Yes, LL says she hopes -L can be made available while further trials advance. But what exactly does that mean?

48:00 She talks about how hopefully in the future patients can get access to treatment while trials continue for proving or disproving efficacy. Goes on to talk of hopefully allowing patient right to try for -L.
That she talks about -L being used via RTT sounds like she has doubts on any near FDA approval.

35:50 Talking about SAP LL notes "and you are aware of the limitations of using external control populations"

42:20 Asked about trial design (ECA) limitations. LL notes that to "mitigate some of the limitations using external controls" they used MAIC to make up for the lack of patient level data in the ECA. She notes "so we are not able to do individual patient level matching which we are all aware is a current limitation of the use of external controls". She goes on to talk of how hopefully the discussion around this trial will put pressure for changes to make patient level data more available.
The patient level data issue is huge. There is a reason why the FDA says in their ECA guidance that patient level data is required. The attempts to get around this limitation have serious issues. MAIC is questionable even if it had all the key data, which did not exist in this case. There assertion the trials were matched is comical. 2 were genetic subgroups and none required for intent for near total resection. Most all allowed biopsies.

On some less significant points:

41:40 LL talks about how the unique immune status if the CNS is a rational for -L.
That is a rational theory as to why a DC vaccine might work better for GBM than other tumors. But if true, then the arguments that DCvax shoudl work in all cancers loses support.

36:50 LL talks about how the crosover arm was added in order to get patients to enroll.
It really does not matter why the crossover arm was added, but some here assert it was required by the FDA. Certainly LL has made contradictory statements on this, but both the SAP and LP have said it was per NWBO to help enrollment.

There was no update to the NWBO corporate structure.,
There was no "activation of RevImmune"

Both of these were just updates of the paperwork on shell subsidiaries that changed nothing. They mean zilch.

That the dot connectors tie these to anything of significance is right there with the Apollo 11 hoax type stuff.

Sure, It was less than 5-1/2 years ago she dumped 3.6M of her shares at $0.17 along with 1.8M warrants as a incentive,

https://www.sec.gov/Archives/edgar/data/1072379/000114420419003609/xslF345X03/tv511975_4.xml

And before the SMA steps in, those were her personal shares. The Toucan shares sold were only 800K.

OK, I think Diver and all are correct on Eden,

Eden is worth $20B. Advent is also.

That is why LP puts cash into that instead of Direct or combo trials.

Waiting on cement to dry on DCVax toombstone..

Should not be hard to understand that a manufcaturing device is not the same as the product.

There are basically no DC;s approved as of today. We do know mfg devices actually being used in trials to make them, Eden is not one.

CliniMACS Prodigy,

It had been manufacturing a commercially approved DC vaccine in Italy (the drug failed the confirmatory trial so was pulled).

$20B for Eden? LMAO.

There are many others in the space (automated cell mfg), and several more advanced. Actually approved and making products. Hundreds of millions have been spent advancing these other options.

Eden was picked up in a firesale (when the space was red hot) and little has been spent developing it. There is zero reason to assume it is any more than a bit player in the space.

Missed that one, was looking at the loan taken out in Mar 2023.

So there were 4 to Street and one to Illiad (Fife), Somebody said those are the same, but I do not know.

Regardless, getting short term loans to pay off short term loans is not great way to do business. Especially as at the end of the day they use discount shares to pay them off.

Just over 1 year ago. Exact same terms.

If that loan is not paid off (from this loan) then the payments on the new loan starts about when the old loan is paid off.

This is the third (or 4th) in the sequence of loans from SttateStreet. They are happy to keep getting 10% OID plus 8% interest year after year. Unknown if they have any hedges in place.

On a very quick read the main point raised is that even an hour is too long a period for the spoofing effect to last. Basis of their argument:

1) A recent court decision just weeks ago,

2) The argument that NWBO has asserted the MMs are flipping the cheap shares just seconds later at fair market prices (no longer impacted by the bating).

No comment as of now, other than we need to see what happened in Pharma where the same plaintiff legal team was on the wrong side of at least some decision.

It is worse than that.

The Poly-ICLC arm only had 5 GBM patuents (the trial design was for both GBM and grade 3 gliomas). In the GBM patients the data showed:

. The OS P value was .78
. The 5 year OS in the Poly-ICLC arm was 0%
. The 3 year OS in the Poy-IICLC arm was 20%

[All the above from figure 3]

Not all that impressive for the 5 GBM patients treated with the combo.

And never forget that the process used to create the DC was very different from -L. They can call it "the same" all they want, but RA's would have a bit of an issue.

So the numbers are 3.2K/year and the total number of GBM patients alive is 12K.

So how long are those patients living?

That is disclosed in the Form 3.

The 3/4/5 forms are totally different from the annual proxy or 10K on this. The 3,4,5 are submitted by any individual who is an insider either by holding 10% or being an officer or director. They need to be submitted as shares are bought/sold when covered, or when becoming an insider as in this case. The corporate 10/K/proxy is an annual submission and has less information.

That the holding information has been partially disclosed in the 10K does not change the requirement for the S3 disclosure.

Yup.

Nice t see he is fitting in with NWBO in not reporting his shares via a Form 3 as required 10 days after becoming a director.

Why bother with rules when the penalties basically don't exist?

Sounded like he said "... point of departure in that we have semaglutide". That is Wegovi.


Would be nice, but for now we need for AMRN to keep on plugging away and do what is in their control.

Calling something a "franchise" does not imply "franchising" as a commercial operation.

Many would call Patrick Mahomes a franchise quarterback. That does not mean he his being sold at McDonalds.

In this pharma space the term is used to describe a drug so large one structures operations around it. The first use I recall was Merck and their "Keytruda Franchise". Yet, Keytruda has not been out licensed in any way.

Since then it became a trendy term for a company to use to refer to a drug that a company expects to be their centerpiece.

LP called DCVax their franchise. That in no way implies they are franchising it.

Nope. He did say when he started treatment though,.

And of course we know this, and the post you replied to, are just pumping nonsense.

The King did not get DCVax.

No, there is no "same concern" in the EU as the Anchor patent has held and that is the only one that matters for the EU.

The issue in the US is that generics have been approved for the Marine indication as that patent has failed. That would be a minor issue if not for the fact that they are selling into the Anchor market. That still has a valid patent, but has been almost impossible to effectively enforce.

In the EU there is no Marine indication approved. Thus there are no Marine generics.

In theory somebody could run trials in the Marine indication in the EU and garner an approval for that. In reality that will never happen for economic reasons.

Did Feb 29th count?

Last year (through Nov) the MHRA approved exactly 7 new drugs (not generics) without reliance on another RA.

Those 7 took 480, 420, 410, 400, 400, 330 and 310 days. Not a single one within the 270 days (and I would think at least the CRSPR drug was on the 150 day path).

This year we don't have any new data as the MHRA has decided to stop publishing the data for drugs that are not already approved. So all we have is data on generics (established initials). For those without reliance on other RAs they are averaging about 500 days this year.

With the new IRP in place I wonder if the MHRA will approve more than one or two new drugs a year with more than a rubber stamp.

That has been said for years and every 10-Q/K shows it to be wrong. NWBO has been selling shares through several channels

. Class C preferred shares being converted. The conversion ratio is fixed but any new C shares go out at some discount to current market.
. Warrants, these are fixed conversion prices, not based on market
. Options, these are fixed conversion prices, not based on market
. Exchanges for debt (even "non-dillutive:" debt). These are based on a discount to current market,
. New share sells. Would be based on a discount to market prices but none such was issued last year (had been in all previous years).

In all of 2023 they issued 34.1M shares for warrant and option conversions. They also issue 30.8M shares for 'C' conversions and 37M shares for debt repayments.

There are also some shares being paid out per Flaskworks/Advent contracts but not certain when any of these were actually issued.

In short, warrants and options were about 1/3 of the total. And most are exercised cashless so bring in no money.

Try harder flipper.

I said "if things go smoothly' then Aug-Sep is a reasonable time-frame for approval.

I expect nothing close to "going smoothly". Nor do I expect approval,

You forget to mention the amended 10-K or 14A, whichever comes out, in the next week.

Can;t wait to see for certain what the long term investor appointed to the BOD actually holds. My guess is nothing.

If things go smoothly that is a reasonable time-frame.

I always have a chuckle with those suggesting March./April/May/...

BTW, there is no reason to assume that a delay need be disclosed.

Yes, The NASDAQ has rules that require companies to allow the filthy peasants to vote on certain issues (such as excessive dillution). They even require the annual ASM every year to allow shareholders to vote on the BOD and other issues.

Disgusting that filthy peasants be allowed to interfere with business of the entitled.

What is so complicated?

Nothing has changed with the status of Reveimmune Inc, the company that has the Il-7 product being discussed.

As far as Revimmune Limited (as I assume that is what you are looking at), I would guess it is some UK paper company owned by the US company. I could care less what changed with it, if anything.

This is a frigged stupid as when DD and friends were asserting some huge event had happened with NWBO Limited for the same reason.

Yes.

To be clear, "Revimmune" is Reviimune Inc, the US company that we have been talking about. Not Reviimmune Limited, a UK wholly owned subsidiary that is not more important than NWBO Limited,.

Yes, as she always has been.

The assertions by DD, ILT and dstock that something changed with them and NWBO Limited is nothing more than there usual nonsense. They posted documents that never said anything at all about such a change.

If you disagree, how about just showing any actual source docs that say some status change happened.

LP (via Toucan) has owned Revimmune for years and you know that.

The documents DD and his cast of clowns never said anything about LP changing the status in any way.

There was no such recent move by LP wrt Revimmune (nor NWBO Limited).

That is just a reply by somebody to the SEC spouting all the fantasy crap about "counterfeit shares".

Even if you believe these billions of fake NWBO shares exist, a new CUSPID does nothing.

A new CUSIP does absolutely nothing about short shares, legal, illegal, naked or not. Same as dividends and up(down)listing. All the talk about forcing an accounting of shares or such is per fantasy. The process for tracking owed shares through such is well established.

The only thing you can be certain of in a merge with Revimune is that LP will be the winner.

WOW. You have been here for 7 years of hype on the ASCO big booth and still pumping it as if it means anything.

NWBO is advertising the one product they sell. Their stock.

LL did not join the BOD.


Because biologics CDMOs are valuable, as LP proved when she sold Cognate. The real question is why is NWBO building a CDMO that LP owns. BTW, people used this logic in 2015/6 when NWBO was spending to expand Cognate that approval was soon.


The Big Booth is Back!!!. I think this makes 8+ years of hyping this stale silly story..


Because they have so little positive to news to pump out.

Clearly not DC-L as they were pulsing DC with KLH in addition to various cytokines.

BTW, that trial completed 12 years ago.

Nobody knows. According to the 10K the contract for commercial production has not been agreed upon. So LP can negotiate what she wants

I so love all this Revimmune hype. Anybody wonder how good a deal LP with negotiate with herself?

Do have to give Rev some credit though, they actually ran a randomized trial for their IL-7 and reported the results properly.

Not exactly a home run. Maybe they should have dug up an ECA to compare to instead?

NW Limited (by either name) is no more than a totally owned subsidiary of NWMO set up years ago to handle the real estate transaction.

Nothing recently has changed, and none of this maters at all.

Definitely the mechanics.

The electronics for this are nothing. a control system with a few dozen inputs and a small number of outputs plus coms.. Once you have a concrete design there are thousands of companies that will build tested circuit boards for you at a modest cost. If they were cost sensitive they could probably get the COGS for a tested board under $100.

Oh, and nobody would build this with either "programmable microchips" or a PLA. It would be a vanilla setup with an Arm SOC and eMMC. The crap one poster here has been talking about has been obsolete in this space for 2 decades.

For disposables, the only issue is the one time setup cost. That may not be chump change.