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What are you expecting to happen at 90 days? The evaluation period target for the MAA with expedited review is 150 days, 90 days might be the earliest any action could be expected, but it's certainly no guarantee. Remember their filing was 1.7 million pages, certainly not every one will be scrutinized, but I believe the company is asking for more than approval in GBM, or even all brain cancers, time will tell how much they get.
While all longs would love to see an early approval, it's foolish to count on it. 150 days puts us well into the second quarter, I'm fine with that. In roughly two weeks we should see the Annual Report, it's hard to say how much will be said there that isn't said in a quarterly, but they certainly have a vehicle that they could say more in. It's up to management as to how much they say, how much they wait for the Annual Meeting or action by the UK, the ball is in their court. We were given a heads up on the EDEN, but it was far from telling us when it should be available for commercial production of DCVax-L.
I would hope that any new trial utilizing DCVax-L clearly indicates it's made in the EDEN unit. I don't believe new trials will be initiated until we have at least UK approval, but anything is possible. From the time an IND is first filed and a trial begins is often many months, in some cases it can take a year or more. In IMGN's case, much time was taken because they wanted a specific Dr. as their lead clinician and a great deal of time was taken by him and the IRB to be available to start the new trial. If the next new trial initiated for DCVax-L isn't in GBM, I would suspect that someone with no current knowledge of DCVax-L, but with expertise in many solid cancers, would be selected to be lead clinician. That person might be from UCLA where Dr. Liau could assist, but I don't believe she'd act as the lead clinician of any such trial.
It seems to me that when we're discussing days, how many days are we into peer review by Nature into the article they're peer reviewing. I really don't know, but if we've learned anything it ought to be that such reviews take a lot of time, perhaps more time than the regulators allow themselves to judge a filing for approval. Nature's manuscript was submitted well before the MAA, what's the likelihood that we'll get approval before publication.
Gary
For those who couldn't read the continuation of the article, here's a link that may work for you.
https://enewspaper.latimes.com/desktop/latimes/default.aspx?token=42e23962a5d74614be16bae3d62d13e7&sfmc_id=6532a15825b3640666b604f8&utm_id=34390806&skey_id=64fdbe8caba24cda07d7606980b89d692e94d76ec9759ee279ef7066a3cacca8&utm_source=Sailthru&utm_medium=email&utm_campaign=ENP-email-Subs-eNewspaper-2024218&utm_term=eNewspaper+Daily+Notify&edid=cf90e1c1-e29c-4052-9044-af7b0f534877
While not specific to ANVX, with no mention of it, I believe it's still very worthwhile reading.
Gary
Doc, it's been many years but I don't believe anything has changed. A company I was invested in went on one of the Russell indexes, that meant that certain Institutions had to take substantial positions. The day they go on the Russell millions of shares trade after the bell at the closing price as MM's have been accumulating shares for their Institutional customers. At the same time a major short position opened up. That company stayed on the Russell for two years and that huge short position was maintained the entire time. When the company went off the Russell, the short position disappeared. My point is, legally or not, the MM's had maintained a major short position, several million shares, for two full years. I suspect the stock may have moved up nicely if they had to close their short position, but instead they essentially created millions of dollars worth of stock that the company was never paid for. I can't believe that the SEC doesn't see actions like this, but they only seem to care if someone makes waves about it.
I believe that if the Judge finds the spoofing charges valid, the SEC could start to take an interest in what was going on.
Gary
They really only mentioned a few companies that are common household names, they indicated many more companies were involved. I suspect that we were one of them. If we gain regulatory approval, you can bet in future articles that our name will be issued. I don't know when our filing will be made, or to which regulator for certain, but regardless, as long as we've filed during the first half of the year, we should have a decision this year. Certainly they can take over 6 months, but I believe they'll get priority review from any regulator and that should result in a decision in 6 months or less. Of course they all can create delays, nothing is certain.
Gary
I'm curious, I'm invested in a few different companies, NWBO is now my biggest, but I post on sites where I've invested, and a few where I'm considering taking a position in. When I look at what posters here, or in other companies, posting history, I often find they're only posting on the one company. The question is, are most investors actually only invested in a single company, or are many posters establishing different identities for each company they post on.
I'm generally open about what I'm investing in, at least about major investments. On occasions I'll take small investments in tiny companies just to see where they're going, I rarely mention them. Some of them go belly up, but if they're successful I'll buy more, and then I'll mention them.
I'd like to hear which way this is going, are most of the investors here really not diversified at all.
Gary
Thanks Barnstormer, hopefully NWBO will begin to do them because most others on whatever exchange they move to typically do them. Before Covid many Annual Meetings weren't webcast, some investors did attend, and posters often gave their impression of what occurred. Since Covid led to webcasting AM's I believe it will continue for most, but as you indicated, it doesn't need to.
Webcasting the AM doesn't get to the best reason for actually attending. If you attend a meeting it generally gives you the opportunity to have one on one time with some of the key people in the company, that's not part of the official meeting, but an advantage to being there. Much the same is true if you can attend receptions many companies have when making presentations at conferences, like ASCO. Year's ago a friend who wasn't an attendee at ASCO asked to attend the reception and found the presentation there far more informative than the actual presentation in the conference which ultimately was webcast. He also got a very nice IMGN polo shirt.
I don't know that NWBO will ever give out polo's, but with success the idea of having such a reception may become a regular practice if they're making a peer reviewed presentation at a major conference. I expect that to happen as DCVax-L is approved and being tried in many solid cancers.
Gary
If this link works, here's the article in the L.A. Times:
https://enewspaper.latimes.com/desktop/latimes/default.aspx?token=42e23962a5d74614be16bae3d62d13e7&sfmc_id=6532a15825b3640666b604f8&utm_id=34390806&skey_id=64fdbe8caba24cda07d7606980b89d692e94d76ec9759ee279ef7066a3cacca8&utm_source=Sailthru&utm_medium=email&utm_campaign=ENP-email-Subs-eNewspaper-2024218&utm_term=eNewspaper+Daily+Notify&edid=cf90e1c1-e29c-4052-9044-af7b0f534877
Gary
Nidan, I don't have one specific source, what I've said is my understanding of the situation after reading what many have had to say.
By the way, this mornings L.A. Times did a front page article on Alzheimer's that was really extensive. It went into the development of definitions for multiple classes of the disease and considered the lowest class one in which amyloid level was tested as high, but no cognitive loss could be determined. Major drugmakers are pushing for this view of the disease. The article took up the entire back page of the front section. I'd recommend someone with the skill to get a link and post the article. Anavex wasn't mentioned among the companies that were, but many companies who participated were not mentioned, I suspect the company would have been involved in establishing the specified classes of the disease.
Gary
There is one thing the bashers are right about, it won't be that long before we know for certain that we have success. At the latest 2025 should have approvals from all the regulators we're working with, the UK decision should certainly come by second quarter this year, but without knowing the company's intentions with the other regulators, it's impossible to say if there will be others this year.
I still believe that the Annual Meeting should answer much of this, some of it may be answered by the Annual Report, which I believe should be out near the end of this month, or perhaps early March. As for the Annual Meeting, they've delayed so long that they might just delay till they have a UK decision and they probably could call it the meeting for both 2023 and 2024, not the right way to do it, but on the OTC it would be okay.
I don't think I've ever been in a Nasdaq or NYSE stock that didn't hold quarterly conference calls when issuing quarterly reports, but I don't know that it's required. If it is, someone please verify that. We know LP wants to make this move, frankly when we're selling at a price that's needed to justify making the move to one of those exchanges, I believe that she'll willingly speak to us quarterly, as well as being invited to many Institutional and Brokerage conferences. We'll go from almost complete silence to how many times is she speaking this month, or this week.
As I see it, by March we should know something as the Annual Report will be out, if at that time the company isn't committing to a date for the Annual Meeting, whether they say it or not, they're waiting for the word from the UK. I also believe that on getting the word from the UK they'll issue a PR and hold a webcast within a day or two, it won't be the Annual Meeting, but it clearly will be very informative.
Gary
George, the question is will they file on Rett first, or Alzheimer's, or will they attempt both in a single filing. I would suspect the answer to that would be, they're working with the FDA and other regulators and they'll do what they're advised to do.
We know the data in Rett's wasn't all they hoped it would be, but it was based on judgement in which the judges had no idea if the patient received the placebo or not. Placebo patients were viewed to have some improvement, I believe that people see what they're hoping to see, so it's human nature to see some improvement even if there isn't any. I believe that improvement was clear on the patients receiving the drug, but the difference they were trying to achieve wasn't met. I suspect that if the same patients were observed say three months later the observed difference would be better defined, but that wasn't the trial protocol.
I'd hope that the regulators could see this, but it's very possible that they'll ask for additional trials. If I were running the regulators I would do a conditional approval, I'd require either an additional trial, or a Phase 4 in which all patients receiving the drug were included and briefly evaluated by the Dr. prescribing the drug in a database that the FDA could evaluate. Substantial anomalies from expectations would need to be discussed in greater depth by the Drs.
Gary
I'll be the first to admit, I like to play devil's advocate to get people thinking of other possibilities, but what bashers are doing is baiting people to discuss issues that most everyone knowledgeable agree have been settled ages ago.
Some of our bashers would have us believing the BLA is DOA because changes were made during the trial. It doesn't matter to them that the regulators were involved in the changes, it's why they say it's a failure. We know better, but while it may not have been discussed for months or years, they make a statement and restart the debate.
No trial is an absolute certainty, but to me it would be a crime if any of the regulators substantially delay it's approval. We all know that DCVax-L will do much better when combined with other therapeutics, but that's no reason not to approve a product that more than doubled life expectancy at 5 years. Most cancer products can be approved if a 10% survival improvement is proven, we did roughly 160%.
Gary
At this point the city a biotech is working from has little influence on the outcome, however early on, cities like New York attract a lot of highly talented candidates for jobs. I certainly don't think being in New York is a hindrance.
Personally I wouldn't want to live there, but my daughter does, and I love visiting for a few weeks and taking in some of the shows and trying some of the wide variety of foods that are found there. Frankly I don't mind taking their subway to get around and probably walk further there than I ever do in L.A. It truly is a city that never sleeps.
Gary
Does anyone know if the company has been doing a rolling submission all along. If so, much of what they'll be submitting has already been reviewed to some degree by the regulator. Unless someone knows how close they really are, the submission could be next week, month, or even year. From the sound of it, they're closer than a year, but this is such a massive document that it could still be several months away.
As I explained, I invested because I wanted to be in before the filing, perhaps they'll be a better indication in the next quarterly, but can anyone state with certainty that it won't be filed before then.
Gary
You're right, but if the patient's safe to return to a home, or other recovery center, shouldn't they be safe to walk out of the hospital. I'd be fine if they were accompanied by someone. If they can walk the floors of the hospital for exercise, why wheelchair to leave. We do too much in fear of what the lawyers might do. That's the lesson of France and many other countries.
Gary
Doc,
I believe in the future far more trials will be run the way this one was, but without the halts unless really necessary. The control will be historical data, the goals will be adjustable based on what's learned during the trial. In short, the trial sponsors, clinicians, DSMB, and regulators will be able to work toward success, rather than maintain a protocol and trial that's leading to failure. I believe this trial caught the attention of all involved regulators for several years, I suspect that discussions with them led the company not to end the trial till the last patient to enter was 5 years into the trial.
Not every trial will be OS based, but if pseudoprogression is found in other trials, and if it's not possible to differentiate between real progression and pseudoprogression the regulators will have no problem with simply dropping that goal completely in the future. You can't blame companies for trying for PFS, it can greatly reduce the duration of the trial, but it's clearly better to succeed on OS than fail on PFS even though a lot of trial patients are alive. I really wonder how many prior trials may have failed because of pseudoprogression and never knew it as the drug was abandoned after failing on PFS.
I would have to say that whether they admit it or not the entire industry has learned a lot because of this trial and it is resulting in numerous regulatory changes.
Gary
Frankly the CEO of NWBO made a mistake in stating that they would file in the UK by a specific date, and then delayed that date a few times. I don't know precisely what Missling has said, but don't believe he's indicated a date certain, then failed to do so. Frankly in many ways I think it's better to file and not say anything, then announce acceptance. If the regulator requests some change in the submission, none would be aware of it, the change could be made, then when accepted it could be announced. NWBO took the other path, announced their submission and didn't announce acceptance, which some companies also do.
NWBO's MAA was 1.7 million pages, anyone have an idea of the size of ANVX's submission. I suspect it's substantially smaller as I believe the NWBO trial had several issues that had to be addressed, though in the end the results should be judged on overall survival, and that really should be the gold standard for trials in deadly diseases. Alzheimer's, on the other hand, often becomes a greater burden on a patients personal support system as patients diminished capacity to do things add ever increasing burdens on the support system.
In my treatment for leukemia I met a lot of really positive patients and Drs. especially at City of Hope. I'll admit however I did see a lot of patients who didn't appear to ever leave their beds, and frankly I don't know that they ever did. In all my treatment I was encouraged to get out of bed and walk, and I did so, though sometimes not as much as they'd like. At times I was not to leave the room, for at least a few days, but most of the time I was encouraged to take laps around the floor. At one point they grouped the patients willing to come and had games, exercises, etc. and frankly I wish they had more of that. If those who were safe to do so could get together and have meals with other patients in a descent setting it would be far more appealing than eating in bed or from a chair on the small portable tabletop you work with in a room.
I know that space is a premium in a hospital, but if patients are more satisfied with their stay, I think the space needed to make that happen would be very worthwhile and might actually result in shorter stays as patients exercise more in walking to meals, exercise groups, etc. Of course some can't, but for those who can, the results could be positive.
A friend who's a retired surgeon was comparing the treatment his wife got in France for a broken arm with what would have been done here. There they set the bones with a couple screws, which were to be removed several weeks later, it hardly got in her way. In the hospital she walked from place to place, X-ray, operating room, recovery, and in leaving the hospital. If here she'd have either been transported on a wheelchair, or gurney, and would have been cast and immobilized for a substantial period of time. The point is, they permit the patient to do what they can without crippling them, while we prevent the patient from taking any risk, like walking, to avoid the possibility of a legal action. The cast is more protective, and restrictive, while the screws permitted an almost completely normal life. Here, even when you're being sent home to walk in your home, climb stairs, etc. when released from a hospital, surgery center, etc. you go in a wheel chair to your car. Why?
Gary
I certainly don't know, but I suspect that if posters here didn't reply to obvious bashing posts the number of posts on the board would be down by at least a third. It wouldn't surprise me if on average one bashers post gets somewhere between 1 and 3 responses.
I'll admit, on occasion I'll answer one of them as well, but only if I believe they're bringing up a subject that hasn't be thoroughly discussed previously. I find most bashers repeat things that have been previously discussed and dismissed, sometimes years ago, but they're non-problems. Problems get solved, but non-problems never can be.
Gary
Frankly I don't know when the company will file, but I wanted to be in before. I don't know that it will move the stock up drastically, but believe it could. The only thing I believe is certain is that after approval with growing revenue, the share price will be substantially higher, assuming the company is not bought out. If it is bought out, it will be at a much higher price.
Gary
I think we all need to learn more about failure. In our Phase 3 Trial we had a number of events that people called failure, they were patients determined to have progressed. I really don't know if some of those failures are still alive, but they could be. If they're not alive, they very probably lived many months or years longer than they thought they would, but they progressed, so they were failures. If they are still alive, they can tell us how bad they feel for having failed, if they're no longer with us we could ask their family and friends if they enjoyed the extra time they had with them. These failures actually had pseudoprogression, but many here would still argue the trial was still a failure because PFS was called on these patients, and not for many who didn't get the vaccine until later, so clearly the PFS goal failed.
I believe that every drugmaker would be thrilled to fail with so much success. People are living longer, but the trial failed, that's what the bashers are telling us, but of course they don't mention the patients living longer, only that PFS was called on many patients who got the vaccine and that's all that matters in their mind. Patients live longer, many are still alive now after ten or more years, but trials a failure because many of the people still alive were judged to progress, so they failed in the PFS goal.
All the people telling us this are also telling us that the four regulators who worked with the company will not approve the vaccine because of the failure in PFS, after all, what matters, a goal that's flawed because of what was learned in the trial, or a lot of people living well beyond what's seen by patients on the SOC. Finally, lets not consider what happens when other therapeutics are added and patients live roughly four times as much as with the vaccine in the trial protocol alone.
I believe it would be criminal if any of the regulators don't approve the vaccine once the company applies for it.
Gary
From several of the posts I've now read from a variety of posters it's clear that management is accused of being far to secretive. Sadly, it's a criticism I've found in practically every biotech I've followed. Certainly Missling found that in working at IMGN. Frankly I hate to say it, but I believe that it's encouraged by the regulators who abhor hype. There are companies who've been much more open, CVM and DNDN come to mind, but they've not been successful, at least not to date, though DNDN did get Provenge approved. CVM has tried their technology against many targets, each time it fails they announce a new target they're confident of curing. I see them as a cure in search of its disease.
I believe the good news will come, but only when the company is ready to announce it. Hopefully they're preparing for a well orchestrated PR campaign.
Gary
Thanks Crescentmotor, I certainly don't know, but I believe that the FDA is taking a more constructive attitude toward drug approvals, rather than insisting on additional trials prior to approval, I believe the could approve for both indications but insist on a conformational trial. If it were up to me Phase 4's would follow approvals with the prescriber simply reporting the new product working acceptably, as long as that was the case, but identifying any problems in greater depth.
We have friends with AD who remember us from decades ago, but don't remember we said hello 5 minute earlier. I really don't know what treatment they're on, or if AVXL's drug would be of benefit at this point, but hopefully it could be.
As I've mentioned, my biggest investment is now NWBO, I suggest having a look at it. They are making solid cancer vaccines from the tumor itself and while the trial was done in brain cancers, they've openly stated that the intention will be to go for a tumor agnostic label and they do have some data, mostly anecdotal, that it's a valid claim. At UCLA, where some of the development was done, they've used the vaccine in combination with Poly-ICLC and/or Keytruda and improved 5 year survival to over 50% in early trials, these drugs are ineffective in GBM without the vaccine. Normal survival at 5 years with the SOC is 5%, it's 13% with the vaccine but without the others, but certainly should gain approval for that. They've applied for approval in the UK where they can commercially produce manually in individual cleanrooms. The EDEN unit, which automatically makes the vaccine, is in the process of gaining approval, I suspect they want that before going to the FDA and perhaps other regulators involved in the Phase 3 trial, Canada and Germany. NWBO is believed to be a buyout target by many at over $20.
I'll take a look at SAVA, I've heard of it before but hadn't looked into it, thanks.
Gary
Thanks George,
Great information there, if it's not stickied here it should be.
I recognized Missling's name from IMGN where he was previously an officer. The money I'm playing with came from their buyout. This is now my second largest holding, NWBO being first. I'm looking forward to more positive information on both companies over the next couple months, or less.
Gary
I believe it's actually the 10-K or Annual Report, so it should have more than a normal quarterly. I believe the company gets an extra month to prepare it so it ought to be due late February or early March. I certainly hope it's more of an update and perhaps ties into an announcement of an Annual Meeting as well.
Gary
Jack,
My question would be can Linde double in the time PLUG could go to $8. I don't need $50.
Gary
Hope your right, I have just taken a sizable position and am looking forward to what I expect to happen here.
Gary
Thanks, I would think an approval with a Phase 4 in which long term use was monitored would make sense.
Gary
I guess I've missed such notes on meetings from the FDA in all the years, the most I ever heard was the company had, or was planning on meetings with the FDA. I've also found that some companies announce when they file with a regulator, others announce acceptance, few announce both, and some wait for investors to find filings in places like clinical trials. After investors find things like a new trials the company often PR it. Would it have been PR'd at that time if investors hadn't found it in a public database, we'll never really know.
I've often wished a company would be more public about what they were doing. IMGN for instance discussed partnering their recently approved drug, Elahere, when the whole time they were selling out the company. Most investors I knew weren't thrilled with the price they got, but we all had healthy profits. Frankly both IMGN and NWBO have been equally secretive, and others I've followed were frankly not that much better with one definite exception, CVM. In their case, the one product they developed was believed to be the answer to nearly anything known to be plaguing mankind, one disease at a time. Each time they had a failure they announced something new they felt certain it would cure. Perhaps some day their cure will find it's disease.
Gary
If I remember correctly you were invested in IMGN as I was, did you have some at the end. I did and now have substantial funds which I'm looking to invest and AVXL is one of the companies I'm considering for a sizeable investment. I believe that what you're saying about the time to get clinical data is really true with practically every company and trial data, certainly NWBO, which I'm heavily into now, is another example.
I'm not yet familiar with the various trials, out of curiosity, how are the AD trials judged. I gathered in the RETT trial judgement was essentially purely observational by people who really weren't trained observers, the parents I think. I believe a problem has to do with people wanting to believe that patients are getting better, so some parents in the control group thought they saw improvement. If I got something wrong here, please let me know. I also believe that long term the control patients weren't found to be better, while those on the drug were, but it was beyond the scope of the trial.
I'm just wondering if the AD trials are more quantifiable, or if once again it's all about the observations of others. Are patients tested in such a way that improvement is clear and not just a matter of hope.
I've been in a trial recently for a blood pressure drug, I honestly don't know for certain if I was on the placebo, or drug, but in general my pressure seemed to be more under control. With all the meds I was on it rarely went far above 140, but that was the minimum required to enter the trial and I met that requirement. My pressure has been lower in recent months, and just a couple weeks ago all patients were put on the lowest dose in the trial, my pressure to date seems to be at excellent levels, and when it's low, which used to really bother me, it no longer does so. My point is that even though I'm in the trial and generally having lower pressure, I can't say 100% that I was on the drug, though in hindsight I believe that's the case. In the very beginning of the trial I frankly thought I was on the placebo.
I recognize a few names here, besides you, as previously being in IMGN and/or NWBO. I hope you had at least some IMGN for the payoff, which frankly I wasn't thrilled with, but it's a nice profit. I'd really like to understand how quickly investors believe the company will be filing for approval, and whether you really believe they go for both AD and RETT in the same filing.
Gary
Out of curiosity, does the company get any notice whatsoever of an upcoming decision by the regulator.
Many years ago in the case of the FDA turning down IMCL's Erbitux, we know that the company had to release the news a day later, but the CEO and Martha Stewart sold the day before, so clearly some notice was given. They both got jail time for insider trading, and the drug was eventually approved, so they were the biggest losers in the deal, but clearly it indicates the company did get some notice. I don't know if it's still the case, or if the UK operates the same way the FDA did.
It's my belief that nearly all early decisions are positive, in the case of IMCL I believe they were at the PDUFA date and they pulled off the equivalence of the Sting in biotech's by convincing BMY to partner because they were certain the FDA approved when they knew all along that the FDA had questions that could result in further trials. Ever since them the FDA is authorized to indicate if their position is being improperly represented, before that time IMCL knew the FDA couldn't speak up when misrepresented.
Gary
I frankly don't believe that the few makers of fuel cell cars will be making many more of them unless there are nationwide initiatives promoting use of hydrogen powered cars. I don't believe that will happen because solid state sodium batteries will extend the range and lower recharging time. Truck, boats, ships, aircraft, etc. are a very different matter, there batteries won't achieve the range that vessels powered by hydrogen can get. Likewise hydrogen fuel cells can provide a stationary source of electricity in the same way diesel generators can, without the pollution.
I'm not yet invested in PLUG, but what I like about it thus far is that it's not just a hydrogen supplier, it's a company that seems to be developing all sorts of hydrogen related devices, I'd love to hear that it's participating in development of fuel cell powered large passenger aircraft, I know some small battery powered short range commuter aircraft should be in operation in a few years, the question is, can we do it with aircraft capable of international travel.
I'm very much a senior, I doubt if I'll see it, but I expect that 30 years from now I doubt if gas or diesel will be used in many ships, boats, trains, cars, trucks or planes. I also doubt that much power will be generated by petroleum based energy by then either. We all should realize that if we want to keep our planet, we need to stop polluting it.
Gary
Jack,
I'm only recently heard of PLUG and yet to invest, but I really wonder if this isn't just the end of the beginning, not the beginning of the end.
I'm old, I don't know that I'll live to see it, but I suspect that the world is rapidly starting to recognize that climate change is real and things need to really change if we're to continue living on our planet.
I hate to say that Shell is making the right move, but they may be. Why? Not because fuel cells won't work well in cars, they could, but because new battery technologies are improving what can be done with batteries to the point where neither range or charging time is a serious problem. In the meantime, however, batteries won't be the answers to long distant truck, train, shipping, or air transportation, hydrogen should be the answer. Whether it's fuel cells running electric motors, or hydrogen rather than JP-5 or diesel actually propelling aircraft, ships, yachts. etc. time will tell.
I know that right now companies are working on commercial aircraft that fly short distance commuter flights with battery powered motors providing the thrust. I don't know if larger range would be accomplished with fuel cells driving electric motors, or hydrogen replacing JP-5 in jet engines, but either are possible. Batteries might be okay for yachts only intended for harbor hopping at no more than say 100 miles, but for world travel, fuel cells will be the answer.
My point is the industry is just approaching the end of the beginning. Even electric cars will be supported by fuel cells as infrastructure may not support chargers on all the nations highways, but fuel cells could easily be strategically located to provide charging stations and their hydrogen tanks refueled far less frequently than most gas stations receive gasolene. In fact, truckers could refill their fuel celled powered trucks at the same place that multiple charging stations were available for car charging.
I don't know if this is the biggest reason to invest in PLUG, but I like the fact that PLUG seems to be involved with all aspects of using hydrogen, not just supplying the hydrogen itself. I hope others will address this, and feel free to point out other companies I should also consider.
As an investor, I might add, that I think the likelihood of a $4 company going to $8 is greater than a $150 company going to $300, so I tend to invest in smaller companies, some even sub-penny, knowing they may go belly up, but if they're successful the percentage gains can be spectacular.
Gary
There certainly are similarities, however, on the other hand, with all the wealth, might they just want to put this behind them for a figure that might be a tiny fraction of what could be awarded in a courtroom. The political stall is about postponing judgement in hope that a pardon can actually proceed a judgement. The financial stall is to bring as much of the evidence to the surface before a trial, if that evidence proves worthy of the trial, I suspect it may encourage a settlement, perhaps before others, like the SEC, stick their noses in to see what happened.
If the Judge rules in favor of NWBO and is satisfied with the evidence, I believe the MM's will recognize that by forcing all the evidence forward the case has largely been decided, the only question is how large the judgement will be. In Trump's recent judgement, the reason punitive damages were so great was Trump's declarations about his wealth. I don't think the MM's want to put themselves in the same picture and let a jury decide what punishment is enough to make them feel it. A settlement allows them to back out without ever exposing all that they've been up to.
I certainly don't know how long we'll need to wait for a decision by the Judge, but I believe if the decision comes down in NWBO's side, it is a strong indication of the direction a trial will go, if it ever goes to trial.
Gary
What you say may be very true, however another possibility certainly exists. If Ms. Posner convinces the Judge of the validity of her case, when the defendants clearly see they cannot avoid it, I don't know that a settlement may not occur rather than going to the risk of what may happen in a trial. Nothing is certain, sometimes cases don't settle until juries are in deliberations. My point is, the money could come in any time from after the Judge determine the case is worth taking to trial and after the trial concluded, or even be delayed further if it goes to appeal. A settlement can come at almost any time.
Gary
To me it doesn't matter what any of you know, or who of you are attorneys, there is only one person who matters, Ms. Posner. She has taken the case on contingency, if she doesn't believe the case can be won, it would be dropped. That doesn't guarantee it will be won, but it certainly indicates that she believes she still has a case. That's all I need to know.
This is not the key to the company being successful, approvals are, but this could supply financial backing that would put the company in a better financial position to advance the growth of the company as approvals come in. If the settlement comes in prior to approval, depending on it's size, NWBO may be able to proceed on new trials, development of production facilities, etc. without the support of partnerships and/or substantial dilutive financing. That's not to say the partnerships, etc. may not occur, but if they do, NWBO will be in a stronger financial position going into negotiations.
Gary
Let's be honest, we all do things that we know cause tax liability a year or so later, but we don't just set aside the money to pay as long as we can deal with it when the taxes are due. Let's not make a big deal of an executive doing the same thing any of us might do.
Gary
I hope that we can do the same thing here that we're talking about doing on Investors Village, keep in touch about how we're investing the gains we've made in IMGN.
Personally I'll be adding to my NWBO position, and as of now am looking at AVXL to establish another substantial biotech position. Also looking at a few other biotech's and a couple others suggested to me, PLUG for example in hydrogen based energy. I welcome suggestions by others.
Gary
As an insider, assuming he needed money, he may have been told that he could sell before positive news he knew about was issued, or he'd have to hold for some period of time. Corporate officers and certain other employees are restricted as to when they can buy or sell.
At IMGN we had a Chief Scientific Officer who held a fair number of shares, but sold each time new options vested, sometimes all, sometimes just enough to pay for all the shares. I knew people who knew him who indicated he had kids in college and needed more than his salary provided rather routinely. You never know why people do what they do.
Gary
I believe the future share prices for the company will be based on a variety of factors before a major partnership, or buyout. Perhaps they fall into two basic categories, technical and emotional. The technical takes into consideration things like regulatory approvals and acceptances, revenue production, licensing agreements, etc. I.E. they're ways investors can access where the company is today, and what they believe will be happening in the future.
The emotional would be things like a banner headline in the NY Times, or the cover of Time magazine, or a major feature in the likes of 60 Minutes did a story on how DCVax-L was the answer to curing all solid cancers in the future. I don't care if the stock was selling under $1. or $5 etc at the time, it might be $100 in the next day, or next few days. The emotion is in seeing something and wanting to buy in at any cost, with little of no DD. While in time I believe NWBO could be worth far more than $100 if it truly has a place in the SOC for most cancers, but the proof of that comes from doing it, not some claim in a banner headline or news show even if what they're saying will turn out to be true a few years later.
I bring this up because if in fact LP has had discussions with one or more BP's regarding either partnership or buyout, such an agreement would normally have the BP paying a healthy premium on the current price once some minimum price is achieved. If the price is achieved based on what I'm calling technicals, it will take some time, could be later this year, but more likely in the next few years. On the other hand, if the share price skyrockets on emotion, it could easily exceed the prices being discussed in a day or so. Both parties might agree to move forward at a higher price, or the deal could be nixed until the price was more in line with what had previously been discussed. The likelihood is after such an emotional rise, it will retrench, perhaps half the gain or more, but even with there it could be well above the price a BP's willing to pay.
I believe that most longs here are wise investors, if they did see banner headlines and the stock took off, they'd profit nicely. Personally I'd set trailing stop loss orders and just keep moving them up until the stock peaked and fell to my latest stop loss. After selling I'd very probably look to buy back once the price came back down to earth and stabilized. That's what I'd do, many would do otherwise, even now some may have sell orders in at prices like $5 or $10 or higher that emotional news could have the price up faster than you can call your broker, or cancel the order on line, you'd be out at a price you were happy with, but might not be so happy if the stock was selling for double or more what you sold at. I don't believe that Fidelity will let me set a sale price at say $50 or $100, I'm not sure I could do anything in double digits, regardless, I'd not put a sell in for anything less as if I were sleeping late, which I generally do, I could be sold out before I heard or saw the great emotional news. I'm not saying it will happen here, only that it could.
Gary
What you say is true Smitty, but something else is also true, at the sort of price LP clearly wants, no deal is possible until DCVax-L is approved by at least one of the regulators, and possibly not until the FDA is among the regulators who've approved. It's really as simple as that.
I suspect that even a partnership to run trials with DCVax-L and a product in the partners ownership isn't likely until we have an approval somewhere so the trial is for a combined use of drugs that are already approved and are being sold. The partner may very well pay for some or all of the DCVax-L that's being used in the trial based on the price set for the vaccine.
In at least one case I'm aware of, a partnership that was essentially complete was delayed for over a year because the drug to be used in a trial spoiled when a low temperature freezer failed and it took over a year to rebuild production capability and make sufficient product to run the trial. NWBO is far from the only company to have products in trials for well over a decade, in fact I suspect that more products involved in longer trials are approved because trials are often stopped when products don't appear to be headed for approval.
Gary
I really believe that management has not changed the goals in all the time LP has run the company, the goal is developing better cancer treatments, first revolving around GBM, but potentially all solid cancers. LP knows that if she achieves that, the share price will be high enough to make everyone happy, and all but the shorts pretty rich.e
Certainly there are many steps in getting there, and she may have done things differently to boost the stock, but the only real goal is developing better cancer treatments.
Gary