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What does that have to do with LTFU numbers moron.
Not that I think the number maters, but I would love to hear why you think 6 of the non crosser placebo arm patients were LTFU for the OS analysis.
Suggest you think hard on your assertion that 6 of the non-crossovers were censored.
LOngs will remember that they used that excuse once getting the flu- years ago
It;s always "soon".
No approval, no buyout and no real partnership in 2024. But hey, it;s only a slight delay.
CVM success bodes well for NWBO as DcVaxL science is much better than the CVM science.
You might want to check out the story on CVM a bit better.
In the trial they are hyping the treatment arm did not outperform the placebo arm. The mOS was numerically better for placebo.and the tails were almost identical but again slightly better for placebo. Poster on trial results
The are trying to hype a subset in today's PR. Two huge issues.
They did not pre-allocate an alpha spend to the subset. What that means is they just are looking at dozens of subsets they planned to analyze and say "look, it worked here". Yeah, things can work by pure chance when you take enough looks. It is called multiplicity.
The other is that the "low risk" subgroup cannot even be defined in advance. They assert they have a method for doing so, but that has issues.
Investing in trials they get futilit holds from the FDA, have predefined endpoints fail and OS between the randomized arms fails is a questionable move.
Yup. More confirmation that the punt is for manufacturing with Flaskworks which could be years out.
Looks like the SMA has the message.
BTW Roman, do you understand that a single run to get 1 test requires a human patient with GBM willing to risk his hope for a vaccine on an unproven tech. How many of these do you think they have done?
And do not forget that as last we heard they are still trying to mail down the actual process to be used by Eden. Until that is done they cannot run trials.
The $600M loan that DNDN took out was in Jan of 2011 and was not needed to get approval. At the time they were only months away and already had established manufacturing that was approved by the FDA. And despite assertions around here, the FDA does not require a company to be able to meet demand in order to get approved.
Back to the loan At the time, the DNDN stock was trading over $30 (IIRC) and they could have raised that much for about 1 10% dilution. The issued was caused by Mtch Gold being a F'ing moron
It is also not the case that the delay in getting mfg scaled up was a core part of their failure. They were at capacity for at most one Q.
What caused their issue was burning cash at an idiotic rate, taking out an uneeded huge loan and being in an enviornment where $200k+ treatments were not being paid out..
So the GBM patient went to a German clinic that provided an ATL-DC vaccine and that failed.
What exactly is your point?
Perhaps you should actually read through the links.
PDFs are used for some files in the submission.
Other files can be SAS, XML, Ascii and numerous others that I do not even know.
How many pages are in an SAS database? And XML file?
As applications are required by law to be electronic I have no idea what "pages" means.
Is data in an spreadsheet format that has 1000 rows 1 page or 50?
And before you clowns assert it is just a PDF, it is not. The submission consists of files in various formats.
DNDN went bankrupt because it spent so much in that time,
It took DNDN 1 year from end of the pivitol IMPACT P3 to be be FDA approved. That they took a moonshot in submitting earlier on failed P2s in a different indication does not change that later timeline.
Everybody in this space know the typical timelines for submissions and approvals after trials.
Maybe you should look up that other dendritic vaccine while you’re at it and tell me how long Provenge took to get approved?
Anybody care to explain this quote?
When the Trial began in 2007, per the demand of investigators and patients it was necessary to include a crossover option in the Protocol in order to recruit and retain patients
Flipper is right on this one.
The AMRN IP was obviously a huge concern and any investor should have know it. Not saying the Courts had to go the wrong way for them, but it was clear and present danger.
Ranting about it being "lawless" is nonsense. Patent law is full of issues where something may or may not obvious. Given that everybody knew that a mix of EPA and DHA provided cardio benefits it might be obvious that one or the other did in some specific indication.
BTW, I do think AMRN is being screwed on the off label use issue by generics. But that is another issue.AMRN can start suing patients and docs for this, but that obviously will end up badly.
I heard very clearly what she said. She said nothing about a partnership where a BP either fully or partially own -L.
She talked about the modest trial costs which are chump change for a BP.
Remember when you said just a couple days ago it doesn’t work like that, and Merck came out today and said work this Ex.
NWBO has been boasting about combination studies with BP since 2017.
Remember that "3 trials, 3 BPs, 3 indications" from back then?
Since when?
Can a company skip ASM this year or announce it this year but that it will be held Q1 2024?
The balance sheet is not an issue. And there is no significant negative cash flow.
The issue is, and has been for years, being able to increase revenue/margin.
"under promise and over deliver"
So you are asserting that NWBO flat out lied when they said "about 2 weeks" in order to create a timeline that makes them look a bit foolish?
OK.
There are 100s of ADC conjugates out there. But there is only one DcVaxL in the world and it is us NWBO. Ok???
Most all of those are rubber stamps of EMA approvals. The data I linked breaks out the MAAs not relying on the EMA review.
That they can read over the CHMP and make a deision in under 150 days is not surprising. When they need to actually to the review themselves it has always taken over a year.
Yeah, not many data points. Wonder why virtually nobody else bothers to take a slow unprofitable pathway?
At least one otther applicant taking this pathway admitted that the reason they did so was the FDA had made clear they had no chance. The are trying to market a China knock-off of bevacizumab and I guess figure the price sensitive NICE might want it.
It is a 20 year lease at $300K if I remember correctly per year
But like NWBO they owned the gear in the building
If one has a stock that they expect to go up, and it goes down, then buying more is very reasonable. After buying at the lower prices, it might well be reasonable money management to sell some off on a recovery to stay reasonable balanced.
If dong so, you are best to avoid the 30 day rules as that allows the loss capture,
One thing that many miss is that the 30 day rule applies both ways. If one wants to capture a loss they can buy the replacement shares 30 days in advance of selling. This avoids FOMO. It does require enough cash, but anybody playing in small cap bios like this should be reasonably liquid.
Anyway, I do agree with you on this thread.
exwannabe : How many doses per month are being produced at Sawston for the Specials program ?
Yesterday's HTA inspection report ranks up there with the importance of the recent Liau joining the SAB announcement.
Someone claimed, without citing any law to back it up, that NWBO had to use a word like ‘plans’ instead of ‘Will’ for a step that is 100% within their control.
Disclaimer Statements made in this news release that are not historical facts, including statements concerning plans for DCVax are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “expect,” “believe,” “intend,” “design,” “plan,” “continue,” “may,”, “will,” “anticipate,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.
2023 YTD MHRA approval stats.
The majority iof MHRA new MAA approvals are rubber stamps for EMA approved drugs. For the rest, they have exactly 5 approvals this year.
Submissions not using Orbis or ACCESS:
1 in March, 370 days
1 in May, 420 days
1 in Aug, 400 days
Submissions using Orbis
1 in March, 220 days.
Submission using Aceess:
1 in May, 440 days
Yup, 5 so far this year and the only one that took under a year was the one driven by the FDA.
MHRA performance Assessment of New Marketing Authorisation Applications and variations
This fairy tale that MHRA approves in a few months is pathetic, Everybody knows they are slow, and that is the reason they are adding programs to rubber stamp other RAs.
[The charts on pages 10, 11 and 13 are key for non-EMA based new MAAs. The chart on page 12 is "reliance", i.e. a rubber stamp of CHMP]]
Why would they even bother paying for a patent with an anticipated expiration date of 2/27/2024?
I guess to feed their SMA.
No, that says DC Vacc.
Sorry if this has been discussed I've not be keeping up today, but is there a reason why the HTA license doesn't check the "Export" box?
The real question is why would any rational investor not want to understand why supposedly 10's of millions of revenue are being generated by Specials but never make it to NWBO.
NWBO pays Advent a few million a year to run Special and manufacture product, And NWBO gets virtually none of the revenue back.
What happens if they actually do go commercial? Does Advent still keep all the revenue?
Why would any investor not be concerned about this? Unless they were part of LP/Advent who of course do better if Advent keeps the revenue.
Oh, If forgot. Per the board leaders there are secret agreements between LP and LP that take care of this. Wonder how the terms are as LP almost certainly has a much larger percent stake in Advent than NWBO. Anybody?
Who said that no Specials patients have had -L manufactured? Your strawman pal? ?
Why is the London facility still being paid to manufacture -L? Why is there virtually no revenue?
You are the one who posted the HTA inspection showing only importation was ongoing at Sawston. No manufacturing.
Is the link you posted valid? Looks good to me.
Again, thanks for finding that.
LMAO.
The only activity they are listed at actually carrying out is importation of tumor materials. Can't be that hard to import frozen tumors safely.
Everything else has an *.
E* = Establishment is licensed to carry out this activity but is not currently carrying it out.