Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
[quotI'm not shocked, because this is NWBO and Linda Powers we're talking about. Completely dysfunctional. However:e][/quote]
NWBO's PR on August 29 informed us that they intend to submit the MAA within approximately 30-45 days
but that PR never confirmed that they will actually PR that submission nor its acceptance.
While I am still hopeful that they will PR the submission or at least the acceptance sometimes this month,
I am also considering the possibility that perhaps the submission already took place or will shortly take
place and that we will only receive a PR of MAA approval sometimes thereafter, in the NOT TOO DISTANT FUTURE.
Newman, don't you mean that 97% of the submitted MAA applications have been accepted within 14 days?
Thank you Flipper for the clarification.
Good point Doc logic. Yes , it could have included patients on a cost basis or nearly
so as to keep Advent going. Then those almost 800 patients should have been identified
by LG as COMPASSIONATE+SEMICOMPASSIONATE patients.
AEK, are you considering the 331 patients in the trial as compassionate
DCVax-L recipients? I am not sure at all that they belong in that
category.
I wonder if many free of charge treatments have been dispensed in the UK
via the Flaskworks/Eden system and that of course would also help to
validate the efficacy of that automated system.
I hope Gary that by the time the next J New Year arrives, the NWBO story will
have undergone an immensely successful development.
Wishing you and all other members of the tribe a Shana Tova and ten days later
a gmar khatima tova.
ILT, I'm with you on that.
While rejection of the MTD may not move the SP needle in the near future, it most likely
will lead to a settlement or a verdict that will force the criminals to pay up which then
most likely will move that needle.
BETTER LATE THAN NEVER.
Thank you Doc Logic for your input. I hope that you are right and from now on
the shorts are not going to be the dominant controllers of the SP trends.
Like many on this MB, I am also waiting for MHRA approval by the end of this
year and hoping that Flaskworks/Eden will be added to the mix in very short order.
Georgebailey-I am not thinking of a May 10 repetition but rather of mini attacks that continue
for days and weeks after reception of good news.
For example, we just received the notice that NWBO is going to submit the MAA application within 30-45
days and therefore the SP rose to 61.5 cents within two days but one day thereafter (today) it lost
about 4 cents. I expect those attacks to continue until submission of the MAA application at which point the
SP will recover somewhat.
Thereafter the shorts will again be busy until the acceptance of the MAA application and after a brief and
limited SP recovery the attacks will continue until the MAA is finally issued by the MHRA.
I am hoping that I am wrong but given NWBO's history, the above seems to me to be a logical scenario.
Attilah, I am guessing that the attacks on the SP will not undergo a significant
reduction with the pending news of MAA submission but will continue to pester
us until MHRA approval.
You are right JD that 0.375 is really bad but better to have this low SP postponed to 5 months
after reception of the MIA and a few months before obtaining the MAA than to have that happen
5 months before the MIA and approximately 12 months before the MAA.
The difference is that now we may only have to wait a few months for a turnaround instead of about
12 months. Cutting 10 months of dilution time is a pretty big deal.
Ex, the best that BP can do now is to run combo trials together with NWBO.
LP would not commit herself in a 10-Q to indicate that NWBO is
having discussions with BP about the possibility of collaborating in combo
trials unless the probability of that happening is very high.
I believe that having made forecasting mistakes in the past, LP has now
immunized herself against forecasting premature events. Furthermore,
NWBO's success in the phase 3 trial and the preliminary success of the UCLA combo
trials suggest to me that BP should take its collaboration with NWBO, very seriously.
Very well said Chiugray. A great rebuttal of the arguments that the shorts
have been promoting.
Can we really believe that BP is not taking NWBO seriously and that NWBO
has not prepared itself for the present attack on the SP? Can we believe that
NWBO has been hiding something, namely the fact that they may not be able
to submit the MAA application this year and may therefore face the possibility
of bankruptcy? My answer to the above is NO.
Somehow my instincts tell me that NWBO is fortunate in that it is better prepared
than we (the long shareholders) to tackle the ever lower SP. However, I hope that we
too are able to maintain some fortitude.
[quoteHe said they are doing the final checks on the application for UK.][/quote]
Thank you Guzzi62 for posting LG's recent statement. However, LG's "final checks on the
application" may mean that they are at the beginning of the second pass review of the MAA submission,
at the end of that review or somewhere in between. Those differences may translate into weeks or even a
few months with respect to when we will receive word that the application submission is a finally a reality.
Why after the new budget year starts or alternatively before September 15?
Is there any connection between those two periods?
Thank you Doc Logic. Come to think of it, some time ago I did see on this MB a
reference to such LG's hints on the BB show but did not know what to make of it.
I hope that NWBO is getting ready to send the application soon. I will be
disappointed if this does not happen by the end of September.
Doc Logic, please refresh my memory as to why it is probable that the second pass of the 1.7 M pages of the MAA application has
probably been completed or about to be completed. I gathered from the most recent 10-Q, that the outside consultants were helping NWBO
with the preparation of the MAA application and are no longer working on the pre-requisites for the application but that does not tell me that the
second pass has been completed or about to be completed nor does it explain what else has to be done before the application's submission.
If the second pass had been completed, I would guess that the MAA application will be submitted by the end of September but that is just a
(wild?) guess.
[quoteAs far as a full K/M curve, obviously NWBO elects not to present that data][/quote]
I believe that after approval, NWBO WILL PRESENT the OS data pertaining to the 29 permanent placebos and 64 crossover patients.
Together those 93 patients represent an "intend to crossover group" that was composed of the following two groups:
1. 29 patients most of whom were the fragile subgroup of the 93 and most of those 29, could no longer benefit from DCVax-L and
their OS was therefore shorter than the OS of the ECAs.
2. 64 patients of the 93 with an above average robustness who even had they not received DCVax-L after progression, would still have had a somewhat
longer OS than the ECAs. The DCVax-L that those 64 received after progression, gave most of those 64 even many more additional months of life.
3. Since the 29 who never received DCVax-L had initially a subpar robustness and the 64 crossovers represented an above average robust group,
the OS of the two groups when taken separately cannot be compared to the OS of the ECAs. However, taken together as an "intend to crossover
group" with an initial average robustness that is comparable to the average robustness of the ECAs, the OS of the 93 can be compared to the OS of
the ECAs,
4. Finally, I estimate that the mOS of the 93 "intend to crossover patients" had an mOS of 24(+) months, which is more than 7 months longer than the mOS of
the ECAs and that longer survival capacity is all due to the DCVax-L treatment of the 64 crossovers.
So please tell me PM what according to you has Advent with its ever additional staff been doing during Q2?
Apparently they have not worked on increasing their capabilities of preparing DCVax-L manually nor do you believe have they perfected their capacity to manufacture DCVax-L via the automated methodology.
The only success they had is to add many workers to their roster and according to LG, despite that additional help, the work (whatever that entails) has been backlogged.
That somehow does not sound like an enterprise that is headed by Mike Scott.
The absence of revenue was IMHO not due to the capacity being used for the combo trials. I am guessing that during Q2 the Advent capacity was used to produce DCVax-L vaccines manufactured by the automated Flaskworks/Eden method and those products were tested for efficacy, free of charge, on a number of patients.
Although treating patients who are willing and able to pay is important, in the long run, perfecting the capacity of the automated system and accelerating its approval is far more important and NWBO would never broadcast from the rooftops (in a 10-Q) that they were undertaking such tests because until they obtain all the pertinent results they will not give us any information.
And how is Flaskworks going to ever be validated if the DCVax-L it produces is not being tested as to its equivalence (superiority?) when compared to manually manufactured DCVax-L?
This type of validation is not revenue friendly because the vaccine produced via Flaskworks/Eden has not yet completed the tests and it would be unethical to charge patients for this treatment.
I cannot believe that by mentioning a backlog at Advent, LG was trying to convey that something negative was happening and in the absence of revenue, I can only come up with the hypothesis mentioned above. I also do not believe that LG has recently been using the Big Biz show as an opportunity to lie to shareholders. Instead, if I were LG, I would have made up for my inaccuracies in the past and would have used the opportunity to convey something accurately while leaving out material information; that is exactly what I suspect happened.
Perhaps the unfortunate absence of revenue (the recent 10-Q), combined strangely nevertheless with a recent backlog at Sawston (LG, Big Biz) and the Flaskworks Device as the Centerpiece of further expansion (the recent 10-Q), may together translate into the Flaskworks/Eden production method being tested for efficacy in numerous patients who are receiving the DCVax-L treatment free of charge.
Agreed Gary. I did say in that post that approval and other good news will catapult the SP in an upward direction. Maybe I should have said that approval by itself (in the UK) will do that. However, I am just wondering how much more time that will take.
The signs as presented in the recent Q suggest a great deal of optimism. It is NWBO's perception of time that I have trouble following, especially recently.
Doc Logic, while the news cycle has a tendency to pick up in September, we don't know whether it will apply to NWBO, a stock with excellent trial results but with long intervals between those results. OTOH, almost 5 months have gone by since the reception of the MIA and one would expect some news soon about submission/acceptance of the MAA.
We can only hope that the pattern of long intervals between results will now undergo a sharp reversal but I do not believe that the year's seasons will by themselves dictate the kinetics of such a reversal.
Thank you Gary. If acceptance of the MAA applications appear on the MHRA website, we will know that the application had been submitted a week or two earlier and then there will be no surprise for either shorts or longs and the shorts can then continue their attacks until approval of the MAA. At that point, the shorts will take a loss for a few days while the SP increases somewhat and then continue their attack to decrease the SP until final approval of the DCVax-L treatment. Finally, that approval and additional good news will most likely catapult the SP in an upward direction. l
Bottom line: for the foreseeable future, nothing great for many longs to look forward to until the final approval and beyond. Great for those longs with cash available to buy on the dips.
Hoffmann, how are they going to approve the Flaskworks system's efficacy without having documenting its equivalence (and hopefully its superiority to the manual system) by using it to treat a number of GBM patients?
I would not be surprised if Advent had been treating a number of patients that way and most likely those patients would have received the treatment free of charge.
Good point Hoffman. Perhaps there were more patients in Q2 who were treated under the specials program and the profit went to Advent and not to NWBO. Furthermore, isn't it possible that DCVax-L prepared via the Flaskworks/Eden method was utilized to treat patients who were exempt from payment because that automatic vaccine production method was still being tested and it would therefore be unethical to charge the patients? This would be a logical way to test the efficacy of the automatic methodology while treating patients at no charge IMHO.
Excellent analysis Thermo but I do have questions pertaining to the your last sentence which reads:
[quoteNorthwest Biotherapeutics Inc. v. Canaccord, et al. is going better than I would have expected. It’s possible the company will receive a large settlement that will minimize dilution][/quote]
1. What makes you believe that the Canaccord et al. law suit is going better than you had expected? Do you have some information or analysis that you are able to share?
2. I was hoping that winning the suit would gross no less than $500M with about let's say $325M (65%) being retained by NWBO and about $175M (35%) going to Cohen-Milstein (if the lawsuit gains are contingency based). A lawsuit gain for NWBO of about $325M or even considerably less should not only minimize dilution but postpone the need to do so for a very long time IMHO.
Are you then perhaps of the opinion that the lawsuit verdict will result in a much more modest gain for the company that may still require some additional dilution(s) within the next few years?
ILT, if there is one RA I believe is dedicated not to throw a roadblock in front of a company intending to bring a superb anti cancer treatment to the market, it is the MHRA. Therefore, the delay in submission of the MAA application to the MHRA may be due to supply chain problems, to other unrelated problems or simply that the MAA application's 2nd pass has not been completed.
Hopefully whatever is causing the hypothetical MAA submission delay, will soon be resolved. If not, at some point the company owes us an explanation.
Thank you ILT but are you not giving an example of drugs that have been approved some time ago and have been sold to customers ad lib until they ran into those delayed supply problems? The regulators cannot reverse approvals for drugs that have already received approval, have been sold to customers for a long time, and now have run into production and/or distribution problems.
The situation with DCVax-L is different because NWBO/Advent may have run into considerable supply chain/equipment delays even before they submitted their application for the MAA.
Thank you Doc for suggesting that CRL's cooperation could be utilized to solve some of the supply chain/equipment backlog problems. I certainly hope that NWBO has already for a long time been in contact with one of the companies that could diminish this problem (most likely CRL) and am wondering how long it will still take before the supply chain/equipment delay is no longer much of an issue. After all, this problem did not surface yesterday but has been apparent for a very long time.
It would have been encouraging if the recent 10-Q had stated how much progress has been made because as stated, the reader (e.g. yours truly) may get the impression that very little or nothing has yet been accomplished and could even deduce that the MAA application is on hold until sufficient progress is made to solve those problems.
Alternatively the Q could have stated that while those problems may somewhat limit vaccine production rates in the near future, it will not delay MAA submission because within a reasonable period of time, the supply chain problem will be gradually resolved. Unfortunately the Q did not contain such a clarification and we may wonder whether a robust resolution plan has or has not already been set into motion.
Fliiper, don't let ridiculous accusations deter you from submitting your valuable/informative posts.
Doc, completing the 2nd or even 3rd pass on the submission document would not help to speed up the resolution of the supply chain and equipment backlog issues. Since those problems have been festering over such a long period of time, what makes one think that they will be resolved over the next few months? In fact, if MAA/BLA submission depends on resolution of those supply chain/equipment backlog problems what would be the reason for hurrying to complete the first and second pass before those problems are resolved.
STILL VERY BULLISH BUT INCEASINGLY FRUSTRATED