Flipper, when did recruitment to the trial restart after the German authority imposed a pause in July 2015?

My Virus checker identifies this site as having malware

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Although I have been an investor in NWBO for 8 years and believe that the treatment works, I do wish that people wouldn't tempt fate and refrain from making predictions of how many billions NWBO will be worth in the next 12 months / 2 years / 5 years.

The words "chickens", "count" and "hatched" keep springing to mind.

That's a logical step until DCVax-Direct gets licenced.
There is no conceivable reason why a lysate made from a peripheral tumour should not behave in the same way as one from a GBM in sensitising the patient's own dendritic cells. The only problem is that insurance companies almost certainly won't pay for the treatment until the FDA licence Direct.

You're right, Dr. Bala.
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JR, if it is as you say, do Mrs Powers and Mr Goodman, lawyers as they are, see themselves as immune from the law or are they just postponing the evil day when they are exposed to the world as cheats and liars?

Ex - I've wanted to know for some time, what did you want to be?

John Wesley had it all down pat about the medical uses of electricity in his book, "Primitive Physick" (1765)



and it was apparently as free of side-effects as DCVax promises to be!

This defines NWBO's shareholders as mushrooms - we are kept constantly in the dark and occasionally we are covered in manure (a more polite word than the usual).

I hope that you are correct but at the moment it is all conjecture - it should be "if" not "when".
I'll believe it when it happens but at the present rate of "?progress?" I've more than a 50-50 chance of being dead when it does (if ever).

Thanks, papa9 - on this I'm with you all the way.

Sleep well.

Thanks for posting that article on Market Makers. It explains a lot and now has me wondering whether one or two of the "Nay-sayers" on this board - with their never ending gloominess and cynicism urging us to sell - might not be MMs or their agents.
In my eyes it certainly puts a different gloss on their messages.

Probably the charity that begins at home!

Are we really expected to believe that the FDA will demand this of NWBO not knowing whether DCVax-L is more efficacious than grapefruit juice or not? I still find that hard to believe. This is the real world and it's far more likely that the FDA know that DCVax-L is more efficacious but not necessarily by how much. That will come out only when they have looked at all the data showing that NWBO has successfully jumped through all the hoops.

Jaws was a horror story ivolving sharks. I hope that you are not suggesting that it is a flimsily disguised allegory describing NWBO.

Best wishes

Biosect. I have now seen your Private Message, for which I thank you. Unfortunately, I cannot reply to you privately.
Your explanation is absolutely clear and sheds a whole new view on a dimension of the licencing process that I never would have conceived as ever being fair or reasonable or sensible.
This one-stage process which includes any and every aspect of getting the product from the testbench to the patient that the FDA might think of at the time is both cumbersome and wasteful, especially at a time when new-drug costs are unbelievably high. Although too late for DCVax-L, I would hope that eventually the FDA (and other regulators) might split the process into validation of the efficacy of the medication and validation into the production and distribution of the validated medication.
Once again, thank you for your reply.

I think that you miss the point.
It is unreasonable for the FDA to require the process of manufacture of a medicine to be validated (at the firm's expense, effort and time) if there is still a chance that the product will not eventually be licenced on therapeutic grounds - ie it doesn't work. That being so, if the FDA has required NWBO to have the manufacturing process validated before DCVax-L is licenced (as Flipper is suggesting), they must have given NWBO more than a nod and a wink that DCVax-L will be licenced once the manufacturing process is GMP certificated.

Flipper, if the FDA will only licence DCVax-L when the production process has been OKayed (as you suggest) then why isn't every man and his dog piling into NWBO now?
If your suggestion is correct, it raises the obvious assumption that the FDA must have already decided that DCVax-L has been shown to be licenceable for GBM but it has not yet been awarded that licence.
Consider - it must be highly unlikely (and grossly unfair) for any regulatory authority [RA] to put a biotech company through the extra expense, time and sheer effort of setting up an industrial size production line (not necessarily one that it owns and operates) and proving that it will work safely, only for the RA then to decide at the end of the day that the production line works fine but that the treatment doesn't actually meet the necessary criteria for licencing. Can you imagine the outcry should that sort of thing happen?
Perhaps that explains why cash-strapped NWBO has gone through all the expense of purchasing Flaskworks and setting up Sawston. I cannot imagine any organisation putting itself out on such a financial limb without knowing that what it was doing was underpinned with something more solid than the mere hope that its product would in the end be licenced.
If this, your suggestion, is correct, why is the SP languishing in the depths?

Thanks, Anders,

I hope that you are right and that publication in a scientific journal is the reason for the delay. However, that being the case I would have hoped that NWBO, knowing the concerns of its shareholders about its inordinately slow progress, would be keeping them informed of the progress towards a scientific publication since I doubt that even Adam Feuerstein could turn that news into something that would break the company.
On that basis I cannot understand the Board's reticence in making any statements at all on the progress towards the publication of the TLD in a learned journal.
That is where the odour comes from.

The data is now fully collected (or if not, why not);
they know how many died despite treatment and they know how many of those receiving DCVax-L lived beyond the historical survival rate using "Standard of Care" and for how long;
they know which carried this mutation or that mutation or both mutations or whatever;
they know which cases exhibited pseudoprogression and which did not;
they now know (or should know) absolutely everything knowable about the outcomes relating to who lived (and for how long) and who died (after how many months of active tretment).
They've been analysing all this data for more months than one can believe is possible without a peep of information from management as to how the analysis is going.
I cannot for one moment believe that the Statistical Analysis is still going on - there are just so many ways that the figures can be juggled. So unless the the Statisticians are being paid on piece rates and are delaying finishing for as long as is financially possible it is difficult not to believe that TLD has not been known within NWBO and that for some time. One can expect there to be some delay as the Board line up all their ducks in a neat row for the announcement of TLD, but not for this length of time.
It is giving rise to an ineffable whiff of something unpleasant brewing.

I hope that Branko's addendum

Mike, Just a bit of nit-picking.
If DI gets paid hundreds of thousands of shares for what he's doing, I doubt that he would willingly accept payment in soon-to-be-worthless bits of virtual paper if he knew that the trial had failed

I didn't know you'd met my sister!

No change in volume since he'll pee it back out eventually.

Thanks, Danish Dude. I agree that any actual threat to DCVax is years away ... but that is almost a blink of the eye in NWBO terms. Even so, if it fulfills its promise, lisavanbulin will likely affect NWBO's earnings significantly in the long run.

Agreed, Gary. Best wishes.

"Will you walk a little faster?" said a whiting to a snail, "There's a porpoise close behind us, and he's treading on my tail". (1)

HEADLINES: Sunday Times (of London) June 20, 2021

"Will you walk a little faster?" said a whiting to a snail, "There's a porpoise close behind us, and he's treading on my tail"

HEADLINES:



- the Lobster Quadrille from "Alice's Adventures in Wonderland".

The photo is of Nikita Kruschev (Soviet Premier) in good-natured discussion with "Tricky Dicky" Nixon shortly after the Cold War began its first thawing.
They were contrasting their 2 systems - the capitalist free market economy of the USA with the cumbersome bureaucratic command economy of the communist USSR. Each, of course, claimed the upper hand in military matters (nuclear bombs, bombers etc etc) and that was adjudged a draw. Tricky Dicky then contrasted the range and availability of kitchen utensils in both systems in which the US was winning hands down. NK conceded the point but claimed that the USSR was fast catching up after the Stalin era and would soon overtake the US!! I don't think that anybody (including NK himself) believed it but diplomatically he was awarded a draw for trying!

It must say something when a (presumed) shareholder feels it important to comment that the CEO of the company is actually found to have been telling the truth about some future event involving the company.

conc. Sulphuric acid + conc. Nitric acid in equal measures is a better bet - even gets rid of the gall stones.

Wednesday - nothing in the Lancet today.

....and none today (6pm news)

Thanks, improvign.