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dennisdave,
Nope!; ). Approval brings attention and interest that can be responded to. Approval allows patients to access set aside funds in the UK immediately. Approval allows Linda to talk about a PLATFORM treatment that initially can be considered for study and off label use in all solid tumor tumors. Approval gets investors talking about partnerships and implications regarding impact on valuations of competitors and potential partners including on companies that they are invested in already. Approval brings steadily rising interest and share price as new investors go through their own learning curves and market makers will no longer be able to control the flow of information by controlling the price as much as they have in the past. Best wishes.
flipper44,
Realistic. We know what others are trying to do and time is what they play with. I am way more than willing to see time “run out” for those holding this down. Until that happens they will use it to their advantage. Weren’t there some folks looking for the new director to disclose his financial position in NWBO if necessary? If so, is the price stability happening so far today after the latest run related to that? Time will tell and Sojourner55’s chart showed the potential to continue to move into the lower $.40s before the breakout. We’ll likely know more about direction from here by Tuesday. Best wishes.
Sojourner55,
The price is also bumping up against waterboarded baseline uptrend from March/April 2020 which MMs want it under to prevent any confidence in the appearance of and that’s currently between $.61-$.62. This puts the bull wedge, long term uptrend and MM desire to keep price low while we wait at odds with one another. MMs have had their way with the continuation of the bill wedge while we wait and dilution continues from converted warrants and C shares being sold. Delays with news may allow for the $.40s to be tested again unless someone starts doing some serious accumulating or covering out in the open. If there is a move to discovery in the court case my guess is that covering might begin in earnest and a breakout occurs. In my opinion it will be up to longs to prevent that from happening at lower prices than approval and other moves will take this to by year end. Best wishes.
meirluc,
The good thing is that there is already awareness of expected need. The next steps would be to secure public and or private funding and plans to build new leukopheresis centers. This requires a certain level of confidence that this is and will be economically feasible over time. This happens when able to forecast that nothing is coming along shortly to eliminate the need for these centers before becoming fully paid for (to create equity) and profitable. Those considerations will always be ongoing. Best wishes.
meirluc,
Front end centers are in short supply compared to expected demand being created. Also storage of leukopheresis material for L has been mostly or only with fresh, not frozen, material due to potential damage to cells unless I have missed an update. Matured cells like L do store well cryogenically. Best wishes.
KRISGO,
Single product company (for now) in process with submission review makes any accidental potential disclosures made publicly or privately a potentially big problem. Better to just stay away from any public forum and stay quiet during the regulatory review period. There will be plenty to talk about when it’s safer to do so without potential severe repercussions from a blunder. Best wishes.
flipper44,
If there is an accelerated pathway for Direct in India that would be a huge threat to all big pharmas including Merck. Closed system process is already available and product release standards may not be as strict in India as they are in the EU or UK even though these are the standards that NWBO and Advent have been living up to. Scale up there would be cost effective and rapid due to availability of qualified work force and motivation. The pressure on other regulators to move to tissue agnostic designation quickly would be potentially huge if India is already thinking along those lines with any accelerated pathway. Lots to think about and look in to. Best wishes.
sentiment_stocks,
I’d like to read it too. Not sure I would be able to add much as I have not dug into that trial too much but might get motivated to do so. Best wishes.
skitahoe,
The demand from just GBM and rGBM won’t be the issue. It’s the demand from other cell therapy trials and off label use that will create the pressure.
I don’t believe that a special center will be needed other than one able to manage fresh cells quickly and appropriately to be used based on L shipping and manufacturing standards. Best wishes.
flipper44,
Reading from last year about leukopheresis center capacity with regard to expected demand being created from cell therapy treatments. The availability is not supposed to catch up to demand for a few years. With each leukopheresis expected to take several hours and off label demand from cell therapy approvals expected to rise substantially while many new trials get under way, the then current availability was not up to speed yet for the coming change and not expected to be for at least two to three years based on then current expansion plans in development. I plan to look for an update around mid year to see if that outlook is changing. Best wishes.
XenaLives,
Hey, just wanted to check in to see how you are doing. You shared your story and experience with Cipro a number of years ago and was wondering how you are holding up. Awesome pic of the ringneck pheasant. Prayers and best wishes.
Inquirig,
And you know that elderly rGBM patients have lower rates of chemo or none at all if not able to tolerate it right?; ). Kind of a surprising mention to come out of the data that these folks with reduced or no chemo protocols were actually doing way better than expected. Guess you missed that part; ). Best wishes.
flipper44,
Closed system manufacturing for Direct has been around for years and improved upon by Flaskworks. Product release issues in the UK are mostly resolved with digitization and closed system manufacturing. Still need leuk centers and supply chain issues resolution confirmed before unbridled acceleration just by word of mouth demand alone once approval hits. Game changer platform with L and Direct separately or in combination. Best wishes.
biosectinvestor,
You don’t need to arrest someone to create a disincentive for promoting knowingly false narrative. Bad publicity, fines, shaming and loss of reputation from same are often times enough and something is better than nothing. No one must “know” in cases like this, rather just a preponderance of evidence is needed and in this case there is more than enough. Nuff said on my end. Last word is yours; ). Best wishes.
biosectinvestor,
If filing a false police report is actionable then filing a false agenda report by the media ought to be actionable when damages occur and there is a history of false reporting ie rebuke by head of DSMB. When “everyone literally knows what is going on…” and nothing is being done then that is a problem especially when financial harm is being done on an ongoing basis. I believe strongly in free speech and believe it should be protected. However, when that speech leads to unwarranted harm then there needs to be consequences/restitution that are not nearly impossible to enforce. There should be no protection for a deliberately biased or financially compensated “opinion” that is used to aid others in illegal activity or protect one’s own financial position and that is exactly what Citadel pointed to when mentioning Adam in their responses to the first complaint of spoofing against them.
Reworking the rules surrounding the use of short trades is needed to be sure but so is the ability to bring accountability to “free speech” because freedom isn’t free and freedoms abused and not corrected lead to great strife and division. See anything like that going on today? Best wishes.
biosectinvestor,
It’s not just that he gets it wrong, it’s the way he gets it wrong and “Adam..antly” insists in spite of the evidence, in spite of the warnings and rebuttals from even the head of a DSMB. The evidence points to collusive efforts being made to target certain companies and that evidence needs to be used to build a coherent case against the abuses that are currently being protected to the point that even those honest and bold enough to rebuke are forced into retractions. These kinds of abuses need to be called out and punished with laws changed to make sure this is not allowed to continue without due recourse for harm being done. Best wishes.
iclight,
Make your case and send it to JAMA Onclogy. We could all use a really, really good belly laugh while we wait for approval ; ). Best wishes.
iclight,
Show me their product that does what Edens does, is validated and in commercial scale production of an approved DC product. Best wishes.
Inquirig,
Lovo nor any of the others produce DCs with the proven ability to pass muster for GBM, rGBM or lower grade glioma commercial scale production so comparisons to these are completely faulty as is the false assumption that Flaskworks is “years away” from validation for commercial scale operations since Sawston is in the process of being fitted out with GMP compliant units even now.
Until your so called comparators can be utilized successfully with equivalence to that of a successfully validated product you will not be able to demonstrate where they are being successfully used in commercial scale operations for such purpose. Therefore, your comparisons, claims and assumptions are useless and very uninformed at the least. Best wishes.
tryn2,
Your broker might offer one. I check the broker price which is at least close to real time though of course does not include dark pool pricing which many OTC trades go to. Best wishes.
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.