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It is 150 days every day and not only business days therefore
150 days end somewhere between May 18-25. Hopefully
we will receive the MAA approval much earlier.
Thank you Improving. apparently, Ben Trotman received the
immunotherapy treatment in November 2022 and only started
to receive the SOC treatment in January 2023. Perhaps administering
the SOC right before the immunotherapy would have suppressed the
immune response and the outcome would perhaps have then been less
favorable.
I am anxious to know the identity of this immunotherapy and its potential
competition with DCvax-L or perhaps it was DCVax-L.
On second thought, Mr. Trotman's GBM immunotherapy treatment
may have been an unconventional DCVax-L treatment if that
treatment was initiated before the standard chemorad treatment
and that allowed the immune system to function
optimally before the immunosuppressive standard
treatment was dispensed. This unconventional (not yet
approved) treatment may have been a reason for not
disclosing the treatment's identity.
Just fishing for an explanation as to the identity of this
spectacular GBM cure that did not mention the treatment's
identity.
[quote Unfortunately that may be negative volume (if news somehow comes out of the CHM, which I don't expect, I think it more likely to be bad news than good news). But other than that, we're just coasting, which is fine by me.][/quote]
Please define why the likelihood of bad news:
Are we talking about possible CHM hints of an MAA
rejection, a lengthy delay in approval due to substantial
RFIs, or what else?
Georgebailey, while I agree with the possibilities concerning
the licensing arrangement with partners, I have a problem with
the following sentence:
[quoteMerck would license DCVax for other indications beyond Gliomas for clinical use and commercial use,
BMY same and so forth and so on.][/quote]
Within the foreseeable future, how can one license DCVax for other indications beyond gliomas when the
pertinent trials have not as yet started and it would take some time before such trials can even begin
or are we talking about plans that may become reality in late 2025 at the earliest?
J Torence, NWBO stated in this 10K that as soon as they are no
longer encumbered by the MAA procedures and inspections and
have recovered their breath, they will proceed with a partner(s)
to the combo trial(s). This plan is not something new and had been
mentioned previously that once the MAA is "cemented" (whatever
that means), attention will be turned to combo trials with a partner.
I don't know how many trials and how many partners are
involved but am guessing that at least one trial and one
partner will be unveiled in the not too distant future.
[quoteWhere are they gonna get the millions of $$$ to fund this trial ???][/quote]
Me thinks from the partner that is willing to dole out the dough for those combo trials.
Agreed Flipper.
A NEW STRATEGY TO DEFEAT THE FUDSTERS: Instead of
responding to their nonsense, the longs on this MB could simply
negatively grade the basher's posts to death with the poop or finger
and/or other disapproval indications. When it comes to the number of
grades per post, we longs still have a commanding numerical superiority
and we can overwhelm this vermin by the the numerous disapproval signs
that we can place under each of their anti NWBO posts
The anti NWBO posts are mainly directed at the irregular visitors
to this board who probably could be swayed to disbelieve those
negative posts and to pay more attention to the pro NWBO
messages if they see that the negative posts are subject
to far more numerous disapprovals than the posts produced
by the longs on this MB.
I know that at this time, the bashing posts are already somewhat more
subject to disapproval than are the posts written by us longs but
with some effort, we can decrease even more the effectiveness of
those paid negative posters.
Bottom Line: we can win the battle of the bulging poop.
Perk_Idaho, more specificity please?
[quotYou don't think many of those antigens are expressed in healthy cells too? Careful what you tout.e][/quote]
No I don't. If those cancerous antigens (epitopes) were expressed on healthy cells, those
cells could not be considered healthy because they would be cancerous and would then
elicit an immune response that would destroy them.
[quoteEtc etc. I guarantee the argument will be that the buck stops with MHRA approval. And I’m kinda worried it’s gonna wor][/quote]
Yes, that argument may be damaging for some time after MHRA approval
but will likely be sidelined completely once reports of the efficacy of those DCVax-L
treatments for UK patients will be released. Also by that time I expect
the Edens manufacturing system to come on board and a BLA to be submitted
to the FDA.
Welcome to the Board, Buccaneerillusionist21
[quoteSo I don't get why people respond.][/quote]
I agree that your reasons Nos. 1, 2 and 3 should not be the
motives for responding to the bashing naysayers.
However, on occasions it is worthwhile to respond to the posts
of the more intelligent anti DCVax-L advocates (e.g. ex) who
with crafty, seemingly logical but inherently flawed arguments
could persuade some of the irregular and less educated MB
visitors that investing in NWBO is likely to be counterproductive.
I would like to emphasize that those occasional rebuttals to the
pseudo intelligent anti NWBO arguments would most likely only
benefit the irregular MB visitors because our MB longs would not
be persuaded by any of the fudster arguments.
For all those bashers who continuously claim that too few pseudoprogressors and/or
too many rapid progressors were excluded from the DCVax-L trial than were excluded
from the ECAs, let me just point out the two most pertinent DCVax-L trial results that
totally negate the basher argument.
1. The mOS of the 122 unmethylated GBM treatment patients (14.9 months) showed no
statistically significant difference from the mOS of the unmethylated GBM patients of
the ECAs (14.6 months). Apparently, those results suggest that any minor differences
in those inclusion/exclusion methodologies of the DCVax-L trial and the ECA trials were
inconsequential.
2. According to Dr. Liau, the original group of 35 permanent placebos did very
poorly as their OS was well below average. That means that about 35% of
the 99 non treatment patients formed a group whose overwhelming majority
were relatively fast progressors and I have no reason to believe that the
initial patient composition of the treatment group or that of the ECAs was
fundamentally different. Thus the DCVax-L trial did not exclude a large
number of OS underperformers and I have no reason to believe that
the ECAs differed a lot in this respect.
Most likely the extreme rapid progressors and pseudoprogressors were excluded
from the NWBO trial as they were excluded from the ECAs but that exclusion would
still leave in all trials a population that varies greatly in their survival capacity.
Bottom line: DCVax-L trial = no cherry picking involved
[quoteThey can’t cry about pseudoprogression messing up the trial then try and claim it didn’t affect rGBM][/quote]
How can pseudo-progression affect rGBM? DCVax-L was administered
to the 64 crossovers only after they had progressed. Please get your
facts straight.
By the way, as a group, those 64 crossovers had a longer mOS than that of
the 232 member Treatment group and a much longer mOS than the ECAs.
I m not sure at all RobotD that the repetitive, mindless and
childlike fudster drivel is aimed at convincing the veteran longs
on this MB that the DCVax-L trial had failed and that they should
therefore sell their NWBO shares ASAP. Such an effort by the
fudsters would be futile because our MB longs have invested
much time and effort in thoroughly analyzing the trial results and
have long ago reached the conclusion that the trial was a great success
and that the OS is substantially increased when nGBM and rGBM
patients are treated with DCVax-L.
Instead, I believe that the ridiculous fudster drivel is aimed at investors
who visit the MB from time to time and who have also not thoroughly studied
the trial results or due to a lack of analytic capacity or education have
misinterpreted the findings. I imagine that the vulnerability of such
investors would be increased when faced with many anti DCVax-L
posters whose poster production capacity is beyond impressive.
Am I only imagining that lately more than 50% of the posts have been
claiming that the DCVax-L trial had failed and that the SP and company
are doomed?
Thank you Inquirg for educating me and let me see if I got
it right.
We had three placebo groups in this trial (with 3, what can go wrong?).
1. A very large number of external controls.
2. A group of 64 placebos who after progression were treated with
DCVax-L and for some mysterious reason displayed an unusually
long mOS.
3. A group of 35 placebos of whom 6-7 dropped out of the trial whereas
the remaining 28-29 never received DCVax-L because most of them
progressed rapidly, needed salvage treatment and had a shorter than
average mOS.
Now if I am doing this correctly, I should entirely discard the OS results of the external
placebos and instead consider the combined mOS of the 64 crossovers and 28-29
permanent placebos, as the true blue placebo group whose combined mOS is (whoopie),
somewhat higher than the mOS of the treatment group.
For all of the above calisthenics, I now give myself an E for effort.
After what journey are you out of the market? Are you out
once we find out whether the MTD was granted? or was denied?
Aren't you going to wait at lest beyond the MHRA approval?
Jester, although I don't agree that the lawsuit is a pie in the sky, I do
concede that it may not be resolved in 2024. However, I am not sure at all
that approval by itself will be a strong catalyst for a sharp SP uptrend.
After all, right now, despite the December 20 submission of the MAA,
the almost certainty that DCVax-L will be approved and NWBO's recent PR concerning
their confidence in EDEN's automatic manufacturing capacity, the SP has
currently been losing more ground than it did before the release of those
uplifting PRs that very much suggest a rosy future for NWBO.
I am guessing that the treatment of many UK patients will start to reverse that SP
losing pattern. but I question whether that can occur much earlier.
Jester, what makes you think that approval alone is going to stop the
attack on the SP? I am now guessing that only substantial profits
resulting in a brisk sale of vaccines brought about by post approval
utilization of the EDEN automatic manufacturing method, will lift the SP
because monetary profits speak for themselves.
A second catalyst for an SP uptrend will be a denial of the MTD
followed by a cash settlement with the 7 criminal companies.
Of course approval by the FDA and other regulators as well as
a partnership could be very strong SP stimulating factors but I don't
expect that to happen till late this year at the earliest.
You are right Ilovetech. Unfortunately there are a lot of mediocre
features in medicine that are worse than an error in the description
of a medical trial.
Think about the mediocrity of the helmet treatment for GBM patients.
The mediocre survival benefits of this treatment may almost be outweighed
by the discomfort it inflicts. Furthermore, the cost of a long term helmet
treatment constitutes an additional drag.
Thank you Ilovetech for pointing out the error in this very recent
article. While the article included the error of stating that the arms
in the DCbax-L trial consisted of non-randomized patients, the
article did contain a very positive feature in pointing out that DCVax
increased the survival of GBM patients and should therefore be
considered as a potential treatment for those patients.
While the longer survival duration seems more profound, it
involves a smaller percentage of the population whereas the
mOS is more indicative of the overall survival trends IMHO.
The dumber the better Robot because it displays the naysayers'
ever decreasing supply of effective anti DCVax arguments.
Attilahthehunt, According to the JAMA article, the mOS of the external controls
(ECAs) was only 16.5 months from randomization whereas the mOS of the trial's
treatment group (treated with DCVax-L right after randomization) was 19.3 months
after randomization. This DCVax-L efficacy was of course also reflected at 5 years
from randomization as more than twice the percentage of treatment patients
than ECA patients were alive at that time.
Bottom line: both early+late timelines reflect the efficacy of DCVax-L treatment.
YesTTsr, An anthem change from God Save the King to DCVax
save the King is something I am looking forward to.
I know Gus. Just checking.
Merck's keytruda patent expires in 2028 not 2024.
[quoteApproval? They’ll work to push it down.
Revenue? They’ll work to push it down.][/quote]
The push it down strategy may still be effective after
Approval but after Revenue, I doubt that this strategy will work.
Outstanding analysis Chiugray
Thanks for the reply, Hankmanhub. I know that you have always been
a long and a great believer in NWBO's technology. Maybe what I should have
written is that while the NWBO technology will likely experience its vast potential and
may become extremely profitable only within 3-5 years, that potential will already
be obvious let's say a year from now and that may not constitute such a long wait
for pharmaceutical companies to plan their move.
Hopefully we may find out in the future whether NWBO will go it alone for
some time, will partner, or will be bought as well as the identity of the partner
or purchaser and maybe we will have an idea as to why certain companies
would not or could not take the NWBO bait.
Sorry folks for butting in but It takes me much longer these days
to compose a post than many of you and by the time I finished, all
the back and forth arguments relating to Hankmann's post, many
replies were already posted.
Not a good comparison Hankmanhub. Within the next 3-5 years, Seagen's
technological accomplishments will amount to a fraction of the life saving
technology that will be introduced by NWBO and that difference will also be
reflected in both companies' MC or the MC of the entities who purchase those
two companies.
Unless some other extremely efficacious cancer treatment can be rapidly
developed and introduced into the market, DCVax is going to be the next
major treatment for most solid cancers because to date, both DCVax-L and
D have shown in their respective trials, a substantial efficacy and smaller
combo trials utilizing DCVax-L with adjuvants (poly-ICLC, keytruda) are showing
an ever increasing life extending capacity.
There is therefore overwhelming evidence from several trials and RWE
(compassionate patients) that DCVax works and will likely improve.
The only major questions remaining are:
1. Right after MHRA approval, how long will NWBO carry the burden alone or will there be soon
thereafter a partnership or BO?
2. The relative difficulty involved ( time and expenses) to bring the treatments to patients with GBM
and later to patients with other solid cancers while NWBO is working alone, with partnership or a BO?
3. When can the Edens automatic manufacturing system be validated and how will that system affect
questions 1 and 2?
If Merck is so desperate to extend their patent on keytruda, why did Davis
recently put a limit of $15 billion on a hypothetical Merck buyout? Seems
to me that this may be a message to NWBO, and maybe others that with about
4 more years of the keytruda patent, Merck is still in a position to play hardball.
Perhaps Merck is willing to go for an extended time into a partnership with NWBO
and then will be able to justify, based on success, a higher than $15 billion BO price
to its shareholders.
Alternatively, in a worse case scenario, I believe (unlike some posters here) that after
approval, NWBO will be able to make enough progress financially to be bought at a price
that is much higher than 20 billion dollars. Granted, this will take additional time but aren't
NWBO's longs the most patient shareholders on this stock market.?