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I certainly agree, but I also believe that at minimum a partnership will occur before regulatory approval, it could be a few partnerships, with each partner having distribution and sales responsibility for a given portion of the world. Of course the company could be acquired, but as I see it, the real value for DCVax-Direct can't be estimated until they're well into a Phase 2 Trial, and I can't see them selling the company before it's value is determined unless they get a spectacular offer.
It's my belief that Direct could very well be bigger than L, but it would not only be used on inoperable tumors. I believe it could be used before operable tumors were operated on to stunt their growth pre-surgery, and possibly eliminate mets. Surgery often isn't performed immediately after a tumor is discovered, it very well could be a month or more before the surgery takes place. If Direct can be made in a week or so, doing the leukapheresis immediately on finding the tumor could give it weeks or longer to work. They might even determine it's best to permit it, and perhaps other treatment forms, to work for a period of time before removing the mass.
I have a friend who had a successful Whipple procedure many months after the tumor was found. Initially it was inoperative, but chemo shrunk it till it could be operated on. DCVax-Direct could be part of such treatment, and when the tumor was removed, DCVax-L could be created if it was determined to be a workable one-two punch.
Of course the other question may be, if the tumor is shrinking with DCVax-Direct, do you continue to treat with it, or do you surgically remove it because you can. Trials may show that with repeated treatment with the vaccine it virtually disappears. The other big question is, just how many different types of cancer do these vaccines work for. If the answer to both these questions are positive, buying the company for anything under triple digit billions would be a bargain, but it will take awhile before the questions can be answered.
Gary
I think it's clear that NWBO didn't have an Abstract accepted at SNO, they may or may not have submitted one, but if they did, it may have been rejected for not discussing anything that hadn't previously been presented. I believe it's equally clear that they met with people a couple times, they were shown on the itinerary for the conference. Dr. Bosch or someone else may have made a presentation at either, or both of these events, and that presentation may be something the company will share with investors.
Whether this is the case, or not, we know it's not long before presentations are scheduled to be made, at that time we should learn what they're up to.
Gary
If in the past they've released blinded information at SNO, they should do it again. If they never did, then the regulators, or the SEC might have concerns about it. While I haven't been in the stock that long, I believe they have issued updates from SNO and at one point guided that more information would be available there.
Gary
Actually the term material event usually refers to actually receiving or expending substantial money. It's not that the company cannot announce unblinding, but in other companies the first we knew it was when they announced top line data. It's unclear how long it takes to go from unblinding a trial to issuing the top line information, but I suspect it's at least a few days, and possibly a few weeks.
Most investors see all sorts of things as material events, sometimes even substantial money isn't if in the company's view, just $1 million or even $5 million isn't considered material. It all gets reported in the quarterly, but no release is made.
I cannot say why, but certain companies seem shy about promoting the smaller positives. Certainly they'll spell out the big positives, and things will be done by regulation, but they don't issue releases. In the case of IMGN, we have a few people who routinely check the clinical trials and patent information for new issuance's or changes. They almost never issue PR's for what these posters turn up.
I really cannot say with certainty that if NWBO filed for a new trial in clinical trials that they'd announce it. It's more likely that an investor would find it in looking through the database.
I know the SEC cautions companies about too much hype, but I believe some companies go overboard in not getting SEC attention. Investors are treated like mushrooms, keep them in the dark, cover them with S-IT, and they'll grow. I don't know that NWBO is concerned about the SEC, but I suspect they don't want to attract their attention.
Gary
I don't know this to be the case, but at some conferences, issuing information about what occurs at the conference is embargoed until the conference is concluded. I hope we'll see a PR before the open tomorrow. Here on the West Coast I'll know when I get up and look at the quote, if it's up substantially, I'll know something positive was said. I rarely get up at the open and I really don't believe the price will exceed $.50 while we're still blinded to the data. I do believe that anything over 50 still being alive in the trial would be sufficient for ultimate approval, but I expect the number to be in the 70's or more. The median for the Top 100 should now be well over 60 months.
Gary
Is there anyone that doesn't believe that DCVax-L or Direct won't work in combination with this, or other therapies under development.
It's my belief that if the SOC for a given cancer cured 95% of patients with the cancer there would still be research on how to cure the 5%. Certainly it wouldn't be heavily funded, but people would still be working on it. Frankly, the more we're able to learn about cancer and other diseases, the more personalized treatment will become. In the above example, the ideal treatment would identify the 5% who didn't see benefits from the treatment that cured 95%, and treat them in a different manner.
It's now been nearly 6 years since my diagnosis with PH+ ALL. Before my treatment began with chemo it was halted for a few hours. Why? Because the final results of the testing they were doing showed that their initial evaluation of my disease as AML was wrong, it had taken roughly a week for the final results to come in. The course of treatment was quite different for the 2 different diseases.
I believe our technology is rapidly improving. The testing that took over a week a half dozen years ago will probably be done in a few hours in the future. This may not be the case if cultures must be grown before a determination can be made. During my treatment on two occasions I had catheter infections, each case took several days to determine the precise infection. In both cases, the antibiotic they initiated treatment with helped, but something with greater efficacy was used when the specifics of the infection were known.
Gary
Hi Bruce,
I knew they had the centers approval to do the trial, the question is whether you fund the trial without the patent approval. If they do, and early on in the trial efficacy is seen, they would have all the more reason to put heat on those evaluating the patent.
Cannabis has created a Catch 22 situation in the medical community, clearly anecdotal evidence says there are benefits. The problem involves the regulators, both patent authorities, as well as Govt. agencies that don't recognize it as legal. Clearly here in the U.S. many States are open to it, but so many agencies are tied to Federal support their is a fear of losing funds if cannabis is used in any way in clinics and research hospitals. Certainly CBD based products are being accepted, but by itself I don't believe it's nearly as effective in certain applications as products that add THC and other components found in cannabis. Frankly little testing has been done in components beyond CBD and THC, no telling what may be found if they are investigated. None of this will happen if patent authorities are unwilling to give patents on products developed with these components. Catch 22 clearly applies to where things stand, and frankly it applies to all sorts of nutriceuticals that can be found in all sorts of stores, the difference is that cannabis hasn't been Federally approved, no similar restriction apply to all sorts of vitamin and mineral supplements.
Gary
I believe we need to be realistic about our expectations. One poster hoped that all, or nearly all of the last 31 people to be added to the trial are still alive. While I wish it were true, I believe it's an unrealistic expectation at 48 months or more. Frankly 15 still alive would be about triple of what the SOC would offer.
I know there has been talk of production improvements in the DCVax-L product, no one from the company has confirmed this to my knowledge, but if it were the case, and the regulators agreed to it, perhaps the last 31 did better than what was achieved previously. It would still be a miracle if these changes kept all, or nearly all alive. In fact, if they were all alive a year ago I would have thought they'd have all they needed to go to the regulators for an immediate approval.
I do believe that the current FDA philosophy would allow a product improvement without starting from scratch if that improvement were essentially chemically the same, but perhaps the purity was improved. If chemically the formulation changed, they'd want a new trial. The FDA has certainly spoken about being more flexible, trials which previously couldn't be modified once underway seem to be permitted to do so, and I think it's clear that this trial has done that. The new SAP is clearly based on lessons learned while doing the trial. Had the trial never been modified, it would have probably ended years ago, and very probably would have missed established goals. It would have shown that a new trial could have been initiated which would lead to an approval based on very different criteria. The costs and time of doing the additional trial would almost certainly been far greater than adapting the trial as they've done.
Gary
Do we in fact know that Dr. Bosch made this presentation, if so, I would hope the company makes it available on the website.
Also, I haven't seen where Dr. Liau made a presentation, but other people from UCLA were involved in the conference. Does anyone believe that one of these people may have brought up the DCVax-L Trial.
Gary
I really think we should acknowledge the market cap commonly seen when biotech's have drugs with good news and are presumed to be approaching approval. Most that I'm familiar with range from half a billion to a few billion dollars. Depending on the O/S if it's truly near a billion shares as the price rises and warrants etc are converted to stock, essentially the market cap and dollar share price are the same.
When people speak about price ranging from $5 to $20 or more, it certainly can happen, but it will require either a partnership, or earnings approaching $1 billion annually. I.E. what I'm suggesting is that without a partnership or buyout, we'll need approval and moderate sales to reach high single digit or double digit dollar figures.
That said, if the clinical news is great and the share price does go to double digits, each of us have choices. I've never been a major trader, but at double, or near double digit share prices I'd be putting in some stop loss orders if I didn't sell out. If I did sell, and if the market cap came back down to a few billion or less, I would very probably be back in bigger than ever. You never know what emotion will do for a stock, if people who've never previously heard of NWBO read an article indicating great results in the DCVax-L Trial, even if the market cap is $2 billion, if it's $2, it still sounds cheap, it will still sound cheap to others at $5, and still others at $10, so no telling how high it may go on emotion. When reality hits and the new investors realize that it will be awhile before earnings justify the current price, some correction should certainly be expected. Practitioners of T/A would probably expect the stock to retrench to 50% of the gain, if it starts at where it is today, that would be half the price. If you do sell at or near the high, you'll probably be able to repurchase your shares for half of what you sold them for, but perhaps even substantially less. .
As most here probably know, I've been invested in IMGN for decades. It currently has completely monetized the one drug that was approved that utilized its technology, and when it failed to meet Phase 3 goals an additional Phase 3 is required, I suspect it will be 2022 before it has another approved drug. Currently it's market cap is $.5 billion. SGEN which clinically has had essentially no more success than IMGN, but who still owns a major position in its one approved drug has a market cap of $20 billion, 40 times that of IMGN. In spite of the fact that SGEN is yet to be profitable, it does have earnings and that has it's price at a huge multiple of IMGN's. I certainly made the wrong choice decades ago when I didn't buy SGEN, and ever since I've felt it overpriced when compared with IMGN. Hopefully NWBO will be much more like SGEN.
Gary
Since we've heard nothing to now from SNO, I still believe something will be coming, but perhaps not until the conference is over. Hopefully Monday morning before the open something will be coming. I believe had they filed an Abstract, we'd know it by now, so at most we'll learn what others may have said who're involved in the trials if it was part of their presentations, otherwise we may just learn what others who stopped in at their booth, or attended the meetings they led may have learned.
We know that other presentations are a matter of weeks away. While I doubt that if they couldn't unblind before SNO they'll unblind that soon, but they still can tell us a lot of things without unblinding. Perhaps the biggest thing is, how many people in the trial are still alive.
It's my belief that patients who've survived 48 months or more are likely to live longer and while a few may pass on in the next year, the numbers are likely to diminish slowly and perhaps not be related to GBM at all.
Gary
It would seem to me that ASH would be the right place to report new data for peer review, it's coming up shortly. I don't know of any indication that they've filed an abstract for presenting at ASH, but hope they do.
I've spoken with my Dr. who heads hematology at City of Hope and he's certainly open to the idea of working with the company. I mentioned it to the company.
I should note that I'm approaching 5 years post stem cells and while I don't attribute it to GVHD, my face still is dry and flacks at times, it certainly could be a mild condition related to the disease, and the chemo I remain on.
Gary
As someone who's a cancer patient I hate to see the time it takes to bring drugs through the trial process. I'm all for the FDA being very cautious with treatments for minor illnesses or injuries, but it should take over a decade to gain approval of drugs intended for terminal diseases.
I believe the answer could be approval out of Phase 1/2's that clearly demonstrate a degree of efficacy, but it's a tentative approval. It can be sold at somewhat reduced prices and each use of it is tracked in a Phase 4 who's duration will be determined by the FDA as results are reported, but the least period of time would be 6 years. During tentative approval, a company could expedite full approval with additional trials approved by the FDA who's duration is at least 2 years for the last patient entering the trial. Potentially the additional trials could lower the tentative period to roughly 3 years.
During the tentative period the drug could be used in any manner Doctors and patients agreed on, but the protocol would be specified so all searching would be aware of ways the drug was being tried, and what did, and didn't work.
When the drug was permanently approved, successful applications would be cataloged and summarized in the label. Certainly off label applications could still be used, but the label should indicate the many diseases and protocols for which the drug was shown to be effective.
In short, such a procedure would lead to many discoveries about the drug, by the time permanent approval was granted, instead of an approval for a single cancer indication it might be found that benefits were seen with dozens of different cancers. Such experimentation currently doesn't occur until after today's drugs are approved, frequently after over a decade of testing.
Gary
While we'd all like much more by year's end, as I see it nothing may happen, or everything we'd like could, it's all dependent on the submission of the SAP to the 4 regulators. If in fact the SAP's been accepted by the regulators, a criteria for judging the trial is established, and the trial can be unblinded. Clearly, if you unblinded before the SAP, it could be written based on what you already know, rather like being able to bet on a horse race after the race has run.
We know the draft SAP is completed, but we don't know that it's accepted, and if not, how much delay could be caused by any changes requested. At this point, I'm hoping they can unblind by year's end, but it wouldn't be the end of the world if we had to wait another month or two. I do hope they will communicate more with us in whatever time it takes.
ASCO has been the place companies and clinicians like to present major trial data. ASCO wants such presentations to have information that hasn't been previously presented. I suspect that while top line data may come much sooner, and perhaps far more information may come out in smaller conferences where Dr. Liau, etc. are presenting. I believe at this point the complete trial data presented for peer review won't be out until ASCO. The Abstract for filing at ASCO is due in February, as I remember it, but even then an Abstract could be provided that indicated the unblinded data would be presented there, even if it hasn't yet been unblinded, so even the February date isn't mandatory for unblinding the trial. I certainly hope it will be, but Abstracts can be updated once submitted, and most importantly, as long as they are accepted for presentation, all the information actually presented at ASCO can be up to the minute and have a great deal more information than what's shown in the Abstract.
Gary
In general I agree with you, but I do believe the company did lead that something would come out of SNO, and of course that's not yet over. I would hope that the least we see from SNO is future guidance, as well as an update on what Dr. Liau knows without unblinding the trial. I believe she knows essentially how many are still alive today, and she knows what the current median of the Top 100 data she previously reported is.
We know that she and others are making presentations elsewhere in the not to distant future, so perhaps we won't even get that out of SNO, but I'm still hoping that we do. Clearly the company has a display at the conference, if anything in the display is something not yet revealed to investors, they could tell us so, and likewise they could share anything new that was being said with the people they're scheduled to meet with. None of these things may be considered peer review, unless they do in fact make a formal presentation, but I don't believe they're prevented from telling investors everything that was told to those attending the conference.
I'm certainly still hoping we hear something by Monday, we'll see.
Gary
Today's my wife's birthday, and also the start of SNO. I don't know when, or if, we'll get a release on anything the company is presenting there, but I certainly hope so. If it came today, it would be like a birthday present, but I'm not counting on it.
We know of upcoming presentations, and more may come out there, but clearly NWBO does have a booth at SNO, and clearly they'll be speaking with certain groups there. In that we've not seen an abstract, it's doubtful any formal presentation is being made.
I don't know what the company's intent is regarding supporting the stock price, I believe they could talk about what's said at SNO, but they may choose to make statements after upcoming presentations in technical forums, or they may hold everything until they can release top line data. My point is, it's up to them, but the longer they wait, the less the support for the stock price until they do act. Perhaps they want the shock value of saying nothing, then issuing top line data that blows away all who're short the stock.
Gary
Doc,
I completely agree with what you're saying, but know the FDA just won't work that way. I do believe the FDA is slowly changing, but clearly the right to try, which should make many products available, is still fraught with problems and companies aren't using it to make their products available.
I believe the rub with right to try is largely based on what can be charged, especially if drug developers have to show the actual cost of making the product without considering the developmental costs to date. I.E. if I already have the production facility for making a product, and don't consider the cost of development, my cost is probably few dollars worth of chemicals, and the cost of the time people spend making the drug, plus operational costs of running all associated equipment.
If instead of divulging costs, under right to try the drug producers could simply charge a reasonable percentage of what was agreed would be the list price for the approved product, I believe the drug makers would be much more willing to cooperate. That reasonable percentage might be as low as 10%, or as high as 50%, that would be negotiated. If at the negotiated price the insurance companies would have a lessened burden, they would participate in paying for the product. If the anticipated benefit would save the insurance company overall, even if treatment cost up front were higher, they should participate in the costs.
When it comes down to list price for drugs, few people with the exception multi millionaires can afford to pay unless they're covered by insurance, and the co-pay's are reasonable. Of course the general public never really knows what price insurance companies actually pay, but I believe it's often a small percentage of the list price.
There is a need to bring healthcare down to what should actually be paid, but that's fodder for our politicians. My personal physician now has a concierge add on that patients can pay for more personal service, to date we've avoided such payments. At least he's not demanding it to continue using him, I believe some Doctors are.
Gary
I'm certainly voting no, and cannot believe the company's failure to do anything to support the share price but asked investors to agree to a R/S so radical that they could get on the Nasdaq with it. I'm all for getting on the Nasdaq, but doing it the right way, by building the share price through actions by the company.
Even if an R/S could achieve a $4 price, without actions by the company it wouldn't keep it. They could ask for 7000 for 1 to get a $40 price, and still they'd have a problem holding $4 if they don't have positive news giving investors a reason to invest.
If they do have positive news, let's have it. Get the share price up to a nickle, a dime, perhaps even a quarter and then ask if a small R/S can be authorized to go over $1, not $4, that should be earned by further actions by the company. If they go belly up, so be it, but if they want investors support, come out and tell us what you're doing to earn it.
Gary
Scotty,
It's clear the company lost credibility years ago, regaining it requires proof. I believe smart money is getting involved now, but clearly some major investors like Woodford couldn't wait out the trial, and lost their shirt. I believe in Dr. Liau more than corporate staff, she's highly respected among her peers, and I believe the statistics she's given though blinded clearly show benefits that couldn't have occurred if not for the vaccine.
If I had been among those who purchased shares in double digit dollars, I would certainly not be happy, but I would hope that I owned many more shares now, and have an average price close to, if not below a dollar.
I kind of like Will Rodger's advice on investing, just one rule, Buy good stock. If it goes up, good, if it goes down, better, buy more. Remember you already made the determination it's good stock.
I cannot say I've always used that advice, at least some of the stocks I've purchased were more speculative, but I believe this is a good one.
Gary
I believe it all comes down to how you define success. If 50 or more people lived beyond 5 years, many more beyond 4 years, and still far more beyond 3 years when the SOC indicated that roughly 15 people would have expected to last that long, I'd call it a success. On the other hand, if going into the trial some statistical figure was established based on progression, and the trial didn't meet that number you can call it a failure.
I believe the FDA has evolved enough to look beyond a goal set more than a decade ago, before pseudoprogression was know, and will be willing to adopt standards learned in the trial process to more properly judge the trial. Personally I wish the FDA would forget their statistical rules and look at the people who're still alive, or who started perhaps a decade or more ago and lived for years with a disease that kills most in 18 months or less, and simply see the benefits. I'm not a big believer in using statistics to make a decision where my eyes can simply tell me what the decision should be. All these people alive, or having lived longer than anticipated should be all anyone needs to see.
The FDA can find a way to say no, run additional trials based on what you've learned, it's not uncommon for the FDA to do so, but if they open their eyes, the answer should be a resounding yes.
Gary
Thanks, my sister is working with someone who only deals with sarcoma in Santa Monica, I really don't believe she wants to change Drs. at this time.
As I noted, I did hear from the company.
Gary
I just checked my email again and received an email from Carol Powers, it's nice to know they pay attention to what people ask. At this point right to try isn't really established, so any involvement by my sister would be in a trial situation, once one is established for DCVax-Direct.
Gary
I knew of Dr. Padzur's loss and have seen his statements on streamlining the process, what I haven't seen is trials truly being expedited. I know many will disagree with me, but as far as I'm concerned, if a Phase 1/2 Trial really indicates a dramatic improvement, especially for what may be a terminal disease, I wish the FDA would simply approve it right then, and establish a Phase 4 that monitor's its use over years until they're satisfied that no further input is necessary about its use.
I've frankly written DI regarding my sister who's looking to get into a trial. While her cancer has nothing to do with what's been tested, I wanted to see if there was a possibility of getting DCVax-Direct in conjunction with whatever her Dr. can find to try on her. I've not yet heard back, but saw no harm in asking.
If DCVax-Direct is shown to be effective against many forms of cancer, it could be a decade or more before they tried in on the rare form of sarcoma my sister has. I believe under right to try such testing should be possible, but doubt that it is.
Gary
We know the company will have a presence at SNO, the question in my mind is will they tell investors what they're saying there. If they did submit an abstract, and make any kind of presentation, I'm sure they'd make that available to investors after the conference. I that in fact doesn't occur, if they do host certain groups and discuss the direction being taken by the company, while it might be information we already know, I would hope they'd still reiterate it to us by P.R.
It's my belief that things are approaching a conclusion rapidly, but I'd like to hear that from the company, and while they could happen sooner, I'd like to hear the company commit to having top line results by at least a specific month, or earlier. We know a few things must happen before top line results, but if they'd commit to top line data no later than a specific month, all else could be trusted to fall in line.
Gary
I won't say the head of the FDA doesn't matter, but people like Dr. Padzur still are the ones implementing whatever comes down from above, at least they make it sound like they are. I'm not saying that nothing changes there, it does, but the cost of clinical trials if anything has been increasing, and it's largely due to the requirements established by people like Dr. Padzur. There has to be a way of getting trials done faster, and cheaper, but by doing so, they need to track how newly approved drugs are doing. I believe all approved drugs going into a Phase 4 where all use is tracked so no negative side effects can be hidden under settlements with confidentiality agreements would bring out any problems not noted during the trials. It doesn't need to be complex if the drug performs as anticipated, but if unexpected side effects are noted, they should be reported.
I use Dr. Padzur's name because he's involved with Oncology, but I believe there are similar dept. heads all over the FDA and their mindset's are largely the same. Lowering costs and saving time has not been something these key people have truly pushed, if it were, FDA investigators would be right in the middle of trials and in our case, I believe the FDA could have seen that people were clearly living longer and declared the vaccine approved some time ago. Too many trials are taking a decade or more where positive results were clearly being seen a few years into the trial. The FDA needs to be more dynamic and stop trials themselves and approve the products, then have them go Phase 4 to validate that they were right in doing it.
Gary
What you're saying is equally true in bigger stocks as well, look at all the big name companies that crashed in 2008 and are no longer with us. Certainly penny and sub penny stocks are high risk, but potentially very high percentage rewards. Just one such stock that moves into dollars can be worth far more than many that go belly up.
I'm not predicting MJNA going belly up, especially as cannabis becomes more acceptable around the world, but at some point I believe there will be consolidation and MJNA will either buy other companies, or be bought. Either way, the potential for profit is good.
Gary
Given the Nasdaq listing requirements, and funds required to do it, the best way to achieve it would be after a partnership that boosts the share price dramatically and provides all the necessary funds. Otherwise, even with a R/S substantial dilution would be needed to fund it.
Personally I hope a R/S is never needed, but after all warrants etc are converted it's said we'll have nearly a billion shares outstanding. While that's a big number, many major companies do have more. I'd like to see a share price well in excess of a dollar before any consideration is given to it.
I believe the most successful R/S's are done with shareholders concurrence, and generally they're very small ratios. At a share price over $2 I believe shareholders would support a 1 for 2 to achieve the Nasdaq, but it would be nice to achieve it without it.
Gary
If NWBO was the keynote speaker, there are still people here who would be dissatisfied, it's clear they have a presence there, and we'll have to wait for additional information about what they say, or present there.
I would suspect that during the conference, poster presentations are scheduled, and made by many companies. In the past it was pointed out to me that a poster presentation is often seen by far more people than when an oral presentation is made at a time when many similar presentations are being made in different rooms. I don't know if they are doing a poster presentation, and certainly they can promote much at their booth, but if they do a poster presentation, it is considered to be peer review, essentially the same is if they make an oral presentation. Once peer reviewed, anything they present should be made available to investors. I don't know, but would suspect that the two scheduled events they're sponsoring might be much the same, something they can talk about.
Hopefully we'll also see a late breaking Abstract for a presentation they're making, but that remains to be seen.
Gary
Out of curiosity, I've seen many products advertising they're made with stem cells from vegetables, as a guess, it sounds to me like they're using seeds. What else could be the stem cells for growing vegetables?
I'm not against safe products that permit people to take choices that fall into the general category of being nutriceuticals, but I think the FDA should insist on clear labeling that indicates no clinical trials have been run on the products if that's the case, or recognize that only safety has been proven. I also think labeling shouldn't be deceptive, if vegetable stem cells are seeds, the label should say so.
Gary
I'm suggesting much more than a double, but perhaps not on day one of top line results, not if they're released in the normal PR. If something more spectacular occurred, a major article in the NY Times or Wall St. Journal, then much could happen on day one, but I'm only speaking of what I'm expecting an hour after the market opens.
On emotion no telling how high the share price will go, but ultimately I think you need to look at market cap, and sustaining a market cap above a few billion until more is known, and perhaps a partnership enters the picture. If we had a half billion shares outstanding, each billion in market cap would represent $2 in share price, but with the higher share price, many warrants, etc would come into play and our share count might be closer to a billion, making each billion just over a dollar in share price.
Of course on approval it's a totally different matter, likewise after a partnership, but a market cap in double digit billions simply needs more than a very positive top line result.
Gary
One day I fully expect to awaken and find that my portfolio has doubled or better in value. Typically I don't get up until at least 7:30 here in California, so the market's been open an hour or more before I check on it. Once the trial is unblinded and top line results are revealed I wouldn't be surprised to see a price that's over $1, over four times where we are today. This could come in stages, they could tell us it's being unblinded and top line will be coming in approximately xx days, but I suspect it will all come at one time. Who knows, it might be at SNO.
I'll certainly admit that I had thought the full data would be presented at SNO, but at this point I don't believe it's possible. That brings up the question of, if they do reveal top line data soon, when should all the data be presented. In reality, while ASCO's not until late May or early June, Abstracts for it are due in February, as I remember it. Certainly, the company can say something more in other opportunities, but they cannot provide a complete set of the data if they want to present it at ASCO as they won't accept Abstracts or presentations that have been delivered elsewhere. I hope they'll not wait for ASCO, but I suspect they will wait and until then, we'll be hanging on for the tidbits they're willing to give us beyond what's in the top line results.
Of course nothing would prevent either partnership or submission of a BLA during this period, and they of course would be announced, but the data would largely be withheld, if not included in the top line data.
Gary
Use your imagination, there are only about 30 patients who never got the vaccine, and essentially all of them entered the trial 5 or more years ago and received the SOC treatment. If you use the statistics for the SOC you would probably be stretching to believe that more than about 3 of them remain alive. Meanwhile Dr. Liau reported over 80 alive the last time she discussed it. What do you think is happening in the trial.
Unblinding will give everyone the more precise information, but something very positive is happening here and the vaccine has to be the reason.
Gary
I understand that, but how long was the break between new patients starting the trial. If it was anything like the year I threw out there, after the last 31 to be dosed, all others would have that additional year of survival.
I certainly don't know, but suspect that the regulators during the halt recognized that those getting the vaccine up front were getting the maximum benefit and agreed that all remaining should get the vaccine initially. For all I know, the halt might have come on a suggestion that the trial end early and the drug be approved, but after the regulators thought it over they wanted the additional data on survival so the benefit was completely clear.
I cannot help but believe that 5 years ago those involved in the trial could see that some patients were having great benefits. On occasion such benefits will see trials ended early. During part of my treatment I was on Gleevec, it was originally approved on data from 70+ patients in a much larger trial because PH+ ALL was almost always deadly. I'm uncertain if the FDA stopped the trial, or it came from actions initiated by the drug developer, but it certainly illustrates how early such action can come.
I suspect if pseudoprogression had been properly identified from the beginning of the trial, this trial too might have been terminated and approved earlier. I'm not complaining as I didn't hear about it until the share price was low, so I'll have a greater percentage gain than many who've been in substantially longer, though I'm sure many will make more as they've accumulated many shares over the years in averaging down.
I have sufficient share to make a million when it reaches double digit dollars.
Gary
Milo,
I feel that the company may be legit, but the lack of acceptance of cannabis may be working against them so much that they simply can't overcome it. Certainly they may get support in Israel, but that can only get them inexpensive Phase 1 and maybe small Phase 2 Trials done cheaply, but international Phase 3 are a very different matter, and if you cannot get the patent approval for what you're testing, no one is going to fund such an effort.
I understand your feeling about the money, but the same can be said for practically any struggling company, but executives still get certain perks, and I cannot begrudge them that.
If they gain one multi-national patent for a major product everything could change. I believe it's clear they'll need a partner to fully develop anything, but with patent approval and a Phase 1 and perhaps a small Phase 2 demonstrating efficacy, a partner would certainly be possible. What's needed is the patent and while the company may be fighting for them, they're not communicating what they're doing to investors.
Gary
Milo,
As I understood it when I first invested in the company, the leadership were people who previously had been successful. I would expect them to have descent cars whether they were leased by the company, or not. I wouldn't expect them to live impoverished lives.
As I remember, they paid a lot of money to be the highest level of contributor at some investors conferences, that as I see it was money wasted, but not having descent transportation.
I cannot support their recent actions, as they've really done nothing except proposing an R/S. I could support a small one after they opened up about what they're doing and hopefully rallied the stock to a nickle or more, but nothing close to the authority they're asking for.
I don't know what's happened to the updates Hirsch said he'd issue semi annually, as I remember it, but I believe we should be entitled to that or more and it seems that we're getting less. I believe the company put out the red carpet for you, but I've got to believe that some investors must live in Israel, and I wish they were routinely seeking out what the company is doing. I know many in the company get more in stock than salary, as such they should want to rally it as well, clearly silence isn't the answer to doing so.
Gary
A very well thought out post Dan,
In that I wasn't here when the trial halted, out of curiosity and from a standpoint of understanding the data, how long was it halted for, and when it was resumed, how long did it take to dose the last 31 patients, as I understand it, in the trial.
If the halt was for 6 months, and it took 6 months until the last patient entered the trial, it would mean that as of now, for the 300 who entered the trial prior to the halt, the last to be dosed there would now be 5 years beyond the initiation of treatment. I'm not saying these are the numbers, I'm asking what they should be, but the point I'm making is that with the exception of those who entered after the halt, most if not all are now survivors for roughly 5 years or more.
I suspect when we see the K-M, the big tail people speak about will really be impressive, and perhaps may extend out a decade or more is some of the earliest people to enter the trial are living or recently passed.
Gary
I agree, the only question in my mind was how long the FDA should be given to do a review before presuming it's okay as is. No matter what the FDA does, or doesn't do, they're in control when it comes to approvals. Drugs are approved all the time that fail to meet preliminary requirements, and likewise approvals are delayed for drugs that do meet requirements as the FDA asks for something not specified when they originally were put into trials.
I know some here have invested in CVM, perhaps they have found a disease their cure works for, but I wouldn't bet on it. Once something has proven not to be of harm, it's developer is free to try it as they choose. It is their money, and the FDA doesn't prevent them from spending it as they choose. In the case of CVM, I've seen them issue essentially the same document, with only a few words changed, on numerous occasions. In each case they express confidence that their drug will benefit people suffering with XXXXXXXX, and they intend to initiate a Phase 3 Trial with it. All the change in the release are the XXXXXXXXXX's and people just keep coming forward to buy their newly issued shares on the announcement. I've observed this over multiple cycles and sadly they're not violating any laws in operating this way. For those in the company now, maybe this is the time their cure has found it's disease. I invested in it when it had the symbol HIV as it was AIDS that they believed their drug would cure, that was probably 2 decades ago, the drug hasn't changed, just what they're targeting it at. Of course when they failed with AIDS, they changed the symbol back to CVM.
Gary
It seems to me that the word event can be taken many ways when it comes to a trial. Often events are the polite way the FDA has found to express deaths, but if a trial is to be based on progression, I believe when progression has been seen, it is considered an event.
I'm uncertain, but I believe the trial was originally based on PFS and would be unblinded after something like 231 events, that clearly should have occurred some time ago. If it was changed to overall survival, even that would have occurred some time ago if 80+ patients remain alive, which was reported some time ago. That could be incorrect if more that nearly 20 were reported as LTFU, which could mean 231, or whatever that number is, hadn't passed on. As a goal is about to be reached, I believe the clinicians work harder to eliminate the LTFU's so if a specific number was truly established to end the trial, the LTFU's would be small as the number approached.
That said, it seems like in this case the company wishes to go beyond the requirement to end the trial after a specific number of events. They seem to want to say, look at how great our survival benefit is by extending the trial well beyond the key event. This is purely my opinion, not based on expertise, but based on logic. All who remain alive in the trial now have been alive for at least 4 years, and perhaps over a decade, we really don't know who's the longest living in the trial, or if the longest living today has lived longer than someone who previously passed on. We do know that for the top 100 the median is roughly 60 months, but that doesn't say what the extremes are there either, or how many of the top 100 remain alive.
I suspect the greatest impact of the trial will be the testimony of patients who've been in the trial for 5 years or more speaking out about their experience. Hopefully some of them are in nearly perfect health and really enjoying their lives. I'm not expecting all to be interview, just a few will get more attention than a ton of statistics about the trial. I look forward to news coverage that includes the testimony of both clinicians and their patients. That sort of news gets attention while technical presentations often go practically unnoticed by most who're not already following a stock.
Gary
In the case of IND submissions a 30 day period is established for FDA review, if they don't act in that time it's presumed to be approved. I don't know that this can be applied to a SPA, but if no dialog is underway with the FDA, perhaps doubling that to 60 days might be smart, but more than that would seem excessive. On the other hand when a BLA or NDA is submitted the FDA has 6 months if its got priority, and a year if it's not, so a case could be made for longer.
I hope they can speak, so no doubt is left as to the acceptance of the SPS, or modifications requested.
Gary
To those who believe it's possible to unblind the trial, but continue to work on the SAP, think about it. How different would that be to going to a race track with all race results know, imagine how much you could make with just a $2 bet in the first race.
Someone mentioned needing the IRB to sign off on the SAP. As I understand the IRB's function, they formalize the trial protocol beyond what's presented in the IND. If they do have a function in the end if a new SAP is being prepared, I'd appreciate it if someone could explain that function.
If in fact the draft SAP has been commented on by the regulators, and revised to incorporate any recommended changes, then we should be very close to a submission followed by unblinding the trial. On the other hand if the Draft is just now being provided to the regulator for comments, I would believe they'd get at least a month, and probably longer to review it. Let's say they get 60 days, the approval wouldn't be documented, if nothing was said after 60 days it would be a presumptive approval, essentially the same way that IND's are approved.