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A friend is having what I think is a nerve sheath tumor removed from her knee next week. The odds of malignancy are incredibly low. It will be examined for malignancy at surgery. If it is malignant the hospital will make slides. Malignant median OS with SOC is 15 months. I was considering suggesting she have a Store My Tumor kit on hand so that it could be preserved potentially for immune treatment. SMT does not accept insurance and I am guessing the procedure is expensive. I do not know whether NWBO is offering dendritic cell compassionate care vaccine creation under these circumstances or whether any other provider is. I also did not want to alarm my friend who probably has avoided researching OS because she was told, almost certainly accurately, she had nothing to worry about. I think I have sort of answered my own question (stay out of this), but if anyone has any thoughts I would be grateful to hear them.
Thanks. Is guidance available online concerning DCVax Resectable and non-resectable compassionate use in UK? I am asking concerning recurrence of Prostate Cancer following salvage radiation. Not sure whether any tumors could be located, could be biological recurrence based solely on PSA.
Is DCVax available in Uk and Germany for cancers other than GBM? And will NWBO provide/produce it for other cancers? Are their regs published?
Is the exercise of warrants by insiders exempt from the rule that they cannot buy securities when in possession of material nonpublic information? If not until release of the P3 results these lockups were superfluous. So is the Powers 61 day lockup. The only legal effect until results release is that (she claims) she is not a beneficial owner of the shares associated with her warrants and options. Assume she knows results will not be released within 61 days. Then her purpose must be to avoid the legal status of beneficial owner of a certain percentage of her shares (or shares she could own by exercise of warrants or options).
Why would that be important to her? It would not insulate her from a shareholder derivative suit. Also, what consideration did she receive for her promise? If the answer is none, her agreement, or promise, is legally unenforceable. She does seem eager to avoid being treated as the beneficial owner of some threshold amount. Who is being reassured and concerning what?
Assuming she already was prohibited from purchasing shares through the exercise of warrants she is telling shareholders and the public that she promises (enforceably or otherwise), that she and their lawyer will not sell out to BP, except on 61 days notice. Even with the exercise of their warrants they could not transfer control to BP. Is this intended as assurance, or incentive, to other large shareholders not to combine to do so? Or small shareholders, in a tender offer? Are there insiders plus large warrant holders who control a majority of the common?
I understand there are poison pills and provisions to prevent change of control, but they can be held unenforceable, especially in companies where officers exercise effective control. We are all in the dark here. Just something else to speculate about.
I may be confused about what’s going on with Advent but my uninformed guess is that she is trying to avoid a conflict of interest. What I thought I had read was that NWBO was leasing the space at Sawsston, which is an industrial park, but that in that space Advent is gearing up to become another Cognate. A conflict like self dealing with Advent concerning DCVax could in theory be managed by truly independent directors and corporate transparency, although the point has been made that NWBO could be working with Advent’s competitors in The U.K. But how do you firewall LP going into the management of an entirely different business, which will be making a lot more money than NWBO, possibly, in the short term? What a time suck for our CEO. And if I’m right about Advent gearing up in space leased by NWBO (and I feel a bit shakey on those details), is Advent leasing the space?
Talkin’ bout my generation . . . In my teens I slid up and down the East Coast to catch all possible blues and rock. Snuck into Led Zep at Carnegie Hall. Saw BB (4x), Albert once, at the Filmore East, Muddy several time. Saw him at some club in Boston. Had to go back to say something to the Great Man in his dressing room, knocked, no answer, opened the door (I’m 15], has a gorgeous young blond on each knee. Not a welcoming look. Howlin’ Wolf (at Ungano’s), Lightning Hopkins (think that was his name, skinny, acoustic), Bo Diddly, Sonny Boy Williamson (nope, it was sonny terry and brownie mcghee, SBW died ‘65}, BlindLemon Jefferson, bunch of shows at the Filmore I can’t remember, definitely Procul Harum when they had that whiz 16 y/o, saw The Who several times, including at The Capitol in Port Chester, when someone was filling in for Keith Moon who was too stoned to play, Hendrix at the old Garden, with the rotating stage, miserable show. When I finally caught Johnny Winter at BB King’s on 42d he was just a shell. Caught Butterfield at some dive in the Village. My musical life, everything that was important to me age 12-16, wrapped around the blues, and bands like Led Zep, which evolved from, Blues Breakers, but Johnny, when he came out with that first album on Columbia. WTF??? School Girl, Good Friend, Careful with a Fool, if you listen his phrasing was as purposeful as BB’s, easily as fast or faster than Clapton when he was “God.” Saw Stevie Winwood two years ago, he’s almost 100%, did Gimmie Some Lovin’ He changed the world. Shanghai Noodle Factory, Mr. Fantasy. Don’t think I caught Bloomfield. Sadly, was not really paying attention to Neil Young then. Caught Big Momma Thornton at Lincoln Center. She wrote Ball and Chain. Took my mom to that show. Thornton was wearing a tux. Sadly I thought Janis/Big Brothers version was better. Still one of my faves. Read Blues People by Leroy Jones, later Amari Baraka, when I was about 15. Worth a read, really made me think about how the blues came to be. Saw Clapton at the Garden just before C19, man was he milkin’ it for every penny, had SRV’s older bro do a long set, then some kid who was ok, he did about five songs, announced before them he would not be speaking to the audience. Saw Leon Russell in 73 at the Nausea Collisium. Saw him again just before he passed. Man was all business, but love his stuff. I’m still too excited about all that amazing music, but I’ll shut up. One more thing. If you’re ever so inclined, I’m in a burb just NE of Manhattan, bring your axe, your bass or just your bad self.
Is it likely that the principal investigator would be attempting to apply public pressure on the FDA or any other agency through sarcasm while waiting for approval of BLA? Won’t a panel of independent experts have to provide an opinion, or is that just for non-biologicals? If an independent panel is going to opine, aren’t there some potential members wedded to strict control arms, and doesn’t Liau know this? Or are the experts and the FDA of one mind now? I looked at a study of applications through 2019 ?? and found quite a few approved without a traditional control arm for diseases like GBM. Maybe she is saying the emperor has no clothes, in our age of personalized medicine, where controls are not truly controls, without deep knowledge of each members’ biomarkers. Which is it?
Were there warrant holders who signed NDAs recently? I assume if there were they could not legally trade, no matter what. That might include the fellow who provided the recent unsecured financing. I think he was a warrant holder. I’m not playing gotcha, I’m just wondering whether folks who held large numbers of warrants/shares might have signed NDAs which allows NWBO to continue to update them. That inside information prevents them from trading, whether the news is good, bad or in between.
That could explain to some extent why the stock price is so vulnerable to short selling. You can borrow 250,000 shares at 9%, place a market sell order for 20% of the day’s volume, and panic retail into free fall. No deep pockets to buy in the secondary and push back. They signed NDAs.
I don’t think there is much naked shorting going on here. There just isn’t enough volume to make it worthwhile. I looked at the short sales for the last ten or so reporting periods, and I did not see the number of short sales holding steady or rising, while the average time to cover increased. If I had, that would have been evidence of naked shorting. There is easy small money to be made legally shorting this stock. You see one or two free falls a week, 250,000 times 10 cents, less $90 to borrow the stock for a day, $24,910 profit in 4 hours. But hedge funds, cabals, whatever, would sneer at that. And who would hold un uncovered short position in this stock long term knowing there have to be results published soon, and there are reasons to believe the results will be positive?
Adam Feurstein lost his mother today in a tragic incident. Sandra Feurstein was the victim of a hit and run in Boca Raton, FL. There is an article in Newsday, but I could not post it from my iPad. She was a well respected federal judge in Islip, NY. newsday.com/long-island/us-district-judge-killed-hit-and-run-florida-remembered-1.50211694
I am not frustrated. I have owned this stock less than a year. Charles River, Flask Works, Advent show that NWBO means business. I continue to add to my holdings. If I were frustrated I'd be investing in other stocks. Instead, I have all my non-retirement investment funds in NWBO, save some 9 Meters Calls. I am curious whether an opportunity was missed. I was asking a question based on the observation that other trials have garnered BTD, based on less convincing data, concerning less devastating cancers. It's that simple, and a discussion of the merits might be worthwhile for a number of reasons.
It is the patients who most want approval faster, not shareholders. There was an opportunity to speed up the the FDA feedback process, trial revision and approval process, without sacrificing the years invested. They could have continued to measure efficacy post marketing. Everyone thought the 2018 publication demonstrated a breakthrough against one of the deadliest cancers. Best case they could have had their BLA approved in under a year. Instead they have spent three years worrying the pharma investment community. Powers made the managers and herself very wealthy when she untangled that conflict. No doubt she will do the same with Advent. All this could work out well, but for the patients it could have worked out better. No crystal ball, but taking the shot would not have reduced their chances because the trial was never really blinded.
Does anyone have a rational explanation why Breakthrough Treatment Designation was not sought in 2018 when the preliminary trial results were published? Results could have been unblinded at that point, and the FDA would have provided a date certain for action on a BLA. The explanation provided as to why NWBO has waited so long to lock data, namely, people were living so much longer than anticipated, does not explain why it did not unblind in 2018, provide TLD and seek Breakthrough Treatment Designation (BTD). They could have followed the same population and had the same data they have now, and possibly brought the treatment to market many years earlier. I would appreciate others' views as to whether this was possible. The BTD Program definitely existed in 2018, and as I pointed out, other immune treatments have been granted BTD based on similar, but less, data.
Didn't NWBO have had a good shot at Breakthrough Treatment Designation (BTD), after the interim results were published in a peer reviewed journal in 2018?
Compare a Phase II open label trial in which 128 patients were infused with Abecma, a CAR-T cell treatment for multiple myeloma. Data cutoff was 10/16/19, at which time median follow up was 11.3 months. Trial results were made public at an ASCO presentation and published online 5/22/20. It reported that 94 had met the primary endpoint, overall response; 40 met the #1 secondary, complete response (although NEJM 2/25/21 noted 11 did not achieve a defined minimal residual disease status); #3 median duration of response was 10.6 months and; #4 PFS was 8.4. The FDA granted Abecma BTD 9/22/20, with a published target action date of 3/27/21. The FDA granted approval on 3/27/21.
A significant majority of Multiple Myeloma patients live at least five years following stem cell treatment. Given the average life span of a GBM patient on SOC, and that both therapies act by creating an immune response--certainly the stuff of which breakthroughs are made--the Phase II results reported for Abecma seem no more worthy of BTD that the efficacy shown in DCVax’s interim Phase III results. Did NWBO apply for BTD? Was it ineligible for some reason?
I would like someone to track everything that happens in an uncovered short sale, both a fail and a deliver, including the DTC's books and brokers' books. I know that more shares can be sold short than are issued by an issuer. A friend once explained how he exposed a "bear raid" as having sold more shares than he had brought to market as the underwriter in an IPO. But what is not clear is how shares are "counterfeited." Does it somehow depend on the sale of shares that have not been borrowed, or is the author claiming a conspiracy involving the DTC and brokers simply to adjust DTC books for brokers to show shares which were never issued?
If "coming months" is an indication of greater maturity I'm for it. I started buying in mid-2020 and joined this board in November. NWBO has been lambasted in the trade press, by everyone wanting to manipulate the SP and frustrated retail shareholders. Some of that could have been avoided had they acknowledged that they have limited control over when they cross the finish line.
Have warrant holders attempted to exercise to purchase more shares than are authorized? How many shares would NWBO have to issue if all warrant holders exercised? How many are outstanding and how many are authorized? What happens if a warrant holder advises NWBO it is exercising and NWBO says "wait." Who is going to kill the goose before it lays its golden egg? It seems a significant number of warrants are held by entities which have helped to finance NWBO. They are in it for the long long run. Why would they care if they hold warrants or shares.
Fife is accused of acting as a dealer in securities without the required SEC licence and registration with an SRO like FINRA. That's it. All the blather about toxic financing is meaningless because none of what he is said toxically to have financed is illegal, only his doing it without a license. It would be like Bond taking out Blofeld with only single 0 designation.
This would be similar to the controversy over payday loans, except in the instant case, the financed is just as savvy as the financier, if not more so.
In my experience most government agencies are seeking publicity to justify their existence. That is obviously the case with Fife. Had he been registered, licensed, insured and whatever elsed, he could legally have done exactly what he did. This is a hoax.
There has never been a catastrophe of any nature that the government has not failed to anticipate. After each catastrophe the government passes laws based on what went wrong, insanely believing that will protect it, from being blamed for the next catastrophe. By definition, catastrophes are not predictable, so government never fails to fail. Repeat.
Thanks for your helpful analysis. DCVax will sell itself among well informed providers and patients. NWBO could get started using CR for almost everything else. Once it begins providing DCVax there will be a large increase in SP and hope for GBM patients. Yay.
But there will be a need for the customary education outreach to the segment of the medical community which GBM patients are likely to encounter. Unlike the members of this board, target MDs will not be as familiar with DCVax as some members are. Unmethylated GBM patient may be cautious about yet another treatment, when their life expectancy is already so short. MDs will need to know about the latest combo trials, to offer the most difficult to treat patients. Sales persons making visits to providers and leading practitioners speaking about the treatment has been an adequate model. NWBO would be foolish to reinvent the wheel.
Can they outsource this function? Is it something Charles River offers?
"Contract development and manufacturing organization Cognate BioServices and Nucleus Biologics have partnered to provide custom and commercial medias and delivery systems for cell and gene therapy clients."
Does custom media refer, in the case of DCVax, to custom gel for gel electrophoresis? What electrophoresis method is used, is that the Flaskworks gizmo?
Roswel claims to have posted results of the P2 last updated Feb 1, 2021. I could not decipher what they posted, although that may be due to lack of sleep, headache and brain flatulence. Can anyone determine whether it adds to what was published on Roswel's website: "93.5% alive a year after diagnosis, compared with expected 65% survival based on historical studies."
What is the dosing interval in P3 trial? I did not find it in the online FDA information.
I just want to clarify what I’ve read. The company owned by Linda powers is going to manufacturer DCL which is used for resectable GBM. Gognate now Charles River will make product for non resectable GBM? Powers have a large immediate market upon approval. If there are trials on non resectable GBM tumor maybe there is a demand for cognate produced DCVaz?
That we can succeed outside the brain seems less clear. GBM did not have to build defenses to being turn off by immunology because historically it was impossible to generate an immune response in the brain unti LL came along.
I don’t believe NWBO capable of the construction to the exacting standards of regulatory agencies of all the facilities necessary to make what we speculate are their plans a reality. They don’t do detail well. A serious ramp up to the necessary capability would make waves, with the poaching of some well know people from BP to manage what NWBO principals cannot. They will have to hire and train at least 100 highly skilled scientific workers. That requires trial runs to get the mistakes out before the FDA or equivalent agency provides approval. Look at the picture of the Flaskworks product which automates part of the production process. It does not bespeak durability.
Only BP can step in, make those plans a reality and get the many needed new trials approved and underway. If NWBO tries it could use up its exclusivity period, or a valuable portion, without results commensurate with the potential of DC Vax et al.
You might think NWBO understands this and is acting rationally to maximize value for shareholders. Even if NWBO’s early near death and revival by LP created such trauma she is unable to envision doing anything other than on her own, surely her large investors have found a way to explain the need to have a PB more than just involved, but in control. But one large investor has explained that she is fearful that her investors will take their profits by exercising their warrants and selling stock, further driving up capital costs. Would she take their advice? I think her fear of exercise and stock sale is a clue.
The post last night of “New hints towards a precision medicine strategy for IDH wild-type glioblastoma” was helpful. I do not know whether DCVax targets down to this level, which the author suggests may be necessary to improve results for patients with this puzzling collection of diseases. I do not think so, but I am not making a scientific point: as time elapses and the decades roll on DCVax may be left behind, by therapies which target opportunities based on new learning.
The only relatively safe means of maximizing SH value and getting its products to patients is a sale of the company to a major player BP, which will probably see DCVax as a nice cash cow until more individualized treatments become available, and continue to offer because of benign side effect profile.
Who is going to deliver this message and be heard where trust is so lacking. Publishing and/or announcing PIII results when anyone who has done their research has a pretty good idea what they will be will move the SP (to the extent not already discounted), but only to a fraction of an acquisition by BP SP.
Yes, there’s more. I don’t think publication needs to proceed acquisition. BP doesn’t need the NEJM to explain what NW is worth. And I don’t think NW gains by first publishing. Yes it’s SP would shoot up, but not the value BP would use in an acquisition where NW got out of the way. I would share the data now with likely bidders if possible under an NDA, and then consider offers. NEJM has had to retract a couple of articles recently. Why would NW trust its fate to a process over which it had no control.
There are a lot of unanswered questions for me in what NW could lawfully do to get the best price, but it would seem logical that is what it is up to, if there is a way to make it happen. And complete control not partnership, preferably ownership by BP, seems the best way to max income Long term.
If they had a BP partner that handled worldwide distribution and sales while owning the majority of the company, they would be raking in a lot of $
I lack full understanding of how DCVax is made, and perhaps I misunderstand you. With those caveats, DCVax relies on electrophoresis to obtain the dendritic cells. Flaskworks significantly automated the process (of electrophoresis, right?), but the contraption they created looks amateurish. They were flaskworks, maybe Corning (?), but not Siemens. No BP is going to risk relying on NW to creates tens of thousands of individualized vax. I’m not sure what distribution would mean here. Delivery of the individualized vax?
Notwithstanding best intentions it will take NW forever to ramp up its treatment process. Imagine their BLA is approved. They have a seven year monopoly in each country/EU with a similar Orphan Drug scheme. In seven years because of its complete lack of experience NW produces some product using the Flaskworks Erector Set Rube Goldberg thingy that injures some patients. Merck’s stock loses $50 billion in 24 hours, assuming it were the partner.
Given the seven year monopoly any deal will have a BP in complete control from the moment the seven years runs, preferably a year or more prior, to develop and test reliable modern machines to automate reliably as much of the process as possible. I think NW must be aware it cannot realistically expect a BP to allow it any role other than counting its share of profits. A partnership is not the way I would structure it if I were running BP. I would get learning NW had at the beginning, then keep them far out of the way. A purchase of NW or a purchase or license of its IP would make,more sense, so by the time BP made its BLA it was ready to role out DCVax, and have by then any attractive trials NW hasn’t been able to afford on other cancers well underway. Many firms are trying to catch NW, which could end up a Betamax, unless it acknowledges the need to turn what it has, now, over to a Merck or Pfizer.
My question for those with experience financing NW or other startups is can NW share the P3 results with a BP pursuant to an NDA, and then announce them publicly at the same time BP makes its offer. Some prejudice to other BPs, less so to shareholders—who might have a hard time proving in the long run they would have benefited from a bidding war. Or NW could disclose to several BPs on NDAs and then announce results and accept bids at the same time. Would that fly?
Sorry to hear that. Always tough. Best to you and your family coping with this loss.
Thank you!
Dr. Bala, by statements from the UCLA team, was there a very recent statement I missed, or are you referring to the optimistic statements we have heard occasionally in videos and presentations? Thanks!
Have not been on the Board all day, do not know whether this was discussed. Is this why we are trading in a lower range today. This sounds very similar but not identical to DCVax:
As someone else previously pointed out a reverse split does not change the percentage of outstanding shares held by each shareholder. It is not dillutive. It might be delusional.
Thanks, this was helpful. I'll remember to get my money from my bank and groceries from my supermarket, and not the other way around :)
According to a Corp lawyer the extension runs out 1/10/21, Sunday. In litigation you get to file the next business day, Monday. Since there is online filing either Sunday or Monday the 10Q for third quarter is due to be filed. No problem valuing warrants or options because of events following the third-quarter can simply be explained. For example we do not know whether the present share price reflects the future value of the company; it could be more or less. In either event the valuation of the warrants and options would covary positively with SP.
Strikes me that NW is playing a rather high stakes waiting game. There are plenty of other comers, including DC vaccines, in P2 and P3 trials. NW had a huge head start, but delays have permitted the competition to put candidates into their pipelines, while potential investors become more wary of NW's current mysterious delay. I see no reason why NW should be sitting on results. They can issue a PR on good results, and state they have submitted to reputable journals or better been accepted by a reputable journal. Filing a 10Q is a completely separate issue, and does not explain this delay.
Margaret Thatcher’s memoir of her time as Prime Minister addresses the Tory’s experience taking back entitlements. The US offers less of a challenge than the Torries faced. England’s major industries were nationalized. Both the government owned and private firms were unionized. To the extent the Torries succeeded it was because they were able to explain to the public how a heavily socialized economy hurt the least able to survive, most, contrary to Labour’s arguments. I don’t see any US politician or political movement being able to generate support for a free market as Thatcher and Reagan did. This has nothing to do with NWBO. I saw a post and it reminded me how useful her memoir was to understanding the challenge. If you can remain awake. She is no Churchill.
What does this mean?
Was also 200ma on 60min [Suppressed Image]
Thanks!
Thank you.
Thanks. This would really be the acid test whether NWBO could be persuaded to be more transparent. At the annual meeting retail investors would express frustration with behavior by insiders and institutions probative of secret communications, give examples and ask for transparency to dispel this impression. The paper trail created by the proposal and meeting should evoke concern of regulatory interest.
Shareholder Proposals are governed by SEC Rule 17 CFR § 240.14a-8. I have no background in securities laws or experience using this provision as a shareholder. Has this been tried to require greater transparency by the Board? Many of the folks expressing frustration on this board would meet the threshold of holding $2,000 of stock for a year. If the criteria are met the company must include the proposal its proxy statement for a shareholder vote. The proponents may speak at the annual or any special meeting via phone or video conference. I can imagine proposals that might improve the flow of information. An amendment to the SEC rule will require either longer or larger holdings but does not seem like much of an impediment and will not take effect until 1/1/2022.
I can also imagine that a groundswell of retail investors getting behind such a proposal could improve communications before the vote. Thoughts, history?
Does the company hold annual shareholders’ meetings, and has anyone attended? There are some shareholders rights laws which allow shareholders to propose new rules. I don’t know whether they would apply.