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So your sayin' there's a chance!
Great post.
I agree that the ability to time the partnership news makes that news more likely than news about L approval; leading into, or at ASCO.
I now agree that the partnerships appear to be for DCVax-L, based on hints by Dr. Prins, however, there remains a small chance that the partnerships are about Direct. If so, there would likely be some good news about longer tail efficacy for Direct to go along with partnering news. But I yield this is unlikely. The partnerships are probably about L.
I was the one that said I saw three NWBO booths at ASCO. I originally saw just one, but found some other list or section of the list where two others were mentioned. One is small, may not technically be a booth, but there are two large booths. Below I have added a little bolded text to clarify my earlier post about the 3 booths.
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Doktornolittle Wednesday, 05/25/16 09:42:26 AM
Re: md1225 post# 62840
Post #
62860 of 62893 Go
Chris, I may be reading the web page wrong, but I think they have multiple booths. The combined square footage is the second largest at the show. Unfortunately, I don't think that guarantees anything since they appear to have been waiting on some kind of news that has not yet arrived.
3 NWBO Booths totaling 9,100 Sq ft.
Genentech is the largest presence at 10,000 sq ft. I think NWBO might be #2.
AbbVie has 4900 sq ft and a market cap of $98B
NWBO Booth Space Dimensions
#10147 4500 sq Ft 90’ x 50’
#10155 4000 sq Ft 80’ x 50’
#Reg85 600 sq Ft 30’ x 20’
Of course I hope you are right. But I don't see how they can time that, unless they have a presentation scheduled at ASCO and the embargo allows / requires them to stay silent. But otherwise, SEC rules would force them to reveal within 4 or 5 days of the news.
I hoped they were sitting on such good news until no abstract was released. If no abstract, then I figure no presentation, thus no embargo, thus no protection from the SEC rules on deadlines for material info disclosure.
Hopefully, you are right, and I have missed something here.
She is a true expert at funding. How do you know whether the expenditures at ASCO have resulted in more available funding than the cost? That is her guess to make, and it is literally her expertise, among many talents.
If perception matters, then perception should be utilized to fund a cure for cancer.
Power Shoes? Power Booths? Whatever.
If Les wearing a Madonna cone bra at ASCO would bring in more funding, then I say do it!
Good stuff DoGood. Very well said.
Fortunately, I think LP has more Edison in her than Tesla. In one regard, however, whoever inspired the PhV articles might be a better comparison to Edison.
In the political fight between Edison and Tesla over national adoption of AC or DC power, Edison (DC) had demonstrations of horses being killed with AC power, to show how dangerous it was. The fact is, DC is far more dangerous, period. There are two reasons for that. One has to do with a larger net migration of biological ions with DC, since AC only keeps one polarity for less than 1/100 of a second, and the other has to do with the Voltage that would be needed at the wall socket to make the two practical.
To transfer large amounts of power efficiently, you must have very high voltages at the power lines. There is no way around it for AC or DC. With AC, however, you can use transformers to drop that high voltage down to a less dangerous voltage at the power poles, before sending it to houses. 110V may sound dangerous, but it is a lot less dangerous than 300V, or 1KV or 10KV.
There would have been some trade-off if DC had become the norm. We would not have had 10KV at our wall sockets, but it would be higher than the chosen 110V. Maybe 300VDC. But then we would have been stuck with that voltage at the power lines. If you compare that to even a low voltage, 10KV AC power line, the loss to heat for the same power transfer is 1000 fold higher in the DC case. The loss is proportional to the inverse of the square of the voltage.
But Edison et al used smoke and mirrors to keep attention away from this by killing horses with AC in demonstrations around the country. In this way, I suppose, LP does not resemble Edison, but she has his business smarts.
I started with the belief that TMZ was a bad thing years ago, but have let go of that simple perspective. It does help with the methylated patient population, and it helps a lot.
However, it is not clear to me why it was ever used in the unmethylated population. Further, it seems very likely that the optimum dose of TMZ that should be used when in conjunction with an immunotherapy will prove to be less than when used alone. Flipper recently posted an Italian study pub that concludes that the timing of the combo may be critical. I think Flipper's net net was that you need to stop with TMZ before starting DCVax-L or you damage immune memory.
I don't know if in the past they were able to determine which patients, or patient's tumors were methylated, and I don't know how difficult, or practical that is now. A complication could be in the heterogenous nature of the tumors. Does that include methylation?
But I do know that TMZ damages the immune system in high enough doses. In the past, when used as a monotherapy, it was likely trueley optimum for the methylated patients to use TMZ to the point of severely, even permanently damaging their immune systems, if you assume the patient was not going to live past X years regardless. At least the extra dose slowed the cancer which was more of an imminent threat than the loss of the immune system. Or something like that.
But with the advent of immunotherapies this has to be all re-tweaked. I personally think this should all have been anticipated, and the FDA should have allowed playing with the TMZ regimen in the DCVax-L trials to accommodate these issues, but I don't think that was the case.
Chris, I may be reading the web page wrong, but I think they have multiple booths. The combined square footage is the second largest at the show. Unfortunately, I don't think that guarantees anything since they appear to have been waiting on some kind of news that has not yet arrived.
3 Booths totaling 9,100 Sq ft.
Genentech is the largest presence at 10,000 sq ft. I think NW might be #2.
AbbVie has 4900 sq ft and a market cap of $98B
Booth Space Dimensions
#10147 4500 sq Ft 90’ x 50’
#10155 4000 sq Ft 80’ x 50’
#Reg85 600 sq Ft 30’ x 20’
They finished automated mfg for Direct according to one of their recent SEC filings. According to the same filing, they have not finished automated mfg for L... as you said.
I wish they had given a hint as to the status of automated mfg for L. Are they still working on it? If not, are they waiting for an imminent efficacy read before deciding to spend more money? If so, you could see why they can't talk about it. But thinking about that brings to mind all sorts of difficult scenarios regarding approval and volume they can't handle, and margins and ... .
Wishful thinking for me would be that they are waiting for early efficacy feedback with a likely outcome of early revenue for a subgroup with high efficacy, and thus high level of reimbursement, that would be profitable without automated mfg for now, and the continuation of the trial for other subgroups, possibly the entire patient population, as they continue working on automated mfg. Of course finishing automated mfg for L also means getting it approved.
This scenario may not be possible since they did not define subgroups, but ignorance is bliss and I am going to ignore those arguments.
I will have to read that a few times, but thanks. As a long, AVII scares the heck out of me, but I am not sure if I am persuaded here. Just because crossover is possible in a PFS trial doesn't mean it should be done, and doesn't mean it is the FDA's business to make that decision.
It would be interesting to see how often the FDA has insisted on crossover when PFS is the primary measure but the drug is not an immunotherapy.
But I will read this a few times. When AVII talks I listen, as much as it hurts sometimes.
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And of course, I was trying to say Touche' this morning, but my darn auto-spell doesn't speak French.
Easier enrollment. That makes sense as a motivation for the sponsor, but I don't see why the FDA would have the right to impose crossover for that reason.
Recall that Dendreon did not initially get approval and was required to drag the trial out. Recall that it was believed that BP influence via one of the FDA members voting was responsible for that decision. Was that same BP Doctor responsible for the decision to have crossover?
People protested the snot out of that situation. If they hadn't, would Provenge ever have gained approval?
Did the FDA insist on crossover in the Provenge trial, or did Dendreon?
It may seem ridiculous to say that the FDA should bear some of the responsibility if the available measures for PFS prove flawed for the immunotherapies. However, consider that according to Lind Liau, the FDA insisted on crossover of the control arm upon progression in the DCVax-L trial.
Maybe Linda Liau misspoke, but I must consider the likelihood that she was accurate. If so, you have to ask, why would the FDA insist on this? The only explanation I remember hearing posed was that the FDA recognized DCVax-L to be so effective that it would be inhumane to not provide it to the patients that progress in the control group. But that is ridiculous. There is no way that the FDA would do that. So what happened? To be honest, either LL misspoke, or this was an attempt at subterfuge by the FDA, which given the Moonshot environment, and the background of the man in charge of it, ... the FDA better try to fix this or somebody is going to hang.
Yes. Not crossover, but false progression in the experimental arm that could be at issue. Moving to OS would solve the issue, but that has the weakness that if DCVax-L helps after progression in the control arm, then the bar gets raised.
I wonder if, for the reasons you state, NWBO could be asking for patients showing long OS but early progression in the experimental arm, to be re-evaluated regarding progression. Maybe some new metric developed after the fact that can be applied after the fact. Such would seem off limits, but if this is what is going on, then I don't think NWBO bears the full responsibility for the problem. I think that the regulators and the broader pharma world should have been better prepared for these issues long ago. The groundwork should have been better laid for measuring PFS, etc., for immunotherapies. I know there is a new criterion, but maybe that has also proven inappropriate. To the extent that the regulators failed to properly anticipate such needed developments in such a promising space, I think they should be flexible on allowing the use of hind-sight and retro-active analysis.
Let me rethink that. I am confusing myself.
Can't argue with you Pyrrhonian because you completely ignored most of what I said. But... I tend to do the same with info you present that doesn't fit my view, so I don't want to give you a hard time about it. But not much being accomplished in the back and forth.
Regarding $40M to Cognate; I know I might be way off rationalizing that kind of money to automated mfg development, but I also know that the cost of such development is extremely high. You look at infrastructure expansion to assess where that money could have gone, but up-front R&D costs are not the same thing as subsequent expansion once a design has been decided on. They said in their SEC filings that they have finished the design work for automated DCVax-Direct mfg, but not for DCVax-L. The efficacy threshold for L approval is 4 months PFS, so they are probably trying to match that in terms of expected reimbursement for 4 months PFS. For that to be worth doing probably requires automated mfg for L, but they have not been able to accomplish such so far, so throwing money at it through Cognate would be their only option. I believe that 10's of $millions might make sense in that effort. Maybe.
In the end, if they only get approved for a subgroup, which many believe cannot happen, that subgroup might show much higher efficacy than 4 months PFS. If so, the reimbursement will be much higher than they are trying to prepare for, so automated mfg might not be needed. But they are shooting for all the marbles, and must have a feasible mfg plan in place prior to consideration for approval by the regulators.
I do believe that if they have been paying Cognate these large sums for R&D in automation, that they would then own that automation, ie patents, etc.. If the deal is that Cognate then owns it, then I believe the internal investigation will red flag that. Similar issues for land purchased for expansion. Or if these expenditures are ridiculously high, as I agree it appears, then I believe the investigation should report that.
I have never complained about your frustrated posts. In fact I always pay attention to what you say about business issues. But there is venting, and there is just Bchng n Moaning. Somehow there is a difference.
I once studied a noise cancellation technology based on the Weiner-Hopf equation. But today I found a much simpler solution...
Drizzle Drazzle Drozzle Drome, time for this one to go on ignore.
The XBI dropped 40% in the same period during NWBO's collapse. So while it is not a dominant contribution, it is double what you estimated.
If a bear wants to complain about NWBO being too shrouded, or complain about the NAS violation, then I would yield to that. But they talk like there is proof of gross mismanagement and lack of efficacy, when that simply isn't the case.
In the end, maybe efficacy will not prove out, and maybe the mismanagement will prove major. But right now we may have only a relatively minor issue with the NAS and that's it. Beyond that is the shrouding, and that may prove to be necessary. Agreed that faith is needed, and no reason that you have to give it, but that is an option that many longs have chosen to take, based on what clinical data is available and what little is known about the NAS issue.
For the most part it looks like the dramatic share price drop is due to manipulation. The market forces and the screening hold and NAS issue are large, but not large enough in my opinion to account for this large a drop; about 1/10 the norm, 1/16 the peak.
So from my view, the largest thing going on is the bears manipulating and or shorting this thing down and then claiming that the extremely low price is proof of a lack of efficacy or gross mismanagement. Heinous, and something I will continue to fight back against.
Yes. Your previous post regarding big pharma aggression sobered me to recall the many examples that have come up over the last couple of years. Not only the likely BP aggression we have seen here, but fines for improper marketing in China, etc.. It may not be all Big Pharma's, but some have been convicted of repeated offenses.
Just watched Dr. Prins video again. I see why so many people think that the partner trials with Blockade Inhibitors will be for DCVax-L, not DCVax-Direct. He doesn't say the trials they have negotiated are with NWBO, but it is by far the most likely company that fits the description.
One thing I got out of this viewing is the likely very good efficacy for DCVax-L regarding mets.
I will watch the video many more times. I got a little more out of it viewing it on my TV, via HDMI, which has better sound than my laptop. Dr. Prins gets pretty quiet at times.
The follow-up focus on improvements beyond DCVax-L might have thrown some people. But it is clear throughout the presentation that he holds DCVax-L as being among the most promising cancer therapies, in the same class as the Blockade Inhibitors and I believe Car-T. Note that while DCVax-L is probably expensive, it is probably much cheaper than the Car-T type therapies.
My point regarding the median OS or PFS. The point I am trying to make is the difference between median and mean, particularly as it relates to the blockade inhibitor trials and the DCVax-L trial where there might be great efficacy, but only for less than half of the patients.
My understanding is that these trials usually specify median efficacy thresholds for approval. While mean is the average, median is the center number within the group of patients. Ie, if there were 401 patients, and you placed them in order of observed efficacy, the efficacy observed for the 201th patient would represent the median efficacy for the entire group. The actual efficacy for the other 400 patients would be of no bearing on the median.
One of the reasons that median is usually used to measure efficacy is because it could take 50 years to learn the mean, or average efficacy. As long as one patient is still alive, for OS, or has not progressed, for PFS, then those mean numbers continue to increase. Mean also unfairly weights any outlier patients.
But the median efficacy has it's own flaw. Take a group of 401 patients. If you list them in order of OS, then the 201th patient's OS would be the median OS. Now increase the OS for the top 200 patients by 10 fold. This would have no effect on the median OS. For that reason it is a horrible means of measuring efficacy, for the Blockade Inhibitors and possibly for DCVax-L if it too shows little or no efficacy for more than half of patients.
The clinicaltrials.gov listing for DCVax-L does not specify whether PFS and OS are to be measured using median or mean measures. Maybe the actual trial protocol does. I think Reefrad got hold of that protocol.
Clearly the FDA did not use median efficacy to evaluate the approved Blockade Inhibitors, and hopefully, if DCVax-L proves very effective for less than half of the patients, the FDA will also not use the median efficacy to determine pass or fail.
CI? I guess I made up a new acronym. It means checkpoint inhibitor. I should have said CM, or BI, Checkpoint Modulator or Blockade Inhibitor...
--Median OS and Subgroups Etc----
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Relative to:
Quote:
What is the median OS improvement for the CI's when they are showing efficacy for only 25% of the patient population? Isn't it zilch by definition?
I don't know what you mean when you say efficacy is 25%. Do you mean the 25% of the population is cured or that OS is 25% better so for example if OS is normally 15 months it is now 18-19 months? In either case MOS will be better. One just has to wait for 50% of the patients to pass away. In the second case that will happen sooner.
I mean 25% of patients receiving some CI's show great efficacy, sometimes an apparent cure. The rest tend to show no benefit... or that is my understanding. The % is lower for some indications for some CI's: We are talking approved CI's and indications.
--------------------------------------------
---------------------------------------------
Relative to:
Quote:
At the same time the statistical taboo in making up subgroups after the fact has a very real basis.
If you go back through some of the posts a few days ago apparently they did identify subgroups. The no-no for the FDA is when you let the data lead you after the fact. If they told them they believed the Mesenchymal subgroup would perform better and they do then that would be OK. Not sure if the phase-III is set up to determine statistical significance for the subgroups . . . that was being argued in various posts.
What do you mean "they" defined subgroups? Subgroups for the CI's or for DCVax-L? I am talking about the CI's here. For DCVax-L there were subgroups defined that might be similar to the subgroups that LL talked about in the long tail of the early open label data... but that is speculation. She spoke about mesenchymal. The pre-defined subgroups were based on observed response, not genetic composition.
Another reason that evidence of some immune response to the tumor, prior to DCVax-L administration, might be predictive of benefit from DCVax-L could be that a primed immune system would have a much stronger initial response to DCVax-L administration. The number of T-Cells for the appropriate mutant antigens would be much higher than for a patient that had not yet detected the tumor (or had a damaged immune system). Giving DCVax-L to such a patient would be like giving a second shot in a more common vaccine, such as in a hepatitis B vaccine series. The immune bloom would potentially be very dramatic. Maybe that is necessary for success of DCVax-L in spite of the very wide, mass-parallel response.
"It's very different to observe differences in clinically determined subtypes which are known to be different outside the context of the trial."
That makes sense to me, and I was hoping that is how the FDA sees it. But I don't know if the CI's responses even fit that description. I don't know if there is an identifiable subgroup for their 15% or 25% of patients that respond. And again, if less than 50% of patients respond, you don't get any improvement in median OS. The improvement in the mean could be huge, but the improvement in the media would be 0. While obviously, if there is a huge improvement in the mean, the drug should be approved, as it was for the CI's. I think the game is changing, though maybe there has always been recognition of these issues, and proper means to deal with them. The level of efficacy for the Phase 1, Phase 2a methylated mesenchymal patients appears to be similar to that of the CI's. A similar percentage of patients with benefit, and a similar level of benefit.
Many do not trust that early, open label, DCVax-L data, as presented, and I don't blame them, but if the phase 3 does prove to resemble the mature phase 1, phase 2a charts that LL presented in that recent lecture, then DCVax-L efficacy is similar to the checkpoint inhibitors.
The data actually showed what may prove to be a cure for about half of the mesenchymals. Clinicians can not use the word cure, but I can. I am assuming that the "about half" is the methylated "about half". If so, and this level of efficacy proves out, then you could argue that DCVax-L is more valuable than the checkpoint inhibitors for 2 reasons: 1) It does not have the horrible side effects that can come from checkpoint inhibitors. 2) It may be possible to identify which 20% of patients will benefit from DCVax-L prior to surgery, allowing other therapies from NWBO or other companies to be trialed for the complement of patients. That is a big deal.
Flipper and Doc Logic and others believe one of the recent studies may indicate a good way to identify patients that will respond to DCVax-L prior to surgery by examining the lymphocytes in the blood to determine whether some immune response to the tumor has begun. This would not necessarily be along known subgroup lines... but again, the CI's were approved, possibly with no defined subgroup for the 15% to 25% response. This initial tumor response, prior to DCVax-L administration, is apparently not strong enough to stop the cancer, but the response indicates a healthy immune system and the existence of mutant antigen targets, making the patient a good candidate for DCVax-L.
And again, Flipper recently provided an example of a CI being approved based on a relatively small phase 2. Not tiny, but small compared to the DCVax-L trial. Flipper and others have also shown a recent case where a CI trial received approval from the FDA without any request from the sponsor.
Median OS, Belated Subgroups, and the Moonshot:
Nothing new in what I am saying here, but I think still worth saying:
What is the median OS improvement for the CI's when they are showing efficacy for only 25% of the patient population? Isn't it zilch by definition? The efficacy is great for the patients where it helps, the mean OS improvement is substantial, but the improvement in median OS is zilch. Right? Regardless of the powering of the trial, the median OS improvement would be 0. Yet the FDA approved them, in some cases even based on phase 2 data. And I don't think the 25% subgroup was identified in advance. I don't know, but I don't think so. Not sure they yet know in advance who will respond.
What do the above considerations mean for DCVax-L? What if it only shows efficacy for 20% of the patients, but for those, shows very high efficacy? The median OS improvement would be 0, but clearly that should not be a stopper for approval, yet it would by traditional rules. One goal of the Moonshot should be to plow through any such nonsensical barriers.
At the same time the statistical taboo in making up subgroups after the fact has a very real basis. It is a difficult topic but may need to evolve to make sense for modern therapies, or perhaps modern analysis that allows resolving efficacy to subgroups.
If DCVax-L proves to have high efficacy for a small subgroup that can be identified prior to surgery then it is in everybody's interest for it to be approved, but for only that subgroup. The reimbursement overall might be the same as if you spread the efficacy, and approved over the entire patient population... but you would be preventing many patients that it will not work for from trying another therapy that might work, and you would be adding manufacturing burden unnecessarily on NWBO. NWBO would make more money with only the proper subgroup(s) approved, and the patients would be better off. This would not be true if DCVax-L was nearly cost-free to manufacture as are many of the existing drugs. In that case approving for everyone when it only works for a small set is bad for patients but not bad for $ for the company.
"If on the other hand you wish to sue on your own, you can do so with a single share. Of course you would not have free legal help."
That just isn't true. In the vast majority of cases... not all cases or all attorneys: You can file a complaint with the SEC, you can attempt to get a legal firm to take the case, or you can try to handle the case yourself.
If you ever hear back from the SEC it will be an email saying that someone will soon contact you, but nobody ever does. Ask anyone.
If you are a genius with some legal background you can try to handle the case yourself. No chance for most people.
So your only real option is to get an attorney or firm to take your case. This is how that works: You will not even be able to speak to an attorney. You will have to speak to a legal assistant. They immediately call the people you are wanting to file a complaint against, warning them, whether deliberately or accidentally. They then research and find you don't have enough money to pay for the case... and they decline the case, with no explanation. It's over, and you have never spoken to an attorney. The assistant you spoke too allowed only a very terse description of your intended complaint and is probably not intelligent enough to read correctly between the lines.
Your next option is to go expose your efforts to the person you are wanting to sue all over again via another firm.
That is how it works. Maybe not for you, but for most people. I have been through it too many times to not stand my ground here.
Well, it is the Judge or Juries job to get it right... so my argument there is flawed, but if you go and watch a trial, which nobody does any more, you will see grossly illegal procedures that should be in the press or at least on some reality cop / law firm show somewhere... but they are not. Nobody goes to trials anymore, and in the darkness what goes on is criminal. Particularly if the state has $ in jeopardy.
Agreed.
Most legal wrongs are only addressable in the civil realm, and the civil realm usually goes to the highest bidder.
Even in the criminal realm it is common practice for a DA's office to check a suspect's bank account before deciding whether to file charges, so why would justice be expected in the private realm which is almost by definition all about money?
It is common to see a requirement of a stock loss of at least $100K to be part of a litigation against a company. I have seen it repeatedly in posted actions on Yahoo news on company stock pages. Everyone has seen it. Do you really think that it takes that much individual loss to be worthwhile for attorneys in a large group action? I don't believe that. What I have seen over and over in the labor and legal realms is an unstated threshold of minimum wealth for participation. A number I have heard more than once is at least $300K in assets.
The system is fundamentally flawed. Issues currently addressable in the civil realm need to have participation by a governmental body. Even in the criminal realm, it is nobody's job to get it right. It is each attorney's job to win, regardless of the facts of the case, and it is the judges job to see that rules are followed that prevent miss-trial or appeal. But it is nobody's job to get it right.
Yet added governmental control does not work either... the gov just doesn't work well in general. So what is the solution? I admit I do not know, but everybody pretending that we have a functional legal system is not part of the answer.
Wow! Lots of excellent posts!
Want to add, regarding Adam Feuerstein's MD adviser with ties to big pharma:
Some would feel comfortable with AF's advising on the clinical side, with no understanding of those issues, because AF has an MD adviser. But I believe that adviser is Dr. Mark Ratain, the co-author of the "Feuerstein-Ratain Rule" usually referred to as an "investment thesis". This "rule" states that drugs in phase 3 will always fail if the company has a market cap below $300M.
What kind of M.D. would involve himself in writing such a paper? That is so unethical, so slimy. This "rule" depends heavily on the assumption that clinical data leaks dominate the biotech investment landscape. It also ignores the possibility of un-natural SP manipulation, yet that appears to be what Feuerstein is all about.
Add Jim Cramer as the third personality in this triangle... and what a mess. These men are exerting significant influence in the retail funding of small-cap oncology trials. Each an exceptionally screwed up human being with no ethical bones. Unbelievable!
Do you think the three phase 2's are CI's with L or Direct or both?
"This board makes me lough
I thought this is a stock massage board, didn't knew that it is a platform for writing mini scientific opinion paper for the scientist who never have the ability of publishing in real journals. What you know about mature immature DC NK cell T-reg TH cell activation sits - how about going ahead and publishing them in real journal favoring or disfavoring the results of what NWBO doing and limit here discussion on the prospect of this stock in terms of making money- instead of making it a jungle. you guys making everyone sick here you know."
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Perhaps you are unaware of how smallcap biotechs trade. Predicting efficacy is necessary in predicting shareprice, particularly if a phase 3 is close to finishing. This is known as a binary event when there is no fallback product... though not exactly the case here.
Sometimes if a product gains FDA or European approval, a stock can jump 3X, or 10X, or 30X, or even 40X if the price is severely depressed at the time due to low expectations of approval and or a general suspicion, however unfounded, that major business issues are improper internal, and such concerns are alleviated about the same time that efficacy is validated or the product gains approval. Same would apply to depression of share-price due to manipulation with the optics cover of the business or efficacy problems because if such problems clearly disappear, and the share-price does not recover in a natural way, it becomes clear that manipulation has been the cause and in the current Moonshot environment would likely lead to a real federal inquiry outside of the SEC dredging up all kinds of sludge and slugs. bndvrndsayahbad.
I said:
"That all makes total sense... yet I am sticking with my guess that there are in-fact talks with BP about combining DCVax-Direct with three different BI's in three trials on three cancers."
Ducking replied:
"So Big Pharma can be neatly divided into a) those major companies that employ minions such ad AF, Cramer, Pyrr etc to trash the stock and b) those companies that are gagging to work with NWBO?
Quite a dichotomy."
I say... read this post by me yesterday Duckling. In the future, please study my work more thoroughly before criticizing. Psyche!!!!!!!!
Doktornolittle Thursday, 05/19/16 12:38:04 PM
Re: spartex post# 62245
Post # 62260 of 62475
I am not a big believer in hanging someone because they had motive for a crime... but if you are looking for people with motive to prevent DCVax-L from succeeding, you might include the insurance companies.
I think that if there is price manipulation, the insurance companies are more likely behind it than BP. BP may have a fundamental character inconsistent with such slimery. Big investors in BP... that could be a different story.
Hedge funds heavily invested in oncology focused BP's... and insurance companies. And of course NW who has been known to be very aggressive in taking over companies. These people have motive. Doesn't make them guilty... but they have motive.
Maybe so. I too had hoped NWBO would buy their own CI. It would certainly better fit their style.
But for whatever reason... it appears to me to not be the plan. It appears to me that the plan is partnering three Direct trials with three BP's and their three CI's.
One thing that would be appealing to BP in that scenario is the completion of automated mfg for Direct. It is cheaper than L to begin with, then they added automated mfg. Of course... BP would probably want to see some efficacy first with Direct alone. Not sure if they would be persuaded by the previously published data or not. Sounds like you are not. Hopefully there is some further data. Maybe some of those early progressors ended up living much longer than historical norms, but admittedly might be hard to tell in such a shotgun with so few patients in each leg.
Thanks Afford, but I do find the big $ side of things worrisome. I too think that demonstrated efficacy will take care of a lot of pot-holes or at least make them moot... but I don't know what to think of the big $ issues that Pyrrho points at.
One thing I noticed is that Pyrrho quotes R&D expenditures and divides by batches of DCVax-L to infer per batch cost. Nothing in there for automated mfg development. Such has been completed for Direct, and that had to cost a lot of money. If such is ongoing for L, which is much more difficult, that too has to be very expensive.... but expensive enough to account for the big $ in question? I'm not sure. It is a loooooot of money. Automated mfg is incredibly expensive... but is it that expensive? Not sure.
If not, maybe we get a chunk of Cognate when all is said and done? Nobody seems to think so. Best prognosis is just many shares of NWBO returned from Cognate. But as you say, that would be pretty good too.
That all makes total sense... yet I am sticking with my guess that there are in-fact talks with BP about combining DCVax-Direct with three different BI's in three trials on three cancers. 9 legs + possibly 3x Direct alone + possibly a 3x a control/placebo group. I hope they do have a placebo group.
Talks is cheap however... as they say.
Dirty Deeds by Adam Feuerstein... agreed.
Quote (AF over a year ago):
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DCVax-Direct? DCVax-Direct is simply a slurry of off-the-shelf, un-modified dendritic cells injected into a tumor. You could probably inject grapefruit juice into the tumor and get the same result.
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DCVax-Direct may ultimately prove to not be as effective as hoped, but to state that it is simply a slurry of un-modified dendritic cells was a flat out lie, and worthy of action.
There was a large share price drop to follow his statement, likely lead by the aforementioned army of winged-monkey nit-wits that regularly short on his command. In fact, his command also gets copied and broadcast by lieutenants, fellow Cramer worshipers, with their own followers... as history will show if DCVax-Direct demonstrates efficacy.
The fact is DCVax-Direct is a combination of patented DC maturation timing, administration details, and at least two adjuncts. It is a patented process and cocktail. That doesn't mean it works, or that something similar won't work better, but such is an assumption, and to say that it is just DC's is a lie. I believe the record will show it to have been a heavily damaging lie.
Maybe, but on the other hand, they started talking about combining blockade inhibitors with DCVax-Direct as part of the upcoming phase 2 some time ago.