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learningcurve2020,
I posted first on Seeking Alpha starting in 2012 stating that the science would win the day then here since 2016 and flipper44 was here before me. Not much come and go with us; ).
I started posting during a time when a relative had brain cancer so I was looking for clinical trials. That relative chose to be involved in Duke’s GBM trial which failed. No cross over to L was allowed when relapse occurred so that ended any chance to benefit from it at the time. Science and perseverance will win the day. Best wishes.
exwannabe,
That would be great if the tech preserves the DCs intact as well as or better than Flaskworks. Working with polarized vs non polarized cells can be a big challenge which Flaskworks overcame to the level needed for optimized results. I’m not sure the others have the same results. Linda pointed to the challenge as if others had not adequately addressed this with regard to what NWBO was looking for. Even little differences matter with signaling optimization. Best wishes.
learningcurve2020,
Science is what leads to being informed about logical next steps with the treatments. This is why I knew the spacing of treatments in Phase 1 Direct were too far apart which leads to greater checkpoint blockade interference. The set up was done sub optimally to prevent any potential aggressive autoimmune response. The company announced that the next trial would shorten the spacing after I shared comments about this so you see, it’s the science that informs before the company does!; ). Best wishes.
learningcurve2020,
Pretty simple really. The UK and EU have the most stringent cell therapy product release and transfer guidelines. Since L paved the way, Direct can follow and other jurisdictions will be less complicated. Direct and L are both DC products produced similarly but with different maturation stages. Everything about L pretty much transfers over to Direct so that the time to approval and patient access has a nearly perfectly clear path after L approval.
When Direct trials get cut short for efficacy and followed for long term benefit there will likely need to be a new measure put in place for reimbursement purposes and measure of long term benefit. Cure rates will need to be established over a longer time frame after patient access is granted because no patient should be held back from treatment or competitor be able to claim superiority based on lack of additional followup due to reimbursement rate needing to be established for patient access. Best wishes.
manibiotech,
I plan to be here for the ROI $ as well. Some things just take much longer and become bigger than initially expected.. by a lot. Getting L automated and digitized for speeding up product release has taken more than a decade and appears to have originally been planned for with a bigger gap between stages but reimbursement and capacity likely became sticking points that only manufacturing could solve. Now that plan is very loosely laid out with more details definitely expected upon approval.
Linda knows she and Les need to have the plan well spelled out in forward looking statements. They will also need to hold themselves to account for the time lines or she will take lots of heat and deservedly so at that point. She loosened up a little at the ASM with forward looking statements. After approval that will require much more explanation. Best wishes.
learningcurve2020,
Sorry if you couldn’t keep up. I do get in too much of a rush sometimes that leaves too many thoughts jammed together if I don’t review before sending. That is a well documented fault that I thank you for reminding me of so that I can be more careful next time; ). Best wishes.
Reefrad,
That is exactly the correct answer!; ). Until the breakthrough comes the burden of carrying the load and the perceived inequity of management gaining so many shares is rather obvious and can’t be ignored completely. However, when the breakthrough comes and the potential begins to be realized the retrospect view will see the burden as having been worth it and management motivated not to sell out cheap. Best wishes.
manibiotech,
Life and death decisions are being made by enforcement of “the process” and leaving patients no choice when they should have one. This is tantamount to homicide which some use “the process” to justify. However, when you run the numbers of patients who would be effectively cured if treated with L bs not being treated there is a problem with trying to justify “the process” when a new paradigm of safe and effective treatment has emerged. So yes, I use the word homicide because patients are being kept from life saving treatment because there are those justifying this based on upholding “the process” that keeps a significant group of patients from what would keep them alive because there are economic considerations.
You are certainly well aware of how automobile recalls are done based on cost of payouts vs cost of recall. It’s an economic decision by many companies based on the dollar value of lives impacted or lost. Regulators of drugs and other treatments are charged with first “do no harm” when considering new treatments and care of patients. That is a little different than what auto manufacturers and laws surrounding them are charged with so when I talk about regulators with regard to “the process” I am pointing out their accountability to this charge.
So think about a current example with checkpoint inhibitors trying to move from IV administration to subcutaneous administration. Both carry a risk of death from use but subcutaneous injection so far has demonstrated an increased risk of death from use compared to IV administration in the attempt to demonstrate non inferiority of treatment effect. In Germany, this attempt to protect patent rights likely would face a huge hurdle since the increased risk of death from sub cutaneous administration would be a major concern. The question facing BMY and their December padufa date is will FDA be as concerned. I wonder if patients think they should be. I know I would be if I was a patient especially if a regulator is supposed to protect me against anything that would do more harm than an existing treatment. L is better than current SOC and in some cases might actually be more effective without part or all of SOC and the harm that does without improved outcomes in some patient subtypes. Best wishes.
exwannabe,
Direct needed tech transfer and also has been improved upon which may require a new IND. in the mean time product release issues that will also affect Direct have been in process of being worked out both by NWBO and regulatory guidance. You know that NWBO wanted to include the Roswell Parks tech in the next iteration of Direct and that agreement has been worked on for the last 2 years. So you see, NWBO has been building up their relationship with MHRA through the Specials program which has provided substantial additional data from use of L outside the full parameters of the Phase 3 trial. That is going to help speed up all future trials and give MHRA a chance to really demonstrate leadership in a field that lays the groundwork for potentially all future cancer care treatment and beyond. Best wishes.
JTORENCE,
Very likely true about what the Chinese would have done. Best wishes.
manibiotech,
Your “all” is not my “many”. Putting the word all in quotations and attributing it to me is misquoting me. I do not speak for all, rather for myself, but I do agree with many who are here and I do appreciate all honest opinions whether I agree with them or not, including yours. Best wishes.
theorysuit,
The only bankruptcy in this picture is the morally bankrupt person making the accusation and anyone who thinks his way is the right way; ). Best wishes.
CaptainObvious,
Now we know we are good as gold!; ). Adam, Martin and Kenny, the trifecta!; ). Best wishes.
manibiotech,
Nope!; ). Just suggesting that what makes NWBO rather unique is that many share the belief that $ROI will follow the initial patient stories ROI. The idea of delayed gratification is lost on many these days and the carnage of instant gratification can be found in addictions, infidelity and the devaluation of human life amongst many others. The taking of human life should always be adjudicated to be justifiable or unjustifiable homicide based on common law. That responsibility has been abdicated for the sake of convenience in many cases and is bringing judgment on the land with it.
The same holds true for cancer patients not given greater access to DCVax-L or Direct or any other safe treatment like them. This is because of their clean safety profile and positive signal of effect known about for over 9 years that should have allowed greater access with set aside funds for those with otherwise terminal illness that would have liked the opportunity to help advance the treatment research and the chance to live longer based on signal of treatment effect. To not have this available because “the process” doesn’t allow it is the same type of thinking that would abdicate responsibility for adjudication of all homicides which is unconscionable and will bring judgment to bear. Some would calm this Karma. I call it judgment because of the unrequited innocent blood spilled in the land. Best wishes.
manibiotech,
ROI includes patient lives changed for the better. Others here share the same view. Best wishes.
Lykiri,
Deliberate ignorance is not really ignorance but rather something much more nefarious. Here’s to hoping that DOJ has some crusaders ready to rock and roll after discovery. Best wishes.
tryn2,
Compare how much the market makers and big pharma are making now in their last few years before L gets the recognition long deserved. With NWBO kept out of the news as a threat to the big pharma oncology drugs and market makers wanting to load up cheap before news, by having the price held down even paying $5,000,000,000 or more in fines and covering bad bets could be considered just the cost of doing business. Best wishes.
learningcurve2020,
Specials was never the answer, just a bridge to a chance to be part of the 13% for the time being. Bridge loans have been for emergency purposes only. Best wishes.
Lykiri,
Methinks learningcurve2020 isn’t here to learn but rather to accuse and mislead by under appreciation of NWBO accomplishments; ). Best wishes.
Lykiri,
Thanks so much for your continued patient advocacy and great due diligence. Blessings and best wishes.
learningcurve2020,
Maybe big pharma has more to lose financially than to gain by doing anything early with NWBO unless THEY are in control. Maybe Linda and educated longs don’t trust them or those who serve them who constantly bash the company and their supporters while manipulating the share price for years. Maybe Linda and staunch longs don’t appreciate the attempt to make them a target for bankruptcy or takeover so that THEY can be in control. Maybe patients are suffering mostly because of “the process” put in place by those defending the status quo and not because a small company does not have the structure or support needed to get the trials they would like to have done in place with anything close to a fair valuation of their platform tech.
Maybe watch It’s A Wonderful Life again and try to figure out which bank’s boss you are working for. Most everyone on this board has already figured it out and I’ll give you a hint, it’s not the one who has an angel helping him restore hope and faith in the midst of what seems to be a hopeless situation. Best wishes.
learningcurve2020,
Maybe being broke has something to do with no pediatric trial start too or maybe they don’t want to start until Poly ICLC can be involved. Feel free to get big pharma to do a combo sponsored trial that starts tomorrow; ). Best wishes.
learningcurve2020,
“Always better to wait it out so this ‘“Wonder drug”’ never gets to patients”- learningcurve2020
Spoken like a true big pharma rep or hedge fund buddy trying to keep their profits rolling in up to the last second. Best wishes.
learningcurve2020,
Maybe remind everyone on the board why the pediatric trial(s) don’t need to start yet?; ). Too painful for you to mention as regards your purpose for being here?; ). Best wishes.
Guzzi62,
Uncontrollable bidding war that Linda and stout major longs control the outcome of. They don’t want that because of the major consolidations that would need to take place because of this. Total market disruptor. Better to wait for rights to pieces being “franchised out”. Best wishes.
learningcurve2020,
How about you prove your own sincerity with regard to patient outcomes and NWBO’s efforts to improve them first!; ). Best wishes.
herwilagn,
Thanks for reminding us. Never hurts to see positive mentions again while we wait; ). Best wishes.
flipper44,
One of the things I have found works pretty well with forming opinions about timing of events is when consensus can be found coming from various points of view. I’d say that between Lykiri, you and sentiment_stocks along with the 237 day “average” and backlog plus priority designation approach we are most certainly in the window and if there are no more unexplained MHRA glitches, your October timing may be spot on; ). Best wishes.
Smitty5150,
I said this years ago when it first was introduced. Now as biosectinvestor pointed out, some funding may have found its way to UCLA but in general it has gone to the benefit of big pharma. Now if something came along to totally reprioritize the focus of the program, there could potentially be a benefit to the expansion rate of uptake in broader use of the DCVax platform especially if big pharma is somewhat involved right?; ). Best wishes.
learningcurve2020,
Ten years ago was when the combo patent got the Street’s attention and Mr. Woodford chose to come on board. The shorts like Steven Giardino and others got burned by that move when followup funding took the price to $12.54 the following Spring. Best wishes.
alphapuppy,
I’ll take the time to correct my first post to you here as L does break down dead and dying cells but creates radiological issues from the immune response in and around the tumor bed. There are other cells that do a better job of removing large amounts of necrotic tissue which are not always fully engaged by L or Direct as originally trialed. So.. what NWBO is working towards is the more complete immune response that clears out tumor debris more quickly instead of leaving it in place as long as has been the case in the past that creates up to a three month wait to determine if progression or pseudoprogression is responsible. Best wishes.
sentiment_stocks,
Remember that Ken said the market makers should be the ones setting the price? I figured that the cycles being created in many stocks were indeed being controlled by big traders or market makers many years ago. Those cycles often are influenced by financing and other news cycles but sometimes corrections were happening too fast and obviously benefitting some entities over others which is why what Ken said explained many of those regular as well as strange situations. May 10th, 2022 was one of those obviously targeted times that I believe was something many market makers were planning for as a weakness created by FDA process and threats of lawsuits if that process was not followed ie a deliberately created weakness built into the system for reporting changes to endpoints that allowed for attacks. NWBO is being forced to prove collusive behavior by way of discovery even though spoofing was obviously in play that day. Best wishes.
flipper44,
Could be, I just don’t remember anything claiming official count starting in March so I’m under the impression that backlog has something to do with the timing. Either way we are close as the average time was 237 days at last MHRA report. Best wishes.
flipper44,
I don’t remember that either as either in guidance or NWBO stating that March date. I’m pretty sure we are within a 0-40 day space now of knowing MHRA’s decision based on the MIA update to Human designation and catching up on the backlog. Best wishes.
Investor82,
The side I am on is that they want a version of DCvax-L production, either artisan or Flaskworks, that makes getting approval and commercialization as quick as possible from start to finish and that they have a starting point in mind already. December looks like the crucible for BMY and Merck likely wants to wait for news about an expected combo trial and potential partnership deal or other until then even though approval likely happens relatively soon. Mitigating factors might push artisan start with someone even if they wanted Flaskworks so I am torn as to which way this will go. Best wishes.
Legend431,
Funny that it wasn’t the “respected investor” saying anything. I agree with you, stirring the pot doesn’t make anyone smart but it might keep the soup from burning; ). Best wishes.
exwannabe,
You know dstock07734 is correct that Linda is looking at combos that rapidly work to shrink the tumor. That moves past checkpoint inhibitors or along with them depending. Best wishes.
alphapuppy,
The idea is quicker turnaround with trial results. Immune response was what L did well with. Shrinking the tumor is what some other tech and existing products help do. Activate the right immune cells and tumors get gobbled up. L wasn’t doing that on it’s own and Direct wasn’t much better but they both can be made better with what Roswell Parks was working on and with other products that stimulate this part of the immune response. Best wishes.
Investor082,
I wish I knew what version of Flaskworks any potential agreement depends on. If it was a non GMP unit to start with and Charles River Labs or other was willing to run with that contractually then I would go with it but if the agreement is holding out for initial validation of the commercial GMP version eventually to be used then no because there are still too many unknowns. Any new trial will likely be at least partially in the US so having a US based manufacturer announced is likely a precondition to starting a trial like that. Would experimental non GMP Flaskworks units be handed over to big pharma in a franchise model agreement? Doubtful, so something needs to give right? Either start with artisan manufacturing and ship worldwide from Sawston, contract with Charles River Labs or other with lead time so that they can be ready to produce artisan or non GMP Flaskworks or wait for GMP Flaskworks. Like I said, non GMP Flaskworks from Sawston would be doable with the right set up, Charles River Labs producing using non GMP Flaskworks by March might be doable but an announcement would need to be made now for that or artisan probably. Merck and BMY won’t have a lot of time after December to decide what they want to do if subcutaneous injections of checkpoint inhibitors are rejected because of safety concerns. So there seems to be quite a bit that can happen after approval but partnership plans do seem to be focused on approval, FDA decision(s) on subcutaneous injection of checkpoint inhibitors and Flaskworks. The wildcard is combo trials with other agents being looked into that look at tumor shrinkage. I think dstock has presented plenty of interesting evidence with that in mind. Best wishes:
flipper44,
Your response here is what we have been attempting to point out for quite some time. The timing for approval seems to be lining up with the sweet spot of reimbursement rate QLYs and Flaskworks readiness. Demand being created must be addressed as well as business model needs and cost to health care systems like NHS with the timing of any announcement. This is why exwannabe and Investor082 apparently feel strongly that they have a good position to stand on because Flaskworks seems to be too far off and interim funding too limited to make any difference for shareholders. I believe ALL parties involved in MAA and reimbursement are interested in advancing Flaskworks ASAP to validation and scale up and that interim funding will be accessed because otherwise the construction of Phase 1B buildout for artisan would likely be for nothing. It’s highly doubtful that Linda would have created the extra capacity at Advent without some indication from regulators that this capacity would be needed because it certainly is not very much used for contracts with others. The 1a, 50 patient per month capacity would have been more than enough without some form of reimbursement mechanism in place that makes usage likely once approval occurs. Best wishes.