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If as I suspect, keytruda increases the potency of DCVax's combo
treatment, NWBO and Merck will be forced into a symbiotic relationship
and due to NWBO's struggle to survive, we will have to overlook
any transgressions that Merck may have committed.
Merck also has no choice whereas NWBO could probably with time
conduct trials with other CIs that may or my not be more efficacious
than Keytruda but right now I believe that path is still very academic.
IRONIC that the criminals' spoofing to protect their Merck investment (e.g. Temodar),
had no clue (and no one else did either) that Keytruda may end up as a component
of the DCVax combo treatment.
If a DCVax combo treatment with Keytruda can effectively be utilized in treatments
of many solid cancers, the profit that Merck will reap from the sale of this product
may by far trump any losses incurred by the reduced sale of Temodar
C'mon Doc, an additional 16 months with LC et al? No way because
well before the end of 2025 we will most likely have the trifecta + several
other milestones in our rear view mirror.
If this marriage soon becomes a reality, what will be the cost of the dowry?
Agreed that the combo primary endpoint date change may be a display
of confidence of an expected preceding MHRA approval.
Granted that a very successful combo treatment is a huge plus.
However, with or without the combo treatment, applications by NWBO or
by a company+NWBO subsidiary to larger markets beyond the UK most likely
cannot materialize until the EDEN automatic manufacturing system is ready
to roll and I don't know how many more months that will take.
Or is it possible that by December 1, that rolling EDEN system may not be
that far away?.
"To offset the loss of revenue, Merck is taking several steps, including:"
Granted that a number of the steps that Merck is taking to offset the loss of revenue
will most likely be beneficial but that does not exclude Merck's additional step of
facilitating the inclusion of keytruda as an integral component of the DCVax-L
treatment.
My bet is that this additional step will trump all Merck's other steps.
Greetings Krisgo. I believe that by the end of 2025, trifecta will be behind
us and in addition, NWBO will have stellar results from combo trials and perhaps
a partnership and positive results from the lawsuit. At least some if not
all those pre and post trifecta milestones will be reached. At that point any attacks
on the company would most likely fail to substantially affect the SP.
Until those positive events unfold one by one, the SP will probably continue
to struggle but with each success, the potency of the attacks on the SP
will diminish and eventually will become inconsequential
Krisgo- I also basically follow a pattern similarly to yours.
Come to think of it, my estimate of 4B after trifecta does not
include an SP increase that is based on positive events that
most likely will become reality before the completion of trifecta.
My estimate of 4B is based on the unlikely assumption that by that
time, no other positive developments have taken place (e.g. MTD
denial, positive combo results, partnership etc.).
I therefore would not be surprised if in addition to my 4B estimate
of post trifecta, we would be enriched by an additional sum of ?B.
"Validation of Edens and beginning of buildout byJanuary 2026 or before is within the 18 months Linda pointed to at the ASM for those goalse"
Am I understanding correctly that you believe that it may take up to the end of
2025 before Edens is validated and the beginning of buildup?
Since we expect approval to occur within the next few months, the above would
mean that the interval between MHRA approval and validation of Edens may exceed
one year. If that is correct, what would take so long? Manufacturing of the new
smaller foot print units or thereafter testing of those units or anything else?
Or perhaps LP's 18 months post ASM goals included much more than the validation
of Edens and their utilization in maximizing Advent's production capacities?
UK Trifecta MC Prediction: 4B
" Maybe approval was denied????"
Nonsense. Had approval been denied Advent would not only have
stopped their recruiting but would have by now fired many of their
workers. Have we heard anything about that? No we haven't.
Furthermore, if approval had been denied, we would have been
informed of that some time ago.
Next time post something one quarter way believable!
If by mid September we have not heard anything about the fate of the
MTD, I would be wondering if the parties had started negotiations
concerned with the indemnities that would convince NWBO nd Cohen
Milstein to terminate their lawsuit.
[quoteI believe approval is more likely than not considering all the due diligence that has been shared on this message board.][/quote]
Approval is more likely now because if approval were unlikely, the MHRA would not
be conducting the expensive inspections that had recently been scheduled.
We got to this point because the trial's results were stellar and the preparation
of the MAA up to par.
While unfortunately the due diligence of us longs had no influence on the MHRA's
decisions, the due diligence of the paid fudsters was fortunately also inconsequential.
i
RobotD, with the exception of the preparation for inspections that
I am sure have been completed, the MAA approval is out of the hands
of NWBO. I am therefore concluding that you are implying that the
MHRA and not NWBO has been causing an approval delay and is
therefore considered by you to be the inept party.
P.S. Right now we have not yet entered the approval delay period
and doom and gloom predictions are therefore premature.
apparently LC, you have serious doubts based on the lack of side effects
that the science is strong for this company.
So please tell us whether you have been suffering side effects
every time that your immune system which is your personal therapy has
eliminated the viruses and bacteria that were responsible for the various
infectious diseases that have attacked you throughout your life.
Apparently, evolution saw to it that your immune defense mechanisms
are not accompanied by substantial side effects.
Why then would we expect the stimulated DCs directed against human
tumor antigens to act any differently and elicit an immune response that
cause side effects?
" by the end of the year we will be an entirely different company"
" How many here believes this means merger"
50% of me believes that an "entirely different company" signals a merger
and 50% of me does not.
Thank you Dennisdave for letting me know that it is not unusual to
withhold a ruling while the parties are negotiating a settlement.
I am therefore also assuming that you believe that if the negotiations were
not ongoing, we would have already received a ruling on the MTD.
You are also most likely right in your belief that our long wait for the
magistrate's decision has nothing to do with the impact that decision
would have on the way the stock market operates because the problems
presented by spoofing and naked shorts have been for some time subjects
that had been litigated.
Do you or your brother (the experienced trial lawyer) have any opinion
about why more than two months after the defendant's last response,
we have not received a ruling concerning our lawsuit?
Is this unusual or perhaps not so unusual for a magistrate to take
much time especially in that kind of a lawsuit because maybe in this case
a decision could have an impact on the future investment patterns
of the USA financial markets?
If no lawsuit settlement or partnership(s) are on the short term
horizon, we will have to wait for EDEN and that may be as long
or even longer than a nine month pregnancy.
Who was it that said that by the end of the year we will be an
entirely different company?
Nevertheless still bullish.
Kabunushi, if by the end of this year no substantial catalyst except MHRA
approval comes to the rescue, I believe that the SP will stagnate until
a validated Eden is firmly established and that may not happen until
sometimes during Q1 2025 at the earliest. Profit from the artisan
methodology may somewhat stabilize the SP but its impact would most
likely be limited.
Therefore hoping for some prior post approval catalyst (lawsuit settlement,
(partnership(s)).
The one year extension of the combo trial results is probably
based on the fact that the results look promising but not yet
convincing and more time is needed to demonstrate positive,
statistically significant results when keytruda is added to the mix.
The additional year and enrollment of a few more patients may
or may not do the trick but the only way to find out is to extend
the trial.
Hankmanhub, it was originally another long (not I) who brought up the
idea that for the interval between approval and validation of EDEN
(which could last for months), the reimbursements for the vaccines would
not exceed their production cost. I don't know whether that will happen and
I have to go back and find out who suggested that possibility but I am not
sure that this is an impossibility.
I certainly hope that NWBO will be reimbursed ASAP for the artisan produced
vaccines for obvious reasons. Flipper hs mentioned to me and others that there
are UK interim funding specifically available for a short time for use
during the interval between approval of a medical treatment before it reaches
the product's desired production capacity. Perhaps the reimbursement from
NICE plus the funds from another source(s) will be sufficient to make the DCVax-L
production profitable from the get go.
JT, you are being way too pessimistic IMHO.
You are correct Attilah in stating that the artisan method has been known
for a long time but that suggests to me that an unofficial agreement may
have already been reached between NWBO and NICE as to the
reimbursement but that may only be revealed once approval is a reality.
As far as reimbursements for the EDEN product is concerned, I am not
sure that the production costs of the latest improved version of the EDEN
is already known and if this has not yet been determined, we will have to wait
for a reimbursement agreement once that has been established.
What bothers me greatly is that no one here seems to know anything about
the true capacity of the artisan method or whether the reimbursement allows for
a profit or will only be equal to the production costs. After all, that methodology
may have to be utilized for 3, 6, or 9 months (or who knows how long) before
EDEN (Flaskworks) is ready. Furthermore, the maximum production capacity of the
artisan method is also unknown to us. Some posts suggest a capacity
of 100-200 vaccines per year whereas others estimate the capacity as 500-1000
per year. This is important because if the interval between artisan and EDEN is
long, the artisan production capacity is limited, and the reimbursement very modest,
NWBO better obtain alternative money sources (e.g. partnership) or will be
forced to continue with its subpar SP until EDEN comes to the rescue.
I wish you were right Attilah, but what evidence do you have that EDEN
will be validated within less than 4 months? In fact, I don't believe that
we have even been told that the final upgraded EDEN units have already been
ordered although I hope that by now, they are on order.
Of course, If you are right, I would agree that NWBO and NICE would
not bother to set the pricing on the basis of the artisan methodology
but will instead focus on the reimbursement for the EDEN products.
Alternatively, if we have to wait for the validation of EDEN until mid 2025,
NWBO and NICE would have to agree on the reimbursement price for
the artisan product before validation of EDEN becomes a reality.
Hankmanhub, I never said that NWBO's application to the MHRA
was based on the EDEN technology because I know that it was
based on the artisan methodology. I was just worried that until
EDEN is fully validated and operational, the limited vaccine production
of the artisan method will restrict the increase of the SP in the interim.
Doc, if after approval, the artisan DCVax-L production reimbursement
is not going to be enough to yield NWBO a reasonable profit for many
months before Flaskworks is validated, I fear that the SP will suffer
greatly in that interim. In that case I hope that some good news, not
related to vaccine production will keep the SP afloat but absent
that possibility, makes me concerned.
Newman, I believe that the validation date was January 24 whereas
the validation confirmation occurred on March 7.
[quotLes was clearly talking about information that he had received from the Regulator, to make he believe that nothing will be moving until the Late Autumn.e][/quote]
What is clearly not a quick fix is your constant misrepresentation of facts,
quotes etc. So here is a correction of your misrepresentation, and one
question+request.
1. Less was talking about an event to be discussed in the "fall", not "late Autumn".
2. Do you really expect anyone to believe that by May 9, MHRA would inform
NWBO that nothing will be moving for the next 6 months? Please give us a
hint about the source of that intriguing information.
Thank you Beartrap for that post.
[quoteLes told a friend at the ASM that the “fall” comment was a misstatement. He says he meant that by late fall all the things they’ve put together will make this a completely different company when they all fall into place. He didn’t mean to refer to MAA approval.][/quote]
Finally a different version of Les's misspoken comments that makes more sense.
In fact,, how would Les already know on May 9 that the MAA was going to be
approved during the fall. IMHO, Les can do us a favor by resigning from talk shows,
thus avoiding any chance of conveying to us his misspoken information
Thank you Beartrap for your excellent explanations.
I hope that by the next Q we will have the approval and hoping
that by that time we will also have much clarity about when we can
expect the initiation of the automatic manufacturing (Eden).
[quotSo, I'm ready to hear that the first unit will arrive in X-number of weeks or months. Or better, that it has arrived and is hooked up and ready to go through validation runse][/quote]
If it still takes a number of months for the first Eden unit(s) to be validated, do
you believe that the MHRA would delay the MAA approval until at least that
first unit(s) is validated? That may take months after completion of
the inspections that LP had mentioned which may already be taking place
right now. I certainly hope that we do not have to wait for approval until
December.
[quoteOfcourse a lot will chance for the good after UK approval but still][/quote]
Chances are that once the UK treatments are initiated, most GBM
patients will receive the combo DCVax-L/polyICLC treatment and
it will not be long before the effectiveness of that treatment will
receive a lot of attention. Sometimes during 2025, a lot of the doors
that were previously locked, will be wide open.
Fortunately DCVax's 2.5 months longer mOS than SOC's mOS
is no longer relevant because the DCVax-L/polyICLC combo
treatment is already greatly increasing that efficacy and probably
additional DCVax-L potentiators (e.g. keytruda) will soon come on
board.
The difference between DCVax-L and Optune or temozolomide
is that DCVax-L's anti tumor activity can be potentiated by combo
treatments whereas Optune and temozolomide lack that capacity.
This bodes very well for DCVax-L+Combos, not well at al for Optune
and probably not well for chemotherapy (Temodar), since its immunity
suppression may often negate its chemotherapeutic benefits.
IMO. monetization and launching into other solid tumor indications
can start after MHRA approval and validation of EDEN which will
allow for a brisk UK vaccine sale business. This will probably begin no
later than mid 2025. This should provide enough money to start one trial.
Alternatively an agreement with a BP to provide aid for a trial could be
reached even earlier perhaps some time after MHRA approval.
I also don't believe that after validation of EDEN, it will be long before
NWBO applies to other regulators and approval in other jurisdictions
will open the markets in many locations.
I do agree that we may have a tough 6-12 months ahead of us but
once past that, I believe tht we will be OK.
[quoteYou're making my point. DCvax isn't a silver bullet. It may not even be a rubber bullet][/quote]
How so, now that poly ICLC has become an integral part of the
vaccine (DCVax-L), the vaccine's efficacy has already been greatly
increased over that seen in the trial results that showed an added
2.5 months survival when DCVax-L alone was added to SOC.
We can therefore delete the concept that this treatment can be
defined as a rubber bullet.
In fact, preliminary trial results are showing that addition of poly ICLC
to DCVax-L, greatly increases the survival benefits and now we are
awaiting the survival results of DCVax-L/polyICLC treated rGBM
patients who are also treated with keytruda.
Furthermore, there is now reason to believe that improvements in the
DCVax-L preparation itself as well as additional superior combination
treatments could increase the efficacy of the vaccine.
Rome was not built in a day and we have to take it step by step.
While this treatment is not yet a silver bullet, it can become one.
A rubber bullet it is not and has never been.
Thanks for the info Flipper.