Does anyone actually review 1.7 million pages, I think not. I certainly don't know, but I would guess that under 1000 pages are deemed to be critical and subjected to such critical review.

To me, the problem with the regulators is that they demand such a document, and of course, the industry complies. If they want to cut the costs of drug development, just reduce the filing to not more than 1000 pages.

Gary

Wouldn't it be interesting if they added DCVax-L and suddenly Keytruda did a much better job. The only way we'll really know is when more trials, or anecdotal experimentation is done.

Gary

I think we all need to realize that a CDMO working for NWBO is very different from a CDMO working for anyone else. Most CDMO's are building big production units to make many doses of the very same thing in ever increasing numbers to meet demand. In NWBO's case you cannot make the EDEN unit bigger to make many more doses, you must make them individually so it's not one big machine, it's tens of thousands, or more, of these relatively tiny machines, and each batch that's made must maintain it's unique identity for the life of the patient who's cancer it was made from.

I'm not saying some CDMO's may not be able to develop this capability, I'm just saying that it will be something that's totally different from anything else they make.

Gary

I'm not suggesting that approval of DCVax-L should be delayed even a single day, but what if the following were found to be true. What if in trials people on SOC plus DCVax-L weren't living any longer than without it, but adding another therapeutic suddenly improved survival ten fold, but only is it was given with DCVax-L. Certainly such findings would require an adequate sized trial, but I don't believe it would have to be very big, or take too long, but it would be an additional trial.

We don't have that situation, DCVax-L is more than doubling the five year life expectancy, which I believe is more than adequate for approval, but we all know that ten times that SOC life expectancy is readily available with additional therapeutics that have been approved for other cancers, but not GBM. I don't believe that getting them off-label will be a problem at all and in fact I think the regulators will encourage it, though not fully endorsing it until some further trials are completed.

Gary

It's been some time, but I believe at one time it was indicated that vaccine made in the EDEN unit would actually be purer than what's made in individual cleanrooms. If this is true, should the higher purity prove to be a problem as it's different from the manually made product.

Gary

You could be right Iron Mike, but as I see it, every week we're one week closer to news. I don't know when it will hit, but I also don't believe that our news will be limited to one major release. I don't know that the company has planned a major PR campaign as they roll out the vaccine toward regulatory approval, but I believe they'll start to open up about all that they've been developing over time.

Of course you can't make news where none exists. When the time is right they'll tell us that the EDEN unit has been accepted by one or more of the regulators, but they can't say, it's almost accepted. It is, or it isn't. Once one regulator has accepted it, I believe the others will go along over time, but I never fail to be amazed at how much time out FDA can take to do anything. I think the decision to go after the UK was a logical one, even though the vaccine was largely developed in the US. Why? Because with all the compassionate use in the UK, and the manufacturing facility in Sawston, the UK has the greatest experience with the vaccine and its production, at least if it's done manually in cleanrooms.

I certainly can't say if the company, or the regulators, if either, have determined to wait for EDEN before applying, or if the submissions will be made regardless of the status of the EDEN. Long term it certainly should be the answer, but if you had to do it all manually, you certainly could, and production could still be very profitable.

Gary

Robot,

I think you're right, next year I believe we'll have greater success than in the recent past, I believe we'll reach a share price in the $5 to $10 range, but in December of next year investors will be saying, Wait until 2025.

Frankly as long as NWBO remains independent, I believe that each succeeding year can be dramatically greater than the past one as long as it's clear that our vaccines work in cancer. The more cancer they're proven to work in, the bigger the company will grow. The more countries that approve our vaccine for use, the bigger the company will grow.

Certainly it's clear that by itself, our vaccine isn't curative, at least not for most patients. The point is, the vaccine leads to incremental change. In some cases, that increment might be small when used with the SOC itself, but as we're finding in GBM, add others and the incremental increase is ten fold over the SOC itself, or over three fold when our vaccine is added to the SOC. GBM is certainly one of the deadliest, I don't know if pancreatic is as bad, or not, but even a small improvement there would be considered huge. On the other hand, if over 90% are already being cured from a given type of cancer, it's hard to say if the regulators will recommend it if it achieves a small incremental improvement there. The potential is huge, even if it's not every solid cancer, but give it time to learn how many it will be.

Gary

It seems to me that without news, each week begins lower, than as the weekend approaches, starts moving up in anticipation of new early the next week. I believe that will be the case again this week.

Dramatically higher prices really need that news, but we could move up to the $1 range before we get the news.

Gary

More success with an IMGN developed product.

https://finance.yahoo.com/news/press-release-sarclisa-isatuximab-phase-063500551.html

I'm frankly uncertain how great IMGN's financial interest is in this, but clearly it's a greater indication of the value of their technology, and further indication that the buyout offer is too low.

I'm purchasing some out of the money future calls in hope that we'll get a better offer.

Gary

I didn't say UK approval, I said acceptance of the filing, I still believe that's possible this year, but certainly early next as long as we've filed this year. Approval will take at least a few months, in the UK they shoot for 4 months, but I believe that their experience with DCVax-L might get the job done in 2 to 3 months. JMHO.

Gary

I suspect that when we get an announcement it will combine the Annual Meeting with the submission or acceptance of the filing in the UK.

Gary

If someone were diagnosed with GBM today, it probably would be January, or later that surgery was done. With a properly preserved tumor the probability of having DCVax-L treatment while it can still be of benefit is probably better than even if all four regulators have approved by the end of 2024, or perhaps even by mid year of 2025 provided that on approval the supply can meet the demand.

I believe the key to that is the EDEN unit, and its ability to be mass produced once it's been approved.

While the sooner you get the vaccine the better, as I gather it people who crossed over after progressing in the trial are still alive today, so for the right patient, even if their tumor was cryogenically preserved early this year, once we have an approval there may be a chance.

I think this is the message that needs to be seen by brain surgeons all over the world. The cost of cryogenic preservation is somewhat higher, but it's certainly worth the added expense. I cannot say if there are other therapies that also need this, but clearly it doesn't hurt. Now the question should also be, should patients undergoing cancer surgeries also have their tumors stored cryogenically. I don't see where it would hurt, but might save a lot of lives.

Gary

It's my belief that if they achieve an acceptance by the UK in time to do so, they'll announce an Annual Meeting before the end of the year as well. A minimum of 10 days are required, if certain actions don't require additional time, so they could do it up to roughly the 20th.

If they fail to do that, I still believe an AM will be announced for some time early in the new year so it shouldn't be that long, but almost certainly not until they have something positive to say about the submission to the UK, and perhaps far more than that.

Gary

It's been a heck of a weekend for a football fan, the mighty have fallen, both LA teams won, the officials blew obvious calls that changed the college rankings completely, and may have cost KC a shot at tying the game. In short it was exciting, but it also showed how flawed the way games are played, and officiated is. I often wonder if the moves on the stock market are better, or worse than what can be observed in football, or other sports on any given day.

I'm no fan of Alabama, but I'd say the odds are pretty good that they'll be the national champion again, all because a review wasn't done after a long completion, where control of the ball was clearly lost on the ground when watched in detail, but they didn't review the play. The resulting touchdown cost Georgia their number 1 rating, and moved them completely out of the playoff picture. My Ram's amazingly were in the playoffs for a few hours until Green Bay knocked off Kansas City, who really should have had a better shot at a tie after an obvious pass interference call wasn't made. Do the refs give home field advantages, perhaps not intentionally, but it generally seems to be the case. In baseball, how many players strike out on balls clearly way out of the electronic device, or oppositely get walks on balls that are clearly in the strike zone. None of the experts picked Green Bay to win, and many self proclaimed experts here are positive that NWBO will lose because they're not doing things the normal way.

I guess I'm saying that you can never be absolutely sure of an outcome, or how the officials will call a play, or the regulators will call the results of a trial. I feel strong about DCVax-L's chances of approval the first time through, but nothing is 100% sure. There is no doubt in my mind that DCVax-L is needed, and at some time will be very big, but I can't say it will happen on a particular day, month, or even year. I've never had a product that I felt certain would be approved and not have it approved, but some were certainly not approved on their first time they were sent to the regulators. I think DCVax-L should be, but nothing is absolutely certain with the regulators any more than an official calling balls and strikes, or penalties in a football game, etc.

Gary

Honestly my position is much bigger than I ever planned, but I'll never say that under the right conditions I won't buy more. I do believe that if the buyout goes through at this, or higher prices, I should diversify into one or more additional stocks. I want to look at other options.

If NWBO does what I believe it will, I'll probably go into more of a wealth preservation mode, stable stocks with substantial dividends. I don't want to make such a move until I'm well into 7 figures, but it's a lot closer than it's been in some time. I really believe that NWBO has nearly unlimited growth potential, if it's not bought out. I can't say that I believe IMGN to have that much potential, but certainly believed it could match or exceed SGEN in time, and I'm sorry that won't be allowed to happen. I still think IMGN's technology is superior to SGEN's in at least some of the areas they've chosen to attack.

Over the years IMGN often acted before they could get maximum value, frequently with offerings just before major gains in stock prices that were predictable based on what they knew was coming. I believe this buyout is much the same thing, they're finally in position to really grow, and they're selling out too cheaply. I'll live with it if it goes through, but hope the Institutional owners feel the same way and say no, we want more.

Time will tell, I'm open to ideas.

Gary

Biosect, I understand the objectives of the bashers. I just hope that when I challenge them with objectivity people can see that I'm right about the flaws in their arguments.

There is no doubt that some knowledgeable, far more technically knowledgeable people than me, are traditionalists, and if you believe that regulatory tradition can't change the way this trial demands, you cannot accept that the regulators have agreed to the changes required to make the trial successful. Perhaps I'm an optimist, but I believe that the regulators have been well briefed on what was happening in the trial and agreed it should proceed with all the changes. I gathered that the German regulators were the ones who insisted that DCVax-L be given up front, not wait for signs of progression, or pseudoprogression, and all the other regulators agreed on that change. Frankly I'm unsure if way back then some of them would have terminated the trial, and approved the vaccine immediately based on what they'd seen, but I certainly don't know this for a fact.

I believe that if regulators were truly dynamic this could have been approved years ago, and all uses of the vaccine could have been treated as a massive Phase 4 that tracked all results regardless of how it was used, or on what cancers. If you look at First, Do No Harm, our vaccine only does good, if it does anything at all. If it could be made available under Right to Try at reasonable prices, without the company having to give up proprietary information, I believe a lot of it would have been sold at pre-approval prices. That's true of a lot of other experimental products as well, almost no companies do Right to Try as they're unwilling to provide the information the authorities want. What good is an FDA program that no one chooses to use.

I don't know how they determined the price to charge in the UK, but I don't believe the Govt. got the same sort of information our FDA wants in permitting Right to Try to charge for experimental treatment. I believe that our trial will be looked upon as an example of the changes that are coming to the way the FDA and other regulators operate. It's far from a perfect example, it certainly could have been done faster, and cheaper, but in the end it is changing the way business will be done in the future. That's something that people who believe in traditional trials with patients in control groups that never see the benefits of the experimental products are going to have to realize is wrong. Control groups should be a part of trials for diseases that are not life threatening or disabling, but if diseases are deadly or disabling, all who volunteer for a trial, and can be properly accommodated, should get the experimental product.

Gary

What bothers me the most about those who attempt to diminish the trial results with DCVax-L is their total ignorance of what happens when other therapeutics are added to DCVax-L. Granted, it's a much smaller and earlier phase trial, but who can ignore that if DCVax-L is approved, using other approved therapeutics with it, suddenly 50% or more are surviving beyond 5 years.

Would these so called experts really want to keep DCVax-L off the market long enough to prove this is a fact in a follow on Pivotal or Registrational Phase 2 or 3. How can these self proclaimed experts ignore the advancement that's possible in GBM and other cancers if they encourage its adoption.

Gary

I'll hold until at least the vote, if they're going ahead with the buyout I may sell, depending on how close the share price is to the offering price. I still believe the price could be moved up, it should be.

Gary

Dstock, I'm not dissatisfied with it being sold, I just believe that if the Institutions examine the agreement they'll realize that IMGN should have been priced substantially higher. I'm hoping they'll reject the deal unless the offer is substantially enhanced, or of course a much higher offer comes in from someone else. I believe even $40 a share is lower than it ought to be.

Gary

I'd strongly recommend taking a look at NWBO, if I'm right their potential may be unlimited as they use the cancer and white cells from the patient to create a vaccine that's specific to that patient. They proved the concept in GBM, one of the toughest cancers, and at UCLA they combined it with Poly-ICLC and/or Keytruda and have taken 5 year survival to 50% or more. The SOC has 5% survival, and the vaccine alone achieved 13%, but the other therapeutics don't work without being combined with the vaccine.

Under compassionate use in the UK several patients with different cancers were treated, and while it's just anecdotal evidence, it's enough for the company to openly say it's a tumor agnostic vaccine. On GBM approval alone the stock should go into double digit prices in a year or so, but with a tumor agnostic label, just move the decimal point a couple or more to the right, if it isn't bought out.

The vaccine has virtually no negative side effects, but in GBM, and perhaps all the other solid cancers it increases T-cell counts dramatically in the cancer, so your own T-cells are fighting your cancer.

There are many bashers casting doubt on the trial, but I believe the regulators have been involved, and accepted all the changes and approvals will come, perhaps with confirming trials required in the future. No doubt there will be several trials post approval to expand the label to truly tumor agnostic.

By the way, I'm really not that certain that the Institutions will agree to the buyout price, ABBV's estimate that sales for Elahere should reach $2 billion a year may tell the Institution's that this price is already too low, and it's not providing any real value to IMGN's extensive pipeline and partnerships.

Gary

Gus, I believe that what you generally say is true is, but there are exceptions. Look at trading in IMGN before a buyout was announced, I don't believe that there is any indication of what was coming. Many execs in the company had recently sold substantial stock, so they certainly couldn't have known what was about to happen.

Given our share price today, there will be days in the future when we'll go up, or down by more than what we're selling at today, but it won't happen until we're selling for dramatically more than we're selling for today. I do believe that with the right news our price could be doubled or more in just a matter of several days. It happened before SUNY, but this time it will stay up because it will be fact based and unassailable by the likes of AdamF, though he may try.

Gary

Honestly I don't see NWBO execs doing anything that other biotechs and other execs in general have been doing as long as I can remember. I'm frankly unhappy with IMGN which after decades searching for success are selling out just months after they finally achieved it. I believe they could have gone much further, and received far more, if they allowed their success to grow. I hope we don't have the same situation here in time.

Frankly execs all over the world, not just in the US are increasing their salary and benefits at rates that are tremendous multiples of what working people do, I really doubt if this can continue much longer. LP has been awarded many shares, but she was wealthy before ever being involved with the company. If DCVax's get tumor agnostic labels and the company remains independent, she could be bigger than Musk in time. No one really needs that kind of money, but it's said that Putin is actually the worlds wealthiest person, though we'll never really know.

Back when the Govt. took most of what execs earned things were actually far better for the average worker, but the lower the tax rates went, the greedier the executives became, as they could keep far more of what they earned. Now with all the loopholes they have they're building yachts as big as smaller cruise ships because they can write them off. Likewise multiple mansions, planes, etc. I suspect that most of our biggest paid people would still do their jobs if the decimal place in their compensation package moved a couple places to the left, but they'd prefer moving them to the right.

As long as money can buy politicians, we'll get laws that are what the wealthiest people want, and the politicians will leave office far wealthier than when they entered public service in spite of having salaries that by executive scales are mediocre. Sadly none of them will be placing the good of the country above that of the party, and few compromises will be developed that really does what's best for the country. If it were up to me, politics would be publicly funded, no campaigning before a few months before an election, in short, our politicians would be working on what's good for the people, not spending most of their time raising money for their next campaign.

At least people like LP are trying to do something that will truly benefit many people. Too many people are only doing what's best for themselves, and many of them are our politicians and those who fund them. The worst, IMHO, are the dictators, or wannabe dictators, who are placing almost no value on the lives of those they rule. Some creative geniuses, like Musk, can do much good, and bad simultaneously. I can't agree with many of his views, but he's certainly created advances that can make for a better world.

Gary

Vinmantoo, we're in much the same position, but I'm far from thrilled about the price IMGN is taking. I understand that ABBV's revenue estimate for Elahere alone is $2 billion a year, that alone should justify a $20 billion buyout with a P/E of only 10 and it could very well be 20 or more over the years. In the clinic they're already getting what should be the second generation of Elahere, an even more effective drug which should have a broader label. Their drug, Pivek, for BPDCN ought to be a sure approval for it, whether it's benefit in leukemia is that great, or not. It may, or may not be a blockbuster, depending on the outcome with leukemia, but it's a miracle worker for BPDCN.

They still have their technology in a number of other partnerships where with approval they could earn substantial milestone and royalty payments, I believe all of those will remain in force, only it will be found money for ABBV, not IMGN.

I may be one of the few who've been in this essentially from it's beginning, I've always felt in time it would have a big payday. I believe this is a moderate one, not one that's really big to celebrate. I hope that one or more of the Institutions see it as I do, if they do and make their opposition clear, I believe others will support a no vote and it will either achieve a better offer from ABBV, or a much higher price if the company operates independently for another year or two. At least in a year or two a much greater knowledge of our pipeline will be known, if it's positive we'll be worth a lot more, if it's not, Elahere sales will still be higher, so we'll be worth more than we are today.

My position in NWBO is already quite large, and if it's up in the next few months, as I expect, it could exceed IMGN, so I don't know that I want to add more to it, though I believe their vaccine could become a part of the SOC in many solid cancers in the next several years with trials proving the vaccine is truly tumor agnostic. I'm considering a position in AVXL, their Alzheimer's drug has a good chance of getting European approval sometime next year, if it does, I believe the FDA and others will follow. I'm certainly happy to learn of other leading edge companies to consider.

Gary

I certainly hope this is possible, if it is, not only will the patient be getting DCVax-L, it should be coming with Poly-ICLC and/or Keytruda. I would think that the key would be UCLA accepting them in the trial before they come to LA.

To my knowledge, UCLA is the only one with an ongoing trial. Compassionate use is still available in the UK, but that's for a fee. I'm uncertain if patients in the UCLA trials pay for all, or part of what they're receiving.

Gary

It's not yet scheduled, but that doesn't mean it won't happen this year, they still have weeks before they must announce.

I don't know if it's proper to announce an Annual Meeting for 2023 that occurs in 2024, but I suppose if it were tied to an Annual Report, which should come in late February, or early March, it probably could be done. If NWBO were on a major exchange this probably wouldn't be acceptable, but things are looser on the OTC. I hope this is the last year that we're an OTC stock at the end of the year.

It's really up to the company, a meeting this year may not have as much to offer shareholders as if they wait. By the same token shareholders may be overjoyed to get whatever crumbs management can announce that indicates progress and a sense of direction. Nothing would prevent an Annual Meeting this month, and a webcast of the Annual Report which further documented what's been accomplished, and what's being planned.

Gary

Flipper, if I'm right I hope they're able to indicate acceptance, but frankly I believe what will be more important in the Annual Meeting is establishing their intent with the other regulators, status of the EDEN unit, and intention to begin additional trials with some indication of how they'll be doing them. I know they won't be giving precise information, but it's been quite awhile since we've been given any guidance at all on their long term plans.

We know the things I'm suggesting they work on will cost substantial funds, while I believe that share prices will be dramatically higher with the submission, and higher still after the approval, it's hard to say if their strategy is funding through newly issued shares, or if they're willing to state that other possibilities are in discussion. Frankly at a share price of $3 or more to go toward 1.7 billion, I know they have a lot of options outstanding, but it seems that they need not be counted when issuing new shares, as they can ask for more if necessary. I believe that if equity partnerships are to be part of the future, they either should ask for more shares to be authorized at the Annual Meeting, or wait to hold a Special Meeting to authorize such shares and approve a partnership. I really believe such a partnership shouldn't occur at less than double digit share prices.

I believe that the EDEN could be the key to substantial revenue, if that's the way NWBO decides to play it. A license with CRL, Advent, or anyone else to make, store, and distribute DCVax-L with licensing the use of the EDEN and establishing a leasing arrangement for them could bring in substantial funds, instead of costing them money to build the EDEN's. Every batch of DCVax-L would make money for both the producer, and NWBO, and those funds could be structured to come in as the vaccine is distributed, or NWBO could receive their full payment when the batch is created. While I'd prefer seeing both share the profit for as long as the patient is getting the benefit of the vaccine, making more the longer the patient lives, either option is possible.

Of course there are other options, a buyout would take it out of their hands completely, but they could also take on substantial additional debt and keep all manufacturing, distribution and sales in house with the EDEN's cranking out 50 or more batches of the vaccine every year. As I understand it, the money they should receive for one batch will more than pay the cost of one EDEN unit. Of course the production facility is far more than that, but the EDEN is the key, I believe that most of the rest is available off the shelf or can be contracted for, at least initially. Production would expand dramatically with a tumor agnostic label, or a lot of off label use.

Gary

This would be in line with him filing taxes at the last date, which was delayed to mid-November. He could sell just in time to have the money clear into his account by the time the check was submitted.

I really don't know why we're making such a big deal about this. No doubt it should have been out weeks ago, but he's not routinely doing such things so I doubt if he'll have a problem, but if he does, it's his, not the companies responsibility. We're making a mountain out of a molehill.

Gary

Out of curiosity I looked up the notice required for an Annual Meeting. At least 10 days must be allowed, and no more than 60 days. Under certain conditions at least 25 days must be allowed.

If an AM is to be held this year, and conditions require it, it would have to be announced this week, but if no such conditions are required they have until the 20th. I'm not certain it will happen, but if it does, we should know fairly shortly.

I certainly think they'll want to have filed, and hopefully have an acceptance by the UK before holding the meeting. I believe this month is still possible, but the filing would have to come real soon. If it doesn't occur, I would hope that by the end of the year, the date of the last Annual Meeting the scheduling of the next meeting is made. With 60 days permitted, if they wished to do so at that time they could hold the meeting rather late in February and be in compliance with the guidance. I think they'd be violating guidance that indicates one should be held every year, but it seems the regulators don't care and unless sharehold.ers formally complain they can do practically anything they wish, as long as they're on the OTC.

I once had a Pink that held no meetings, issued no quarterlies for a few years, then suddenly they filed all the back reports and sold the corporate shell to a completely unrelated company. The Pinks are even looser than the OTC, though little governance seems to occur in either exchange. In recent quarters LP has been on time, or even early, with quarterly filings. I believe she's trying to do things in the manner they'd be expected to be done on the bigger exchanges, and hope the Annual Meeting isn't delayed to over 12 months from the last meeting.

Gary

I thought that was the case, it seems like a mistake was clearly made and rather than ignore it, they did it late, but it was done. I don't know if the SEC or anyone else makes this big issue, but hopefully not.

Gary

Dr Bala,

As you may have read, I've been congratulated for the gains I've made in the announced buyout of IMGN. In my answer you may have seen that while it's a nice profit, I really wasn't thrilled with the price and am hoping we get other offers or that the Institutions, who own 92% of IMGN turn it down. I feel the same way about NWBO, a buyout could be a great thing, but only if it comes in at a price we welcome. From what I've gathered here, I believe that most investors want to see $20 a share or more, I certainly could live with that far better than what IMGN was offered.

As of now, IMGN investors apparently don't have the option of taking stock in ABBV in lieu of cash, thus all will face the taxes it generates. If we have a buyout, I'm hoping we can opt for shares or cash, and ideally a mix of both. Frankly, if it were up to me a buyout decision wouldn't come until DCVax-Direct has at least reported preliminary trial results from a new trial, and DCVax-L has reported similar results from a new trial for multiple solid cancers. I doubt this could happen in less than 3 to 5 years, but at that time the true value of the company could be accessed. I would expect by then if we've only taken the GBM market worldwide we'd be somewhere in the $30 to $60 range, or higher, so we'll hardly be hurting for not taking a $20 buyout a few years earlier.

Even if we look at my worst case, $30, and it took 3 more years, if you took stock in say a BP that was selling for $200, I.E. one share in the BP for every ten of NWBO at a $20 buyout price, do you believe 3 years later that BP is likely to be worth $300 including all dividends. I don't think that kind of growth is seen in many BP's, at least not on a sustained basis. As long as what we have is very promising, I'd rather stay independent. Nothing says that in 5 to 10 years we can't be trading in triple digits, like a BP.

Gary

I don't know if there was any particular strategy in putting out what they did after the bell, but it sure got a lot of attention. Frankly I believe it's meaningless, probably had to be issued by regulations, so it was dumped after the bell on Friday.

What's important is what's happening in December, and then on through 2024. I know we've been waiting quite awhile since our predictions for 2022, but I believe 2024 will be the first year of many that we can truly call OUR YEAR'S.

Gary

Please correct me if I'm wrong, however it looks to me like all transactions occurred on Nov. 16th and 17th, I don't know why they were reported today, but they didn't happen today unless the transaction dates are incorrect.

Gary

Yesterday I suggested that todays trading would indicate the thoughts of investors on what's anticipated in the early part of next week. I really wasn't thinking that FOMO would generate as big a gain as it did, but clearly I believe that investors are of the belief that not just next week will be big, but we'll close the year with a big December.

I certainly believe that December will give us an announcement of filing with the UK. I think it could still have an Annual Meeting scheduled late in the month, and if not at least an indication of when it will be scheduled.

To me, the Annual Meeting is a major event because it's the one time a year the company states what their progress is on things like the status of the EDEN unit, regulatory filings, and plans for new trials. Clearly there are other times when such information could be discussed, but the Annual Meeting is one time it can be relied on.

It's my hope that as this company's share price rises, as it's moving toward a listing on a major index, it will begin to act more like the companies that are listed on the major exchanges. To begin with, I'd like to see webcasts with each quarterly where updates like I discussed as part of the Annual Meeting could be given, Analysts questions could be answered, etc. Secondly the CEO or other representative could make appearances at a wide variety of Brokerage and Institutional Conferences. In short, the company could start to attract investor rather than leaving it up to investors to find them.

I don't know that this will happen overnight, but I believe over time the demand for NWBO will grow dramatically as most of the investment public who've never heard of NWBO do hear about it. The more they hear, the greater the demand, and the higher the price. I don't know that the company's done enough to get an invitation, but I'd be thrilled to learn that they were invited to make a presentation at the JP Morgan Healthcare Conference, normally the first major such conference of the year. Frankly I doubt it this January, but in a year I'd practically bet they'll have a major presentation there.

I don't know what will be announced next week, but I like the odds of breaking $1 next week, and perhaps new 52 week highs before the end of the year.

Gary

Thanks Jesster,

My first shot did have benefits, the Dr. believed a second one just below the first may produce further improvement. It's worth a try. I'll also be getting physical therapy and acupuncture. I've use chiropractors before and don't really want to this time. To many of them think they can cure anything with chiropractic, including leukemia or other cancers.

I suspect that some of the aches may be caused by the need for certain nutrients and/or vitamins. I started taking them more frequently and something seems to be improving, but at time the pains seem to come in swarms. I frequently slap a salon pas on when I cramp in my sleep, some nights I use a half dozen of them.

I suppose that aches and pains while growing old is better than the alternative. I'm reminded of the story I heard where an elderly couple arose one morning and the wife complained, it's terrible, what's wrong the husband asked, she repeated, it's terrible, awful, what's the matter he asked, nothing hurts, I must be dead, she answered.

Gary

Tomorrow we begin the last month of the year, whether we're up tomorrow or down may largely depend on what the thinking is about what's anticipated for next week. If investors believe that Monday, or early next week news will be forthcoming, then FOMO will probably lead to higher prices tomorrow. If no news is anticipated in the early part of next week, it's likely we could have a loss.

Personally I'm having another spinal injection tomorrow, I'm hoping it's all that will be needed to avoid further surgery, at least for the immediate future. I'm of the belief that the cramping I have is not caused by the spine, but I still need to get to the reason, which may be age and perhaps arthritis. Today I saw my nephrologist who's very pleased with blood pressure and kidney function, which is my reason for seeing him. Three Dr. appts. in one week is about as much as I can take, hopefully between all the Drs. we'll arrive at some way of sleeping without Charlie horses, trigger finger, etc. while attempting to sleep.

Gary

I don't believe that DNDN worked nearly as closely with the regulators as NWBO has. I'm uncertain if DNDN management had anything to do with the way the investors went after the FDA, tried to make a case in Congress, etc. but I suspect that they didn't try to quash it in any way. I don't believe the FDA or other regulators ever like to be lectured by overly enthusiast shareholders, I don't know that they caused delays, but I very much doubt that they helped. I frankly forget if DNDN was only dealing with the FDA, or if they were working with other regulators as well, I can only remember investors trying to push the authorities here in the US.

I suspect that if DNDN had a device, like the EDEN, in development for making Provenge, they may have been able to profitably operate at a lower list price and the company thrived. I never had a position in DNDN, but did have some calls at one time, however I know people who did profit very nicely, but others who rode it down to oblivion.

I've believed in what IMGN's been doing for roughly 40 years. While I'm pleased to finally be right, I really believe they could get a substantially higher priced offer. If they don't, I'll have profited nicely, but not nearly what I'd hoped for after all this time.

I believe that there are people here who've been involved in NWBO essentially from its infancy. While that's not as long as I'd been with IMGN, the belief is equally strong. Hopefully nearly all are profitable today, or nearly so. It won't take much for all to have essentially the same percentage profit that I've had in IMGN, and you'll be doing it in less than half the time. I don't think it will be that much longer before the percentage gain is well over that in IMGN, unless they get a much improved offer.

Gary

pgsd, would you describe the original trial they did in DCVax-Direct as a basket trial. Any idea of how many patients would need to be in such a trial to consider it a Pivotal or Registrational trial.

It really sounds like the trials beyond what's currently being run should be basket trials. The question may be, should the therapeutics added to the DCVax's be different for different forms of cancer. I would hope that the regulators would allow clinicians to try what they believe would work best for each patient rather than take a fixed protocol of say DCVax-L and say Poly-ICLC with every patient, especially if a specialist in the given form of cancer believed a different therapeutic should be used.

I look forward to whatever path is taken to prove that our vaccines are truly tumor agnostic.

Gary

pgsd, would you describe the original trial they did in DCVax-Direct as a basket trial. Any idea of how many patients would need to be in such a trial to consider it a Pivotal or Registrational trial.

It really sounds like the trials beyond what's currently being run should be basket trials. The question may be, should the therapeutics added to the DCVax's be different for different forms of cancer. I would hope that the regulators would allow clinicians to try what they believe would work best for each patient rather than take a fixed protocol of say DCVax-L and say Poly-ICLC with every patient, especially if a specialist in the given form of cancer believed a different therapeutic should be used.

I look forward to whatever path is taken to prove that our vaccines are truly tumor agnostic.

Gary

I certainly believe that Oncologists worth their salt will use Poly-ICLC and/or Keytruda, and perhaps other therapeutics off label in treating patients, however, I doubt the regulators will consider the trials run to date at UCLA are deemed to be sufficient to utilize for labeling considerations on these products, and likewise for acceptance of DCVax-L itself.

Don't get me wrong, I believe the regulators will encourage the expansion of Phase 2 Trials to gain this acceptance, not require Phase 3, but I think they'll want the total numbers to go higher, and more institutions to be added to where the trial is being run.

What I'm really eager to see is trials in additional cancers, and of course the initiation of DCVax-Direct back into the clinic. Our potential is so much greater than what's been confirmed to date. If the company is right about tumor agnostic, once that's recognized, if NWBO isn't bought out, it will be among the giants rather quickly.

Gary

HL,

I believe that many do live to two or more years post surgery. The question might be, how great is the benefit of taking the vaccine at that time. If it is given with the other therapeutics shown to be of major benefit, it could have tremendous benefits, but we really won't know until it is tried.

Assuming that you don't have unlimited production capability, the question may be, who gets priority in making the vaccine. Once the EDEN is approved and built in massive quantities, it may not be a problem, but until then, who decides the priority.

Gary