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I think the point of contention, if I am correct, is that the original bet was for submission only. In your response you accepted, but introduced approval as well, which was not the original bet.
As I had already edited into my reply to you, I had missed that Stonk had accepted. I agree that I made a fair and accepted bet in 2023 on no approval this year. And now have made the same bet with you.
I offered a bet. Not taken then. Do you understand how bets work?
Things have changed a tad with the submission actually having happened a few days after that. So odds have gone up a tad.
But regardless, I will gladly bet you on no 2024 approval. Terms are leaving the board.
EDIT: I missed that Stonk actually dd agree. So he too is on for end of 24 no more posting.
Could HIV's patient's dendritic cells cultured together in vitro with an adequate concentration of HIV be immunologically stimulated enough when injected back into the patient, to initiate an effective anti HIV immunological response that would lead to a cure?
Point-blank, do you think DCVax-L will receive MHRA approval?
No if you are wrong you will leave this board as you said you would which is probably as of Aug 1 this year
Ex, you already lost the bet. But you don’t honor your promise that you gracefully won’t post any FUD again.
So do you still believe it is just speculation that UK will approve NWBO within 6 months?
For instance, the potential of delivering the cure for HIV alone would deserve the number you came up with.
Many of the pipelines related to Cancer are small molecules. I did not see the word “vaccine” there.
And I am asking myself. What stuff are they going to manufacture? The stuff must have huge market to warrant the profitability. I suspect we will find out soon what kind of biologics products these facilities are going to deliver.
StonkMaster - Thanks for sharing. Apparently I was under the wrong impression. I thought the final requisite amended briefs and objections were submitted on the 12th?
I am aware of that. It does not mean what Hoffscam implies and he knows it,.
Doesn’t the 150 day max apply?
I love it.! An X post be Hoffy asserting some nonsense is now some sort of quality DD that proves the MAA was validated as submitted and accepted per 150 day review.
Both the latter may be true, but Hoffy's tweet has zero proof of it.
About as good as the idea that Merck and Amgen do not constantly hire research scientists for their own work.
Would every long agree that MMs never anticipated that NWBO could survive the OTC and even thrive?
That storyline is very stale.
Last I checked there were about 30 individualized (autologous) approvals by the FDA. About half of these are products you would count as stuff BP does not want, as not being a pill, yet has brought to market anyway.
One thing is clear, blockbusters are not left in the hands of baby bios. Top 10 drugs from last year:
1) Keytruda. MRK acquired pre-clincial.
2) Comimaly, Pfizer - COVID
3) Humira, Abbvie - Acquired by Abbot early stage trials
4) Paxlovid, Pfizer - COVID
5) Elquis, Pfizer/BMS - pre-clinical
6) Opdivo BMS - pre-clinical
7) Dupexent, Sanifi - Regeneron - Sani partnered with Regeneron in phase 2 trials Arguably REGN was close to BP status by then.
8) Stelara, J&J - Purchased Centocore in 1999, several years prior to approval
9) Spikevax, Moderna - COVID
10) BKtarvy, Gillead.- Developed n house.
So, if BP wants a drug, they buy it.
Gus, NWBO would not be allowed to market off label.
Many do not understand what "market" means. NWBO would not be allowed to manufacturer -L based on non approved tumor cells and sell it commercially under the approved label.
There is some off label use that could and would happen. But they will be limited to the fringe cases. Non GBM brain tumors. Patients who have low WBCs. Patients who cannot get off steroids, patients with previous use of XYZ, patients with other health issues and similar stuff.
OTOH, If a doc sent in a a lung cancer sample to have -L produced commercially it would absolutely be illegal for NWBO to manufacture and sell it.
OK, this is US law. I am 99.999% certain UK law is the same though.
And again, unless the meeting minutes are promptly updated (fat chance), we won't really have any way of knowing whether their MAA was covered at that March meeting, will we?
Re: MHRA Day 0
Does not really matter because of the slot system, If the submission on the 22'nd was valid then the first assessment is completed at the Mar 21/22 CHM meeting. Does not matter exactly when it was validated.
But if they have to fix something then the completed submission would be after the cutoff, and the CHM meeting slips a month.
The time from cutoff to meeting is actually about 87 days. Whether one wants to charge the extra 7 days to validation or scheduling of possible snow hardly matter.
The key is the 3/21 CHM meeting (assuming the MAA was valid as submitted (which is likely IMO),. That complete phase 1.
To be clear, does not matter if the validation is late. All that matters is when the final valid MAA is submitted with respect to 12/25 cuttoff.
Advent was paid $11.5M in 2022 to manufacture and run the Specials program There is no reason for them to also take a cut of revenue in addition. Besides which, any such deal is clearly a mandatory disclosure as Advent is a related party. They can keep the exact terms confidential, but not the general mature of the deal.
The books say NWBO pulled in $1.5M for the first 9 months of 2023. That is that.
If there is some undisclosed deal such that Advent is also collecting revenue from the program then NWBO has a lot of explaining to do. Besides being a mandatory disclosure (related party) it is totally insane to both pay a very nice chunk of change and be given some chunk of the revenue.
Why the number is that low is up for debate. But the published number is the revenue, it can't be netted out as some assert.
I have a question on the warrants. What is the strike price on them? Aren't we way below the strike price?
Doc- I reviewed the last K and Q there are no milestone payments related to Edens. This makes sense because Flaskworks is a wholly owned sub - as such, milestone rewards/payments from the parent company to a subsidiary(flaskworks)for Eden validation would not be appropriate.
Back to Edens. IMO, We are waiting for optimization and submisssion of application for Edens device approval.Optimization may have been finished but Edens device approval has probably not been applied for yet. I’m assuming NWBO would announce submission of the Eden device application…..but maybe not. In any event, we don’t know if Eden has been optimized/validated yet.
So it is March!
Cementing, the ASM, the 10-K and of course the NCAA basketball tournament!
Madness.
BTW, what exactly was in the pipe?
Agreed. Though there is no formal definition of SOC the NCCN guidelines are the best practical measure here in the US.
In countries with nationalized health insurance, it is that which counts. So the NICE opinion matters.
Will be interesting to see if the -L NICE review ever gets going. Though prices will be redacted, much will be public.
" A good faith combo trial with upfront and milestone payments..."
Many are confusing partnering drugs with jointly sponsoring trials.
BP can pay a lot to partner a drug. When they do so though, they either take ownership of the drug or split it.
Trials? That is a nothingburger. The parties contribute their drugs and some techincal support. That is all,
Back with the withdrawn CI combo trial, LP could not get BMY to cover the cost of manufacturing -L for them. So that never happened.
Going forwards, LP wants combo trials where BP will pay Advent to manufacture the -L. Whoop dee doo.
Here on the US east coast it is wet and cold which is really sucky weather for cementing.
Must wait for sunnier days.,
How about an update on the naked-short position? Does it still spell impending doom for several hedge funds?
Per the latest SEC numbers there were 0 undelivered shares as of Dec 29, 2023 (the last reported date),
The maximum balance on any day in the last half of Dec was a whopping 44,986 shares on 12/20.
But keep believing the scammers who try to get retail to buy overpriced crap by making up stories like L Smith's "Wolf Pack".
NWBO has continually been issuing shares in various forms.
NWBO issues warrants as kickers for financing deals. When the holder converts NWBO must print shares.,
NWBO has to pay loans back and is often printing shares at a discount to do so.
NWBO sells C shares. When those shares are converted to common NWBO prints more common shares.
NWBO has recently started selling convertible loans. The lenders might elect to be paid in discount shares
There is a reason why the issued shares have gone from 80M when the hold was announced to 1180M today. And every one was printed by NWBO.
Sure.
Problems start with the basic factor that the version of the patent that could be approved is so narrow it does not even cover -L or the UCLA ATL-DC variant. It requires IL-11(?) to be used in the maturation and neither NWBO nor UCLA do so.
The other version would cover current combo trial, but is still being objected to as obvious based on other's work.
Then there is also the issue of the multiple assignees. What that means is any of them can give permission to use it. UCLA will presumably assign rights to NCI and that will not be an issue. But CRL and Revimune are separate companies that anybody could come to and get a license. That is, if the patent is ever issued.
Further, the patent only covers gliomas. It does not cover other cancers.
Contract and biologic protection from biosimilars.
Wow. So even if true an exec at a trade show was pressing flesh. Whoop de doo.
For all you know they were thinking of buying Cognate as we know that was up for sale.
Or was not even Dr P. The poster first just reported it was a person in a suit with grey hair and he had no idea who it was. It was others who suggested it was Dr P and the poster later agreed.
Or maybe he was just waiting for his food order at the lunch stand next to the booth.
Or who knows what. What we do know is that BP is not shy about putting up cash to get deals done. They do not wait around when they see something they want. And now 5 years later...
II agree with Doc. UCLA doesn’t own the commercial rights. NWBO does.
Regardless of when these are published, the company is informed and will certainly PR it upon the actual decision date.
There is zero chance the first indication of a DC-L approval is on that site.,
Bad comparison.
As much as I often disagree with Flipper, on a 0-10 scale for posting "reality", he is at least 5 points above dstock.
The SPA is good news (did expect it, but sometimes can drag out),
Norse 8 is a non-inferiority study,. What that means is that they do not have to prove to be better than the ranibizumab, just as good as it. That is very reasonable from a common sense point, but has a tricky stat issue,
There is no such concept as "as good as" in clinical trial stats. Either one is better or not. But we all need the real world concept, so how to fix this?
The trial stat guys came up with a concept of a NI margin. Basically OTLK will be spotted a letter or 2 (do not know the details) and with that must prove to be better. This sounds a bit contorted, but there is no easy way to solve the conundrum
Now back to the FDA.. Obviously if the sponsor just says they want their drug to be spotted some advantage, the FDA may push back. And that is why getting the SPA for a NI trial really matters. The FDA has agreed that whatever NI margin is, is OK by them.
As far as executing the trial, That should be a given. There is ton of data here, we are not talking unknowns.
It will be interesting going forward to see when the proper generic name of murcidencel is used. And when it is not.
Maybe longs should demand corrections when it is not used.
Why should NWO shareholders care? The freezers belong to Advent, The freezers are the 2560 ft^2 of nitrogen cryostorage listed in the Adevnt sublease When equipment is part of leasehold improvements that makes it part of the facility. At least until 2037.
NWBO collects 125K/year on the Advent space. Now, the terms on that would get rational shareholders furious. But most here still believe the comical hype that Advent exists to support NWBO.
On December 31, 2021, the Company entered into a Sub-lease Agreement (the “Agreement”) with Advent. The Agreement permits use by Advent of a portion of the space in the Sawston facility, which is leased by the Company under a separate head lease with a different counterparty (Huawei) that commenced on December 14, 2018. The Company subleased approximately 14,459 square feet of the 88,000 square foot building interior space, plus corresponding exterior support space and parking. The lease payments amount under the Agreement are two times the £5.75 (approximate $6.96 per square foot based on exchange rate as of December 31, 2022) rate per square foot payable under the head lease, but subject to a cap of $10 per square foot. Accordingly, the monthly lease payments under the Sublease are based on $145,000 annually for 2022. The total lease payments paid by the Company to Huawei for the facility, exterior spaces and parking under the head lease are 500,000 pounds (approximately $600,000) per year. The term of the Agreement shall end on the same date as the head lease term ends.
During the year ended December 31, 2022, the Company recognized sub-lease income of $145,000.
Want to see if the hold on LP shares still in effect.