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He actually said he withdrew from the trial prior to receiving DCVax-L
You do understand that these are not pricing/payment discussions, but simply discussions about when and how the NICE process can proceed?
One would have expected to start this at least 6 months ago when NICE was calling them. But maybe NWBO knows they are in no hurry.
The real question will be where does the NICE process pick back up at.
I think there is reason for them to say another scope/matrix are needed. The previous ado not have the right indication, have incorrect statements about what is now being reviewed and is six years old.
Will they issue a new set of docs? Will those be draft or guidance? Or do they just forget that and start the meeting invite process.
Good news is that NICE is a lot more visible than RAs.
About $150k/year is list, but I guarantee you NICE is not paying nearly that much (it is already being reimbursed for HER2+ patients).
A summary of Canada's rejection of the same drug/indcation
Is there a way to get somebody to piss in the bottle for you to fake the genetic market test for HER2?
Biosec, you are missing the point that spoofing by definition requires intent.
If you place a buy limit order with the intent to buy, and then cancel later when it does not fill, that is not spoofing.
If you place a buy limit order with no intent to buy hoping that causes other buyers to raise the bid, that is a spoof.
Intent is core to the issue.
I am sorry you cannot understand the fact that being "basically" the same does not make them the same.
The manufacturing process is known to be different. And somebody once said "In this space, the process is the product"
From the combo trial pre-print
Who cares what George Baily said, he is just citing material circling around from other ignorant posters.
He is mistaken. He stated the definition of a well established use of a medicine in EU law (or EMA regs or whatnot).
An established medicine is one where the active substance has already been approved.
There was a post in winter of 2023 saying almost the exact same thing. Something like :"We (NICE) are working with NWBO and hope to update the website in the next week or so".. Reported by some poster (forget who) that had asked and received an email.
Even if this nth hand copy of an undated email is current, is it any more reliable than the previous?
I do think there is a decent chance NICE will update the webpage this month. It will just be a progress report, it will not be a NICE approval.
So what is Dr Mulholland talking about for a cure in 10 years? He talks about needing charity funds and BP drug donations. He talks about combinations of drugs used used in melanoma and blood cancers.
We know his recent IP-GLIO was charity funded with Yervoy contributed by Merck. But that failed badly, real badly. Yervoy+SOC was 22.7mOS vs SOC at 26.4mOS. Though 22.7 mOS for Yervoy+SOC does beat NWBO's ECA by 6 months (and the -L arm by 3 months).
Anyway, what is the combo he wants to push. Sounds like it will be Yervoy plus a CAR-T.
IMO, he is off the deep end if he thinks he can push through to results of a P3 (it will need a P1/2 first) in 10 years without BP cash. Though it may be he just means to the point of a P2 trial.
You missed the point that the FT writer made in that very quote.
If Citadel settles they will get a flood of copycat lawsuits. That is why they need to proceed through discovery and not settle.
Though I am happy to see the article, this is a clear violation of Financial Times copyright rules. Very likely part of the reason why certain cut and post posters get posts deleted and even banned.
March News:
90%) lawsuit amended complaint in next 2 weeks
90%) 10-K in next 2 weeks
50%) Nice update
20%) ASM Proxy
20%) Update by NWBO on MAA status
05%) Update on Flaskworks
05%) Bluebird
Did I miss anything?
NWBO has been using Monte Carlo for derivative valuations for years. Nothing new, nor uncommon.
What happened here s somebody miss classify the 2 loans as standard, not converts, so the accounts booked took them at face value. Must have been caught at the very last moment because it could have been corrected quite fast.
Or maybe it was just convenient it was not found until the last moment.
2022 2021 2020
Change in fair value of derivative liabilities (25,821) 239,347 (435,351)
But Fall is just a few months away in Linda (P) time.
As it drags into fall it will be more like paying chicken against a turtle.
Sure, 1B naked shares short. I will call BS.
Problem is this. Naked shorts (FTDs) are shares that have not been delivered to the DTC (which books most all US stock transactions). DTC knows the shares have not been delivered to them. They are legally required to report this. And the semi-monthly reports show almost no NWBO FTDs,.
The theory that DTC is complicit is insane. It is not DTC that would be looking to make a profit on the short transaction, it is the party that sold. But the DTC woulkd be on the hook for a failure, and also would be committing a massive securities fraud in not reporting.
So plenty of reason to call BS on the theory. And the reason to support it? Nothing. Not a single piece of real evidence that the open FTD balance is more than the few thousand on average (with occasional days when it pops as high as a million or so only to be delivered shortly.
P.S.: Single-stoick, I know I am abusing the language here on "naked", but sometime easier to go with the flow than continually fighting it.
I see you are spinning this crap again,.
NWBO was forced to put out a retraction just a week later saying how some may have been confused by the first PR to think that the -L was actually available. Really? Was it the lawsuit or the SEC letter that caused LP to react?
How confused was Nevid Malik who was all over the place pumping the "first commercially approved oncology vaccine", and patients flocking from all over Europe to get it?
How many shares did he manage to sell to fools who bought in at a price that has no chance to even be seen again? Sure, some got money back by the lawsuit, but NWBO was to broke to really cough up much so the settlement was minor.
I like the way LP never keeps much cash in NWBO. Makes lawsuits kind of pointless.
It is not being approved in 2024.
You can see the longs already pushing back on the earlier nonsense of posts by Hoff and Flip that predicted under 80(?) days.
Sometime around Fall it will be biosec leading the charge saying that nobody expected an approval that fast. Then the timeline shifts to 2025 and a new story likely takes the lead. Maybe Faskworks or a new trial.
Why do you lie about me making assertions?
I never came close to saying they would never submit. That is a flat out lie by you. Why lie?
On the paper, that is a bit marginal. I did say they would not get published w/o explaining some of the crap. They did explain some, but I will admit I was wrong in thinking they could publish w/o the 232 vs 99 number.
I would say the prediction that it will not be approved based on the P3 trial is solid.
. Trial failed designed primary endpoint
. IA performed that would be expected to call a futility halt on the above.
. FDA halts further patient enrollment.
. Trial continues (as is legit) hoping for OS.
. Trial blows past defined OS endpoint comparing 232 vs 99 with company now saying waiting for more events.
. Presto, randomized trial changed to a comp vs ECAs.
. OS between those on treatment(232) vs placebo (99) never disclosed despite still being an endpoint
Anybody who expects this cluster F to be approved need to invest in some other space.
BTW, will post later on the extent of resection problem. That is a huge issue for those who deny real problems exist.
What are you talking about?
Thermo has stated he has sold, even sold short at times. Though not explained by Thermo I assume they were hedges against loans.
And how does Alpha saying that Navid sold shares somehow read on that?
Your entire thesis is confused and unexplained., To accuse other of lying when they have no clue what you are actually saying is bit self-confused as best.
Yeah, the corrupt FDA theory exposed by those who back failed biotechs.
Reminds me of the AMRN girls crying about the FDA delay (which was caused by a AMRN submission) while ignoring the fact that the EU did not approve for another year. And AMRN is EU based.
Why has NWBO not disclosed the meetings with the FDA on how to proceed towards approval? Anybody with a clue on the space knows the reason for NWBO's radio silence on it.
GermanCol, your argument on censors being discarded fails, badly.
First, Flipper is correct. If the LTFU's are gone, that is because they were found. One does not delete censored data when the SAP says otherwise. This one is trial stats 101.
That aside, if your read of the K/M was correct it would provide support for Flipper's more properly stated analysis of the issue,, that LTFU's being found brought the curve down and that explains why the JAMA paper shows the 232 OS as being less that the 2018 blended data.
Your key point is the read at 24 months where you assert the K/M shows 35% OS and thus no censors prior to then (when about 8 or 9 would have been expected in the 2018 dataset).
Problem is that 35% read. I put the graph into a digitizer and see the number more like 36% (precision is clearly an issue, even with tech assistance). And that is enough to allow for several censors, even 8 or 9 is possible.
I do not assert I have proof that the LTFU theory is wrong. But I do assert your proof is invalid. And Fipper's more properly stated argument is speculative.
What is a fact is that a "win" in the 232 vs 99 OS comp would be huge, even if not stat sig. It is still an endpoint of the trial. And team NWBO has buried it.
BTW, on a minor point. "left censors": are something totally different than what you assert. That refers to if censors are prior to or after the unknown event. In this trial, all censors were right censors as is the norm in OS trials such as this. The term is sometime incorrectly used as you describe, and as English is not your main language I am not trying to flame you, just letting you know., See this paper from Oxford