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Inquirig,
So why would anyone buy a product that had no known time frame for completion of scalability due to manufacturing, product release and supply chain issues “a long time ago”?; ). You must be advocating for big pharma indeterminate period dead money investments. I am pretty certain they do not try to head in that direction except as a last gasp effort to stay relevant with the introduction of a game changing technology like the DCVax platform. Best wishes.
rick172,
Likely too early to make that call. Sojourner’s charts point to more time elapsing before complete turn around and are in line with a potential clock off period. Best to be prepared and positioned for early or later news. Best wishes.
manibiotech,
Yes, those remaining shares will need to be issued. However, as explained in the post you responded to, they won’t be made available to those who want to cover but rather to those who are strong longs who hold on thus forcing an increase in the value of their own shares because of those desiring to cover. Dilution will be seen by the market thus creating a counterintuitive investment opportunity for those who at least recognize if not understand the dynamics. Best wishes.
Nemesis18,
I explained this in another post in the not too distant past regarding a thread started by comments on GermanCol’s posts but since you asked I’ll point out the rational again.
First crossover design, asked for by FDA, was what was best for patients due to the invasive nature of the trial protocols which includes leukopheresis and the desire by patients to know that they would have access to the treatment created by their own cells and tumor tissue. Beyond this, the crossover insured that if treatment was actively working that a true SOC/placebo comparator would not be readily available due to this requirement. Remember that FDA was not working in a vacuum of evidence, they had Phase 1 data to look at before making their comments about how to set up the Phase 2 converted to Phase 3. When you add in the issue of SOC induced pseudoprogression where patients were crossed over to treatment prior to actually eventing they no longer could be a suitable comparator group because they never truly evented before receiving the treatment. Therefore, three groups eventually emerged from SOC/placebo. Those that never crossed over ( many supposedly very ill according to Dr. Linda Liau) those that crossed over due to SOC pseudoprogression without truly becoming a rGBM patient by actual event and the third group was those that truly PFS evented and crossed over to treatment. The problem has always been that treatment was expected to be active based on Phase 1 evidence and other so crossover created a likely active to active comparison more than active to true placebo.
Now you say why would regulators like FDA do this. Well, their guidance allowed for changes to be made by the company as long as they remained blinded if measures for treatment effect could be proven to be inadequate. The duration of the trial allowed the suspicion of pseudoprogression interference at the beginning of the change to the Phase 3 trial to become a well known and community wide accepted fact instead of just a suspicion. I believe both FDA, Dr. Linda Liau and NWBO knew this would happen and that led to the need for new treatment measures which are allowed under the exceptions to adequate and well controlled trials. In this case ECAs were independently developed and checked thoroughly for bias and endpoints were changed to OS so that both GBM treatment and rGBM treatment comparisons could be adequately if not perfectly made. The final “approval” of these measures does not come until FDA review although they also had to be “accepted” provisionally before a SAP would be utilized by a company for their analysis of data and submission of same to regulators under a formal review process for commercial manufacturing and sales of said product.
As far as regulatory examination, the regulators have had more than 15 years to look at all the data, properly guide and instruct and understand what NWBO, Dr. Linda Liau, Dr. Keyoumars Ashkan and others have signed off on and they will very likely use this example as a case study in future guidance resources because of the time taken to do everything as correctly as possible with the limitations that were always in play. Best wishes.
flipper44,
I do… on occasion; ). Some folks, not you, just NEED to be worn out 😂. Best wishes.
Nemesis18,
Regulators basically already agreed that early treatment is better for patients than late treatment because some early patients would have no chance to receive benefit if not treated early enough. Why do I suspect this so strongly?; ). Well maybe interference by regulators into this trial tells the story that couldn’t be told outright while additional data was being collected. Regulators interfere for safety issues or efficacy ie Fraunhofer stating that enrollment occurred to the point statistically necessary. No safety issues were found with regard to treatment but Germany does not allow experimentation on patients with known lesser treatments and regulators are responsible for making determinations along the way if issues arise. The DSMB is in charge of investigating safety issues and that includes looking through data that allows comparative eventing by one group or another if eventing appears to be more rapid than expected ie treatment induced
pseudoprogreession. The DSMB is allowed to unblind data to the point needed to make their safety determination which is why NWBO would not confirm or deny that an interim analysis had been done because they knew the DSMB had done one although the one NWBO saw was based on blinded data. What they saw led to the screening hold which led to all treatment patients being enrolled and 17 remaining SOC/placebo patients being left out. This is consistent with Germany’s laws about experimentation and Fraunhofer’s claim that the trial was enrolled to the point statistically necessary.
The issue has always been since then about manufacturing, adjustments needed to properly measure treatment effect, data analysis to determine the method of action by the treatment, identification of targets ie proteomics and long term data that creates a better picture of effect. The wealth of data and fitting out of novel manufacturing processes being developed and validated for mass commercial scale manufacturing pave the way for a highly detailed presentation of complex issues overcome by sufficient measures of treatment effect, manufacturing, handling and product release breakthroughs all described in the marketing application. You can’t stop that validation process from happening now but you can try to stop enthusiasm for what has already basically been initially but not finally affirmed by both regulators and JAMA Oncology. Best wishes.
learnincurve2020,
You need to read my post again!; ). Differences in manufacturing and process are not what is important. What is important is knowing the cell characteristics necessary for positive treatment effect and creating equivalence between processes. This is what makes the product “the same” and no one knows how they exactly compare but they must fall into the range within the patent applications for protection and equivalence. Exwannabe does not have the exact numbers from the data for either product and is asking readers to trust him. Dr. Linda Liau and Linda Powers do have those numbers and calls them the same. Exwannabe wants readers to trust him vs Dr. Linda Liau and others who actually know since almost none of his readers know how the products compare but are left to trust one group or another. It’s a confidence game you all are playing at the poker table where lives, not just money, are at stake. You have been and will continue to be called out; ). Best wishes.
Zadie420,
I know he knows; ). We have been going at it for many years. I respond to clarify for those who don’t. By the way Zadie, why do you think that according to the most recent complaint by NWBO and Laura Posner that spoofing increases when positive and perhaps explanatory posts are shared?; ). I’ll give everyone a hint. It’s a confidence game being played which is why I often compare biotech investing to playing poker because they both thrive on understanding odds and deception. Best wishes.
Investor082,
Partnership/franchise model perhaps. Buyout is too early and Linda has connections to get help with whatever comes next once the approval comes to create a risk off scenario for conservative business minded folks looking to invest into expansion. “If you build it they will come”- Field of Dreams ; )
Best wishes.
exwannabe,
ATL-DC is the experimental and L (murcidencel non proprietary name) is the commercial scale product that has passed equivalence studies along the way with manufacturing changes. You conveniently keep forgetting that you said anyone can make a DC vaccine and that is true including the one approved in India and Provenge. The question is who has the commercial scale needed and sufficient to optimum activation equivalence which includes DC chemokine and cytokine production characteristics. This and various forms of IP protection in place are what makes a product commercially viable and likely to be profitable. Differences in the process of making DCs is not what’s most important. What is important is that they turn out with the desired characteristics to adequately treat the targeted disease state and that is what makes ATL-DC and L the same and is something Dr. Linda Liau and others would know for sure based on actual data but not you. Best wishes.
Inquirig,
How does one do harm to an anonymous poster using an alias unless that alias has been linked to a real person and the comment causes harm to the real person? It’s like a fictional persona being called out then that persona being owned by a real person to create real harm.
Now if an investigation into illegal activity leads to a fictional character being linked to a paid or even unpaid real person posting in concert with others in order to do harm to a real entity then that might be a real problem; ). Best wishes.
tryn2,
Oncovir added value to themselves with patent protection extension and that also adds value to use with L and Direct. Let’s see what’s cooking in the next few months as we head into “The Zone” for major news and possible amplification from the lawsuit, journal articles, Flaskworks etc. Best wishes.
Investor082,
I suggest you take a really good look at Linda Powers bio. Now is not the time for M&A or she would have already looked into getting some extra help. She knows that stuff as well as probably the top 10% of all those firms in the field so when the time comes there will be the appropriate help. Franchise is the last key word used in regards to plans for near and mid term value driving growth. Best wishes.
Inquirig,
Bankruptcy?; ). Maybe you should ask someone at NVCR about when they plan to file chapter 11 or other. As for NWBO not even close to being in the cards. Really cheap shares right now while we wait? Sure, but not bankruptcy. That chicken flew the coop years ago. I think Chick-fil-A got that one so not coming back ; ). Best wishes.
tryn2,
Along this lines, would you want NWBO shares as part of the deal or big pharma cash?; ). Cash goes down in value with inflation while NWBO shares at current prices or even a little higher mushrooms into really big $$$. Hmmm… I think I would go for the gusto of the future of cancer treatment and with that play put the spoofers and their supporters into submission and all the rest of the cheaters and helpers on Wall Street, big pharma and in government on notice. Best wishes.
newman2021,
Isn’t that what mechanical engineers do?; ). Best wishes.
DJPele,
Possible but that first half note does not distinguish between artisan and Flaskworks which if in side by side presentations to MHRA could be the reason for stating this as they do while not hinting that L could be approved with artisan first without delay while moving Flaskworks into position for rapid approval afterwards. All depends on what has been agreed to. Best wishes.
Kgeo,
CHM is an advisory committee not unlike what FDA has. If and when overwhelming evidence and support are in play the CHM meeting may not really be needed as just another rubber stamp. If there are significant questions or potential delays due to certain issues then a CHM meeting might be employed to make a recommendation based on their perspective. This is a normal course of action for many approvals because of safety and risk factors. With this treatment being called a placebo by the basher/bears even they profess there is no real safety risk factors to consider hence the POTENTIAL to jump past CHM. This is not a guarantee by any stretch of the imagination but… this is a well understood treatment from all the external and internal evidence compiled over more than 20 plus years in at least 5 jurisdictions including Israel, Germany, UK, Canada and USA with India having their own version of L similar but just confirming patent protection for Direct. Can longs hear NWBO now?; ). Best wishes.
newman2021,
Correct. The irreparable harm for the company is not being able to supply product to more patients due to lack of ability to finance without more harm done to financial stability of the company. The harm to patients is loss of opportunity to extend life. The boiler plate ongoing concern and financials can always be turned to for proof of financial instability and the cost of financing vs during the time they had a backer like the Woodford Funds. That backing came before the Phase Five report and October 2015 bear raid as just one historic example of good news turned into bad, the explanation for which may come up at just the right time. Best wishes.
hankmanhub,
This is a civil case trial so while damages get figured out an injunction can cause breech of it to have logarithmically increasing fines imposed by the court for each episode irrespective of final damages award. Since defendants have already basically admitted to spoofing, placing an injunction kind of puts them in the old fashioned “stocks” designed for public humiliation for a while. Rotten tomatoes anyone?; ). Best wishes.
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.