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Simple thesis to US approval (EU already in hand): known therapeutic profile + SPA
Then one needs to develop a view on revenue, which is also a fairly simple exercise since we know that off label bevacizumab is widely used and, if an approved product is available, regulations prohibit the use of an off-label product*.
I love it.
Anybody remember HEB (Hemershperex)? They were the scammy company pumping Ampligen a couple decades ago for almost any disease.
Given the fact that AF loved to mock Dr Carter back then I suspect he will have a ,laugh about NWBO licensing the tech.
No wonder Roswell dumped the tech for pennies.
EDIT: BTW, the DC vaccine being used in clearly neither Direct not -L.
Glad you agree that LP would be a bad role model.
I updated my post just after your reply. Give it a look and follow the link.
1. Agreement to Vote. During the Term of this Agreement, the Investor agrees that for purposes of any shareholder meeting or action of any kind, (a) the Investor will cause the Covered Shares (as defined in Section 6(e) hereof) to be counted as present for purposes of establishing a quorum, and will respond to each request by the Company for written consent, if any, and (b) the Investor will vote (or consent), or cause to be voted (or cause consent to be granted), all Covered Shares in accordance with the recommendations of the Company’s Board of Directors with respect to any amendment to the Company’s certificate of incorporation as the Board of Directors may deem necessary or appropriate to increase the Company’s authorized common stock and/or preferred stock.
It would be against SEC regulation IF Powers and the holders of the 600 million shares you mention agreed to vote on Powers her wimps in exchange for discounts. However it would not surprise me
"Merck's binary bet ends badly..."
No, that was AVTE that blew up as its only candidate failed.
The article mentions Merck as getting their pneumonia vaccine approved. They are the largest non-covid vaccine bio, so do have some reasons for that expansion and hiring other than to connect NWBO dots.
In an odd quirk,. MRK is a winner in AVTE's blowup as SOC is MRKs.
So what does a licensing deal for DCVax look like?
OK, if so, what did the other 90 get in their licensing deals?
Bright Boy or anyone please. Are we getting the money or are we paying the money??? It has not affected the pps at all. lcan't figure it out. anyone plese. Peace Reg2015
That is it!!!
Roswell and Kaliniski had a tech worth billions and just sold it for nothing.
BTW, when many longs on this board called all other tech in the space garbage, does that magically change now that NWBO has licensed it?
In what way are we "exclusive" license?
The 4% is what NWBO would pay Roswell (in addition to a potential $3.2M).
With zero up front and tiny potential, this is basically giving it away.
Ex, I am not aware that the fda has said another trial will be needed. Do you have any evidence for this?
Oncovir cannot live without DCVax-L.
The company is filing for approval globally.
Hence the change to overall survival — The GOLD STANDARD ..
...mOS was 23.1 mos compared to 13–15 mos in pts receiving SOC alone.
The people that understand what agnostic means are fully invested because they understand the science and the investment.
For the purpose of this guidance, the term tissue agnostic oncology drug refers to a drug that targets a specific molecular alteration(s)3 (a kind of biomarker) across multiple cancer types as defined, for example by organ, tissue, or tumor type.
Level with us what is the increase in the number of GBM patients. At least between 200% and 300%. So you can save your solid growth BS to yourself.
I suspect that enrollment will indeed take about that 'year' - unless some big pharma with deep pockets signs on an starts opening some doors for them and shaking the 'money tree' to grease the skids. That could speed things up by at least a couple of months.
I do think that a conditional approval for Multikine, based on beneficial tumor regression data, is possible by sometime in 2026 as well.
Wouldn’t the sponsors of the referenced trials want to provide that data? Especially since the inference is that the patent level data would show that there was no positive outcome?
NWBO asked for and was denied the patient level data by the sponsors of the ECA trials they used. So what were they supposed to do? The FDA has ALL of the patient level data for those trials and nothing is preventing them from looking at it. Try again, Ex.
25% of NVCR revenue was EMEA , which 2022 vs 2023 dropped 2.2%, this year it will show a far greater drop as UK for sure have stopped prescribing it.
First, it is various posters asserting an approval in the next several weeks, not the MHRA. I think many rational longs would acknowledge that 4 months is more reasonable than several weeks.
And it is not true that NWBO is no factor in the timeline. They could be on the clock for 2 60 day RFI responses. They could be on the clock for an appeal. Not sure if they are on the clock for requests for oral hearings. And not sure what hap[pens if they are given a provisional response requiring them to resolve a problem first.
There is a reason the process can take a long time, and it is not just MHRA foot dragging.
As expected the reply focuses on 2 issues.
One is the argument that the effect of spoofing only lasts a few seconds, thus did not effect the price at close thus no loss (as NWBO sales were based on close). a main basis of this is Phumware were the MTD was granted on this basis. In that case though the plaintiffs were selling via a continual ATM so were able to refile with sales with seconds of the alleged spoof.
The other is the assertion that no individual event contains all the indications of possible spoofing. The issue here is that it is impossible to show spoofing just by this level of market data, therefore the courts have established guidelines to show what looks enough like possible spoofing to warrant a trial. In this case, defends argue no single event meets the criterion.
IMO, the first issue is much more serious. If the Court follows Phumware, then NWBO would have to show spoofing in the seconds prior to close on pricing dates, and the listed examples did not I do not see a decision in a few weeks.
There is also a request for oral arguments. .
.
"next several weeks"
Can you translate that from LP time to standard time? Is it by end of 2025 or not?
Feel free to revisit your answer in fall.
LL et all have stated clearly they do not have patient level data. She acknowledges that is an issue with using the P3 for approval while saying she hopes -L can be made available somehow (RTT, etc) while they run try to establish efficacy.
The FDA and others repeatedly state how patent level data is important for ECAs. They also talk about defining the protocol in advance of trial initiation. That biosec and others think the FDA does not know what they are talking about is odd.
1. If the only issue is cost, then why would Amarin not just drop the price of branded Vascepa to undercut the generics?, and
2. If the issue is that insurers (and the industry trend in general) want generics simply because they are "generics", then why hasn't Amarin launched yet?
So who are the regulators fooling with this whole notion of capacity requirements,
Mr C C is correct that they do not need a capacity number for BLA approval, but they do need some manufacturing capacity. It is unclear if they can use Advent for US based on both live cell regulations and practical constraints.
The argument that it is in place via CRL is pure solid excrement of male cattle for many reasons.
First, they need a contract. This would be a mandatory 4 day disclosure (material contract) and would also show up in the financials on cash on commitments. So that has not happened. CRL has disclosed that companies are reserving space in advance to have capacity available, so unclear how soon they could have capacity ready.
Second, CRL would need to to set this up. They last produced -L 10 years using equipment first put in place 20 years ago. There is no reason to assume this exists today. And NWBO has stated how Advent needed to source alternatives as the old components no longer existed.
And last, it takes time to prep for the PAI (pre-approval inspection). This is very different from GMP. See this from the FDA and search around, you will find many recommended starting prep for this a year or more prior to inspection (which can be anytime after the BLA is accepted).
In short, unless one thinks they can leverage Advent for the US (unclear to me), this is not happening "soon".
The lenders getting repaid in stock mentioned in the spoofing suit git better terms.
They had a q5% discount over the lowest closes in a 30 day windows centered on the deal.
The entire concept of "friendlies" is humorous. Ever since NW fled in disgust with LP governance, all they have are loan sharks floating them.
If there are that many naked shorts then I guess the voting would reflect "Yes" votes greater than the legal outstanding shares...
The owners of the naked bought need shares would be able to vote...I doubt we will see a large number of absentee votes so the total vote tally my be revealing.
Serious questions: how does one "buy" from a naked short seller? How does one ever know if one bought from a naked short seller? I always buy through Schwab. How do I know if any shares I have bought are illegitimate?
If your position is so solid, why must you make up lies about what I have said?
Never said they would not submit.
And I still maintain there will be no approval w/o further trials.
But keep up the lies, they demonstrate the weakness of your position.
Try "validation"
Based on what I’ve heard since last December, I’m pretty sure the f…ng MHRA doesn’t have a clue either. MHRA bureaucrats slow walk a life saving treatment application. How many more corpses are going to pile up on their doorstep?
Ms. Powers continued: “We believe it is now appropriate for the Company to move forward with the several stages of work that are needed to reach completion of this trial program, despite the fact that there are good arguments for allowing the data to mature even further. The upcoming stages include finalizing the Statistical Analysis Plan, conducting the final data collection, data validation and data lock, and then unblinding and analyzing the data.
Parsing LP's contorted words is a sucker's game. But let's play for fun..
There are 2 steps in validation. The first is technical validation that verifies the various components for being complete and correct. After that comes content verification where they actually look at what is in it.
So LP let you know they passed technical validation then they had content validation confirmed. And the later is the confirmation that counts.
When LP uses language like this it is always with intent to allow the SMA to spin a favorable version.
See this for a starting point.
LP on the other hand gets compensation that pretty much parallels what others in the biotech industries receive. Until a company achieves success everyone is investing in what the technology will do in the future. A CEO's who's been awarded billions of shares is broke if the company goes belly up, and many do.
Absolutely.
LG doing infomercials on the Big Booze show while LP says they must stay quiet to shareholders is how they should do business.
I so loved my Lionel's.
his bets have no meaning anyway, he has never honored them or he would not be here.
Try again flipper.
As I have always said, I do not expect an approval based on the current trial. If so, there is no approval by either early Oct or EOY.