if the update on that site is late
This is where approval will first be published. It's refreshed twice a month. https://www.gov.uk/government/publications/marketing-authorisations-granted-in-2023#full-publication-update-history
Despite the reference to 2023, this link will take you to current information. Scroll down.
It's supposed to be secret until it's listed here. NWBO can't say anything, even if they have been told directly by MHRA.
The bimonthly list is a 2 page report in small print. I recommend using the "find" feature to look for the term "Northwest". It won't be "NWBO".
One more date on the calendar, though we do not you know when.
Sometime around late spring to early summer MHRA will publish the minuets of the March CHM meeting. They will note if -L is being discussed (they will not mention it by name, but a ATL-DC GBM treatment will be a solid clue).
Of course this could be made moot by NWBO PR'ing validation. But as of now it looks like DI is making clear that (a PR) ain't happening based on the story being spread through others.
Plenty of published results on their trials can be found here
It is definitely not DCvax-L despite being lysate based. And one of the 2 flavors does not even extract monocytes to grow DCs, it injects the lysate into the patient so it is recognized by DCs and other APC in vivo.
Two trial can be found on ct.gov. One of each type.
There core differentiator from the other numerous ATL-DCs is that they embed the lysate into a particle made of yeast cell wall material. Supposedly makes it tastier to the DCs.
They do extract the lysate via a freeze-thaw cycle, which I think was NWBO's core differentiator from the late 1990s.
No, I am suggesting LG left it in the pile of unpaid bills.
How much would it have cost NWBO to submit the declaration to the OTC a few years ago? About a few hundred bucks as it was all cookie cutter?
Well it's not that, does not expire till 2031, but seems there was some sort of update today of the DNS or nameserver from what I can tell. Could be a simple DNS nameserver issue, just not sure. Registrant Contact Information is in Toronto, CA. I do not recall if its always been that way.
They have been at that registry in Toronto for a while.
It is squarespace that owns it. What is unknown now is if it is a squarespace glitch with the DNS records or NWBO did not pay the bill. My bet is on the latter.
NWBO's AP indicates issues with paying bills. But who cares?
Nope, not a website issue.
Looks like they "forgot" to pay squarespace for the domain name.
Probably LG was in charge of paying the bill to the hosting site.
Not nearly as embarrassing as when he forgot to submit the OTC profile causing the, to be temporarily unlisted, or when he forget to respond to lawsuit causing a summary judgement against NWBO.
But LG does do well hanging out at the BIg Booze show.. Hope he uber's home.
No autologous treatment with a manufacturing system like this has ever existed.
Update: Project Orbis
Someone correct me if I'm wrong, but I believe, Aug 2024 for completion of Phase III. Preliminary phase II (outstanding) results were published in Nature.com pre-print -- awaiting full publication.
Agreed that in the hypothetical case of -L approval commercial sales GM (which is basically Advents cut) will be disclosed.
But what would it be? Advent has the MFG, that has been asserted as being so critical. NWBO can not kick them out of the space, the lease is as long as NWBO has the building. NWBO does not have the tech to manufacturer. Advent controls that.
So why can Advent not demand whatever cut they want?
It is stunning shareholders do not see this issue.