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[quoteSpringbok80 great find. Now maybe this will quiet the BS pumpers on this board. Probably not][/quote]
Springbok did well by posting MRHA's guideline to the effect that companies
should not PR acceptance of their MAA application and this has already been
posted by kusterer yesterday. If that is the case, we may have to wait for several
weeks or up to a month and if we do not receive any notification, we may assume
that the application has been accepted/validated.
In the interval the shorts most probably will have a rip roaring success;
This is a great time to accumulate more shares.
Agreed Newman, from your post to G-D's ears.
Excellent point BB.
Agreed Bio. No reason to believe that the MHRA will deviate from its
ILAP program of granting an MAA within 150 days of the application's acceptance.
Hence if the MAA acceptance occurs in early January, NWBO should receive the
approval by early June. It could of course be earlier but February-March still
seem to me overoptimistic.
Crash, While I have always been a very optimistic long and still am,
I believe that your assessment of a February or March approval is
a bit overoptimistic. This is an extremely voluminous application and
will probably take a few months longer before the reviewers will give us
the approval signal.
Wish it wasn't so, but if this investment has required from us longs anything
special, it is our patience, patience, patience......
Thank you Flipper and DD for your answers. If we obtain
enough evidence of CSF-1R's utility in the combo and/or
that keytruda is a plus, than Merck is the BP with the
partnership/BO advantage. Otherwise I am looking forward
to a fierce BP competition for NWBO's favors and that is also
not a bad alternative.
If utilization of poly ICLC with DCVax-L substantially reduces the need to
include a CI in the mix, wouldn't that counter the advantage for NWBO to
partner with a CI manufacturer (Merck) ?
JTORENCE, being past 90, my time is also very much on the
short side but I hope that you and I and all our MB posters will live
long enough to witness the revolutionary improvements in cancer
treatment that will be delivered by DCVax+synergistic treatments.
Let's drink to that on this very rapidly coming NEW YEAR.
Who is saying that no big guys will be involved in helping
NWBO during the next 3-5 years? It is a pipe dream to
believe that for the coming 3-5 years, NWBO will continue
to be ignored by the big guys.
I partially disagree JTORENCE because from now on,
positive results will be obtained at a much accelerated
pace.
I am estimating 3-5 years before the routine administration
of Direct as a treatment for various solid cancers.
A great, insightful post Beartrap, and may very well constitute
the direction that will be utilized for the early elimination of
solid cancers and hopefully also for the treatment of various infections.
LC, agreed that one should never waive of the history. However,
one should also never waive of the future if there is strong evidence
that the future is most likely destined to be quite different than the past.
That evidence concerning a very bright future is already here, loud and clear.
Smokey, I am very much wishing that the planned radiation and chemotherapy
treatments will lead to your full recovery but I am also hopeful that if you need
any additional therapy, the appropriate Direct trial will already be available for you.
It is also quite possible that if you need further treatments, the appropriate,
APPROVED Direct therapy will already be available at that time.
HL, so far the NWBO promoting catalysts had an underwhelming
positive impact on the SP because they only included superb results
outlined in a Journal article and in many presentations, one MIA, and very recently,
one MAA submission, all of which were so far no match against desperate BPs that were
rightly sensing in DCVax, a mortal danger to their overmatched cancer fighting
technology. NWBO's losing battle so far is a logical consequence of an unequal battle
and the suppressed SP is not the fault of NWBO's management.
That is about to change because the upcoming MAA approvals, the preliminary
results of the combo trials and a successful lawsuit (if we are lucky), are inherently much
more potent catalysts and are therefore much more likely to overwhelm the defenses of
the entrenched obsolete methodologies and their financial promoters.
NWBO will not have to highlight the importance of the upcoming catalysts because
those catalysts will be able to highlight themselves with a consequential positive impact
on the SP.
HL, isn't it possible that a MTD that may not be so far away, could
shorten BP's foot dragging time in that it may greatly increase NWBO's
future financial prospects and bargaining position?
How would this scenario fit in with a BP partnership?
I agree ATL; Those are most probably 4 good reasons why the Specials / Compassionate
program has been very important in developing the therapeutic potential of DCVax-L
yet has not to date been translated as a money maker for the company.
IMO, solidifying the therapeutic and manufacturing (EDEN/Flaskworks)
capabilities of the vaccine in the long run, is far more important than gaining a
few bucks in the short run.
Unfortunately many on this MB are shortsighted (IMO) and claim that the fact that the
10Qs have not yet displayed a hefty Specials-derived monetary gain, is proof
of the inadequacies of NWBO's management. Nothing can be further from the truth.
[quoteDoc logic, in my opinion, the £25,000 per dose cost for the DCVax-L vaccine, is done by NWBio to primarily accommodate Specials / Compassionate Use patients who are having to pay for the vaccine out-of-pocket][/quote]
Could not this explain why we did not yet see any windfalls from the Specials / Compassionate program?
[quoteHey Linda P!!!
Are you submitting MAA application this week and get PR out?][/quote]
Oh, I m sorry; I forgot that it is now the publisher's responsibility to send
the application to the MHRA. Please accept my apologies Linda P., how silly
of me.
Than please tell us Winston, how it works.
Substantial material surfacing after submission that may counter the
expected short attacks may include:
1. Denial of the MTD.
2. Publication of the "Nature" article.
3. Update of Combo Trial results.
Don't know if those 3 will be sufficient to seriously blunt the
short attacks that may plague us between submission and MHRA
approval but all we can do is hope.
Not selling any shares between submission and approval,
NO MATTER WHAT.
Better a lately created productive handle than
an early created destructive monkey wrench.
I understand Doc but another few days or even a few weeks of delay
are not at this time a reflection of the companies abilities especially since
it is now in the hands of the publisher. If it was again a question of months
of delays, I would fault the company but at this time I will give them at least
a few weeks of the benefit of doubt.
My bet expressed by my buying plenty of shares yesterday and not
buy a posing or not posting bet. If I recall, Dan posted yesterday a 33K
buy so together we bought north of 125K which must have been a good
chunk of the shares bought that day.
I guess I have more guts in buying NWBO shares than in a post or no
post bet that is dependent on a submission time.
Absolutely right GermanCol but let's look carefully at lessons to be learned
from No. 2.
Thanks Starric. Unfortunately Maccari et al's GBM review article is seriously
deficient in its coverage of DCVax-L.
It gave the reader a very rough and limited overview of the 2018 JTM
results and made no mention at all of the 2022 JAMA article. Needless to
say, the absence of any results and discussions of the JAMA article
or the UCLA combo trials, render this review article useless for yours
truly because the data known to date about DCVax-L has simply not been
presented.
I am guessing Flipper, that once the PR is out, DI will be allowed to
tell you the date on which the MAA was submitted.
Anyway I am guessing that there is a better than 50/50 chance that
both the MAA submission and PR will occur during this month.
Nothing is for certain except that there are 39 days between
November 22 and December 31 and in my book that is a time span
that exceeds "several weeks".
I may of course be wrong (until now usually have been) but I have the
feeling that this time finally, NWBO believes and has signaled that the
submission will still occur during this year.
I totally agree Alphapuppy that we are dealing with political forces
that have been forever trying to sink NWBO's ship but remember that NWBO
is starting with UK's MHRA and that regulator is most likely much less
willing to be bent by BP and regulators outside its jurisdiction.
Success in the UK could be a powerful tool that may very well
counteract the forces that would like to prevent the worldwide
introduction of this new vaccine technology.
I would like to know alphapuppy, why the the phase 3 results as
presented in JAMA and elsewhere are not good enough for an
approval request from the regulators and are instead in need of
conformation from combo trial results?
If that were true and the trial results were borderline good or displayed
some serious deficiencies in terms of some suspicion of cherry picking in
selection of patients, I would go along with the suggestion of running a
confirmatory trial or waiting for the results of an existing combo trial.
However, in this trial, there was no statistically significant differences between
the mOS of the trial's unmethylated GBM treatment patients and the mOS of the
ECAs counterpart (therefore no cherry picking happened here), while the mOS
of the trial's methylated GBM treatment patients was about 9 months longer than
the mOS of the methylated GBM patients of the ECAs. Rather impressive.
Also, although the group that ended up with 92 placebos included 29 permanent
placebos who per Dr. Liau had a dismal mOS, the mOS of the entire trial of 331
patients (including 232 treatment patients) had an mOS which was 0.8 months
longer than the mOS of the group of 232 treatment patients. That means that
despite including 29 permanent placebos whose average mOS was short, with
only 64 crossover patients, the mOS of the entire trial of 331 patients was increased
from 19.3 to the 20.1 months mOS of the entire trial (331 patients).
We can assume that when taken together, the combined mOS of the 232 treatment
patients and 29 permanent placebos (261 patients) would have ended up somewhat
below the 19.3 months post randomization of the 232 treatment patients. That those 64
crossovers were able to lift the mOS of 261 patients from below 19.3 months to
20.1 months, suggests that the mOS of the 64 crossovers could have exceeded
24 months. That would be a very impressive mOS for those crossover patients.
Of course we do not know whether those 64 crossovers benefited from a greater
proportion of methylated GBM patients than were present in the rest of the trial
but if that was not the case, the impressively long mOS of those 64 should also
be taken in consideration by the regulators.
[quoteNWBO instead flips between the cone of silence and overly precise.[/quote]
I can also finally agree with you on that one.
Absolutely correct Pgsd. Their whole enterprise is riddled with misinformation,
deletions and distortions. With the impending MHRA approval a number of
months away, this may be a desperate effort to delay a subsequent FDA approval.
In my opinion their efforts won't work.
AEK, As far as I know, the 3 major errors found to date in Reardon's
review article (Chen et al.) have only been presented here in separate posts.
1. The first error was the reviewers' claim that the mOS of the
entire trial of 331 patients was almost 4 months longer than the mOS
of the 232 patients in the treatment group when in fact the mOS of the entire
trial was only about 0.8 months longer than the mOS of the treatment
group; This error was committed because the reviewers were apparently
unaware of the fact that the mOS of all 331 patients in the trial was measured
from surgery whereas the mOS of the 232 treatment patients was measured
from randomization.
2. The second error is described in the post I am replying to (your post) and
that error stated that 90% of the 99 patient placebo group crossed over after
disease progression when in fact only 64 of those 99 did so.
3. The third error found by Senti deals with the review's claim that no
information concerning the IDH1 mutant status was presented in the trial
results when in fact that data was presented. It was reported that very few
(about 7?) GBM patients did carry that mutation.
4. In my opinion, the fourth reviewer error was the fact that Chen et al.
had the nerve to actually publish their blatant lies.
NWBO can and will shortly submit its MAA to the MHRA and
the subsequent MAA approval will constitute a stinging rebuttal
of the Neuro--Oncology hit piece.
ATL, you are right that a third error was uncovered by Sentiment
Stocks that demonstrated that Chen et al. falsely claimed that
the JAMA scientists failed to report the incidence of
IDH mutations and who knows whether even additional careful reading
of that garbage would perhaps uncover additional unforced review
errors.
I strongly believe that given enough time, this article will represent
a debacle and a low point for SNO and its editorial board. It is one
thing for scientists to occasionally make mistakes while tackling
results whose interpretation presents difficult challenges. It is
very different when lay people on a message board have no trouble
in identifying a number of blatant errors in a scientific review article.
Good point Arby. While I have trouble believing that this pathetic,
misinformation loaded Chen/Reardon/Ling/Chiocca hit piece will
be able to suppress the SP in the interval between MAA submission
and MHRA approval, I realize that nowadays a large proportion of the
investing public can be swayed by outrageous misinformation and lies
and can be persuaded by such hit pieces.
OTOH, don't the perpetrators realize that their insidious efforts will
not succeed in stopping DCVax's approval and once this happens,
they will end up with egg (and more) on their faces?
[quoteAre you saying it was a monumental error to accept what LL said?][/quote]
I vaguely remember that Dr. Liau did state at some point (erroneously)
that 90% of the placebos crossed over but that apparently was a verbal
error which may or may not have been corrected but is far less important
than an error in Ethan Chen's printed review article which unless retracted
will continue to convey wrong facts to the readers.
It is possible that Chen et al., instead of checking the trial they were
reviewing, simply introduced Dr. Liau's verbal error into their review
and that in itself would constitute a sloppy piece of work.