skitahoe
21 minutes ago
Dmb, it may be politics, but frankly I believe the regulators are hearing from the not only the politicians, but also the public, to reduce the cost of developing drugs. I believe the streamlining the regulators are doing is a good start, but frankly they have a long way to go.
I believe that if regulators see with their own eyes that a product is clearly of benefit, with no further paperwork they should be able to issue an EMU that applies until they can review a proper filing and act, or at least for a limited number of years. Any product on an EMU should be sold at a fair price, but each use should be logged in a Phase 4 database which should establish it's efficacy. If negative side effects are seen, it can result in mods to how it's used, or it can be removed from the market. In our case, years ago an EUA would have been possible, the company would have had to build many small cleanrooms, as the EDEN was too far off, but it would still have been very profitable.
Gary
skitahoe
59 minutes ago
The first time it happened to me I took much of my holdings out of Fidelity and put it elsewhere where I still had margin available. The last time it happened I had very little margin, but rather than making the call, I sold some out of the money calls to eliminate the tiny amount that I'd taken. When IMGN was $5+ I'd had perhaps $50K available in margin, and used a few K, when it suddenly went to over $20 they took all margin away, even the $50K available when the stock was $5 was allowed when it was $20. I called Fidelity at that time and spoke with brokers, with their managers as well, I was assured that none of the broker who made that decision could be spoken with, the decision was made by a group that don't speak with regular investors about their actions.
I really can't say how many companies this happens with, or how often, I only had it happen with IMGN, but heard from others who'd had it happen with other companies, and with other brokerages. My point is, the brokers, like the MM's, can influence the share price with their actions. Today, if brokers who allowed investors to take naked short positions in NWBO, if those brokers acted in a coordinated way to say all shorts had to be eliminated the short squeeze would be magnificent even at these low prices, which wouldn't remain for long. I don't believe any routine investor can do a naked short, but if you're a big enough client, anything may be possible. Of course no brokerage want to destroy the relationship with their biggest customers, so they won't independently act against them. They do have rules, and if their short positions are deeply in the hole the rules force them to have their customers eliminate their short and we get a big, beautiful short squeeze.
Gary
ae kusterer
4 hours ago
dmb2
Re: Doc logic post# 706926
Sunday, July 21, 2024 7:39:11 PM
Post#
707465
of 707475
Doc logic, I think FDA has become more political in recent years, it once was the drug regulatory leader in the world regarding its processes and its scientific decision making. That appears to be changing and it has become more apparent that there is more than a noble agenda of protecting the public at play at FDA, sounds a bit like the USA financial markets. The UK has always been quite analytical in its approach and its processes. We always knew at site inspection time the FDA would require massive documents to review at the site while the UK inspectors would take more time to physically inspect the site, and more thoroughly review the physical processing areas and equipment.
The EU has always been a bit of a maze to work with due to the country differences which still exist, though approvals are now more streamlined due to the single process. There are still country level differences regarding labeling, transportation, distribution as well as quality issue resolution though the ICH process continues to reduce major regulatory differences.
All in all it is fair to say what NWBO has undertaken has been a significant set of accomplishments and their strategy will hopefully turn out to be valuable as well as telling regarding how the FDA has slipped. I would love to know more about their pivot to the UK, but that is probably never to be revealed completely.
I am hoping the PIM designation comes through with some prioritization for DCVax-L approval soon.
GLTA
ae kusterer
4 hours ago
Citadel and the 6 other market makers have bought 90% of the American stock market order flow. With this, they exact a trading tax on American stock market investors. In the case of Ken Griffin-Citadel ,$10 billion a year is their annual profit via algorithmic spoofing and naked short selling .
$nwbo @alphavestcap @hoffmann6383 @kshaughnessy2 @BrianEgolf2 @SmithOnStocks1 @ATLnsider @TiltMyBrain @glen_bwrhr42
If Judge Woods denies Citadel's motion to dismiss(MTD), will that result in Laura Posner's capabilities moving U.S. regulators to finally address the Citadel tax… https://t.co/hggX3CJ8iB— alphavestcapital.com (@alphavestcap) July 21, 2024
The $nwbo-Laura Posner lawsuit against Citadel and the other six market makers (https://storage.courtlistener.com/recap/gov.uscourts.nysd.590344/gov.uscourts.nysd.590344.150.0.pdf)
is being brought to a head by the MTD ruling Judge Woods will make in the next 1-3 weeks. Because the $nwbo case presents the first extensively detailed proofs of pervasive naked short selling and spoofing, Judge Woods' ruling will be one of landmark status (https://famous-trials.com). If he rules to grant the MTD, that will mean the legal system in the U.S. will continue allow this cancer affecting the American public stock trading capitalist system to continue. If he denies the MTD , there will be an ensuing plethora of lawsuits that will root out these manipulartive trading schemes, thereby restoring the stock market to a system where natural supply and demand sets prices.
Considering that the Citadel algorithms have “set" the price of nwbo for at least 10 years, it will take the maa approval and/or the dismissal of the MTD to break that grip. Retail and institutional investors have been scared away from $nwbo’s manipulated trading on the OTC market . And it’s that same grip on 1000s of American stocks that earns Ken Griffin -Citadel $ 10 billion per year. And its his $200 million in annual on campaign cotitrbtuions to Congressman and Senators that keeps securities regulators (SEC, Finra, DOJ) from enforcing laws already on the books. But this David-Goliath war(see
@cvpayne
link below) can be turned in David’s favor by the huge cash that can be generated by Judge Woods dismissing the MTD and the MAA approval allowing the start of the commercial sale of DC VAX L. NWBO’s combination trial data has shown MOS extension from 16.5 months with current SOC to 10 years with the Liau combination formulas (see Allen Turner links below).
Impressive LCM strategy before initial approval! #dcvax $nwbo
DCVax-L + Poly-ICLC. Est primary completion Jan 2024. Unpublished interim results: ~50% survival at >8 YEARS.
DCVax-L + PD-1. Est primary completion Aug 2024. Unpublished interim results: ~65% survival at >26 mos. pic.twitter.com/T0jAwH65Uo— Allen Turner (@AllenTurner206) February 15, 2023
?
https://storage.courtlistener.com/recap/gov.uscourts.nysd.590344/gov.uscourts.nysd.590344.150.0.pdfhttps://x.com/alphavestcap/status/1814297519473541421
dmb2
6 hours ago
Doc logic, I think FDA has become more political in recent years, it once was the drug regulatory leader in the world regarding its processes and its scientific decision making. That appears to be changing and it has become more apparent that there is more than a noble agenda of protecting the public at play at FDA, sounds a bit like the USA financial markets. The UK has always been quite analytical in its approach and its processes. We always knew at site inspection time the FDA would require massive documents to review at the site while the UK inspectors would take more time to physically inspect the site, and more thoroughly review the physical processing areas and equipment.
The EU has always been a bit of a maze to work with due to the country differences which still exist, though approvals are now more streamlined due to the single process. There are still country level differences regarding labeling, transportation, distribution as well as quality issue resolution though the ICH process continues to reduce major regulatory differences.
All in all it is fair to say what NWBO has undertaken has been a significant set of accomplishments and their strategy will hopefully turn out to be valuable as well as telling regarding how the FDA has slipped. I would love to know more about their pivot to the UK, but that is probably never to be revealed completely.
I am hoping the PIM designation comes through with some prioritization for DCVax-L approval soon.
GLTA
flipper44
7 hours ago
Yes, Coley’s discovery was interrupted by 130 years, including two World Wars, Chemotherapy, and a pharmaceutical industry that lives to put real answers on the back burner — exceptions being hepatitis C cure, polio and other vaccines for communicable diseases.
You’re right, science is ahead of the curve.
skitahoe
8 hours ago
Thanks ILT,
Frankly it's been many years since many who would have invested in NWBO would consider it again. I'm speaking of a large percentage of investors who won't buy penny stocks, and many in that class consider anything under $5 a penny stock. This of course also includes probably over 90% of Institutional Investors. Some investors and Institutions won't buy OTC's at any price.
I don't see Institutions buying on emotion, unless they're essentially computer traders who're buying, and selling, perhaps many times in the very same day. The Institutions that buy, and hold will come in when the price is stably trading at a few dollars or more, many not till $5 or even $7 is achieved. Many brokers won't allow margin trading on NWBO even at $5 or more instantly, but eventually it will gain that status, and some investors will use it to increase their holding as well. On more than one occasion Fidelity suddenly stopped permitting margin on IMGN after it made a major move up, this forced sales by some investors in spite of having far more equity than before the move. I don't like it when brokerages take such action, how can you say you allowed full margin when a share is $7 and no margin when the price is $20, but they do and in their own way they were holding the share price down by their actions. When brokers take such actions you can move to a different brokerage, but often they act together in this manner. I don't know if major Institutions use margin, but I suspect if they do they're not affected by the decisions of brokers the way individual investors are.
Frankly I expect that when we're stable at $5 or more and on a major exchange the company will conduct offerings priced slightly below the current trading price. The purpose is both funding the company, but also to meet a heavy demand by Institutional Investors who want to establish large positions which provide stability to the company. Even if the company doesn't need the funds at precisely that time, they'll still agree to do the offering that will go entirely to Institutional investors. Individual investors may not like this, but in the long run it's for the benefit of the company, and us investors. In time I'd also suspect they'll ask to raise the authorized shares, perhaps to as much as 3 billion shares, that would give them the flexibility to either take in an equity partner, or acquire a company, like Oncovir, for instance, in exchange for shares. Nothing like this should occur before $5 or more is seen, and we're on a major exchange, but in time I'd bet it will happen unless there is a buyout.
Gary
ilovetech
9 hours ago
Gary - Well said. I have to feel very strongly in my gut, when I choose to make a large commitment. We can call it emotion, euphoria, or just a great story, that motivates people to buy-in. If the story is well told, and all the boxes checked at the right time, FOMO, combined with wanting to buy-in when prices appear undervalued as it rises, we could be looking at something really unexpected. Plus, with the MTD news, if positive, add an up-list with trailing PR's, like you said, anything is possible.
GLTU
skitahoe
9 hours ago
A win, or loss is based on approval. Precisely what day, week, month, or even year that approval occurs doesn't matter as long as it's an approval. If a company fails on one attempt, but still has other shots on goal it's only a failure if all it's shots fail. A shot can be defined almost any way you wish. Some companies have many different products in development, that's what IMGN did until first they gained approval on Kadcyla, but it's Roche's drug, but finally they gained approval on Elahere, which they developed and owned. I often put down CVM, for at least a few decades they've had one product, they keep trying that product against different targets, it keeps failing and they just turn around, select another target, and use a good search and replace program on all their prior press releases and insert their new target for the abandoned old one. Perhaps some day their cure will find it's disease and they'll have great success, meanwhile they do reverse splits and issue a lot of new shares along with PR's that are confident that this time their technology works on the newly selected disease. I will admit that I invested in it many years ago, it was called CVM even back then, but they used the symbol HIV, and of course the target back then was AIDS.
I believe our first full shot, DCVax-L, will be a winner and it won't be that long before we know it. I say full shot because I wasn't in the company at its genesis but believe they had others, like DCVax-Prostate and I'm not certain they didn't have it before DCVax-L, but it was the first they determined to take into pivotal trials, so it's their first real shot. I frankly don't know if in the future there is a place for DCVax-Prostate, of if DCVax-L and/or Direct will fill that role without a separate product being brought through trials.
I certainly believe the company will be developing, or acquiring new technology, as in their recent agreement. New products will either build on the success of the DCVax's, or perhaps improve on them, and ultimately replace them. Almost nothing is absolutely forever, but some products are good for over a century, like aspirin, while others last a decade or two before improvements lead to better versions that ultimately replace the earlier versions. A decade from now we might see improvements on the DCVax's by others, it won't matter, we'll be wealthy beyond our expectations far before then.
Gary
skitahoe
9 hours ago
There is almost nothing a CEO can do to expedite what's demanded by the regulators to approve a therapeutic. In IMGN's case, the regulators could have approved Elahere years before they did, but they insisted that IMGN try the drug in a greater percentage of the patients than it was originally targeted at, when the trial proved that rather than approving the drug based on the benefits by those it was targeted at they said, there weren't enough of them, go run more trials. The did allow a smaller trials to reach an approval, but wanted a larger confirmational trial which eventually showed the same thing. By the time the confirmational trial was completed, the company had been sold for a low ball price IMHO.
In short, companies are at the mercy of the regulators, and the regulators are generally thought to favor the BP's over the tiny Biotech's. LP has done an amazing job getting the company to the brink of tremendous success. I believe we'll achieve that success well before she either sells, or retires from the company.
Gary
skitahoe
9 hours ago
Ilovetech, you're partially right about what I've said about sustained prices being revenue based. What you're wrong about is what I've said about what could happen on mass media coverage. If we get the right mass media coverage trading won't be based on revenue at all, not even on anticipated future revenue, it will become emotionally based. When you have emotionally based trading, trying to guess how high up is isn't possible. Many years ago NY Times headlines on Judah Folkman curing cancer took a $1 company to over $100, that's what emotion can do as without really doing any DD new investors want in and with share price rising on practically every trade market orders sustain this trend.
I certainly believe any price you name possible, but it won't be sustained. Personally at $10 I'd start placing stop loss orders for a substantial part of my holdings, I'd put more shares on those orders at $15, and all the shares would be in at $20 or more. I'd be thrilled if it went to $100, but out when if fell back to $90. If it went to $20, I'd probably be out by $18. While I don't love paying taxes, I'd gladly pay for these huge gains and probably by back perhaps as much as double my holdings when the price drops to where it actually belongs.
When the emotion is removed, I believe a market cap of $3 to $7 billion could be sustained, so I might buy back in as low as $2 or as high as $5, but until we have more than UK approval, a market cap above those levels isn't justified. When I say more than UK approval I'm not saying we must have other approvals, I'm saying we need news that's clearly leading that way. The news could be the approval of the EDEN, or perhaps filing with one or more of the other regulators including perhaps our FDA in the belief that the EDEN would be approved in the time the filing was under review.
With approvals by all, which I believe very possible in 2025, revenue may not yet be huge, but the world will recognize the potential going to double digit billions rapidly. Let's look at what anticipating $10 billion in future revenue does for NWBO. I believe that a company with rapidly increasing revenue warrants a P/E of 30 or even more, that's a market cap of $300 billion. If our shares outstanding grow to 2 billion we're taking $150 a share, even if we go to 3 billion shares we're still at $100. I'm not saying that in 2025, but 2026 is certainly a possibility.
I've never seen myself as someone who'd ever possibly pay over $1 million in taxes, but clearly it would be possible if I see a runup on emotion to $10 or more with UK approval. I'll take it and be thrilled with it, but I won't be selling as it's moving up, rather with trailing stop losses that are a buck or two below the price the stock is currently trading at. The higher it goes, the bigger my spread will be, at $100 my stop loss might be as low as $90 and I'd be thrilled to take it higher if the stock ran to well over $100 even. It could happen, but remember it would be trading purely on emotion. Many wealthy people reading the headlines would have to be saying, I want into that company at any price. That's what happened years ago with Dr. Folkman curing mice and it could happen again if NWBO becomes acknowledged as being the new paradigm in the treatment of cancer.
Perhaps the best news for all who purchase on emotion is that if they hold on to their shares for just a few years, regardless of how low it falls, in time those shares will be in the money. Of course I'd also expect those willing to hold on to average down, so their break even is somewhere in the $20 to $30 range if we see $100, that would be very achievable by 2026, and perhaps in 2025. When it occurs it would be on earnings, or more likely anticipated earnings, but the really good news is that there is no top to how high earnings could go if DCVax-L becomes a part of the SOC in most solid cancers, and finally DCVax-Direct is approved for inoperable cancers. I'm still of the strong belief that when DCVax-Direct is approved, many smart oncologists will inject it into the tumor prior to surgery to get it into the mets so that mets that can't be found, or removed during surgery are pretreated. Follow that with DCVax-L after surgery and I believe you greatly reduce the chance of coming out of remission many years later, as what happened after a decade with my sister and ultimately killed her.
I believe what I'm suggesting makes common sense, DCVax-Direct can be made at any time, you don't have to wait for a determination a cancer is inoperable. I'm not sure DCVax-Direct wouldn't benefit other diseases, I just don't know where you'd inject it into. A cancer before surgery is certainly injectable, most are sampled with needle biopsy's, so they're certainly injectable. I frankly don't know if when injecting DCVax-Direct you put all of it in one spot in the tumor, or if you try to spread it around in multiple sites in the same tumor. Certainly if more than one tumor is present some of the vaccine should be targeted into each of them. In that DCVax-Direct only requires leukapheresis there is no limit on how much, or how many times it's made.
Clearly I'm not an expert, this is JMHO.
Gary
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