Apologies for butting in but I am guessing that if I were an oncologist
of a patient with unlimited funds, I would not recommend the helmet
because I would not know whether or not the helmet negates the
immunological benefits of the DCVax-L treatment.

OTOH, I would definitely add poly ICLC to the DCvax-L treatment.
In fact, I would treat all patients (affluent and poor) with both DCVax-L
and polyICLC. With respect to adding keytruda to the mix, I do not yet
know whether enough decisive data is available.

Well Hopeforthefuture, I hope that we hear something about approval by
the end of May, June, July or August and we don't have to wait for this till
the end of 2024 (about one year from submission).

Remember that NWBO applied for the 150 day fast track MAA submission on
12/20/23 and even with 14 days until MAA acceptance and a 60 day RFI, approval
may be granted already by early August.

JT, congratulations for your patient bullishness but I believe
it will be already approved this year.

If they don't anticipate approval this year, why are you so bullish, JT?

Thank you Hyperopia. Until now I somehow missed your post and
just read it now. I completely agree with the contents of your post
as to the reasons it took so long to get to this point and I have rarely
faulted NWBO for most of the problems (delays, low SP etc.) since it
has been clear to me for a long time that a number of powerful actors
have been trying to destroy our little company.

While I perfectly understand the importance of the breakthrough
technology of Flaskworks and its superiority over the artisan methodology,
I do not know whether or not at the time of MAA approval, this automated
methodology would have already received the required MHRA approval.

Therefore with regard to whether NWBO starts with the artisan or automated
technology. I am on the fence but I am confident that the company is not on
that fence, has planned all the steps that have to be followed and is ready
for all contingencies.

The silent witness can't be you Nemesis, since you have
been for some time the most prolific lying loudmouth on
this MB.

If according to Senti and Hyperopia, the submission of the MAA was
delayed so that the MAA approval was delayed to occur a number
of months prior to the approval of the Flaskworks process, why was the
MAA submission not even further delayed so that it would coincide with
the flaskworks process approval?

What is the point of having a gap of few months between those two
approvals if that time gap ( a number of months) would not be sufficient
for NICE and NWBO to agree on a reimbursement sum for the artisan
treatment and for said treatment to be utilized before it is replaced
by the Flaskworks methodology?

Seems to me that kind of delay in the MAA submission would have simply
harmed patients who could have benefited from the artisan manufactured
vaccine but due to the delay could potentially miss the lifesaving boat.

While NWBO was often late in the past, it is now
out of their hands and it is MHRA's turn to be late
or early.

Why are you engaging in discussions concerning the cost
that NICE will agree to pay for the treatment if you are of the
opinion that the MHRA is never going to approve that treatment?

I can only conclude that you changed your mind and now believe
that the MAA will be approved by the MHRA.

Regardless of Dr. Liau's misstatement that 90% of the original
placebos crossed over, all those sloppy authors had to do was
to look at the JAMA article graph that presented the post
progression survival times of all the crossovers and there were
only 64 such patients in the trial.

Even if at the end of the trial, only about 92 of the original
99 placebos were left ( about 7 dropped out?), the 64 crossovers
barely comprised 70% of those 92 original placebos, not 90%.

Instead of revising the article by correcting only one of
several outrageous errors, the entire article should have been
withdrawn.

I agree Horse4CarT that the 7 MM criminals are not facing bankruptcy
directly from the NWBO/CM lawsuit that would end in a settlement. However,
the 7 MMs may face a heavy financial loss or even bankruptcy over time or via a
trial if the analysts who believe that NWBO had been invaded by a huge number
of naked shorts, are correct.

In the case of a huge naked short infection, even after any financial settlement,
the seven defendants would be forced to avoid disaster by continuing their
spoofing in order to keep the SP from rising to the point where the naked shorts
have to be covered. However, despite the continuous spoofing, NWBO's
tremendous cancer treatment potential, multiple regulator approvals and
the upregulating to a major exchange, could with time overwhelm the spoofing
effects. This can also transpire as a consequence of a trial that completely
exposes the MMs misdeeds and that could also be devastating for the 7 MMs
and their clients.

Of course, if few or no naked shorts exist, then the 7 defendants would not be
forced to continue with their spoofing and a good financial settlement for NWBO
would go a long way to solve its SP problems.

Hopefully with time we will be much wiser than we are now.

Excellent analysis JFR. It would be UK's feather in the cap to have
introduced the first cancer vaccine well before the January 28, 2025
elections.

While this is a novel platform therapy, it isn't so novel for
MHRA since in the UK, the compassionate treatments
have already been carried out over a long period of time
and the need to develop cancer vaccines has received much
awareness in UK government circles. Consequently, the
150 fast track approval goal is not unrealistic although
of course it may take a few months longer. However,
I am guessing that it will not go beyond 210 days from
the date of MAA acceptance.

By "it sounds more immediate" are you implying that an
MAA can be soon submitted to the FDA (via Orbis?) after
MHRA approval and before Edens has been certified
to replace the artisan methodology?

I am asking that question because some of your previous
posts indicate that you believe that after MHRA approval,
the artisan methodology will be utilized and we will be waiting
for some time before the Edens system can take its place.

[quoteAnd then why has not an application not been submitted to FDA or any status update given .][/quote]

You know as well as most of us here that no application to the
FDA will be submitted until NWBO can demonstrate that its
DCVax-L manufacturing capacity can satisfy the current
demand in the USA.

Once the EDEN manufacturing system has been validated and
can potentially satisfy the medical demands in the USA, NWBO
will submit a MAA to the FDA.

Has anyone on this MB estimated what is Sawaton's current annual
DCVax-L artisan manufacturing capacity?
If there is a delay in the validation of the EDENs units, can the artisan
manufacturing capacity handle for even a few months an annual case load
equivalent to about 3200 new GBM cases and additional cases of glioma
grade 3 cases as well.

I hope that Sawston does have that capacity but that implies that many more
clean rooms have been made available. I am wondering about the money
spent on the conversion to clean rooms especially since once the EDEN system
is in place, those rooms are no longer needed.

Actually I am fairly certain that NWBO took all the above mentioned items
into account before submitting their MAA but am just wondering how they did it.

All logical responses are welcome.

A partnership for combo trials could perhaps be a potent
defense against SP manipulations that may be planned
by the criminals even after MHRA approval. The intention
to join such a partnership once the MAA was cemented
was mentioned in NWBO's MAA submission PR. I believe that
would be a more realistic defensive tool before any uplisting to a
major exchange can take place.

I am speculating that while NWBO may have earned very modest monetary
gains from compassionate program patients, the company may have
also tested the EDEN system by treating gratis a number of less affluent
patients. If those treatments were part of the EDEN validation process,
than those treatments will prove to be worth much more than the
cash profits gained from utilizing the artisan method to treat patients
who did pay for their treatment.

Kudos to you Gary. If after your recent surgery you still have the capacity
to produce so many thought provoking posts, you will probably make
it well beyond 100 and you will live to see the extension of those NWBO
patents in the mid 2030s.

Zadie, I may be wrong but my guess is that after approval,
the utilization of temodar for patients receiving DCVax-l
will become more infrequent for those with methylated nGBM
and will not be used at all for those with unmethylated nGBM.

And yes, I believe that it was Flipper who first suggested that
patients receiving DCVax-l, should not be treated with
temozolamide.

Since the overall survival at five years for DCVax-l treated nGBM patients
was very similar for patients with significant residual disease as it was
for those with minimal residual disease, can we therefore speculate
that employment of temodar, even for methylated nGBM patients is
counterproductive because while somewhat reducing the tumor
load, temodar is likely to suppress the immunological response
capacity of DCVax-L.

Wishing you Gary a speedy and complete recovery. You have done it
before and I am sure that you are doing it right now again.
I am also confident that you will be here to enjoy NWBO's fruits
of success for many years to come.

Best wishes to you and your family.

Doc, all your comments about the consequences for the SP after
approval seem very valid to me but with respect to partnership, has
not NWBO hinted at the time of MAA submission that a combo
trial(s) agreement with a BP is likely to be initiated already before
approval (when MAA has been cemented)?

When that partnership is announced, I expect the SP to be affected
in a positive way, even if that event has occurred prior to MHRA approval.

Thank you Doc logic.

Whether the new board member is or is not fluent in one of
the many Indian languages is not that important IMHO because
when interacting on a national business level, mostly English
is probably still universally employed in India.

This is interesting because linguistically India may be similar to
Europe. How does a Romanian company conduct its business
with a Bulgarian company that is only 100 miles away. They
are unlikely to use Bulgarian (a Slavic language) nor Romanian
(a Latin offshoot) but maybe a more International language like
English?, Russian?, French? or German?

Thanks Doc for the info. If the problem is severe, NWBO
must be aware of it. Have you heard anything about how they
plan to deal with this leukapheresis and freezer storage problem.
Obviously if this is not solved, even MHRA approval would
be compromised because fewer patients will be able to
receive DCVax-L treatment.

Doc logic, are you talking about backlog in the capacity to conduct
sufficient leukapheresis procedures during which monocytes (pre dendritic cells) are
separated from the rest of the blood cells or are you referring to insufficient
cryogenic or storage capacities of those cells once the leukapheresis had
been carried out?

Well Krisgo, maybe NWBO believed that they would be too busy
after MAA submission with MHRA inspections or other follow up
work related to that submission and therefore decided to skip
that conference.

But that is the point Zadie. Without the manufacturing validation
of the EDEN system they will not have adequate production to
satisfy the demands in the USA or EU whereas they can meet
the demand in the UK with the manual vaccine manufacturing
system.

Once they validate the EDEN system, no problem, they
can and should submit an MAA to any jurisdiction where they
can meet the demand.

That makes sense Jimmy667

Investor082, NWBO will only be able to submit a MAA to the FDA or EU once they
have enough of the EDEN automatic manufacturing units on hand and utilization
of that system has been approved in the UK because the manual manufacturing
system cannot produce enough vaccine units that are needed to treat patients
in the EU and/or the USA.

What is your evidence that Posner has gotten paid, either in cash or company shares?

[quoteNWBO should ideally Partner Up and Uplist to a Major Exchange prior to Approval][/quote]

Isn't that what NWBO said about a partnership for a combo trial(s) once the MAA is "cemented"
which most likely implies that it should happen before approval. This of course does not include
an uplisting which may not occur for sometime.

Your response Gary is interesting and seems quite logical. It is your
belief that after approval, much depends on the ability of NWBO to
inform the public about the importance of the DCVax treatment without
giving the impression of overselling the news which may give an
opening to our adversaries. With regards to that, I am fairly confident that
LP&CO. are up to the task and I believe that after approval, NWBO will be
much more active in participating in business conferences and scientific
meetings. In other words, that first approval (MHRA) will allow LP to come
out of her hideout to face the public and institutions that she has to convince.
I also believe that NWBO and the SP may benefit if after approval and perhaps
a partnership, the media will expose the public to information concerning the
lawsuit.

My main concern is the ever decreasing SP. If by the time of approval the SP
is still extremely low, it could take much time before that approval and other favorable
events will bring the SP to a level that reflect the recent achievements. I may be wrong
but that is something I fear because I am concerned that the defendants may feel
that their survival may depend on preventing the SP to reach a level that forces them
to cover a large number of naked shorts. I now do believe that those naked shorts are
most likely a reality.

Thank you Gary for the clarification. I am hoping that sooner or
later the SP will recover and we will get out of this mess. That
may happen once we experience not one but a few favorable events
such as MHRA approval, a partnership for combo trial(s),
utilization of the EDEN system, followed by MAA submissions
to multiple regulators. I am not counting on the lawsuit because
that may take a long time before it is settled. However, I do fear
that until we reach the goals I have outlined, the company and we
the shareholders will be struggling with an ever decreasing SP.

I very much like to know what is your take concerning the struggle
that NWBO is currently facing. Perhaps you have a different
vision as to what the company and shareholders will face in the
not too distant future.

Holy smoke Gary. Are you saying that establishing and maintaining
a naked short position in a company over a short period of time is
a legal and often desirable action and that there is no specific timeline
established when that naked short position must be reduced or
eliminated? As you can see, allowing this naked short insanity
to flourish is potentially both catastrophic for NWBO and possibly also
for the defendants because the only way the MMs can now save their
skin is to keep on spoofing.

Did the SEC not see what the consequences could be when huge
naked short positions could torpedo both the invaded companies
as well as the MMs who have embedded those invisible invading
shares?

XMaster, what evidence do you have that the criminals
are beginning to cover until their desperation clicks in.
Can you please clarify your statement?

Hi AngeloFoca. Maybe you can extend somewhat the
end of your rope. I expect the approval anywhere from
the beginning of April till the end of September with May,
June and July the most likely months.

With respect to the SP, we may have to struggle for
some time to come but perhaps the approval, a
partnership and the consequent publicity may bring
us some relief.

No, I did not list reasons for having an ASM but please
enlighten me and tell me why you think I did.

The 150 days to approval = all days.