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dennisdave,
If patients continue to live and the average benefit of treatment keeps rising while the reimbursement rate is still too low for sustained manufacturing of artisan L, don’t you think that you would have timed your application expected approval date with close to an optimized reimbursement rate so that artisan manufacturing isn’t running the business or NHS into the ground because of demand while waiting for Flaskworks to be approved?; ). This isn’t just about NWBO but rather about the broad scale cost of healthcare and the steps yet needed to bring the total cost down. Best wishes.
manibiotech,
I think Fall was the reference Les made towards approval. I think end of the year was Linda’s reference to the look of the company. I could be wrong but that is how I remember it. Best wishes.
theorysuit,
The subcutaneous injection of checkpoint inhibitors is no shoe in. I think both Merck and BMY know this but BMY simply has no choice but to try with their padufa date while Merck is sitting pretty on the combo results. See any reason for Merck to strike first?; ). Best wishes.
manibiotech,
I think flipper44 was on to something with the change in primary completion date for the combo trial. Perhaps Merck senses the need to be able to announce major news like a partnership with NWBO before BMY might receive a favorable decision in December. If BMY gets turned down then they look even smarter for preemptive news and results likely published in January which is the time for big investor forum presentations. Best wishes.
manibiotech,
Some of the bears correctly pointed to $.30 and others were insisting a drop much lower. We have held in this range because we are now aware that this process was going to have a start date in January not December and that the backlog would have some affect on the final decision. There was news expected in June about Flaskworks and that did not come as they chose to go one more step towards a smaller footprint with that. Lack of news on that front pushed back the date expected for full validation of Flaskworks and allowed the typical downdraft in the summer to take over so yep, I missed on that because I hoped for updated and advancing Flaskworks news which their decision to move to a smaller footprint delayed. Longer term that is the right decision but the market, and that includes longs, were/are tired of waiting even if for good cause. Best wishes.
PS I was wrong about HyGro or LessIsMore being next to chime in too. Turns out it was theorysuit; ). Lol!; ).
Investor82,
You are correct…about one thing!; ). I am not holding up reimbursement, nor is NWBO. However, reimbursement with artisan must be a doable exercise both for NHS after a NICE agreement and for NWBO until Flaskworks comes on board. Hence getting the interim reimbursement that flipper44 and exwannabe have been talking over is what I believe Dr. Keyoumars Ashkan is referring to about the authorities finding a way during the interim. In the middle of all of this there seems to be some leverage by/with NWBO with regard to when a partnership or other might be announced by Merck which in my opinion happens by about the time that the BMY padufa date reveals how FDA looks at the increased rate of death from sub cutaneous injection of checkpoint inhibitors. Best wishes.
laser777,
That was an awesome move. I was paying attention to stock price movements more carefully back then as I was looking for the bottom to load up on. You simply nailed it!; ). So glad you are still around and about ready for the party to begin. I have a feeling some longs on this board could use some of your sage wisdom if willing to share a little bit more about your experience here. Best wishes.
dstock07734,
I know enough about the science in certain areas to be dangerous; ). I defer to many others who are well versed in the intricacies. I know that you, flipper44, DoGoodDoWell and iwasadiver (Dr. Zivic) are very well versed in the science. There are some other rare posters as well. Best wishes.
iclight,
Wow! My comments got you to show up!; ). I’m flattered; ). Will HyGro show up next or LessIsMore?; ). I see you are just as anxious as all the long time longs for MHRA approval of the MAA for DCVax-L. Good to know you will be around for the celebration. Don’t get shy on us afterwards, though, because what would we do without you and the others helping to make this board #1?; ). Best wishes.
sentiment_stocks,
That is exactly what happened when one of our posters set up a 40,000 share bid at $.146 (I think that was the bid) as the market makers were working it down with 100 and 200 share blocks to under $.145 to set the double bottom at a rounded $.14 then the price immediately bounced off of that back up to over $.15. That’s when I knew the double bottom had been set because they chose to get the double bottom in spite of giving up those 40,000 shares. That was later confirmed with a retest and uptrend from there. Best wishes.
exwannabe,
Actually they are likely just waiting for another share count update and hankmanhub to take down his bid to trade on; ). Best wishes.
StonkMaster,
I think flipper44 laid out a good case to be made for earlier access to pre agreement funds while evidence for QLYs continues to be gathered. Question is whether or not QLYs with regard to Poly ICLC use with L are being offered to be cut short based on a conceptual partnership agreement. When is BMY’s PADUFA date for sub cutaneous injections of their checkpoint inhibitor scheduled?; ). Best wishes.
Investor82,
Coming to the rescue of exwannabe?; ). Your alias hasn’t been around long enough for you to remember that I was suggesting stuff with manufacturing going on back in 2015-2016. Then, many disagreed with me that manufacturing was creating the hold up. So now you want to call this issue a carrot after all these years and complaints from both bulls and bears that manufacturing couldn’t possibly be the hold up because I was linking it to demand instead of reimbursement when it really is very likely both. Obviously the reimbursement rate is initially more tied to the operating business model but longer term meeting demand is critical. Try again. You simply want to ignore the truth that has been shared here for quite some time; ). Best wishes.
hankmanhub,
You have inadvertently learned how to set an anchor by submitting a large order that MMs want to work around when trading volume is light by filling smaller orders that generate larger profits from commissions on smaller orders. Yes, they are bidding against you until you pay the price they want or remove the order. The longer you hold tight the longer the price holds above that price. You likely would be able to accumulate smaller amounts at slightly higher price while leaving the anchor in place or remove the anchor and let them take it back to $.29+. Best wishes.
Smitty5150,
One of the points flipper44 has been making is that quality life years continues to increase every month as this metric is based on averages that continue to increase because of survivors. The other data that can be shared is from programs like Specials and the trial of DCVax-L plus Poly ICLC because of the long term statistically significant data with the use of an immune system activator that is not an approved mono therapy but rather used as a priming mechanism. It seems a decision was made to accept the QLYs from primary completion this December instead of waiting out another year. Leverage ie gapping primary completion out one year may have created an agreed upon economic adjustment in value of the L franchise in non formal discussions. If nothing formalized by December that date might get pushed back again in my opinion. I would think others might be seeing this too but the general investment community certainly has not. Best wishes.
exwannabe,
Wow, a detailed paraphrase of manufacturing, manufacturing, manufacturing. You’ve come a long way!; ). Best wishes.
flipper44,
Totally agree and wish that the approval process created an opportunity for much earlier access to treatments like L and Direct that are safe and have demonstrated an early signal of treatment effect in otherwise terminal illnesses. Even treatment on only a limited lottery style basis over the course of so many years would have made a very significant difference in patient outcomes. That so many years have passed without a more significant level of access by patients in the US and elsewhere is a travesty that can be counted in lives lost based on actual numbers and known statistically significant reasons since 2015 based on what Fraunhofer said about the screening halt. Best wishes.
dstock07734,
I was about to ask a question but the picture you sent answered it. The freezer shows -81degrees centigrade which is what is needed for L. Best wishes.
dstock07734,
I forgot if you ever found out if those facilities are equipped with the kind of cryo storage needed for DCVax. If you don’t mind, what was it you found out? The cryo storage temp is one of the keys to identifying what products might be involved. Best wishes.
hankmanhub,
You might want to check your order again. You mentioned a bid of$.0304 multiple times in your posts and that is only 3.04 cents per share😊. A little bit low to get filled methinks😊. Best wishes.
learningcurve2020,
Yep Linda is managing something you, in your wildest dreams, would never even have been able to conceive a picture of. Glad she is managing this and not you.. me or about 7,000,000,000 other people on this earth; ). The vision and wherewithal this has taken comes from more than just her but Linda is bringing this ship to port having survived many storms that would have led to the ship sinking by most other captains, including if someone had put you in that position that you are not even qualified for let alone seaman first class. Best wishes.
JFR161162,
Except that an economy based on a cashless society is just a better way to control people by the same elite who pushed this forward even when it was initially failing. There is nothing truly tangible when a crisis comes and electronic access is denied. The weakness will only be exposed with the crisis. Best wishes.
JTORENCE,
A company ill prepared for nearly out of control growth can be done in quickly by poor decisions along the way. Linda is managing everything so as to be prepared for this before it becomes that kind of problem and that has been painstakingly slow but necessary for the big picture to play out for the benefit of those with the greatest vision and an honest look at how that vision is and has been opposed at every turn by the powers that be. Best wishes.
sentiment_stocks,
… and worldwide ramp up with Flaskworks and new Direct trial(s) ongoing or perhaps even halted for efficacy by around Q3 2026 depending on priorities and plans for roll out. The groundwork has been laid for a smooth transition to ramp up with Flaskworks from artisan and then to a move with Direct. Best wishes.
CrashOverride,
Plausible deniability is the phrase of the day. There is always a fall guy who will get well compensated indirectly for their time and big pharma would never short directly or even let a conversation be anything more than indirect hints of what they would like to see happen. I think you know how this works; ). Best wishes.
Rh2022,
Anyone who does not understand what the change to “Human” designation for the MIA means during an MAA review process needs to look into it better. Tic toc!; ). Best wishes.
As an add on to my previous post, think about who has a chance to gain with price suppression and when would NWBO most like to partner. Would a partnership be a better deal for NWBO if done when NWBO price is $15-$30+ dollars a share or when it is less than $1 per share?; ). Linda won’t be bullied into a bad deal when approval allows the world to know what they have and why big pharma needs it so badly before patent expirations which is also when Flaskworks will be full steam ahead. Best wishes.
Investor82,
Merck just recently went into recalibration mode since their injectable Keytruda is more deadly than their IV method. BMY had the same issue. Care to try and rethink their leverage position with regard to final deal with NWBO?; ). Linda most certainly has been since every big pharma attempt at a work around has failed and generics are not very far away are they?; ). Best wishes.
theorysuit,
“It is beyond comprehension that there are actual investors that can defend this…..”- theorysuit
Glad to see that you acknowledge comprehension abilities. That helps explain many of your posts. We are a patient bunch on this board and will do our best to help you understand the incredible breakthrough that NWBO represents ; ). Best wishes.
theorysuit,
Total foolishness to think that a non GMP model has not already been proven out before investing in a GMP model for final approval. Shows your total lack of understanding how process development works. Try another line of approach; ). Best wishes.
flipper44,
Correct!; ). I switched it when thinking about the null hypothesis and then as a joke. Best wishes.
learningcurve2020,
Been around farms enough to know there is no sense stepping into the manure pit with you ; ). Don’t let the methane get you; ). Best wishes.
kund,
No, not a doctor but a strong science background. NWBO made a breakthrough discovery more than a decade ago that very few realize the importance of. Creating a successful business model to launch into with what has been learned by the science has been very time consuming but the base model is now within a year or so of Flaskworks and digitization processes being fully validated. NWBO May look quite a bit different by then with MAA approval expected near term since the MIA was upgraded to human manufacturing readiness which is one of the last steps before marketing approval is granted. Best wishes.
flipper44,
Goes back to our early discussions about the relative importance of mesenchymal signature vs methylation status in DCVax m-L treated patients. Both do better than average with response but mesenchymal signature had been generally associated with poorer prognosis because of its more aggressive nature and yet we see these patients benefitting now. Best wishes.
FeMike,
Nah, not the waiting. It’s the Human designation on the MIA pointing to approval soon and Flaskworks moving forward. We’ve been waiting for these things for a long time and now we see what others are blind to.
Being in the driver’s seat of a 1,000 plus horsepower car kind of gives one a different perspective knowing that you were there for the ride and the patients that will be cheering many years down the line because you stayed the course and finished the race under the checkered flag; ). Best wishes.
learningcurve2020,
That was a great speech about the need for a little biotech to stay out of bankruptcy; ). Even AI isn’t up to speed on lawyer speak yet and you sure didn’t understand. Maybe you should hire a translator!; ). Best wishes.
Investor082,
Nope, you have it all wrong!; ). You see once approval hits the story goes forward into what comes next and that includes announcing the move to full scale manufacturing with Flaskworks with the obvious question being “Who will partner?”. NWBO will talk about patent cliffs, combo successes and the need of big pharma for what NWBO has which will be enough to get major investor interest and big pharma knows this. They most certainly have some contingency plans in place right now with regard to timing of announcements based on market reaction.
What you don’t understand is the leverage shift that comes with approval because apart from excitement about a platform basis to treat all solid tumor cancers, the story will come out about how the perps have been trying to keep this company down. That will cause the lawsuit case to take on a life all its own regarding interest by the public and investors and the market will respond accordingly. Those that want to “stick it to the man” will do so and rightfully so. Linda will know when the right time is to appeal to the masses and the story line is one the masses will rally around and that includes Dr. Linda Liau and UCLA in the lime light too. Best wishes.
CaptainObvious,
After the MIA designation change to “Human” investors either understand the implications as explained pretty well by this board or they simply have no clue and those who you mention are happy to help keep it that way. Based on the price and volume many still have no clue. Best wishes.
exwannabe,
All indications that MHRA is catching up on their backlog expeditiously. Still thinking no approval this year?; ). I’d say the 300 day target is very conservative and that 210 plus a month addresses priority and quality submission designations if the backlog is still being dealt with at the earlier pace. If not then October but the MIA human designation likely puts September within reach and investors seem to be supporting that or October as most likely. Moves generally happen 3 weeks or 3 months out. Best wishes.
exwannabe,
NWBO is well past survival mode now. That water under the bridge has been recycled many times now methinks; ). Best wishes.