exwannabe

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Posts	18,057
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Alias Born	09/06/2006

exwannabe

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exwannabe

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exwannabe

07/15/24 9:53 AM

Post #706103 on NorthWest Biotherapeutics Inc (NWBO)

At 45:18 she says there appears to be a signal of efficacy. For those who do not know that term, it means early evidene that is not proof.

At 45:45 she says "given the very favorable toxicity profile and potential for efficacy. I do hope it can be FDA approved someday"

At 46:16 she is asked if there will be a randomized controlled study with single agent plus SOC. She says that is up to the sponsor.

At 49:20 is when she closes by saying she hopes it could be made accessable somehow and allow patients the right to try.

The tone of this is clear. She has strong hopes for -L eith solo or combo, but more trials are needed. Until then RTT.

exwannabe

07/15/24 9:07 AM

Post #706080 on NorthWest Biotherapeutics Inc (NWBO)

You said no datalock and it happened

I never said that. You are lying.

You said no submission and we got it.

I never said that, you are lying

You said 5th tier journal and we hit jama

I did doubt they could get published in a top tier paper w/o some details on key issues. They did disclose some info, like the efficacy IA in 2015. But I admit I am surprised by what was allowed to be left out.

exwannabe

07/15/24 8:55 AM

Post #706078 on NorthWest Biotherapeutics Inc (NWBO)

Provide me a link to a video where LL implies that she expects DCVAXL not to be approved but she then has confidence that it will continue as RTT.
SHOW ME THAT VIDEO NOW. Yes Im saying alomst everything you say is fake

Start at minuet 42.

exwannabe

07/15/24 8:06 AM

Post #706067 on NorthWest Biotherapeutics Inc (NWBO)

I got it now

The FDA says they want to see patient level data (not summary data) for ECAs. The JAMA paper notes lack of this as a limitation. LL bemoanes the fact that this lack of data creates an issue.

Yet you and Senti think the FDA is wrong because nobody could run an ECA based trial under these conditions.

What about the Medicenna P3 in rGBM ?

Cleared by the FDA, and it will use individual patient level data.

P.S.: Senti, MAIC has serious limitations.

exwannabe

07/14/24 5:17 PM

Post #948 on Outlook Therapeutics Inc (OTLK)

UK and NICE. In the UK the NICE guidance establishes how the NHS will pay for and use drugs.

Read through the most recent guidance for wet AMD. In short, it does not pay for bavi because it is not approved for the indication. It also says generic Lucentis should be used as first choice (because it is cheaper than branded).

What does this mean for Lytevana when they go to NICE to update the guidance?

First, there is no price pressure form the off label bavi. That is very good.

Second, I would guess that they would basically try to split the non branded market with generic Lucentis,

IMO, this is good. My concern with markets like the UK has been they will force the price down close to the off label bavi. And that does not look to be the case.

Have no clue about all the other dozens of EU states,.

exwannabe

07/14/24 4:34 PM

Post #706005 on NorthWest Biotherapeutics Inc (NWBO)

You just posted a statement that individual patient level data for the ECA is required, and NWBO has made clear they do do have it.

I will be glad to see you gone by end of year.,

exwannabe

07/14/24 4:24 PM

Post #706001 on NorthWest Biotherapeutics Inc (NWBO)

NWBO did adhere to the patient patient-level data. as set by the FDA.,,

Per the JAMA paper:

This study has limitations. Since individual patient-level data for the ECPs were not available for this trial, as is often the case, propensity score matching could not be performed, which is a potential limitation of this study.

exwannabe

07/14/24 2:07 PM

Post #705978 on NorthWest Biotherapeutics Inc (NWBO)

DCVAX is 13% SOC is 5 %

DCVax was 13% when they only enrolled those with intent for near total resection and excluded those who subsequently progressed.,

Gee, cut out most all the cancer and when in does not start coming back one lives longer. What a surprise.

The ECA patients with near total resections did just as well.

Lesson learned, get good docs (like LL) who can cut most of the tumor out and prey it dose not quickly grow back.

exwannabe

07/14/24 11:49 AM

Post #705957 on NorthWest Biotherapeutics Inc (NWBO)

All detailed patient data has, of course, been provided to the MHRA by NWBO. So what is your problem here exactly?

I will assume this is simply ignorance and not baseless pumping,.

The patient level data in question is from the ECA.. NWBO does not posses it, so cannot provide. There is a reason why the FDA and others state this level of data is needed. And this submission does not have. And even the JAMA paper notes it, are they lying?

LL never said.

Are you saying the video posted here was a fake?

exwannabe

07/14/24 10:26 AM

Post #705940 on NorthWest Biotherapeutics Inc (NWBO)

The Journal Article indicates DCVax-L achieved Statistical Significance in rGBM and nGBM. First trial in over 2,000 or 27 years to do so

Yes, it was stat sig against the ECA. Alas that has serious issues wrt approval as has been discussed here many times.

The paper notes one huge point, lack of patient level data. LL herself has talked on the video from last year as she notes RA want patient level data for EC comps. And goes on to say how she hopes -L can be made available by some kind of RTT while studies are run to prove the OS benefit.

And no, it did not say the "first trial ..." line. That is just spin longs on this message board make up.

Flaskworks 3.0 a closed manufacturing system will be approved within months

Can you not understand what LP said on this, or do you think she was laying a trap?

They are still designing tweeks and when done will order initial units. They have said once that order happens it may be delayed by supply chain issues. Once they are in they house (which may not be this year) NWBO needs to perform internal runs to see if it checks out. After that they need to perform the comparability study. Then they submit for approval, and that is not a pro minor step for commercially approved drugs.There s no commercial Flaskworks in the comigng months.

exwannabe

07/14/24 9:00 AM

Post #705922 on NorthWest Biotherapeutics Inc (NWBO)

For God's sake, do you know what condition does Outlook's approved product treat, and what will Northwest Bio vaccine treat if approved?

And the price of each treatment, the market potential?

Yes, I have to assume you do not.

Wet AMD market revenue is significantly larger than GBM. Various numbers can be found, but all agree that it is several times larger than the GBM market,

exwannabe

07/13/24 1:46 PM

Post #705834 on NorthWest Biotherapeutics Inc (NWBO)

.. what is potentially at worst an excellent treatment ...

And therein lies the issue.

They ran a randomized trial where 233 patients received DC-L and 99 received placebo. The 233 did no better than the 99. Not on either PFS nor OS. That is far from an excellent treatment, it is more like grape fruit juice.

Longs can say but, but, but all day long. But reality is approval based on the P3 looks very questionable.

Even if DC-L does work (which I think is possible, but not clear), the value is not much if they have to run another trial. And neither of the combo trials that longs want to hype will do the trick.

exwannabe

07/13/24 11:22 AM

Post #705788 on NorthWest Biotherapeutics Inc (NWBO)

Given a choice, who would pick taking a poison over DCVax?

DCvax-L is used in addition to chemo, not instead of it. Every single patient in the P3 trial used chemo.

exwannabe

07/11/24 6:00 PM

Post #705521 on NorthWest Biotherapeutics Inc (NWBO)

Was a shame there was no video recording of the ASM. The scenes of the man in red could have gone viral.

Did anybody figure out if he was the new BOD member? He looked really, really excited.

EDIT: Did the "oh, the mike is live" audio get captured in the audio recording, or did they edit that out?

exwannabe

07/11/24 5:48 PM

Post #705518 on NorthWest Biotherapeutics Inc (NWBO)

Can you tell the board why the price of NWBO at around 3:57 today was below the bid and the asking price! How does that work since you and Theory seem to gave it all figured out?

Why should the price (the last trade) be between the current bid and ask? A trade should be be between the current bid and ask, but that is not the same thing.

Say the bid ask is 1-1.10 and the last trade was at 1.05. All looks as you expect. Then somebody places a buy limit at 1.08.So now the ticker shows a bid-ask of 1.08-1.10 with a price of 1.05.

It always amazes me how many can read the ticker and declare it is manipulation while not knowing even the basics of stock trading.

exwannabe

07/11/24 1:41 PM

Post #705455 on NorthWest Biotherapeutics Inc (NWBO)

As to your loss claim, I don’t think you will find a single investor who has lost 99% of their investment in NWBO.

Maybe true, maybe not.

I do know the single largest investor lost over 95% of their investment. And as he said, he failed to take into account the damage cause by governance issues.

exwannabe

07/11/24 12:08 PM

Post #705428 on NorthWest Biotherapeutics Inc (NWBO)

I don't think anyone got it for less than 40c at whatsover deals, imo. SIO got the common shares for 40c. I think 40 is set at stone.

NWBO has been selling shares at about a 15% discount to whatever the market is. Shares being sold to "investors" today are like for around $0.33 or so.

And some deals are being "true up" so they get a discount if the price drops after the transaction. So the "investors" dump at the close causing the deal to be "trued up" and they get more shares.

exwannabe

07/10/24 5:49 PM

Post #705216 on NorthWest Biotherapeutics Inc (NWBO)

It doesn’t mean that. There are typically agreements that cover those details.

That is true.

The NH will have standard terms for grant. They are basically harmless other than a tiny royalty.

But nobody knows the terms LP negotiated between her 3 companies. Given that she had larger interest in the other 2 one might wonder how any such contract was structured.

exwannabe

07/10/24 5:11 PM

Post #705214 on NorthWest Biotherapeutics Inc (NWBO)

Every inventor assigns their rights separately. All versions of the combo patent are presently assigned to all 4 of NWBO, Revimune, CRL and NIH.

What that means is all 4 can use the invention (which s the idea of treating a GBM patient with both an ATL-DC and a CI). And all 4 can license it,

The NIH does not matter. It is standard for University work done under a NIH grant to be assigned back to them, but they rarely (if ever) use it.

exwannabe

07/10/24 2:17 PM

Post #705167 on NorthWest Biotherapeutics Inc (NWBO)

It is unclear if the -L application would qualify for the "high quality application" standard that yields the 150 day review.

Yes, we know they took a lot of time to triple check the submission. We know they switched to a new set of consultants late in the game to insure it was done. And we know from Senti and others that LP and LG personally took over the final submission because the consultants were not getting it done.. But still, one might wonder.

That it took till March to get validation verified might make one suspect the quality was not as high as all the longs here assume.

And if so, then the deadline would move to 210+60. And after that one can blame MHRA for being slow.

exwannabe

07/10/24 1:33 PM

Post #705153 on NorthWest Biotherapeutics Inc (NWBO)

On an ironic side note, I wonder when KIPK will learn that I get paid based on total emojoes regardless of positive/negative?

exwannabe

07/10/24 1:22 PM

Post #705144 on NorthWest Biotherapeutics Inc (NWBO)

I wonder, if true, how you KNOW about this and the company doesn't? Unless you are saying the company is also in violation of Fair Disclosure?

If in fact your allegations are true, I am surprised you didn't have to sign a NDA since you are broadcasting significant news on a public company and thus could be held liable of sharing insider information.

I am making no comments on the validity of nem's post, just some comments on disclosure laws.

First, Reg Fair Disclosure does not require material inside information to be disclosed. It says if it is disclosed it must be done so in a fair manner. A broad PR or 8K. Not a phone call or the Big Biz show.

Second, if somebody happens to poses the same material inside information a company has, but from side channels, they are free to do whatever they want with it. If I am sitting at the cafe and overhear LP saying they have a partner offer from a BP, I could (and would) legally buy. EDIT: Inside information obtained though channels like companies bankers, lawyers and even friends and family is subject to insider trading laws.

If somehow material the company thinks is confidential inside material information becomes public, via any channel, the company must promptly disclose

exwannabe

07/10/24 1:06 PM

Post #705133 on NorthWest Biotherapeutics Inc (NWBO)

Someday NWBO will experience a trading day with such high volume, I hope. https://finance.yahoo.com/quote/KZIA/Kazia Therapeutics Announces Phase II/III Clinical Trial Results for Paxalisib in Glioblastoma

Wow, Kazia's spin on their Agile results has popped it over 250%. Impressive.

Looks like in the overall trial their paxalisib showed nothing for OS. In the 130 nGBM (all unmeth, per initial design) is trended a modest 14.8 vs 13.8 mOS benefit (almost certainly not stat sig). rGBM trended a month the wrong way. They were stat sig on a secondary, but that would be data mining.

Maybe their drug does have some value, but at best the Agile data will be exploratory for them.

NWBO could hire their PR team though.

exwannabe

07/10/24 12:40 PM

Post #705120 on NorthWest Biotherapeutics Inc (NWBO)

And who revealed this to you?

LP, at the ASM.

So now that the adaptation for clinical grade GMP, that design work has been done. The remaining steps are; complete the the streamlining, or condensing some of the portions of it, get the units ordered, have the units delivered, and then Advent will need to conduct a large amount of, what are referred to as, engineering runs. They're practice runs. You have to run, do practice runs with the Flaskworks machine in the Sawston facility, collect all the data, compare the data with the data from the DCVax products produced by the existing manual process, because they have to show, they have to demonstrate to the regulator, not only that the Flaskworks machine operates properly, doesn't shed particles into the clean room air, things like that.

We have to show that it produces a product that's the same, or as close to the same, as a biologic product can be. So they'll be in addition, after they do all of these engineering runs, and they collect all the data, they'll do comparability studies, equivalency studies, and collect the data from that. And then all of that will be submitted to the regulator, and the regulator will give approval.

Steps:
1) Streamline/condense steps in the Eden process
2) Order the units
3) Wait for delivery (previously have noted supply chain issues will effect this step)
4) Engineering runs for internal testing
5) Comparability studies
6) RA approval

The huge unknown is the comparability study. I expect that to be clinical, as the RA to likely will want to see data with actual human material (WBCs and tumor). But even before that I would think 1-1/2 years is reasonable, if not aggressive.

exwannabe

07/10/24 7:55 AM

Post #705010 on NorthWest Biotherapeutics Inc (NWBO)

We know a lot of details wrt Advent.

There are 3 operational contracts (outside the leas).

1) The mfg agreement to run Specials in Sawston. $8.3M/year. This includes a minimum manufacturing quantity and presumably operational costs for the program.
2) The mfg agreement to run Specials out of London. $6.6M/year. Same as above
3) The Ancillary Services agreement that is an umbrella contract under which Advent provides various work at cost + 15% (?).

On the first 2 they are paying about twice what the paid Cognate because of the 2 facilities. We know after LP sold off Cognate she stopped paying Cognate and claimed it was an unfair contract, But now she pays Advent twice as much. and why 2 facilities? Certainly not at capacity now, and is not Sawston much bigger?

For the services, there are certainly many recent SOWs that are as you say and I cannot question. But there were also the contracts to build out Sawston. The clean rooms, the freezers etc. Advent was paid cost plus to have those installed, and now they are Advent's by way of the $140K/year lease on the GMP (phase 1A and 1B) portion of facility. That is insane.

And last, we have the comical costs where NWBO paid Advent to transfer the tech from Cognate when they had already Paid Cognate to set it up. By that logic Advent could restructure every year to get more cash for "transferring" the tech

At the end f the day we do know Advent has managed to set up a profit making CDMO on virtually no cash. They have an approved facility under long term lease for chump change. .

exwannabe

07/10/24 5:43 AM

Post #704993 on NorthWest Biotherapeutics Inc (NWBO)

Will NICE even accept pricing model etc. before the drug is approved?

Yes.

NICE has a goal to decide and issue the appraisal by just after MHRA approval. In order to do that, they start work in advance. The first real step in the process s for the the sponsor to submit the scientific evidence (what is loosely being called the pricing model). This is not a trivial project, once can look at the detail that other sponsors have submitted. It takes time to put together the evidence, and time for NICE to review.

That NWBO has not even hired contractors to start on this is more than a bit odd.

exwannabe

07/09/24 12:17 PM

Post #704813 on NorthWest Biotherapeutics Inc (NWBO)

Hopefully Direct restart PR happens in the meantime and kickstarts us.

You mean this PR?

Other terms provide for a dedicated cleanroom suite, an upfront payment of $2 million for partial payment of certain past obligations, restart of new manufacturing of DCVax-Direct, and revised product manufacturing fees which incorporate certain volume discounts.

exwannabe

07/08/24 3:49 PM

Post #704619 on NorthWest Biotherapeutics Inc (NWBO)

wont be long and NWBO can start making 100 million in 2022

Missed it by that much.

exwannabe

07/08/24 1:45 PM

Post #704587 on NorthWest Biotherapeutics Inc (NWBO)

So I asked a friend who is very familiar with clinical drug trials about this very question: If you were admitted into patient selection, included in the patient pool of Phase 3 Clinical Trial participants, participated through the whole series of treatments, and your data was collected, stored and INCLUDED into the overall trial results, in this case OS, there would be some issues which would most likely have to answered. But the fact you never took part of in the trial, never took the vaccine, and your name NEVER shows up even once on any of the medical records associated with the Phase 3 clinical trial, it will not lead to any investigation whatsoever.

The trial Master File will include all 1500+ who passed initial screening for the trial, not just the 331 that were randomized.

How does you expert not know that?

exwannabe

07/08/24 11:49 AM

Post #704558 on NorthWest Biotherapeutics Inc (NWBO)

You are still posting NWBO's counter to the MTD. There are no quotes in that from MMs. The actual material from the MTD was:

Third, NWBO’s allegations do not establish the required “strong” inference of scienter for the independent reason that they fail to account for multiple other “cogent” and more plausible explanations, including that Defendants were engaged in ordinary market activity and trading on behalf of clients—indeed, the Complaint fails to acknowledge that Defendants trade at the direction of clients—and that any stock decline during the narrow windows identified in the Complaint was attributable to negative investor sentiment surrounding NWBO.

If you consider the MMs stating that they trade orders for clients to be an admission of guilt then I understand all your posts better.

exwannabe

07/08/24 10:55 AM

Post #704526 on NorthWest Biotherapeutics Inc (NWBO)

Now that's a fast turnaround. Must have been a lot less than a million 'pages'

It was based on the EMA approval and therefor falls under the new IRP program that approved in 60 days after the positive CHMP opinion.

exwannabe

07/08/24 10:23 AM

Post #704505 on NorthWest Biotherapeutics Inc (NWBO)

The quoted text is what the FAC (First Ammended Complaint) alleges. So that is NWBO quoting themselves.

exwannabe

07/08/24 9:47 AM

Post #704475 on NorthWest Biotherapeutics Inc (NWBO)

Except they did not admit to spoofing. Just more message board nonsense.

Making statements along the lines of "even if we traded the orders for our own accounts then ..." is not an admission they did. It is just a hypothetical arguing a further point. Further, even if they had admitted they placed the orders, that in itself is not spoofing.

The MTD (both versions) are public documents. Feel free to actually show any admission of guilt. You can't.

exwannabe

07/08/24 7:16 AM

Post #704433 on NorthWest Biotherapeutics Inc (NWBO)

Interesting. Dr. Greg Zivik (Iwasadiver) predicted July 15th for MA approval several months ago on Twitter

He was also willing to bet on MA approval by June of 2023 in post 570835

Haha! Oh boy. Well Ex, let’s make a bet. I’m thinking MAA approval in June 2023. I know I’ve been wrong on a lot of timeline predictions, but when in life new information comes to light most intelligent people reserve the right to change their minds and create new views based upon that new information

Prior to that he predicted MA approval by end of 2022 based on secret submissions and vodoo regulations.

And these July predictions will look equally wrong when get the next status update.

exwannabe

07/08/24 7:00 AM

Post #704432 on NorthWest Biotherapeutics Inc (NWBO)

The biggest challenge in the lawsuit isn't the admission that they spoof/ are spoofing/ spoofed(?). Its providing evidence that damages have been endured and to what extent.

That is just for the MTD.

Past that, the 2 large hurdles would be establishing:
1) The supposed spoofing orders were placed with intent to manipulate the market
2) The MMs either placed the orders for themselves or were somehow complicit

The first issue is complicated by the fact that the MMs are placing orders for retail. If I place a limit sell and 30 seconds later you buy that is not evidence of a spoof even if both routed through Citadel. If the orders were on behalf of the same beneficial owner (be if the MM, hedge or retail) then that is fairly solid evidence. At present no such evidence exists and it is far from clear it will.

For the second, if the MM themselves are the traders then agreed the case looks easy. If somebody else though it gets murky. In the example of you and me, if we both used E*Trade then all the MM sees is 2 orders from E*Trade and nothing unusual. In the case of one of the "Island Boys" (my nickname for the low rent finacers who flip stock sold by fledging companies at a discount) then they would also not see anything unusual as the buy side would be private. And if the MM sees nothing unusual they cannot be guilty by any rational argument.

On the issue of damages, at present the Court is not allowing any assertion of long term damage so NWBO has to show their stock sales were temporally proximate to there sales. NWBO has listed several within an hour, but the MMs are arguing that is still too remote. I suspect the Court will allow the 1 hour and the case goes on, but if not it could be difficult as the examples are all over a couple minutes.

On a related issue, if the Court sticks to the 1 hour window, then one can calculate the damages as listed in the complaint, They are a only few hundred thousand dollars. Not exactly huge.

exwannabe

07/07/24 1:43 PM

Post #704346 on NorthWest Biotherapeutics Inc (NWBO)

Do we have any examples of drugs approved by the MHRA but not approved by the FDA?

There are some drugs the EMA has approved that the FDA has not.

There is virtually no data on the MHRA as most all they do is rubber stamp EMA approvals. Last year they had a grand total of novel drugs that were not just EMA based rubber stamps.

The one drug (outside of COVID) that anybody knows of which was approved first by MHRA was CRISPER based sickle cell anemia drug last year. It was a month or so earlier than the FDA. Was launched in Q1 here in the states and some other places but no launch in the UK yet.

exwannabe

07/07/24 1:17 PM

Post #704337 on NorthWest Biotherapeutics Inc (NWBO)

Wait for the MTD denial

Sure, I think it is likely the MTD is denied in the next month or so.

I expect that to be the only substantial news this year.

exwannabe

07/07/24 11:41 AM

Post #704303 on NorthWest Biotherapeutics Inc (NWBO)

We’ve already proven in the case that spoofing did exist 3000 cases ...

No. All NWBO has stated as facts is that there were limit sell orders that were not executed and the same MM who placed them purchased shares immediately after, That does not make for spoofing in itself. Sorry if you do not understand how markets work.

Even the judge admits in this case there was spoofing, but it’s up to Northwest bio to prove damages ..

No. The Judge has stated that if NWBO assertions are true they have sufficient grounds to go to discovery.

We will see if and how quickly Citadwl wishes to settle.

There will be no settlement at this stage. This was clearly explained in one if the editorial comments in a law journal discussing it,

exwannabe

07/07/24 11:31 AM

Post #704293 on NorthWest Biotherapeutics Inc (NWBO)

Griffin and Citadel admitted to spoofing.

If you mean in thie NWBO case, no they did not. And I am not aware of any such admission elsewhere.

But by all means keep in the NWBO tradition of asserting facts based on other NWBO longs stating them based on other NWBO longs stating them ....

Kind of like the Hitonol approval Everybody knows how to find approved drugs easily, yet many here keep accepting it is approved because DD cites Peter who is qouted be AE citing Chiuguy ...

exwannabe

07/06/24 3:39 PM

Post #704163 on NorthWest Biotherapeutics Inc (NWBO)

Run trials for what moron? These are combo therapies designed to increase efficacy. They don’t need to get approval if each therapy is independently approved.

Hiltonol is not approved by any RA, so obviously more trials are needed.

And ATL-DC does not "carry over" to -L. That was even disclosed by NWBO:

Because DCVax-Brain is not identical to the product used in the UCLA trial, there can be no assurance that the FDA will not require us to perform Phase I clinical trials using DCVax-Brain prior to proceeding to Phase II.

And subsequently NWBO did need to perform another P1 because UCLA's ATL-DC did not carry over to -L.

And also, off-label use of expensive drugs is marginal. There is a reason Specials and the German HE are nothing burgers.

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