Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
FeMike,
I did not mention break even. That was your extension of thought. I consider $30,000,000 significant revenue and that 200 patients would approach that revenue mark and is doable even with manual production if approval comes by July to early August. Now how the revenue from patients comes in has much to do with meeting this goal by year end and since not all payments will come in up front the number of patients actually needed to hit this mark will likely be significantly more. Even this is doable if validation of new closed system manufacturing happens by late 3rd quarter to early 4th quarter. We can both agree that most time frames do find a way to get pushed out due to multiple factors but as long as the possibility exists for a significant rise in revenue this year I’ll be looking for it. One thing to realize though is that NWBO will not guide on this until they have “the process” decisions well in hand and manufacturing up and running strong. That will happen well after the time investors already know what is coming. Best wishes.
manibiotech,
And in the last two decades how many products have moved the needle on GBM, rGBM and lower grade gliomas? Most approvals during that time have been based on very low standard incremental increase along with significant side effects from treatment. This product has almost no safety issues, can be combined for significantly improved outcomes and has moved the needle on GBM, rGBM and lower grade gliomas. The only real concern has been price because of the expected demand it will create until it can act as a true replacement treatment to reduce costs instead of being totally additive. Best wishes.
Single Stock,
Maybe, maybe not about Dr. Keyoumars Ashkan but you have no clue about Linda based on pricing you have posted and that is a fact. Best wishes.
FeMike,
There are tumors being stored now and there is reimbursement through set asides. There may be other steps but those include applying for reimbursement based on ability to pay out of the set asides. Meaningful revenue is anything that starts to move production levels up and move towards break even which starts when the $30,000,000 overhead to Advent gets taken care of which is likely going to be near 200 patients treated. Even 5 months at 50 per month gets us there by year end if approval by 210 day target for full accelerated time frame happens because this is a priority and there will be way more than that many patients wanting access to this treatment if approved in July to early August. Best wishes.
Single Stock,
You may have some idea how NHS works in the UK but you seem not to understand the very significant influence of Dr. Keyoumars Ashkan or the current set aside funding for products approved but not yet reimbursed or the fact that NICE has granted reimbursement decisions with approval in some cases more recently. The fact that NWBO took so long to submit ought to be a clue to you and others that improved closed system manufacturing and reduced costs were key parts of all decisions regarding timing of application and reimbursement rate. This is not going to be drawn out as if good quality of life, exceptional combo considerations and a lengthy effort with manufacturing do not exist. Dr. Keyoumars Ashkan has not been silent about wanting a reasonable price so all his patients can have this treatment nor will he be silent about any delay by NICE after all that has been done to accommodate by NWBO.
Beyond this, your minimalist projections do not line up with Linda Powers long time insistence that DCvax is a platform treatment for all solid tumor cancers and there will be no agreement that does not have a value that agrees with this. Anyone who thinks otherwise values their opinion above that of Linda Powers and will be proven VERY WRONG because they underestimated her just like so many others in the past who have paid the price. Age is no issue with Linda Powers. She will wait to get what she knows is true value and no deal gets done without her stamp of approval. Your values don’t get her stamp of approval nor that of those who support her. Best wishes.
biosectinvestor,
If I remember the protocols correctly there was a 3 month or up to a 3 month wait before treatment with L could begin once possible progression occurred. This was in place so that true progression could be confirmed. Best wishes.
AngeloFoca,
I am commanded to love my enemies the way Jesus loved even those who nailed him to the cross. He prayed “Father forgive them for they know not what the do”. I may never achieve that kind of love but at least trying to work towards that by the grace of God. Best wishes.
muee88,
I think you meant to reply to someone else; ). Best wishes.
learningcurve2020,
I don’t know why you think I didn’t know market makers keep an inventory of shares to make the market with but even so they are given leave to naked sell shares for a short time to use that time to locate shares at a better price to collect a better spread. This and they do not want to sell at a loss to create liquidity in the market or buy at a loss to cover shares held short. Hence fails to deliver develop and the temptation to make trades in dark pools where prices are not seen by the public and where activity can remain more anonymous is an issue because motives and activities are not as easily detected there. I’m all for transparency whether on long side claims and warrant holders or short side activity. Best wishes.
miltong,
The gem in that post is the concession that longs might be correct about L. The rest is as you say the same old same old. What really matters is the concession not the other junk. That is a turning point, intended that way or not, for this member of the group.
I look for little things like this to determine changes in strategy by them. This is why I brought it to the board’s attention as many have him on ignore. In the future I’ll just point stuff out and maybe take a screen shot without any request to have others go back and confirm. Best wishes.
StonkMaster,
The value of the DCVax PLATFORM just jumped up in value again. This patent is why big pharmas didn’t want to negotiate good terms early in the hope that this would not happen. Now that at least in Europe folks will give credit where credit is due the tables have turned considerably into NWBO’s favor with regard to price leverage and who they will pick to combo with and where they will be willing to start combos at with approvals. At least Merck was smart enough to develop some good will value with NWBO before formal negotiations; ). Best wishes.
learningcurve2020,
This post should be read by all longs as an important turning point in the fudster narrative. You see, this post represents a concession that longs “turn out to be right about L”. Eventually the concessions will include being right about tissue agnostic designation, Direct and longer term potential valuations.
For now, however, the concerted effort points to the idea that longs will never benefit financially even though some to many long time longs are already above their cost average even at these depressed prices. Bottom line is that the providential revelation of the science wins the day eventually whether about the topic of a flat earth vs more round or man reaching the moon to give God the glory (go back and listen to what was said while taking the first pictures of the Earth rise while orbiting the moon). Best wishes.
exwannabe,
1). There is no spinning when treatment effect in crossover patients is real and easy to recognize because nothing else given causes this OS increase in rGBM patients.
2). To this day there is still no absolute way to distinguish treatment induced pseudoprogression from actual progression in all patients with radiological visual examination readouts.
3). Noted treatment benefit from crossover benefit has reason to be studied and discussed not just discounted and thrown out like you attempt to do. JAMA Oncology published the article and its conclusions based on the rigor and independence of the ECA comparators utilized in the comparison of ndGBM and rGBM patients treated with DCVax-L thus affirming the conclusions made. [You and no one on this board is in any position of authority to refute JAMA’s affirmation of this data and methods used to determine treatment effect when they published this study. All you can do is cast opinion and doubt from the grandstands while you root for another team.]
4). Switching endpoints in blinded fashion is completely legit. Inferring that NWBO was unblinded to results before the switch to OS was made is blatant misinformation and infers NWBO is a scam company trying to extend the process not for the sake of patients but only for their own financial benefit. If NWBO had been unblinded or did not have a legitimate reason to make the switch to OS, such as treatment induced pseudoprogression, then JAMA Oncology would not have peer reviewed the results because their reputation is on the line. The SAP would not have been accepted by all the regulators either which was the first clue that the data and measures used to test for treatment effect were and are sufficient for such a determination.
One last point being that Advent is not being built up on support from a scam company as claimed by you and the rest of the team but on support for the effort from the likes of Dr. Keyoumars Ashkan who has stated that he wants DCVax-L for all of his patients.
5). Patient matching was not possible for this trial, however, these ECAs were independently composed by a very capable panel and every effort was made to produce a fair comparison. This was validated by regulator acceptance of the ECAs by way of acceptance of the SAP and further validation by MHRA acceptance of the PIP which is for a future pediatric trial based on these same type of ECAs and JAMA Oncology peer review. Your inferences that these ECAs are biased or unacceptable are completely unfounded fabrications that the experts have overruled you on and soon will use as the basis for approval of DCVax-L for GBM, rGBM and likely lower grade gliomas. Best wishes.
Inquirig,
“All posts are my opinion only..” -Inquirig
We all know that but you left out a very important word in that statement. You did not state “honest opinion” you just said “opinion”. Jesus said to the Samaritan woman he met at the well that her statement was true then went on to clarify the shambles that her life had truly been in. So too we agree that this statement above you made is true but your “opinion” is not just your opinion only but a reflection on who you are currently as a person. The woman at the well was changed radically the day she met Jesus because he did something that put his own reputation on the line by meeting with her privately and then without condemnation speaking the truth to her about herself. He then got to the point of calling out the hidden hope within her that one day things could be made right. His presence was all the affirmation she needed to instantly become someone completely different. Praying the same for you. Best wishes.
theorysuit,
Have you purchased your one way ticket yet?; ). When is your planned departure date?; ). Enquiring minds want to know ; ). Best wishes.
learningcurve2020,
You do an awful lot of talking to yourself and others in your group recently and Inquirig has developed this habit as well. Maybe that’s the best way to bump up your response rate and pay?; ).
Of course market makers have inventory which is part of making the market. They are often the determinants in cycle high and low points as they watch the buying and selling carefully with algorithms which leads to changes in trading price direction based on their algorithm after outside input is received. Traders pick up on this and respond accordingly shortly after the new price direction is established. Those that respond too late or anticipate poorly get left off the gravy train.
Those who choose longer term horizons are not affected by early price fluctuations as much since they are anticipating a longer term payout. The cycles do help some accumulate more at depressed prices and in some cases sell an interim high to buy back at an interim low. Those with vested Roth IRAs are not penalized for doing this tax free so there is certainly a motivation for doing so even if not all have done so.
As far as discovery, yes it needs to happen and it needs to happen for every reason possible including calling out any longs for their part in all the price swings. I’m all for it and I think most longs are too ; ). Best wishes.
alphapuppy,
You had the proof long ago. By 2012 DC therapy was KNOWN to be safe with at least a signal of effect. We have taken 12 years to validate L when access should have been granted as an option to all patients desiring an alternative to SOC after surgery. You know how I detest “the process” which in this case everyone who understands the science knows and has known is nothing short of an unnecessary gauntlet placed in front of a known safe treatment for the sake of the status quo. I agree, this has taken too long and too many lives but the vast majority of the fault lies on “the process” and those who staunchly uphold it in my opinion. Best wishes.
alphapuppy,
Yes he sold but he holds many more than he sold. Maybe he expects to get those all back once there is an approval or a deal perhaps negotiated in part by him and didn’t have a better place to get the cash from when he needed it. Life happens and timing everything out just right doesn’t always work out. Yes the timing stinks because we are waiting on approval which is a binary event such that the bears want to use everything they can to create the perception of failure before expected success and greater accountability by NWBO would be great but it’s likely not going to change much until the next steps after approval get finalized. One great suggestion shared often in this board is to know what you hold because the rest is all a show no matter who is involved ; ). Best wishes.
theorysuit,
I’ll be checking for your response sooner than that but by then I expect you will disappear or more likely morph as some recent names on this board seem to have done to eradicate direct ties to the past ; ). Best wishes.
Inquirig,
And yet Allan, a pancreatic cancer patient, is likely still alive today 11 years after being told that palliative care was all that was left except for Direct since there is a Linked In profile for him still up. In this case you don’t need to just talk to the hand, perhaps you ought to go talk to a survivor face to face ; ).
Maybe someone could put together a TV conversation interview between all the survivors of L and Direct on one side of the stage and all the fudsters, spoofers and those eventually connected to them on the other. Granted it might be a bit tricky getting so many fudsters, spoofers and associates out of jail for the interview one day but sure would make for some interesting conversation; ). Best wishes.
theorysuit,
No, the cabal claim about the inappropriateness of endpoint change is the Hail Mary!; ). When measures used to measure treatment effect are found to be inadequate, as all measures for PFS in this trial have turned out to be due to treatment induced pseudoprogression creating inadequate radiological imaging measures to this day, the endpoint change becomes justified as validated by JAMA Oncology peer review and originally pointed out in the exceptions to adequate and well controlled trials. All the discussion between yourselves is just revolving door FUD.
The statistical analysis plan, which included independent third party derived external controls, was presented to the regulators and accepted by them before unblinding of NWBO to the data and that is why JAMA Oncology accepted the conclusions based on those guidelines. Only the most terribly misinformed could possibly fall for your FUD at this point and this board is not that place as much as you would desire it to be by conversing between yourselves more now that your words are falling on deaf ears ; ). Best wishes.
learningcurve2020,
Making a market allows for sales of shares not yet located for a short period of time so that the Market maker can use time to find shares made available at the price they chose to sell at. They are not given the additional tool of spoofing to get the price they want because price setting is not their job. Price setting and beating others to the sale by milliseconds is where billions of dollars are made though in high speed trading. Nearly everyone that has ever participated in the modern market recognizes this and knows changes need to be made. NWBO and Cohen plan on helping those changes along with what they have but timing is also important and having an approved product will put a big exclamation point on the outrage expressed by a jury with regard to damage award. Best wishes.
exkitteryff,
Asks and bids come up in order of best bid or best ask still remaining but whatever the limit might be on best ask overnight or best bid may show up during non trading hours if no lower ask has been put up against it on the board yet. There are some who play games with this on low volume tickers trying to catch market orders off guard in either direction when orders on the board are limited or able to be taken out quickly and cheaply. Best wishes.
learningcurve2020,
Spoofing is illegal. Proving loss causation takes time, money and tracking resources that many do not have. However, if a class action suit were to be developed that potentially thousands to millions of entities could be a part of then that could cause a big problem for market makers that knowingly and admittedly have broken the law. All one needs to do is go back and find the formula for loss causation and apply it to each trade affected by the spoofing incidents found in the trade records. NWBO’s MAA of 1.7 million pages might look a little skimpy compared to what might be dug up in discovery over a 5 year plus period; ). Best wishes.
JTORENCE,
It’s been posted several times already but it’s 30 days out. Best wishes.
alphapuppy,
No, actually much before; ). By the way, this is all going to get good soon and just like exwannabe will be glued to the amended complaint, I expect many others will be too. In the mean time the count down to a MHRA decision continues. Best wishes.
Margin Buu,
Correct and this was what exwannabe was pointing out as well. He is keenly interested in what will be presented. I would think there will be plenty of “eyes on” for that amended complaint as that is when “the beef” gets found and some figure out just how well they are protected.. or not. Best wishes.
Truthfan,
Yes!; ). Best wishes.
CrashOverride,
She is also moving the timing more in line with discovery and jury trial after formal validation and the chance for widespread public awareness of what NWBO has been attempting to do all these years while nefarious forces have been at work to slow them down and try to bankrupt them. Let the word get out so that everyone is paying attention when this case moves forward. By the time this all happens FDA may well be considering a BLA for L or even have it approved. Now that would be really bad press for these spoofers and all those that supported them that might be uncovered during discovery. Best wishes.
theorysuit,
So you agree that NWBO found enough financial support along the way by hook, crook or by safe harbor forward looking statements to finish this Phase 3 trial and get the results to MHRA so patients might have an opportunity at a treatment that doesn’t kill them or cause nasty side effects and actually offers a better quality of life than existing SOC by itself. That’s good because you are well aware of the constant attacks against this company and that in spite of this they were able to overcome the long odds that biotechs face of ever getting to a successful product before bankruptcy.
Congratulations you figured this out and now the world will have a chance to see how Poly ICLC, combos and Direct will improve outcomes much more after the coming expected approval in the UK. Like you, I can’t wait for everyone else to find out that a new day for cancer patients is almost here; ). Best wishes.
Inquirig,
How many times can a single share be sold short before being covered and returned to the original lender? How many shares can appear to be sold from that one share. Kind of like printing shares right?; ). Best wishes.
ilovetech,
So how long do you think it will take to get everyone to obey the speed limits so you can get back into the market?; ). Best wishes.
theorysuit,
So tell me how a $.55 market price benefits those who have warrants convertible for $.55. Warrants converted to shares and held represents additional controlling interest. Do the nefarious forces want more or less controlling interest held by insiders?; ). Best wishes.
barnstormer,
Lending shares can be counter productive to one’s own investment strategy if those shares are being used to sell short before financings to create a lower share price and greater dilution. For those who want the share price lower to buy more cheap shares because of the net gain expected later vs difference in dilution without their participation this could be a viable strategy but obviously others are affected as well, some without the ability to take advantage at the best available times. This is part of what makes a market so it’s best for all to be aware. Best wishes.
tryn2,
There was a flash crash blip on record that took it to almost zero but that was quickly corrected. Don’t remember exactly when but it has been mentioned and documented on here several times. Someone was obviously playing with the system. Best wishes.
vator,
Anyone in his position is a salesman and many try to sell stuff that may not have much value at the time but might have good potential and look flashy in the right light. How do you think venture capitalists get lobbied? I believe Navid has stayed associated with NWBO precisely BECAUSE he has always believed in the potential that NWBO has had. We now know he was justified in that belief and he has been well rewarded because of it. This really is not that difficult to understand. I believe he sold the idea that the Swiss response on the surface had given him to work with. When a car is sold “As is” it’s buyer beware. Anyone doing their due diligence back then knew NWBO was not well funded and was looking for a path forward. Kind of important not to just trust the salesman on the used car lot but maybe take the car to your mechanic before buying would be a good idea right?; ). Sometimes people just want to buy a lottery ticket instead of doing the hard work and discipline of saving while waiting out the benefit of compound interest. Best wishes.
manibiotech,
Tissue agnostic designation for L and Direct, because DCs are tissue and indication agnostic naturally, is worth waiting for regulators to figure out or patients to demand. Linda knows this and knows that this is not only the key value driver but that after all the manipulation and defamatory accusations, while trying to get this to patients deserving access, no way this gets handed over to anyone until this happens. You don’t know Linda and her supporters very well if you think otherwise. Best wishes.
Single Stock,
The price for a buyout at this point in time would be too much for any big pharma to justify because there is simply too much that would be given up both NWBO investors. NO WAY FOR BUYOUT NOW OR AT APPROVAL unless something astronomical comes along and you aren’t advocating astronomical. Linda has options and there will be plenty of very smart and influential folks lined up to help along with all the bad actors trying to convince retail investors that they are the ones trying to help. Best wishes.
theorysuit,
The reality of investing in any biotech is that there is almost always a very long development stage and anyone who says differently should be viewed cautiously. Traders react quickly to news that they think will get others to bite on then they dump when the buying dries up. Happens all the time because so many are hoping for the quick score but are not in position to know that they are the mark. Wise investors, not just traders, would have known that subsequent expectations being set by the Swiss news were not credible any more than Les trying to cover for the enrollment discrepancy that left out 17 SOC/placebo patients which NWBO apparently felt needed to be done to help protect the blind and ongoing collection of long term data. Biotech investing 101, believe grudgingly and carefully but when certain hold on to what others want to take away; ). Best wishes.
theorysuit,
And now for the rest of the story. Navid Malik, while working for Cenkos, was instrumental in getting Mr. Neil Woodford to substantially fund NWBO. Mr. Woodford was well connected to the then current CEO of Cenkos who then turned on Navid when he really did not need to although for what can be viewed as likely legit reasons. That funding helped NWBO finish enrollment from half way in 2014 after almost 7 years to completed by early November 2015. Kind of a big deal for all long time NWBO investors. For traders and shorts, not so much. Interesting too that the CEO of Cenkos involved with all of this later resigned rather suddenly without much explanation and Mr. Woodford was replaced as fiduciary after the Ondra affair and before shares of NWBO were liquidated at fire sale prices which drove the price down to $.14. Best wishes.