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I agree Beartrap, I've always believed that CRL has the potential of providing the vaccine in much of the world, and the remainder handled in Sawston. The question in my mind is, does CRL pay NWBO for the rights to produce the vaccine and use the EDEN units, or is it the other way around with NWBO paying them to do it. The difference between on scenario and the other would be how much each receives for every batch of the vaccine that's made and distributed over time. There are virtually unlimited ways the agreement could be structured.
It's my belief that if this is done with CRL, it will be them, not NWBO, who'll be taking almost total responsibility for manufacturing, storage, distribution and sales in much of the world. CRL is already a large company, but some growth may be needed. NWBO on the other hand may minimize growth mainly to develop new trials and products. If NWBO chooses to continue to contract out much of their work, the growth of the company could be quite small, but FlaskWorks itself might grow dramatically depending on the demand for the EDEN unit, and perhaps other similar devices for producing other personalized products.
Gary
Just a thought, whether fully approved, or not, wouldn't it be possible for any new trials utilizing DCVax-L be done with the EDEN unit. If so, an additional question would be, are the EDEN units provided to the clinical sites which probably already have the other capabilities needed to utilize them, or will the trial vaccine all be made at some centralized sites.
Gary
Thanks Dstock,
Would they rename the product, or can they simply extend patent rights and all else remains the same.
Gary
Is this the answer to my question. If this patent is approved, is Onclovir granted additional patent coverage for Poly-ICLC in all applications.
Gary
I agree, the only real question is whether NWBO contracts with CRL or others in the US, or chooses to develop their own facility for producing it all with the EDEN units. In saying others, I'm including the possibility of one or more BP partners who take on production, storage, distribution and sales.
I believe that CRL has worldwide capabilities if NWBO chooses to use them. If the company places nearly all the responsibility on both CRL and Advent, it would be possible for NWBO to only have modest expansion, largely for new trials and regulatory filings, but hands off production, other than monitoring it, which could be done by tracking every disposable cassette.
Gary
I agree that they're ready at least in the UK for the demand for the vaccine. I believe with the acceptance of the EDEN they'll be able to quickly gear up for any demands, including solid cancers of all types.
This brings up the question. If DCVax-L is truly seen as a new paradigm in the treatment of solid cancers, will they truly need a sales force to increase sales, or will it be more a case of scheduling the vaccine to be made, properly stored, and distributed as needed.
Gary
UCLA didn't develop DCVax-L by themselves, it was collaborative with NWBO as I understand it.
I believe that UCLA would handle this in a manner that's much like City of Hope does based on a presentation I attended where they discussed products that they truly did develop, like Herceptin. Essentially they find a company that will fund its development through the remainder of the clinical process and they receive a small royalty stream for doing so. The speaker didn't go into just how small the revenue stream was, but I'd have to guess that in a blockbuster drug like Herceptin, and other drugs based on it, like Kadcyla, they'd have brought in substantial money over the years.
I don't know that we'll ever get precise accounting for what UCLA will receive, but I believe they'll do quite well.
Gary
After reading the last 200+ posts I believe that certain things should be becoming clear to all. One is that in the two phase UK process, if at the end of Phase 1 there is no information being requested, the process simply moves into Phase 2 with no delay. The other is that inspections are not mandatory, but may be done as determined necessary.
In that all manufacturing of commercial products for the UK is at the Sawston facility utilizing manual techniques, the facility was previously inspected and accepted. Since that time I believe additional suites have been added, while they should duplicate the previously approved suites, I could understand if an inspection is made of those suites.
I believe it's also clear from LG's presentation yesterday that they're working on a larger cleanroom to house a large quantity of EDEN devices. As I understand it, the small cleanrooms being used for manual production can each accommodate ten EDEN units when they're approved, but that doesn't have anything to do with the approval and any current inspections.
In short, it's up to the UK authorities if they even want to do inspections, and if they do it should be just to verify that the facility they approved previously has essentially been duplicated in the additional cleanroom suites. If this is the case, I doubt if it will take inspectors more than a day to inspect the Sawston facility.
Gary
I'd like to ask a question as clearly I know nothing about patent law. It was pointed out elsewhere that Poly-ICLC is near the point where it goes off patent. The question is, can the patent be extended by proving it's benefits when used with DCVax-L?
If such an extension is possible, I could see substantial value in Onclovir, but without it, is there any real advantage to NWBO to acquire or partner with Oncovir if generic Poly-ICLC could be available shortly, or perhaps NWBO could actually make it themselves.
It seems to me that discussion had been made that if Keytruda worked with DCVax-L it could extend it's patent life, if that's true, the same should be true of Onclovir and Poly-ICLC.
For the people who developed Poly-ICLC I would hope this does benefit them, but if it comes completely off patent and can be easily made, it may be a blockbuster product that they fail to benefit that much from unless they're willing to sell it for less than competitors.
Gary
I would think that the inspections would be timed to meet the 150 day schedule. I know nothing about them, but others indicated they'd be inspecting at least some of the clinician to be contacted. I'm unsure if clinicians who were inspected would immediately, or ever, report it to the company. I don't know what else would be inspected, but I think that the timing would be tied to the 150 day period, which could be next week, or a month later depending on what day is the proper start time.
Any further inspection of Sawston, or any other company site, would certainly be reported immediately, but clinical sites could be a different matter and may have been underway for some time without anyone reporting it back to the company.
Time will tell, I'll admit being wrong when we go beyond both potential 150 day dates, roughly May 21st or June 24th. If approval comes by then, or sooner I expect others to say I was right.
Gary
The quarterly report was made at day 140 if you go by submission, and roughly day 110 if you use the January date. While the report was for first quarter financials, comments made in the report should be up to the minute. All indications are that the UK should issue RFI's well before either of the above times. I'm not saying that at day 149 they can't do it, but that's not the way they plan to do things, if they wanted, or needed more information, I believe it would have been far earlier in the process.
In truth, I believe the UK regulators have been watching the development of DCVax-L for many years, they've seen the demand for it in their compassionate use program and frankly they also have done a rolling review of the filing. I believe that for the most part they knew what they needed to know by the time of the submission, reviewing it just validated what they already knew.
I may be the only one who still believes we'll have a decision in no more than about 6 weeks or less, and possibly by this time next week.
Gary
What justifies the +60 RFI when it's clear that there was no RFI I have no idea. A company doesn't request 60 more days when they're not needed. Without them, August 3rd would be your date if based on the March 7th date. While I believe the date should be December 20th or January 24th, without a +60 RFI when no information is requested, we'd be no later than about June 24th.
I'm still hoping all this goes away by next week because we've gotten the answer, but I may be the only one left on the board that believes it.
Gary
I'll agree that she has control, but I believe her past behaviour clearly demonstrates she's doesn't want to be in opposition to many individual stockholder at any time she's speaking to a group of us. I don't think any CEO wants to face law suits from investors, but there are law firms who openly seek running such suits. The Gross Law Group seems to be initiating suits against many companies, one of them is AVXL which I have stock in, their headline often shows up as news multiple times a week here on I-H.
I don't know that she can do anything without informing all shareholders even if she has control of over 50% of shares. That stated, I do believe the company can choose the format of an Annual Meeting, if they wish to minimize investor interference they can hold it in their offices and not webcast it and limit business to issues to be voted. They would simply post results and that would constitute the meeting.
In recent years most companies are doing webcast, or hybrid meetings, but I don't believe the regulators have established how such meetings must be done. Holding a meeting at a time when shareholders are happy with the direction a company is taking is a no brainer if a company has the ability to do it. Sometimes they do, and other times meetings are clearly adversarial with those attending live. Perhaps when we're on a major exchange the company won't have the freedom they've had on the OTC with doing, or not doing meetings in a timely way.
Gary
Out of curiosity Flipper, do you know when UCLA was working on the Phase 3 Trial, which clearly was sponsored by NWBO, if patients being treated right at UCLA were receiving vaccine made by the company through Sawston or Cognant, or did they make it themselves. I would think that NWBO was responsible for supplying it, but don't know that to be a fact.
Gary
JFR,
I believe that if you look at LP's background there is no shortage of bankers she could be speaking with. I know I'll sound like a believe the company is going after the shorts, the MM's, etc. but Posner's efforts are already saying that. What better way of getting these people than to allow them to think they have time, and suddenly spring approval on them. I don't know this is happening, but whether it's by next week, or by the middle of next month barring a major change in the share price before, indicating they're clearing out of their short position, we could see the mother of all short squeezes.
As I understand it, we're just a few weeks from also knowing that the MM's have no more MTD available to them, if they don't get a dismissal they'll either be going to trial, or they'll settle. I know none of this happens quickly unless they determine they want it behind them with a quick settlement rather than having it hanging over their heads for years.
I know I sound like a conspiracy theorist in saying, this, that's okay. If I'm wrong, no harm done, if I'm right, we'll all be far better off quickly. I know that DI wouldn't say, you're right, or your wrong, he just doesn't work that way. Frankly I don't believe that DI is aware of all the company is planning so that he does have deniability for not providing false information. He could very well be planning a PR campaign for after approval, or for the release of new information on the EDEN or other things without having any knowledge of when events were anticipated to happen. I know that DI has told other investors that the company plans to roll out more than just approval, once they have approval, I'm sure he's working on that, but the timing is clearly an unknown, at least to him, and I doubt if the company knows much about it.
Gary
You're correct, I do speculate all the time, I believe others here do much the same. Based on experience, the company has waited on having something positive to say before holding Annual Meetings, and in the past they've forecast dates and delayed until something they wished to discuss occurred. I believe establishing June, but not a specific date yet, indicates a belief they'll have approval before then, if not, something else of real substance, like acceptance of the EDEN unit. If nothing positive comes out prior to the Annual Meeting being formally announced, roughly 20 or more days before the meeting, I'd not be surprised to see a delay into July, or even later.
I'm of the belief that we'll get a proxy to vote on that will include the authority to raise the authorized shares again. I don't believe that's something they'd want to ask for at prices even close to current prices. Of course it's possible they won't ask for it now, they could also do it later in a special meeting, but I doubt if they can go to the 2025 Annual Meeting for asking for such action even if nearly all holding options hold on without taking stock. With approval the company will clearly need additional funds from somewhere, it could come from a partnership that didn't result in substantial share involvement, but it's likely they'll need more shares. I believe they'll want shareholders to feel comfortable with the share price at the time before voting on authorizing more shares.
Gary
JFR, I'll agree, but after approval don't you suspect that many brokers will want to become associated with NWBO over time.
I believe that LP is well connected, but those connections are meaningless until success changes the way the investment public is looking at NWBO. The MM's may have largely been controlling what's happening up to now, but post approval I really don't believe they'll be able to keep the share price down and the short squeeze will be a thing of beauty for all who're long. Once the short position is largely cleared we'll be a very different company.
Many who've spoken with DI have been assured the news won't end when an approval is announced. I suspect that once we get that approval a month won't go by without some meaningful release will come out of the company, at least for awhile. Perhaps some things could be said before approval, but holding them until after may greatly increase their impact. Other things frankly are keyed to at least the initial approval, so that's when we'll start to get word of them.
I think we all know that the company will have many choices as to the direction they want to take after approval. They may have already decided, or they could be waiting. Personally I still believe that CRL could play a major role, but it's not impossible to do it completely without them. I suspect that CRL already knows what NWBO will be doing, but no one can say anything until the time is right and that could be dependent on acceptance of the EDEN unit as well. Of course if CRL is purely intended to support the US it could all be dependent on an FDA submission as well.
Gary
In the quarterly the company states in black and white no RFI. They also specified validation days. If the submission date isn't when the 150 day clock begins it certainly would be by the initial validation date, a little over one month later.
I don't believe you ask for an extension when you aren't asked for anything more. We all know that regulators don't alway meet their own deadlines, but I believe the 250 day average people discuss about the UK includes products not getting priority review. Les may be using 250 days out of caution, but with no RFI, I still believe in 150 days, the only real question is whether it began on December 20th, on submission, or a little over a month later, on initial validation. I'll believe submission is possible until we're past about May 25th, allowing some time to make the announcement after receiving notice by roughly May 21st.
You can criticize as much as you wish, but this week is still in play until it's over.
Gary
They announced that there was no RFI, why would they ask for a 60 day extension to answer questions that haven't been asked.
It looks like the MM's managed to keep today's gain down to only $.003, it's sad that they can maintain such control in spite of solid progress that management announced in the quarterly. This can't continue forever, the lower they keep the price down now, the bigger the gap up when approval is announced. I still believe that this week is still in play.
Gary
I have no idea what the Big Biz show costs, but personally I'd rather see the money spent on appearing at BIO Conferences. I don't know that that costs, but I do know for years it was a conference that IMGN's CEO routinely appeared at until he was more routinely invited to major Brokerage and Institutional Conferences, I'm sure they were paying to appear.
I don't think it will be long before we'll be getting invites to many Brokerage and Institutional Conferences once the UK approves DCVax-L. Some of this may not happen until we're on a major exchange, but I believe many won't care, they'll want to hear the story of a new paradigm in the treatment of cancer. It won't hurt to get more attention, so also getting on BIO isn't a bad thing, as for the Big Biz show, I can't say that we're not getting new investors through it, if we are, and if it's cheap to appear at, I don't think it's causing harm. Out of curiosity, do we have any longs here who first heard of NWBO on the Big Biz show.
Gary
I agree. Frankly, I thought we should be substantially higher than we are based on the quarterly. I suspect that the shorts are working hard to keep it down, but I also believe that most of us longs have purchased about as much as we want. Les's appearance is more to attract new investors than to inform existing ones.
I would hope that we close the day near the high, but I believe that it is pretty clear that those of us who are serious longs are not looking to add substantially more shares. I know that I already have more shares than I ever dreamed of holding, but adding more would seriously upset my family, though I have done that in the past.
I suspect that in the not to distant future, most of us will have million dollar positions, and some do today. We are satisfied to be where we are today.
Gary
Barnstormer, you may be right, but it is very possible that Les too is looking at their 250 day track record, and not at how much they already knew going into a 150 day process in which they have requested no further information. I still believe that it could happen by next week, and worst case before the Annual Meeting next month.
I doubt if the meeting will be scheduled until they feel confident that they will have the outcome before the day they schedule it for.
Gary
I believe that he was being conservative in saying fall. We should know in. weeks and almost certainly before the Annual Meeting. Otherwise I thought it was a good review of what is happening. The EDEN unit may be further along than we were thinking.
Gary
While I agree with that, I'd actually do a Phase 4 where all uses of the vaccine, and all newly approved products, are tracked until the FDA is completely satisfied with their safety, and efficacy. Perhaps more importantly, Drs. would be asked to discuss successes in which they tried new therapeutic combinations and protocols that could assist others.
I believe that very few products are limited in use to only the protocol used in the clinical trials. Dr. Liau, beyond any doubt, is trying new ideas to increase the effectiveness of DCVax-L and that's why Poly-ICLC, etc. has been added. Her goal is curing all with brain cancer, so she'll keep working to improve on the gains she's already reached.
Hopefully all the regulators will begin to work together more, and do things more dynamically. New products shouldn't take one to two decades or more from genesis to approval, but they do. DCVax-Direct is clearly the victim of insufficient funding and it's sad that some agencies didn't offer NWBO a means to keep it in the clinic.
Gary
I certainly hope you're right Hank, my experience is that trials move slowly especially if annual costs are being held down. If a partner came in with billions, and the trials were run at hundreds of sites, perhaps 5 years or less is possible, especially if the goal of treatment duration of 3 years or less was possible. I really don't know how low you can take the treatment duration and satisfy the regulators, 5 years for GBM certainly made the point as it's one of the deadliest, it would be likewise true for the likes of pancreatic, but others nearly as deadly kill slower, so I really don't know how quickly such a trial could be done. With hundreds of trials sites it may be possible to recruit hundreds of patients in one to two years time, if they want 5 years survival to examine, you can see where I'm going.
It's my believe that off label treatment can proceed approval by many years. With peeks at the trial authorized at a few occasions, sufficient information may be out in 3 to 5 years to get a great deal of off label treatment authorized by insurance years in advance of actual approvals. We've all learned that even after the trial ends it takes substantial time to create the documentation to file for approval. No doubt greater funding can expedite this, but without dynamic work from the regulators, all these things take time. I wish the regulators could make dynamic approvals by observing what's happening in trials, but barring that it just takes lots of time to gain official approvals.
Of course we all could be wrong about how long it will take for off label use covered by insurance if the data from off label use in the compassionate use in the UK were released and made many oncologists realize that they should be using DCVax-L now with their patient with a variety of solid cancers. I don't know if such data will ever be released, and what it will show if it is, but I suspect that DCVax-L may have worked miracles in patients with certain solid cancers. Solid anecdotal data can be all that's needed for the insurance companies to authorize DCVax-L.
Gary
Would anyone here really care if the company in order to do the trials needed, and perhaps take in equity partners, raised the authorized shares to 3 or even 4 billions if during the time they did so the DCVax's were approved to be part of the SOC for most solid cancers. I don't see a problem with such dilution provided the gains are being achieved.
This won't happen overnight, it could easily take a decade or longer, but where would we be when it happened. I suspect that our market cap could be as big, or bigger than todays largest BP's, but of course they too would have grown, and some may be our partners. I doubt if we'd come close to the market cap of Apple, they have over 15 billion shares outstanding, but we might have half their market cap, which is a trillion dollar number.
We're doing things very differently than the likes of Apple, Tesla, etc. They drove up the price dramatically, then they did splits to take up the share count. We've issued many shares, now it's time to make those shares worth a lot more money so we can rightfully issued more as needed to support growth and/or achieve equity partners.
We have an Annual Meeting coming up in June. As long as we have UK approval before it would not surprise me at all if we're once again asked to raise the authorized shares. The question is, do they just go to 2 billion, or is it 2.5 or 3 billion. It may be premature to bring in an equity partner, but if we do at some point, many shares well be needed for that alone unless a large part of it comes from shareholders tindering shares. I prefer a partner bringing a lot of money into the company over buying a lot of shareholders shares at a nice premium. The share price should rise to very nearly the price a partner is paying for the shares.
Gary
I've said that many times for CVM's one drug. Not what AVXL has developed.
Gary
We as shareholders should receive something for anything that's spun off from the company. If Galaxy Batteries becomes an independent company, at some ratio, we should have shares in that new company. Much of the success of Galaxy Batteries may require substantial new funding, but some percentage should be owned by current investors. I wouldn't expect anything close to 1 for 1, most likely more like 1 for 10,000 shares, but something saying we have ownership in Galaxy Batteries.
On the other hand, if Galaxy Batteries is being sold, the price it's sold for should enhance the value of the company. It should be clear that the company received fair value for what it was sold for. At minimum I would think that was bringing in millions of dollars into the company.
Gary
As I understand the UK operation post approval, I believe that everything supporting the manufacture, storage and distribution of the vaccine is centered around Sawston doing it with manual manufacturing. If this is the case, any inspections needed prior to approval should be in Sawston.
On the other hand, if EDEN has entered the picture, then several facilities might rightfully require govt. inspections in a variety of places in the world. NWBO has a FlaskWorks unit that would have to be inspected, and that unit will be purchasing components that come from many source throughout the world, they too should probably be inspected and approved for supplying components used in the EDEN including the disposable cassette from St. Gobain's Glass, which may contract for parts that go into the disposable cassette.
I short, if multiple inspections are ongoing in multiple locations, I'd suggest it's for the EDEN, not to initiate commercial manufacturing manually at Sawston to support the UK approval.
Gary
If you don't know what an inspection is for, and if you over the years have spent time working with the regulators, perhaps you've already been inspected without even knowing it. I suspect the British Regulators already know all they need to about NWBO.
Gary
Marty,
I previously brought up the point that many at some point take back their money, that's fine with me if at the time you do it you either need it, or have a better place to invest it in. My point was only that if you believe the potential is as good, or better than in the past, why sell. Of course if you need the money, that's a different matter.
I know people who automatically sell half after doubling, they often forgo tremendous growth just to get their initial investment back, though they don't need the money. I just think before selling, if I don't know of a better investment or need the money, I'd ask myself why. In the case of NWBO, if it's still advancing on a tumor agnostic label, I doubt if a stock with more potential can be found.
Gary
Going from 5% to 13% survival at 5 years is certainly no failure, it's over 150% improvement in 5 year survival, that by itself would be worthy of approval, and actually far better than what's achieved with many approved products. A 10% to 20% improvement in OS has moved many a product to approval, we're better than 150%, but it's in a cancer that's among the deadliest. I frankly don't believe the regulators will ignore the benefits achieved with Poly-ICLC taking the survival to over 50%, but they'll permit it by adding them to a compendium list permitting use covered by insurance essentially from the time DCVax-L is approved.
Clearly you're also right, many others are benefitted by living longer than previously, but not over 5 years. I would love to see a K-M that showed every patient to enter the trial extended out to the present. I don't know, but believe we might find that some of the patients who were first to enter the trial are still alive today.
Gary
Marty, I suggest you consider what's happening at the time before selling at $4. If you really don't think it's going much higher at the time, fine, sell, but if you like the potential of rising to double digits, and beyond, why sell.
My biggest complaint with many Analysts is when a stock reaches their target they lower their rating on it. Rating it a Hold is really a sell signal to those who buy on their new buy recommendations. When the stock doubles again the Analyst takes full credit for the entire gain, they told you to hold, if you held you'd have the entire gain. In my view when the target is hit it's time to reexamine the stock, if you can't raise your target at that point, say so, but perhaps the rating in that case should be sell rather than hold. On the other hand, if you raise your target by 10% or more, perhaps hold is justified, while putting a buy on a stock that should do better than that.
Analysts for the most part work from brokerage houses, therefore they push the stocks they're told to. The only broker I'd care to follow is one who's independent of brokers, but also has subject matter expertise. A poli-sci major does not constitute having medical expertise. I'm really not following anyone in particular right now, but used to like Jim McCammant's when he was around and writing his newsletter.
Gary
Marty, I think that figure is an average between products getting priority reviews and the ones getting normal reviews. The 150-day mark is established for priority reviews, and they want to shorten it to 120 days.
Gary
Marty, there has been a great deal of language saying the 150 day is from submission, I can't remember previously seeing validation as a starting date. I certainly can live with it if it is validation, it's roughly one month longer, but I still like the idea that we should know in just over a week, or less. Remember, 150 days is the last day they target to make the decision by, they frequently do it in less time than that.
If they made the decision by May 20th, we really couldn't say that they made it at about day 150, or was it actually day 120 based on a later start time. Perhaps they even met their newer 120 day guidance, but clearly from validation. All I'm suggesting is, the regulators just keep everyone guessing, and companies are no better when giving guidance, it's just not concrete, there is always wiggle room.
In the case of the FDA they set the PDUFA at 6 months after they accept a BLA or NDA, but I don't believe they say how long they spend in accepting, or whether they have precise guidelines on how much time they take. Al least once a PDUFA date is established, all know what their target is.
Gary
Marty, if there is an RFI at this point or beyond, the UK would not be following their own guidelines. It is possible, but I believe it is doubtful.
Gary
I still like the odds that we will have an answer from the UK by May 21st, and it will be yes. The question in my mind is whether they will want a confirmation trial.
Gary
Please correct me if I am wrong, but I believe that Sawston was inspected and approved for commercial production some time ago. I don't think further inspections are required unless modifications require additional inspections.
Of course, if they were proposing that the EDEN Unit be used, that would be a new ball game.
Gary
If the March 7th date is to be taken as the 80 mark, the calendar would have been starting with the submission in December.
Gary
I think the quarterly may have revealed something more. In discussion of the EDEN unit it was indicated that material changes were being made to make sanitizing the unit easier. While there is no proof as to why the move was made, I think there is a good chance if was recommended by one or more of the regulators evaluating it. I have no proof of this, but perhaps we're further along than most people think.
Gary
I love it,
My first boat, a 40 ft Challenger sloop, was named Impossible Dream. We lived on it for 3 years, until I shattered my leg in a ski accident. Once we moved ashore we never returned full time to the boat, mostly cruising to Catalina and around Southern California.
Gary