Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
He's no different than most CEO's in that way, most quarterlies are scheduled on or near the last day they're supposed to report. I live in L.A., decades ago most quarterly and other presentations were scheduled about a half hour after the market closed. Suddenly I found most companies switching to an hour or so before the open. I asked my broker what was going on and the explanation was simple, nearly all the Analysts are on the East Coast and nearly all come in well before the bell to get up to date on the news. They complained that when the day ended they wanted to leave, not wait around for nearly two hours to first read the financial, then listen to the quarterly report which followed the release.
While I'm interested, I don't get up at 5 a.m. to see the release, or 5:30 to hear the call, and only rarely am up when the market opens at 6:30 my time. I may use the bathroom about then, so I'll take a glance, but unless I find a big move in one or more of my stocks I just go back to bed until I normally wake up, 1 to 3 hours later. One of these days, if I miss the open, when I do wake up I'll learn I'm half a million or more dollars richer, from NWBO news, I don't own enough AVXL to make that sort of gain, at least not yet.
Gary
Powerwalker, clearly they'll be speaking with a quarterly in the next two weeks, but how much they can reveal above and beyond a normal quarterly may be in others hands. If no material or data that's never been peer reviewed is released, they're limited about what they can say. On the other hand, if they're in control of an issue, like filing with a regulator, they can certainly update about that.
I know that when they discuss million page filings there are companies that specialize in getting them out, just the announcement that such a company has been engaged would be positive news rather than trying to do it all themselves. I'm frankly unsure if even the BP's do it themselves. If they were to announce an intention to file somewhere no later than say the end of the third quarter, it would be greeted positively.
If you're right about discussions with one or more BP's, it would be big news to indicate they're in a quiet period, so it's cannot be discussed. Sometimes the best news available is that we're not free to discuss anything. During such periods they're still required to issue financials, but the failure to say certain things in the financials may be telling a story by itself.
I do suspect that sooner, or later, a BP will either partner, or look to buy the company. Personally I would like the price much higher before it happens, but that can only happen with one or more approvals. Offers very rarely pay more than double the current price, I would hope the company's trading in at least low double digits before considering any offer. Under confidentiality agreements, a potential partner, or buyer, would gain access to all the data we're being denied until it's peer reviewed. That's information that could lead to a much higher offering price, but only after the stock price reflects the news that's not yet been released to investors.
I for one believe that when we get the full story on RETT's we may see a possible path to approval without further trials, but that's purely my opinion. On more than one occasion the regulators have agreed that more than specific goals in a trial should be considered if a product has some benefit where nothing else exists.
Gary
Powerwalker, I'm sure you're right about the company doing the quarterly webcast in a timely way, and yes, they certainly speak with investors whereas NWBO doesn't do such webcasts, so all you get is the written text. As for the Annual Meeting, if Missling gives investors a reason he'd prefer to wait, I believe investors would support it.
Investors want to hear more about the data, until that data's been presented for peer review, the company shouldn't do it. Wouldn't you rather have a Journal out, or peer reviewed presentation first, then have open discussion of the data, or have the meeting and be told that the data won't be discussed until it's been peer reviewed.
I don't believe Missling will delay more than a few months, but I'd rather have a meaningful Annual Meeting in perhaps August or September than a meaningless one in May, June or July.
Another possibility does exist, but only after peer reviewed data's out. Hold a Science Day. It's really just a few hours, but allow the scientists to do far more of the presentation. I don't know them, but hopefully among them there are better presenters than Missling. I know other companies have done Science Days so when the time's right, why not AVXL.
Gary
You're correct, if either NWBO or a contractor decided to build a major new manual production facility here in the US it would be acceptable, but I don't believe they've made that choice. I believe such a facility would cost tens to hundreds of millions and might not be completed before the EDEN was available. If I'm right about biological products not being importable to the US, no matter how much capacity is added at Sawston, it will be of no benefit here in the US.
One large cleanroom with 100 EDEN units would probably cost less than ten individual cleanrooms, each with their own HVAC system to assure no cross contamination between rooms. Even if US approval is delayed substantially, I believe that's the course the company has chosen, probably with the concurrence of CRL who I believe will be contracted for US support, but if they determined to do it themselves, it will be with the EDEN unit.
It's never been about whether it can be done manually, yes it can, but a decision not to do it that way is up to the company and I believe that decision was made some time ago. The company is making and qualifying the EDEN units in Sawston, once it's approved there I believe they'll get little resistance from the US, or anywhere else. I believe that CRL has sufficient cleanroom capacity to operate hundreds of EDEN's or more without requiring new structures to be built in Memphis, they have other facilities that can probably be adapted as well worldwide.
It's rather interesting that shorts are now fighting about US production when previously they indicated that the FDA would never approve the vaccine, that's a refreshing change. I wonder how AdamF feels about it.
Gary
I don't know for certain, but believe that like me, Doc Logic took the change of clinical trials made by the regulators themselves as formal acceptance. If NWBO had pushed for such a change here in the US before the NYAS presentation much of the confusion generated by bashers at that time couldn't have been. We'll never really know if NWBO's submission was very late, or if those responsible for the update were just slow in getting their job done, but of course the submission could have been made well before the conference had they wished to do so.
Frankly I believe that all four regulators have worked close together in this trial, but sadly they all can't just get together on approval. I still believe it's held up for the EDEN here in the US, while it's possible the other regulators, with smaller numbers, may be open to using Sawston with manual manufacturing as meeting at least their initial demands. I could be mistaken, but I believe US laws cannot currently accept products made biologically being made in a foreign country, but I don't think the same applies elsewhere.
Gary
I completely agree with you Chris. Any CEO would prefer to have their Annual Meeting after some good news, rather than when under fire for nothing new happening. On the Nasdaq a CEO probably doesn't have the freedom an OTC stock does, in NWBO's case they didn't have a meeting in 2023 after holding the meeting for 2022 on the last business day of the year, but I suspect that Missling can delay a couple months without a serious penalty. I believe if shareholders wish to force the issue 13 months after the last meeting they can sue, which will take time, but ultimately they can force the meeting, If I were Missling and I expected a Journal publication at any time, I'd wait until I had it unless I had something even bigger to announce, like actually filing for approval.
As for Missling's ability to be CEO, some will deem him a failure right up to the day the company gets it's first approval, then everyone becomes a hero. I believe that CEO's are given entirely too much credit, or blame for what most companies do. If they put together a good mix of the right people, it's all of them that are doing the job. Ultimately it's the science that determines if a product is really approvable, I don't know Missling at all, but I doubt if he contributed much to the science that's produced the company's products.
Sadly, in at least a few companies I've seen good science fail because companies tried to gain approval quickly by using pancreatic cancer as the target for products that worked far better against cancers that took much longer to kill. The company didn't have the funds to do the additional trials so the products were abandoned and the company went belly up. Missling has the company well positioned financially, now the science must prove worthy of approval, I believe that's happening.
Gary
Your fight isn't with me, the peer review publications limit the size and determine the content that they accept, if they wanted that information in, something else would have been out. None of us know what was submitted, included, excluded. Had it been up to me, a simple statement would have been made about progression not working for this trial, and everything else about it left out, but that's not how they saw it.
As for what you said about the SAP, both the UK and Europeans changed their versions of Clinical Trials after the halt and acceptance of what the company proposed, that's as close to acceptance as you'll ever get, the company was actually surprised that they made the change.
Many things the regulators do are not formally accepted, if you submit a change or make certain submissions and nothing requesting changes in a specific amount of time is returned, your submission is presumed to have been accepted. It actually all begins with an IND to initiate a trial, no formal document accepting it occurs.
It's very common for shorts to ask for documents that don't exist, you know they don't exist, but asking for them creates doubt, and that's what bashers are all about. Approvals are the answer to everything and I don't believe it will be that much longer before we have at least the UK saying yes.
Gary
As a reasonably new investor in AVXL I've seen a great deal of criticism of the CEO, but honestly it's nothing that I haven't seen in other biotechs, and in most cases it's been for the same reasons. In most cases it's because investors believe that once a trial end, they're entitled to in depth trial data. In reality, the company does give Top Line Data, but that's just a paragraph or two summarizing what's seen in the trial, after that, once data's been peer reviewed and presented, then they can talk about it.
Sadly, companies want the peer review to be done by organizations deemed to be highly respected, and they'll wait for them rather than finding the first conference or Journal willing to permit a presentation. I'm much more familiar with Oncological products, and there conferences like ASCO are where they want to be. I'm sure much the same applies here, though I don't really know the key conferences, or publications they're working to get into. My point is, it often takes many months, sometimes in excess of a year to get the data presented in the manner they wish it to be, and until that happens they simply would be violating proper protocol to discuss them beyond what's in that TLD statement.
When a peer reviewed presentation is made it won't be just the positives, it will be a review that has positives, negatives, questions, etc. seen in the trial, it's rare that nothing negative can be found. Peer review will cite both good and bad, that's what it's all about. Competitors, who fear approval of a competing products may have their own "experts" develop presentations that counter the good as well, money will buy almost anything, and some lessor publications or conferences will accept what's provided and consider it peer reviewed by their staff.
Finally there are the geniuses like AdamF, with his degree in PoliSci, as I remember it, that work in support of shorts to put down companies who put their spin on the results, and sadly many people do follow them, as well as the hedge funds that no doubt employ them.
In time, all of this becomes meaningless if the company applies for approval with the regulators, and gets it. When revenue builds, that's something that can't be denied, but until that happens, one minute the CEO's terrible, the next he's brilliant, it's all dependent on the current stock price.
Gary
Dstock,
I know there has been a lot of talk about synergies with RevImmune, as well as Advent, which LP has control of. As I see it, it's up to her whether it's to both her best interest, as well as shareholders, to act on what she's clearly in control of. Clearly whether she does act, or allows things to continue as is, her holdings are so great that effectively she has control of all three companies.
My thinking would be, she won't do anything prior to much higher prices for NWBO, and at that time if she acts it not only may combine all three, but to add a fourth, the developer of Poly-ICLC. When I invested 5 years ago the thinking was NWBO would eventually be bought out, that may still be the plan, but another possibility may be developing to make NWBO, or something with a new corporate name that includes all the above, into a greater sized biotech. With some success, anything is possible.
While I'm still of the belief that CRL will be part of the plan for the production, storage and distribution of the vaccine in much of the world, it's not impossible that LP will look to acquire production capability rather than contracting for it. It's clear that LP has substantial financial resources, or knows where she can get them, so nothing is out of the realm of possibilities, but it all starts with approval of DCVax-L and the EDEN unit for making it.
Gary
LC,
In reply to your multiple posts, first I believe that most if not all in the control had real progression, not pseudoprogression, but regardless, at that point all were permitted to cross over. I believe the reason that many chose not to cross over was that their conditions were so bad that they resigned themselves to die. As for the data, the JAMA publication does what the peer reviewers permitted to present it. I don't know if the presentation would have been substantially different if peer review were different, as I stated, benefits would have been much more clearly made if all mention of progression was eliminated as some progression was truly progression and some was pseudoprogression, but no real attempt was made to differentiate one from the other.
I believe new trials will not have control groups, even if pseudoprogression can be differentiated from progression. The FDA has clearly in their Journal publication has been open to using historical information rather than control groups when it comes to terminal diseases. I suppose it will be up to the trial sponsor, but I believe in any trial NWBO runs all patients in the trial will get the vaccine from the beginning and the comparisons will be drawn against historical information. Ultimately I believe most companies will opt to design their trials this way. No doubt placebo's do make differences in some diseases, but in deadly disease long term they make little difference in overall survival, but perhaps more when it comes to determining progression. In reality, the FDA has found that some products approved on PFS are not really improving on OS, but they remain approved as they clearly give Drs. more choices and they're not doing harm.
I believe the more options Drs. have the longer patients can survive, not because one is necessarily better than another, but rather because as a patients becoming refractory to one, a Dr. can switch, they can alternate many times rather than allowing the cancer to become refractory to the treatment the patient is on. I can't say if a cure can be obtained this way, or not, but years can be added and if products like DCVax-L are helping to add the years it will be at high qualities of life.
I've spent time on the oncology floor of a major hospital where certain patients lives may be extended, but they never left their rooms, and probably never got out of bed, it's not much of a way of living. I was fortunate enough to never be in that state, though at times I was isolated to my room, but at minimum could walk within it. I actually met the wife of someone I hadn't seen for years who was there to visit her husband, I couldn't visit as he was isolated, and after I left did pass on. Quality of life really is an important issue and I believe that in virtually all cases, our vaccine will not adversely effect quality of life and may help to eliminate the need for certain other products that may have benefits, but have terrible side effects while on them. Cancer itself my offer a terrible quality of life, but many of our treatments for it make it substantially worse, our vaccine has virtually no negative side effects and may in fact make the quality of life far better, especially if it's use ultimately yields a cure. A failure to approve it would really represent a failure in the system, not the vaccine, as its approval would not be denied, only delayed. I've seen many blockbuster drugs that were delayed by the regulators, and sadly it's the patients that could have used them who were denied, their success was delayed.
Gary
I had not heard of NWBO decades ago when the trials began with DCVax-L. As I understand it a Phase 2 essentially morphed into a Phase 3 and while it was a blinded trial, what was learned during the trial couldn't be blinded, for if it was, the trial would almost certainly be abandoned. What was being seen in the trial was patients deemed to have progressed, but in spite of being deemed to progress, they were living longer and their health improving. This was determined to be pseudoprogression.
The result of what was being seen ultimately led to a temporary halt in the trials, and during that halt the trial, still blind to the company in terms of details, was redesigned in terms of utilizing what was learned about pseudoprogression to properly evaluate what was happening in the trial. If the trial had been simplified to what mattered, all references to progression would have been eliminated, all that should have mattered was overall survival, but it wasn't that simply redefined. The analysis of progression remained within the trial, even though it was known that many who received the vaccine initially were judged to have progressed quickly, because it was actually pseudoprogression, while those in the control were living longer before the determination of progression. The K-M plots gave the appearance of those on placebo doing better than those on the vaccine.
If all this data had simply been ignored, the likes of AdamF and many other shorts wouldn't have a leg to stand on in discussing the trial, but it wasn't. Many have successfully called the trial a failure based on the K-M's which are based on PFS showing those getting the vaccine were deemed to progress before those in the control. Thankfully the regulators understood what was happening and accepted the redesign of the trial after the halt, but they didn't completely remove all discussion of progression, so it remained a target for all trying to put down the vaccine.
Presentations may have documented what pseudoprogression is well, but things like the misleading K-M plots remained in what was being reported and therefore remained a target for criticism. I certainly don't know, but suspect that if we looked at many of the longest living patients we'd find that many had been found to progress very shortly after treatment with the vaccine began, while as a whole, nearly all who purely stayed on the control, never getting the vaccine had passed on among the earliest to do so. The good news was for some in the control who progressed, treatment with the vaccine did help, but it was clearly seen that none should wait for progression to be treated and after the halt, all received the vaccine immediately.
If knowing what's known now a new trial was designed, from the beginning it would have no control, but likewise, knowing what's been happening at UCLA they'd add Poly-ICLC and/or Keytruda and take survival to somewhere over 50% at 5 years. A 5 year trial shouldn't be needed, perhaps 70 to 90% would be alive at 2 or 3 years, certainly enough to make an approval determination, but hopefully the regulators can act without waiting for such proof. They may not put Poly-ICLC and/or Keytruda into the approved protocol, but encourage its use regardless.
Gary
I'm certainly no expert, but I suspect that many of those pages are generated as a product works its way from preclinical development through clinical trials. They essentially provide the backup to significantly fewer pages that are the real guts of the filing. On the 1.7 million pages in the NWBO filing almost everyone I discussed it with agreed that less than 10% will probably see the light of day.
Gary
While it would be great to learn that the King, or any other major newsmaker, was getting DCVax-L for what would be considered an off label use, it's not nearly as important as the UK regulators saying we have an approval.
In the past celebrities often haven't seemed to have gotten the best treatments, at least not when it comes to taking experimental products. If they do, it's generally not until the SOC treatment is clearly seen to be failing. No doubt they get some of the finest physicians, but not necessarily the ones doing a great deal of experimental work. I doubt if the treatment protocols for most celebrity treatment is ever made public, whether successful, or not.
Gary
Just a thought on the RFI issue at the company. While I believe that there is a good chance that no such request was made, if it was, it's not something that people like DI or others involved with the investment public would be permitted to discuss, so it would be my contention that they would never be told. I would suspect that the only ones to learn of a RFI from the company would be those given the responsibility of answering it, and very probably those on the BOD. Of course it's already very possible one or more contractor could be involved.
I believe may are developing a course of action once the outcome is known, but if they're not involved in responding to a RFI, they won't know if the company was ever asked.
Gary
If I were the company and expected something positive, like a Journal or regulatory filing in the near future, I would not call an Annual Meeting until I knew that it had happened or was about to. It should be within 13 months of the last meeting, but the regulators really don't seem to care, so if shareholders don't force the issue by suing, they can do what they wish.
Gary
I wish the German Col the best in what he's purchased with proceeds from the NWBO he's sold, but I believe that it's what he retained that will make him the greater gain, and it won't be much longer.
I got to thinking about all the people I've suggested NWBO to who bought, I really don't know how many shares each one purchased, but I'm certain the total holdings on my part and those who've joined me is well in excess of half a million, but I don't know how close we could be to the one million mark.
I really don't believe the UK regulators will wait for the entire 150 day period, but while reliable posters don't believe an RFI came in, I don't think we can be absolutely certain. I think we can be certain the company wouldn't PR an RFI. If I'm right we have less than a month before we know.
For anyone who also looks at I-V, I'm happy to say it's back up and hope they can keep it that way. Most there are shorts, but largely intelligent ones, and some I respect, even if we don't agree, but we do have some longs there as well.
Gary
Newman, the question I might have is if DCVax-L is approved and a patient has unlimited funds, would any oncologist recommend using both the vaccine and the helmet, and of course Keytruda and or Poly ICLC.
Gary
That is simple, LP has set a price point that they would be considered to be insane to meet until the share price is near half that price.
Gary
I believe that the company, and Drs. primarily in the UK have enough tumors in storage and patients lined up to keep their limited production capacity working for some time. Once word of the approval is out, this will grow dramatically without a major sales or advertising program. Furthermore, we know the company has contracted for all sorts of things, I still believe that both Advent and CRL will be involved in the commercial production, storage and distribution of the vaccine, if there is a need to line up more patients, because they have the capacity, perhaps that too will be their responsibility.
Of course Advent and CRL will do well in this arrangement, but so will NWBO, they'd have almost no added expenses, but would be collecting for every patient being treated with the vaccine. As I see it, it could be a very win-win proposition for all concerned.
Gary
Remember, they are going for the UK first. They have Advent setup to do what is needed there, no need for a major staffing growth. If even in the US they choose CRL to function in a similar capacity, they could do it without major staffing increases.
The company has used contracts to get this far, what makes you think that now they will do things themselves.
Gary
Jester, I'm not saying that at all, it's purely a coincidence but if the 150 day period applies, the approval should come in before ASCO, if there are delays, it could happen during or after ASCO. I'm sure the submission wasn't intentionally timed this way, they planned to do the submission over a month earlier. If they do have the approval by ASCO I'm sure that both their booth and Expert's Theater presentation will reflect it.
My timing is no different from others here, I just brought up the point that it could tie in nicely to ASCO.
Gary
If you look at the law firm they sue all sorts of companies, that doesn't overly concern me. I bought in after it was down substantially on RETT trial with data which was flawed by observers on placebo patients being optimistic. I believe eventually they'll get RETT approval, but more importantly they'll get Alzheimer's approval, first in Europe, but everywhere in time. It will take time, but that will be huge. Off label the drug will be used in RETT's, Parkinson's, etc. until further approvals come in.
We should gain approval far sooner, but I do invest in more than NWBO, though it's my biggest investment by far since IMGN was bought out.
Gary
Just wanted to wish all my fellow members of the tribe a Happy Passover.
Hopefully by the last Sedar we'll have some positive news from NWBO.
Gary
They would have been smarter to only say what quarter they intended to file and have left it at that. I suspect they must have felt pretty confident when they gave us dates, but clearly s-it happens, and it happens frequently in biotech's, so why shoot yourself in the foot.
I believe that good things are coming, the patent news today is certainly a positive, but until the EDEN is approved the patent by itself has little value.
I've recently bought share in AVXL, the CEO there is under constant criticism, he's been indicating for some time they intend to file with Europe first, but so much time has passed that no one gives him any credibility. Once a filing is made the attitudes will probably change, but no real guidance exists as to when that will be.
Gary
I have no knowledge of Anavex's capabilities, but I know that NWBO used a contractor who specializes in regulatory submission to do the submission to the UK. I believe it's done electronically and doubt if many pages are actually printed at all.
I would suspect the company will seek out a specialist when they're ready, I know in NWBO's case it took longer than anticipated, and I suspect that either the specialist, or regulator itself, wanted changes prior to finalizing the submission. Such things are generally not discussed by most companies, and frankly NWBO made a mistake by providing an estimated time, then delaying it twice. It would have been smarter to forecast roughly the quarter and erred on the side of caution if they thought it would be in the last month of the quarter. Filing early would be great, but issuing guidance delaying the filing is a big negative, and NWBO did that twice.
Gary
By ASCO we'll either have UK approval, or we won't. If we do, I suspect that our booth will get a great deal of attention and likewise if we present in the Expert's Theater, that will be well attended as well. If not, the impact of being there will be much the same as prior years, hard to say what's to be presented in the Expert's Theater, it might concentrate on the EDEN which hasn't received much attention in the past. If by chance Dr. Liau, or anyone else submitted Abstracts on the early phase trials and they're selected for presentation that could be big news.
ASCO comes at the very end of May, the UK decision, if not delayed, should be out by then. Of course we all know the regulators often have delays, so it's not a sure thing, I've given it a 90% probability. I would like to see clarification on the 150 day timeline. Some have said it begins on submission, others on acceptance. We know when the submission was, but people are assuming when it was accepted, nobody but the UK authorities, and perhaps the company know. The difference could mean the difference of a decision before ASCO or a decision essentially right at the time of ASCO if the UK holds to the 150th day, if in fact it's based on acceptance and that didn't occur until sometime in the first, or even second week of 2024. 150 days is essentially 5 months, depending on the acceptance date it could fall during ASCO.
On thing is certain, the UK cannot review even a meaningful fraction of 1.7 million pages in days, weeks, or even a couple months, so no real review was done to accept the filing. That stated, I would think there is still a good chance the submission was accepted nearly immediately, perhaps even before XMAS if the staff there doesn't take the Holiday weeks off. I would suspect that acceptance isn't much more than a time stamp placed on when the entire package was received, which I suspect is electronically, but 1.7 million pages do take some time to transmit.
Gary
I certainly agree and also believe that both LP and LL are driven by what they're doing, as another poster stated.
If tomorrow's the day something big will happen, we're about 6 hours away from when it should be announced, before the market opens. Not saying this is the case, only that it could be.
Some tomorrow it will be the case and as Annie says so lyrically, tomorrow is only a day away.
Gary
It seems to me that Zena will be doing everything that Epazz is, I'd have to think that this will be like a combination of a reverse split and IPO where existing Epazz shareholders get shares, perhaps at a ratio of hundreds or more shares to one and in the end Epazz will cease to exist. It still could be a positive for us, depending on the ratio, I just don't know why they can't spell it out that way.
Gary
I certainly wanted to retire early, and did so just before hitting 55 with 31 years when where I was working was closed. There were times when I enjoyed what I was doing and would have done it much longer, but that wasn't the case for at least the last ten years.
It's said that a person who enjoys what they're doing will never work a day of their life. I don't know that LP doesn't really enjoy what she's doing and she may surround herself with people who feel the same. Additionally, after some success she could easily retire potentially a billionaire, or close to it, and let someone new come in at CEO and grow her equity. Same can probably be said of virtually all the key people there, once they're successful with the regulators and have the EDEN working almost anyone with the right experience can build on to what they've created.
Gary
Shouldn't CRTG put out first quarter results based on their books without Core Optics inclusion?
Gary
It's my understanding that Posner's suit is only for spoofing, but I've got to believe that if she can prove the same MM's were involved in a massive naked short the case could grow dramatically. I know it's legal for MM's to have a short position, but if it's proven that they're intentionally maintaining a massive naked condition by moving naked shares between them to hide what they're doing, I would think the SEC would be interested.
Gary
I believe that nearly every long here believe this stock has the potential of going to $5 or probably much more. If that's true, I think it's worth remembering the investment wisdom of the cowboy philosopher, Will Rodgers, it doesn't get any simpler, BUY GOOD STOCK.
He added that if it goes up, good, if it goes down, better. Buy More. Remember you already determined it was good stock.
I believe we potentially have a very good stock, and I think most of us have taken the opportunity to buy more, many times more. I believe that others will be deciding what we already know, it's a good stock, but they'll be deciding at $5, or $10 or more, but they'll be buying it then, not now, because they've yet to learn of it and know it's a good stock.
Gary
Even on the OTC they should be issuing quarterlies in a couple weeks. The real question is what will be in them?
Gary
While we're in agreement, I'm not sure that billionaires even pay 3 to 7% certainly not all of them. Worst case, many companies earning billions paid absolutely nothing, it was legal, our tax laws are what's at fault, you can't blame the people or companies from using them. I wish they'd throw them all out and start fresh with laws written at about 10th grade level. If it were up to me everything would be so simple it could be done in under 100 pages, 12 pt. double spaced.
I'm a boater, but if you look at big yachts today many are the size of smaller cruise ships. I'm sure there are huge tax advantages, and most are available for charter, probably losing millions a year in that business. The paid crews often outnumber the passengers they can accommodate, and they're the ones really enjoying the mega-yachts. So many other things have similar tax advantages, I can't blame the wealthy from taking advantage, I blame the laws for allowing it. Our govt. has confiscated many of the yachts owned by Russian Oligarch's and we're now paying the millions it takes to keep them up. After the war in the Ukraine is over those Oligarch's will probably be able to reacquire the yachts, but of course many of them have fallen out of tall buildings, etc. and are no longer with us. The Govt. will probably have a difficult time selling these units unless there are big tax benefits for purchasing them.
Personally I'd feel very wealthy with equity of a few million, however for the people in the billionaire class, a few million is pocket change.
Gary
To my knowledge they can't buy on the open market except at times which they're deemed not to be trading on inside information. A quiet period would certainly not be such a period. On the other hand, if they have options that can be purchased at a fixed price, they should be able to convert them to shares and certainly would be able to do so if they're about to expire.
Some companies have very limited periods that employees can buy on the open market, but they're generous with the options employees earn each year. In IMGN's case, with the buyout, employees who had years before their options vested became instant multi-millionaires because all options became available immediately. I would imagine the same arrangement would apply here if the company were bought out.
Gary
BB, while I'd love Posner's suit to really punish the MM's, the reality is, we must deal with them, they get involved anytime we either buy, or sell. Frankly we live in a world where computers could probably be set up to replace them, the market would probably be fairer, but that won't happen.
Likewise we live in a world where Institutional holdings could be reported as they buy and sell, and nothing could be hidden when they buy on or after the first day of the quarter and sell by the last day, but not only is none of this reported, when they do report, we're half way through the next quarter.
The small investor is certainly handicapped when compared with all the others, but I don't think the SEC or anyone else wants to change this. As a small investor, all we can do is hope that the Institutions want the company to move where we want it to. To date the MM's have clearly been working against us, but we have virtually nothing in the hands of the institutions. As Institutional holdings grow, this ought to turn around as the MM's work with Institutions to build their equity. Perhaps some day the MM's will become our friends, but hopefully not until after they've paid us a great deal of money from Posner's suit.
It's sort of fun to see that even the likes of Musk and Trump are complaining about naked shorting of their stocks, maybe they'll join us in our suit. Please realize, I'm saying this in gest.
Gary
Let's get an approval before fighting for how much they should charge. You need not recover all developmental costs in the first year. If in fact AD is first, it's probably the biggest application and worldwide acceptance shouldn't take all that long. How many patients should be estimated to benefit if applied worldwide, I'd think the number goes into the millions. Certainly not everyone will get it, but new patients will be added every year and existing patients will continue treatment, so revenue will be growing. Even if the annual cost was in the single digit thousands for the average patient the potential would be huge.
I've got to believe the news of an application being filed, regardless of the authority it's filed with, will be huge for the share price. No telling when, but it will happen.
Gary
I never meant to suggest this would be at close to current prices. If we're well into double digits and they were offered a few hundred million dollars for tens of millions of shares, it may be hard to say no. By that time I don't believe naked shorts will be a serious problem.
I hate to say it, but IMGN all to often sold in such offerings shortly before they knew good news was going to be announced. The institutional buyers not only got shares at a slightly discounted price, they also got a nice sized gain shortly thereafter. IMGN liked having 80% or greater Institutional ownership and they fully backed the company on the buyout, while many individual investors like myself opposed it. Once a company grows into a profit making operation, or headed that way, individual investors have little say about how votes go, even 20 to 30% ownership by Institutions or a BP partner almost assures any vote they pursue to pass.
It will be interesting to learn what we're to vote on at an Annual Meeting. I don't think it will be announced until we have an approval or other positive news, but when it is, if they're telling us they're looking to pursue an equity partnership with a BP, at the same time they should be asking us to authorize more shares as they'll need them for such a partnership. It may be too early for such an announcement if LP's still looking for at least say $20 a share for such an agreement. I suspect she might be willing to do a tiny percentage at $10 which could be achievable once we're at $5 or more.
$5 will bring in many Institutions and permit a move to the exchange of LP's choice. Will it happen shortly after approval, or require something more, it's anyone's guess. At $5 or more I don't know that LP may not be eager to offer enough stock to bring in say $100 million to be in a better financial position to initiate new trials as well as gaining further regulatory approvals. It will take awhile for income from sales to build, having cash on hand is not a bad idea rather than trickling out some shares almost every day. I respect LP's ability with money, I feel confident that what she does will benefit all of us.
Gary
George, your numbers may be right on the money, but the main thing to users is what will their cost be after insurance. I suspect that will run the gamut between zero coverage and zero cost. Personally my Drs. are often surprised, first by the fact that they don't have to fight when prescribing certain drugs for me, and finally when I tell them with my coverage I'm getting the drug for free. Often they're drugs that have triple digit list prices. I don't believe the insurance pays triple digits, but I'll never know. I do have coverage from two insurance companies plus medicare, so my coverage is better than most, but my wife isn't covered by both companies and her copays aren't that different from mine.
Drug companies need to consider what happens after patent coverage ends. I believe the courts were wrong doing what they did with Vascepa, but AMRN has dealt with it by lowering their prices to the point that while I received the generics for awhile, now I'm getting the name brand. It may take them longer to be profitable, but I believe in time they will be.
Meanwhile, many people still pay substantial premiums for name brands, like Bayer Aspirin that sits right next to the Kirkland generic at Costco, though I really doubt there is much difference. Personally I've bought the Kirkland product for almost everything and often found it better than the name brand, which they often also sell for less than at other stores.
I doubt if our products will ever be available without prescription, at least not in the US, perhaps it will be elsewhere. I know people who go to Mexico to buy bulk amounts of drugs which would require a prescription here with no prescription required. The drugs appear to be made by the same companies, but made in Mexico. The people are satisfied that they're the same, I can't vouch for it. Of course the cost is dramatically lower.
With worldwide acceptance of our drug revenue won't be a concern no matter how low the pills are priced. Billions in earnings and growing each quarter will become common and that should warrant a P/E of 30 or more. Even if our O/S grows to a couple hundred million shares, well over double what it is today, our share price will be at or approaching triple digits.
Gary
There is no doubt in my mind no single price will apply to all. A list price may be established, but does anyone think they'll pay it in third world countries. Likewise insurance companies will make their own deals, as will Medicare. Finally the company will no doubt make arrangements with poorer people who either don't have insurance, or who get little benefit from them, for lower priced, and perhaps even free drugs for some of them. Investors will never be told how many pills were sold, they'll be given revenue figures and does it really matter if a billion dollars in revenue represents 100,000 pills sold, or 100 million pills sold, or more.
Medical costs are worst than the assurances of a used car salesman. A 7 figure hospital bill might easily settle in 5 figures, and all are satisfied. Drs. everywhere are learning how to use the medicare and other insurance rules to their benefit. Some Drs. refuse to work in the system, but those who do are still doing very well.
Here in LA I cannot say how many buildings I've seen with Cedar's, Kaiser, or UCLA on the outdoor sign. Inside the building I've gone into, often various floors are actually for different providers. At City of Hope Kaiser has their own staff of Drs. working there, I'm sure they all share ideas. I don't know if Kaiser does any research work there.
Gary