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flipper44,
Taking a look at the big picture well ahead of time and using some common sense based on the need for a realistic path for massive growth in demand helps too; ). Manufacturing, manufacturing, manufacturing. Those 17 missing SOC/placebo patients turns out to have been a huge clue that even Les could not completely cover up. Then the issues of hiring sufficient qualified personnel timely and the product release complications helped point out the need even more as did Dr. Keyoumars Ashkan’s comments about favorable pricing so that all of his patients could have access. That same pricing concern would be on the minds of any other company thinking about combo reimbursement hence the wait for Flaskworks answers. Best wishes.
lefty49,
This is in the regulator’s hands now so timing of a decision is such that it’s reasonable to assume something major will be known in a time frame that includes two months on either side of July and an outside chance between now and then. I believe the UK sees this as an opportunity to lead and will do all they can to move expeditiously. It’s been a long haul but this is finally the realistic year for news and perhaps from more than one regulator. Best wishes.
manibiotech,
Those who understand the science understand the enthusiasm. They also understand the reason why there has been so much ill will and vitriol expressed against this company while they have worked tirelessly to bring this platform from research into clinical practice for the sake of patients while still being held mostly by long term investors. It’s called the threat of extreme wealth transfer. Not there yet but the threat still exists and it comes against producers of chemo, radiation and immunotherapies that are less important than L and Direct on the pathway to a cure. A cure, however, is not in the financial interests of big pharma or their supporters as it puts an end to a great amount of their current revenue. A pathway to a cure is, however, a little bit exciting to investors and patients motivated to support the effort to find one. Best wishes.
theorysuit,
You are the one being scorned by MHRA because the Specials program offers promising unproven treatments to those who can find a way to afford them precisely because it is ethical to do so and that includes DCVax-L. Not only are they offering this but the leading neuro oncologist in the UK is on record as stating that he wants this L treatment for all of his patients.
Now who to believe… hmmm… theorysuit the crass anonymous message board poster with obvious animosity towards NWBO investors who won’t part easily with their shares or the highly respected Dr. Keyoumars Ashkan, Dr. Linda Liau and others who support getting this treatment to patients ASAP?; ). I think I’ll go with those well known doctors who actually want and KNOW what’s best for their patients vs the anonymous poster who only bad mouths the 28 year effort by a company and those working with them to bring a potential pathway for a cure to various solid tumor cancers and beyond to the forefront of clinical practice. Very easy choice at this poker table forum; ). Best wishes.
skitahoe,
Both flipper44 and I agreed that ICT-107 should have been approved for a subset of patients. No go and those patients were left without something that was likely to help with their particular situation because of it. The limited approval may not have been able to make the company lots of money but at least some patients would have started having the opportunity for better outcomes. This is the same line of thinking that limited access to experimental treatments like L, where safety is not a concern, should be made available at a regulated price equal to about 50% of the cost of SOC and paid for with set asides for such treatments and patient funds based on reasonable ability to pay. Best wishes.
iclight,
My post was in regard to macrophage interference with immune response and how that is related to L’s need for help but Direct, properly administered, needs none. This topic is definitely related to both treatments and once again demonstrates your lack of understanding the science. You need to stick to the script.
L is the weaker version on purpose with regard to immune response within the brain where swelling is an issue. Controlled immune response is essential with this treatment alone. Now if you want to add something that shrinks the tumor but has not proven itself able to eradicate it then great, if it is safe and there is synergy. The goal is still to eradicate the cancer not just shrink tumors for a while.
It’s also important to use a control arm that does not have an active treatment being used which at least two non L trials had to consider as having had happened and which NWBO was basically placed into the situation of with crossover being offered to patients and regulator desire for this to happen. Turns out that was best for the patients but made the trial more difficult to get adequate measures for treatment effect but is allowed for and has been in the exceptions to adequate and well controlled trials as something to be done before unblinding. Best wishes.
abc1212,
I challenged Steven Giardino to demonstrate the importance of macrophage interference years ago and how Direct overcomes it. Nothing from him or any other bears. The science wins the day in the long run and at least some big pharma execs and researchers knows this. Their hedgie friends might have some understanding of this from them as well. Direct Phase 1 provided a wealth of confirmatory information even with regard to L and its limitations. Best wishes.
Astavakra,
Very likely correct. Regulators can choose to expand into other indications, though, if convinced that evidence supporting such a move is warranted. Best wishes.
TTsr,
Did you notice that Inquirig accused Nemesis18 of losing money here. Sure looks like there won’t be any problem for Cohen to find a whistleblower with this kind of dissension going on ; ). Best wishes.
manibiotech,
Once suspicions arise and a target identified the tracking is doable on that target over time. It happens and is not unlike what Homeland Security does.
The fire at Bartlett IL is probably more about actual trades and dates and how that might relate to naked shorting. Best wishes.
Margin Buu,
Older rGBM patients responded better than many in the Phase 3 trial and most probably had reduced or no chemo. This observation supports your conclusion about this particular rGBM situation to the extent that it should be a strong consideration for clinical guidance of the patient. Best wishes.
Inquirig,
Still having trouble with that ignore feature?; ). You have said you would correct any lie on multiple occasions to different posters yet here you are still replying to my posts after saying you were going to put me on ignore even after claiming that the ignore feature was evidently too difficult for you to employ when you didn’t. When it comes to integrity it seems to me that where there is smoke there is fire and yet you say you are here to protect investors? Very obviously not believable so would you like to come clean and tell us why you are you really here?; ). My guess is that would be too much for you to handle but please, prove me wrong about this. Best wishes.
Single Stock,
What happens when those records are destroyed in a fire, especially a very suspicious one that was basically allowed to burn out because sprinkler systems were messed up then have everything that remained removed to a landfill quickly? Must they be stored in multiple locations for additional protection? Best wishes.
hyperopia,
This is exactly why manufacturing and cost limitations needed to be dealt with first because the awareness of what DCVax as a platform means to cancer patients because of being a safe and effective treatment will happen quickly once word gets out. Best wishes.
PS,
This comment of mine is what was basically stated in the article. There is no mention of complete responses yet just greatly reduced and stable and everyone knows that if given a chance cancer will come back. This is why immune memory is so important. Avastin has a much reduced initial response too but then the cancer returns. Controlling the cancer is good, especially for some company’s bottom line, but eliminating it needs to be the goal for patients. Best wishes.
JTORENCE,
Promising but needs more time to figure out longer term response and tweaks. Immune memory is the goal right? Best wishes.
Inquirig,
So first it was Optune seeing L as a threat and now it’s CAR-T? Who is NWBO you ask. Well NWBO is the one who brings cell therapy to the masses at an affordable price point and doesn’t cause a bunch of nasty side effects while it works to improve outcomes to the point of cure with immune memory for some now and many later with combos or Direct. So glad you asked!; ). Best wishes.
iclight,
Different mechanism of action. Direct causes pseudoprogression and then cell death that leads to necrosis. What was left behind in some cases was a completely dead tumor which was then surgically removed. Pseudoprogression caused treatment to be stopped leading to incomplete immune response in many as well. Two versions, three different dose levels, deliberate improper spacing of treatments and only one tumor injected kept this “first in man” approach from being throughly effective as well.
What was learned has created an improved Direct treatment regimen that is extremely effective but would have faced many of the same product release hurdles that L has faced but now is ready to rock and roll as soon as L is approved and the next steps are financially feasible. Your work here is almost done; ). Best wishes.
skitahoe,
Probably not. More likely resected tumor from those outside this trial that is donated or claimed for use in research with patient consent. Best wishes.
exwannabe,
I agree!; ). The question becomes does approval bring a partner or will NWBO just do another trial with Poly ICLC without checkpoint inhibitor to prove their independent value. Do you really think big pharmas are preparing to just roll the dice after word gets out?; ). I don’t think they want to take that gamble after playing their hand as long as they could without NWBO getting the limelight. Best wishes.
RobotDroid,
Not true. Sojourner55 clearly showed a chart pointing to the possibility of going lower towards $.40 before a full turn around. The hope for an earlier turn around always depends on the expected news cycle. Any potential additional financing before good news, other than as currently done, will help take the price down faster as will continued silence afterwards. The only price sustaining news will be approval or partnership. Best wishes.
dennisdave,
The first half inspections will likely include inspections for Flaskworks too so artisan can be approved separately and first prior to the time Hoffman points to as prerequisite first half inspections before any advance. They may be doing side by side submissions with regard to manufacturing with artisan already prepared for inspections and Flaskworks expected to be ready soon once fitted out. Best wishes.
alphapuppy,
Who “owns” the big media outlets by their personal contacts and advertising money? NWBO does not have replacement advertising dollars headed their way yet so do you really think big media will bite the hand that feeds them?; ). When approval is announced and then a partnership, that will allow a freer flow of news. Best wishes.
manibiotech,
Prior to submission all kinds of things can interfere with submission time lines. Once in regulator hands the time frames are tighter even if not always perfectly timely. Less wild guessing. Best wishes.
GermanCol,
I am just glad you made the effort in spite of feeling limited by language. Believe me, I understood you much better than the translation program used in 2015 for the PR about the hold understood “screening hold” in translating from German to English; ). Best wishes.
Sir Pumpernickel,
Thanks for the cheering section but I really don’t deserve it and am truly humbled that both you and Inquirig are devout members now ; ). Best wishes.
exwannabe,
What I stated about missing data is obvious and is well explained by what would have been expected to occur with late pseudoprogression or any other reason for crossover by SOC without true progression first. The reason for regulators deliberately lowering the powering of this trial by pressing NWBO to leave out 17 SOC/placebo patients while all treatment patients were enrolled is also obvious when taking into account that all those or almost all missing were from Germany, you know, the ones who don’t like experimentation with known lesser treatments on their people (ie Fraunhofer’s claim that enrollment occurred to the point statistically necessary). By the way, low absolute lymphocyte count patients enrolled in SOC/placebo only in Germany would not have done very well compared to those enrolled in the treatment arm as those low ALC patients typically event much sooner. Data showed that some low ALC patients were among the longer lived patients. That is a discrepancy that likely showed up quickly.
Just because you don’t like the way this data has been handled or the way the trial was set up does not mean that the trial was set up, or other actions taken, without the best possible outcomes for patients clearly in mind. The set up in this trial clearly helped as many patients as possible benefit as the long tail in GBM and rGBM data clearly shows in peer reviewed data, methods and conclusions. Best wishes.
exwannabe,
With L, MHRA can leverage their connection to the Specials program and MIA granted based on use of L. They also know that product release issues, based on standards more stringent than FDA requires, have been and will be adequately addressed by digitization and Flaskworks advances in preparation for ramp up. Bottom line, it’s a big submission but mostly well understood by the regulator who has been walking lockstep with Advent and NWBO for years. Best wishes.
GermanCol,
I appreciate your effort at this because as you know, I once suggested that there might have been a stealth crossover by SOC to treatment which would have had to remain very quiet. Lykiri assured me this did not happen so your analysis of the sensors kind of hits home with me about what might have really happened. Bottom line is that some patients were purposely left out of all of the published data and analysis to date and more of an explanation is to be expected at some point. Again, I appreciate your attempt to interpret this. Best wishes.
manibiotech,
I know you have been frustrated in the past with the way things have gone down with this ticker but “the process” is just so slow and it’s so much worse for all things novel like this manufacturing, transport and administration after proper thawing. This is one reason why I said from the beginning that I was going to be in to the end because I would love to see L and Direct methods combined at some point if Direct can’t be modified enough on its own in some cases. That becomes possible if not probable when L gets approved ; ). Best wishes.
flipper44,
All great points and not disagreeing. I personally like the odds for a shortened time frame but that is NOT the guidance management gave us so I will not begrudge anyone who supports the idea of backing what management stated they expected. Hope is not the same as hype and I hope as you do that this gets an approval sooner rather than later for the very reasons you listed. Patients need and deserve the best effort possible with this. Best wishes.
ATLnsider,
The big consideration isn’t the cost of the treatment per se, I believe it’s the additive up front cost to SOC that needs to be addressed by those who know this will quickly be ramping up into other indications. The need to control costs when it does will likely impact the perceived relative importance for chemo and radiation in all of these indications. Temodar will likely not be SOC for unmethylated GBM and other indications where it provides no benefit and in older patients where lower dose or elimination of it led to better results with DCVax-L. NICE will want MHRA to adjust SOC according to actual benefit as soon as possible once L usage ramp up begins in earnest. Patients will also experience a better quality of life with these adjustments so I expect a balancing act begin to play out between the old SOC and new SOC being established once L is approved as this will help mitigate the impact of additional up front costs created by treatment with L. Best wishes.
meirluc,
No one hoping for a shorter time frame is pumping anything. There is no volume to support that claim of pumping and that is what market makers have the advantage with when they “make the market” and perhaps use social media to their advantage when creating direction by volume.
The reality, though, is that the 150 day process also has a potential 60 day clock off period added on to this time line and NWBO stated they expected this clock off period to occur. We can all hope that this does not happen but guidance given suggests it will.
Anyone defending management’s guidance on this issue should not be viewed as creating some kind of negative vibe for that. There are plenty of other things that can be found and pointed out in some cases but this definitely should not be one of them. I don’t even see the mention of boiler plate cautions as a problem because they should be discussed and longs can easily demonstrate the history of this company getting past all of those concerns for new investors when they respond to them when posed. Best wishes.
meirluc,
First of all I believe the patients that had dismal OS were the ones who declined rapidly and never crossed over or had second resections and did more poorly on crossover than those that did not. I believe these groups skewed mOS downward but that late pseudos that received treatment and were likely sensors pushed it back up again as did the true progression patients that crossed over as the data we have seen indicates. Dr. Linda Liau would be careful not to comment about data that could not be included in the final analysis and late pseudo crossovers are part of those not included in my opinion. I do believe early progressors could have been part of the data if late pseudos had never received DCVax-L before true progression. As it stands, both groups had to be eliminated so as not to skew the data from those that could be given a fair comparison with ECAs. I believe GermanCol made a good attempt to get the numbers figured out with what there is to work with. Best wishes.
Nemesis18,
Your “considered opinion” leaves out way too much consideration. This is why you are not taken very seriously. You do not consider what patient advocate groups want nor do you consider data from additional trials indicating that combos and adjuvants are known to significantly increase survival. You don’t consider data gathered from compassionate use or other arms of the original trial. You also ignore regulator intervention that kept out 17 SOC/placebo patients that lowered the powering of this trial and the fact that Fraunhaufer stated that the trial was enrolled to the point statistically necessary.
Bottom line is that you ignore what has been learned to improve outcomes beyond the limitations of this trial while this trial was in process. Regulators will be looking at that too because the outside data indicates that there will be benefit for many more patients than those that showed the best improvement in this trial. Ancillary evidence IS CONSIDERED by regulators even if not by you.
Any suggestion that most GBM and rGBM patients will not have access granted to L by MHRA after they approved manufacturing based on it and based the approval of the PIP (the proposed pediatric trial) on the existing trial SAP without limiting the patient population in the way you suggest is a huge stretch that points strongly to a biased viewpoint. You might want to reconsider your “considered opinion”; ). Best wishes.
Smokey21,
Praying for the victory over that cancer we all know is possible and Godspeed for your recovery. Blessings and best wishes.
TTsr,
Notice his AI picks up on common historical language related to DCVax. We all know about Linda’s “stay tuned” mantra and how often that has been repeated. Then there is the idea of a new day, dawning of a new era or the AI version of “new dawn”. “Future of oncology” has also been repeated often as has “groundbreaking” which is not unlike “sod busting”. The newer term used is “franchise” which is used here as well as has “beacon of hope”.
AI is headed towards being Cliff notes on steroids but with the ability to create and disseminate vast amounts of disinformation as well. Best wishes.
sentiment_stocks,
No I do not think that is what he is trying to convey. He is saying that those who were SOC/placebo and had late pseudoprogression from chemo/rad that were then crossed over to DCVax-L treatment actually became unusable for comparative purposes. This is because they essentially became delayed treatment arm patients and no longer fit early treatment protocol or SOC/placebo true progression crossover protocol. This is why GermanCol believes all sensors ended up coming from the SOC/placebo group of 35 not utilized in the NYAS or JAMA Oncology data for rGBM comparison. Best wishes.
flipper44,
Understood. My point being timing not just targets. Cohen could be waiting on the possibility of potential news before submitting is all. Best wishes.
exwannabe,
The 80 day first phase of MHRA review is either done or about to be. Maybe NWBO will be advised soon about what comes next and a more strategic move can be made from there. Defendants have been buying time while Cohen and NWBO are working to be strategic with timing ; ). Seems obvious that the right timing of news creates more attention. Best wishes.