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My theory again in more detail. The lack of trial,transparency is due to FDA gag order. After seeing the data and signaling stop, FDA sternly informed Linda that in choosing to continue she risked influencing the trial and introducing bias if any suggestion about trial dat was ever even hinted at. So LP goes dark. I mean completely done because she was not going to risk her first, second or third home run by leaking anything. Linda basically states that the reporting delay was to document history with another homer un (long tail).
Finally, I know researchers and can tell youthat 65 do not sign their name to a loser. Shoot, a loser never gets published (reporting bias) or at least not in a top or mid class journal...only winners. The premier neuro oncs of the Western World are lining up to get onboard this train. All aboard! Next stop destructive medicine innovation with broad prescriber support. Welcome t blockbuster town, population DCVAX.
And remember that steering committee. Get ready to broaden indication. We need more boxcars for this train cause we have way too much success to carry in the future.
As lLes once reportedly stated, this is a game with billions at stake (not millions baby, billions)
CO Dendream - I can't wait to be gliding down the Rocky slopes in the winter after water skiing my way through summer.
I am talking to you, Little Tommy!
Doc,
As to the additional say 31. My opinion is that FDA told Linda that she could not continue enrolling patients to placebo as this would be unethical, however since there was a pool of already consented patients with tumor processing intitiated, these screened patients could still enroll as they had already committed prior to futility knowledge being available. It is not clear whether these 30ish were randomized or all,placed on DCVAX. That could have gone either way.
What I have become reasonably certain of is that we will win on PFS, may win on OS (cross-over throws a wrinkle into that time), and for absolute certainty milestone survival and long tail survival data will show incredible numbers. Mind-blowing really. And this point is certain TRUTH! Which only needs back of napkin stats to prove it.
My biggest regret is not buying to the direct sophisticated investor offering.
We are literally away from a life -saving theory for GbM which will launch us to MCR, renal cell, Liver and about a dozen other DCVAx-L targets.
Price prediction: short term=$6, mid term=$12, long term $84
MI Dendream
Doc,
If I am following your logic correctly, you are suggesting that randomization took place but that those randomized to placebo (I.e., SOC only) were not enrolled. Thus 331 instead of 348. While I applaud your outside the box thinking, I can say with experience and reasonable certainty that this did not happen. Randomization is double blind, no one knows who gets what except the individual administering the code and even then the participant is also coded so as to remain blind to them.
I am sticking with my theory that dates back to August 2015. Here it is more clearly defined than my previous post on the subject: A futility analysis was performed summer of 2015 (interim analysis in layman terms), and a recommendation to stop the trial was issued by the DMC. Since it was for a difference observed in blinded cohorts rather than futility, FDA was brought in to evaluate the data. The data can remain blind at this point because approximately 55 PFS events per arms tells you one arm is doing 2x more poorly than the other. While FDA signaled stopping the trial would be met favorably, Linda stated publically that she wanted to go all the way to OS. She also said the halt was good news and invested hundreds of millions in capacity expansion. If I am to believe the recent ASM transcript she now also stated that documenting a long tail survival would be historically important at this point
Go back to 2015 and recall that IMUC was anticipating OS results after a positive phase 2 trial result. Linda need to continue the trial so as to have a marketing advantage against and assumed positive IMUC trial. This is why she past on the bird in hand going for two in the bush.
Long and stronger than ever,
Michigan dendream achieved, Colorado dendream next ( a shout out to my DNDN boys who also achieved their Michigan dendream - I don't have time to call but since I know one of you is reading, get on this train fast...it is heading to Colorado for a ski villa soon)
If manufacturing process and development is outsourced to a single source without request for competitive bidding, how did you ensure Fair Market value rates were agreed upon with Cognate given the apparent conflict of interest due to a in mutual ownership stake in both Northwest Bio and Cognate by key decision makers?
I myself looked into the offering, but said pass since I had already taken a tax loss earlier to offset substantial gains in FOLD, After long deliberation I decided erasing my tax bill was worth letting go of stock at what amounts to about a $2 wash price for NWBO.
Thus buying series B was a tricky move to pull off. Now, although my dad too is an accredited investor, it was theoretically possible to pull off a purchase, but the short timing made it damn difficult.
I offer this because I bet several well financed longs were in a similar boat. They saw the opportunity to trim a small piece of NWBO off to offset gains earned elsewhere, and were thus challenged by the timing of the offering. The accredited requirement limited the pool and also biased towards more savvy individuals who play the tax loss swap game.
I am not surprised by a smaller than full allotment, and am hoping to buy back up in the market if the news holds off for my 30 day window. Good news is my remaining share price is now $0.58 after selling those 2014-15 shares. I am a short way to,profitability and a short time from cancer-curing wealth.
Wisconsin-turned Michigan, now Colorado Dendream
"Dreaming about a future with some cancer cured while I ski the slopes in winter and the lake in summer"
I still believe that we will get positive news on the trial, but am not confident it will occur before insiders have the opportunity to fleece another 50-150M shares with accompanying BS warrants to boot or even worse.
I have been asking myself lately about NW. What if he had gained the activist board member to watch over the wolves in sheeps clothing? How do I know any of the existing board members were any more qualified than his proposed man? Who cares his biotech experience if his purpose was to protect shareholder interest? What have the replacement people LP brought onboard done for me? I know I haven't seen any benefit from the investigation or any deep, dark financing conspiracy. What was the true risk posed by Ondra and is it any worse than what has happened to me since? Does NW have any power to stop this madness and if so, how can I help?
Oh sages of the board, if you can shed light on these questions, I am interested to read your response. I have seen things differently before and am open to broad explanations. My gut, however, tells me that this was always the plan and we are seeing it unfold. The lawsuits were BS as many felt, I just didn't realize which side we were actually on and should have been rooting for until now. I am not certain the clause preventing further suit has legal merit, but it is extremely curious and something I have never seen before. I don't think it happens ads well for my investment. When we finally do get news, I for one will not be satisfied breaking even, but fear that may be my best outcome. I thought that I had learned a lesson with Oxford Biosciences but apearantly did not. I expect the carpet is about to be pulled right out from under my feet and I can do nothing to stop it.
This is what has me worried.
Could it possibly be that we still have not hit the target 233 OS events to end the trial? My gut says no way it lasted beyond August, but it would only take about 35-40% of treatment arm patients and 15-20% of crossovers to have moderately long tail survival to make our wait an enormous one.
Could it e 99 patients are still living and data lock has not yet begun? Maybe
I am so frustrated by the lack of communication with shareholders it's not even fun to dream anymore. I am with you that there is no end in sight now. GIVE ME AN UPDATE DAMMIT!
It matters because of what I had suggested in my removed posts, that is that perhaps this funding deal needed to occur before results are announced. Why?
"The shares are also subject to a voting agreement, under which the investors have agreed to vote in support of such increase in authorized shares"
Well, as far as I understand the prior Cognate deal requires shareholder approval because it requires more shares than are available be issued. This deal requires investors to vote for a share increase. Perhaps, there were no longer enough friendly votes to see the deal go through at such advantageous pricing. They need each other now.
As far as those speculating the end is not imminent, I say this... Treatment in studies alomost always continues until data is reported and usually for much longer afterwards in an extension trial. The statement about treatment say nothing about data readout. Again, the Feb PR laid out an expectation on timing. The June presentation further narrowed that expectation. The result of these is that one should reasonablly expect results have either been viewed or will be viewed by management in the coming few weeks. The Sept 8k, reinforces this "anticipated" timing. Any change in this requires a clear PR or SEC filing as to the change in expectations.
Results are pending any day now. AND we have been diluted to oblivion in the past month. shame! Shame! Shame!
Longfellow, as with other PRs this statement is very carefully worded with compound, complex language. It does not necessarily mean that the new investors are new as of this funding, but rather are new as of this year.
I have never, after investing in dozens of start up biotechs over the past 20 years, seen a management team that despises their long-term shareholders more than this NWBO team. The pumping that occurred prior to halt roped people in and the silence that followed destroyed equity. They then strategically placed nuggets of information to create an air of news pending (see September 8k) all the while diluting long term holders into oblivion. In the past month alone 50% more shares were created despite Feb And June PRs indicating results should either be available already or literally at any moment now, and despite there being no room in their share shelf. Where are the updates owed us after June? WTF.
I have been such a fool! Shame!
Again, I am very, very long this stock and believe the results will prove positive. Thus, I am in deep and will remain so. Any suggestion by do-know-wrong longs to sell is crazy talk.
Having said that Kab, perhaps the answer to your misunderstanding is that the run up that we recently saw and possibly even a much higher run would have occurred in August or early September if reaching the OS target was announced and transparency over the expected timeline were given. A statement such as "we expect to report results in late Q4" as is expected in this sector may have even driven the price into the $2-3 range by now. And as you know, why this is relevant is that it would have been very hard to grab all those shares for themselves at ridiculously low prices if this had occurred. Who knows, we may have even had a white knight step in and provide serious funding by now. Wouldn't that have been something for long time shareholders to see again, especially with about 20% less dilution in place.
This company has a potential 2019 blockbuster with phase 3 results pending any day and our market cap is less than $100 million. This is so far from the typical valuation for an even somewhat promising biotech that it is beyond laughable AND insider leadership silence is largely to blame.
The way to combat lying bloggers is to be transparent with the truth!
Agree - what options do retail investors have? Those that suggest sell and walk away are being ridiculous. At this stage and share price, one must see this through. But are we powerless to prevent being completely fleeced? I got deep into this stock because of my knowledge of the industry and trial process, but admit that I am pretty clueless when it comes to the games that powerful can play in the market. I have been played.
Here's my issue Fear, most every biopharm company makes 60-70% of their revenue in the US. In the fist 2 years of a launch this is closer to 100% than it is 60% for certain. NWBO and Cognate have had sufficient capacity in the states to service the launch and could have built our European capacity as the prolonged process to EU marketing transpired. EMEA Approval is the first step in a long process to gaining access to EU markets that are far less profitable than the homeland. Fish where the fish are. That is what most every company does.
The idea that they leveraged literally hundreds of millions of shares (and thus diluting me several fold) in order to prepare European capacity pees me off. This may be a legal maneuver but it smells very fishy to me. Clearly a share grab. Shame!
I am allied to LP despite my distrust of this situation. I will chalk my truncated gain up as another market learning lesson. I am reminded again that the powerful play with a different deck of cards than I do and that just sucks. At least, I am certain I will profit handsomely regardless and at the same time I know that I helped make a positive I've impact on the world by doing so.
At $0.22 and $0.17 repayment price, I'd say the silence has served them very well.
I am long since 2013 and have always appreciated both sides of the Cognate relationship. While it is somewhat unseemly that LP is at the helm of both the customer and sole source supplier, I also understand the financial flexibility this has offered over the typical small Bio contract manufacturer relationship.
I, however, am very disheartened by the recent 10Q share exchange as I question the basis of the billed value. There were no new patients added in 2017 and yet we have been billed $17 million this year. I understand there was some cost to maintaining space as well as additional build-out activity, but this is clearly excessive billing. If, as I assume, no competitive bidding for services took place and one hand is transferring assets to the other, then the value of the services should be at a low end fair market valuation so as to avoid appearance of wrong-doing. This value far exceeds what I would call typical contract manufacturing fees and services charged to either start up or established biotech companies.
I also appreciate that I have (at no small expense) been able to average down my investment while LP has been held in a fixed situation. I believe she has a right to recoup some of her lost position. The flip side being that I did not have full transparency and added at 9, 6, 5, 3, 1, 0.8, 0.4, 0.25, and 0.17 while the Pelican posee' was in full view to hold out for ideal pricing for this exchange. This all seems rather fishy and I don't like the stench one bit. I especially question the whole warrant BS. Insiders have had knowledge of timing and financing needs that I have not and have clearly leveraged this knowledge for personal gain.
Having said that, it is clearly positive that Cognate is willing to take stock instead of a cash lean on Swanson property at this stage in the game. Insiders also have at their disposal certain knowledge of many indicators that although blinded can be used to reasonably predict success or failure. I fully expect to still make a ton of doe for this investment albeit much lower than I feel will be the fair return on my commitment. This due to the extreme dilution that has transpired over the past 12 months and last week. It is the last week that broke this camel's back.
Just stop the gaming and give us the damn results already!
You misunderstand my position. I do not believe the DMC found the study to be futile, just the opposite. I believe they recommended the trial be halted for efficacy and the company refused.
Thus, FDA said "say what?, you really want to wait? We recommend that you don't...wink, wink. Say what? You want to go all the way to OS? Your choice but we cannot let you put anyone else on PBO, that's just not ethical. You can have the patients that already consented and no more. If you want more, you will have to run an EAP and give it away, give it away, give it away now. And BTW, you are now formally under review, so we are going to watch every damn word that you say. Every damn day, every damn night and especially at every damn conference and earnings call. You best not bias your trial, baby! Shut the Frack up about every damn thing, you got that brah?"
Linda "understood"
The rationale for refusing would be that they would have limited data to market. Trials stopped early are caught with the data in hand and although a long term benefit can potentially be inferred, it cannot be implied or marketed. Without hitting 50% PFS in each arm, you have no median, without hitting predefined milestones by proportion of patients nor 50% OS you have no survival to market. In August (really July), IMUC looked to be poised to have both, leaving a potentially superior therapy with its hands tied re: sales & marketing of weak data. The market understands median and 2-, and 3 year survival rates. The market does not give much value to an early stop due to efficacy.
Just as a long investor really hasn't lost or made money until they sell, a short (I struggle to find the right term -gambler, counterfeiter maybe, but certainly not investor) does not truly book a position until they cover the counterfeit stock sold. They haven't netted out yet.
We shall see in the end which side truly makes money. This short manipulation, however, has forced a promising technology that could potentially help many solid tumor cancer patients to be sidelined and this company to raise capital at ridiculously low terms.
SHAME, SHAME, SHAME!
Here is what is clear regarding the hold. After the regulatory hold on new screening of patients was put in place, several critically important activities occurred:
1) data was submitted to a regulator (assumed to be FDA) and ongoing conversations occurred
2) patients already enrolled in the trial continued treatment
3) patients in screening were allowed to enroll in the trial - LP indicated that she planned to complete the trial through OS
4) Early Access Program(s) which require regulatory approval and treated in most ways as a single arm clinical trial without enrollment limits were initiated and implemented.
5) Approximately 30ish patient entered the trial after halt and over 100 received active treatment under EAP.
6) construction of new manufacturing capacity in England continued
7) manufacturing partnership in Europe were renewed
8) additional sites were activated in the trial because the process to onboard a site for commercial purposes is similar to the research activation process (thus speeding the time to commercializations in those centers)
8) the company announced that it agreed to stop enrollment at 331 instead of the previously defined 348 and the hold from FDA was lifted in February.
9) the company announced that the primary event trigger of 248 was reached by February 2017 and indicated that it would take several months to reach the OS trigger and a few months after wards to complete data lock.
10) the company announced in June that they were approximately 1 month away from reaching OS trigger of 231 and that ONLY 7 SAEs have been reported.
That's the facts, Jack! Based on points 1-5 and 10 it can be concluded that the hold was not due to safety or manufacturing concerns as has been widely speculated here by naysayers.
For those not familiar with clinical operations within industry, it should be understood that initial data analysis typically precedes final data lock. Final data lock is a process of verifying clinical reports against source data and quality checking data entry at sites. Preliminary results can vary somewhat but generally the first read is very close to the final set. Thus, I believe the result at least for PFS and likely OS is and has been in hand. I also believe that if it were negative it must be immediately shared publically. Clearly raising funds with knowledge of negative results would be criminal.
My base theory has always been that the hold in August 2015 was initiated due to a futility review and DSM recommendation after viewing blinded data, but that extreme efficacy on PFS was presumed. EAP approval supports this theory as does several other clues along the way.
Those two were officially released with the program and other abstracts, thus fulfilling the embargo release. I can no longer find the information on their website but am reasonably certain that previously posted Late Breaker guidelines indicated that abstracts presented throughout the conference would lift on the morning of the first day 11/17 regardless of day it is presented.
The embargo of abstract information is a two way street subject to litigation and/or other penalty if broken. There is no way the authors of a Late Breaker was leaked. Besides, if it involves Dr. Bosch that would also constitute a violation of insider trading rules.
Stunning find!
I am now convinced that this was the plan all along and their February PR which stated several months to reach OS with data lock and results a few months later informed us of this. All 8k's, PRs and presentations along the way were done to provide small status insights to the astute listener.
I am SO DAMN excited for next Friday that I can hardly breathe!
10...9...8...
I am sorry, Friday, November 17th - the day late breaker embargo is lifted (7 am EST). I expect an 8 am PR with positive top line results.
Bosch' Sept 1 presentation actually answers the question about whether data will be released today or not since he states that the authors are finalizing the publication. The standard abstract deadline for SNO passed at the end of June, but the late breaker deadline occurred in September.
This doesn't prohibit there being an abstract released today. Many companies will surround a major Late Breaker with secondary papers like baseline population characteristics and overall safety findings. I think we know however, that Friday Sept 17th will be a very big day for NWBio...one way or another.
First you defend the paper publicly, then you publish it. Now that's peer review. Following the proven path is the safest bet, whether that be median PFS, median OS, or platform followed by paper.
Ballad of Immuno-truth
The journey 'as been long
Painful at times, we all know
17 or six, Six or 17
Wisdom 'n strength tested
Fortitude the price you owe
Six or 17, 17 or six
Logic o'er ample fear
Skullduggery master known
17 or six, six or 17
Karma now in the zone
Cometh down to Powers owned
Six or 17, 17 or six
..., ...
We win, no fix
The booth just tells a story. The likelihood that at this very point in time, I mean right this very day. Right now. Linda knows the answer. What happens next foretells what happens next.
Feb 6 led to the process of data lock (TRUTH) and whether or not they spent alpha and took a peek at those or whether they were patient and waited, June 6 told us that the summit was in sight (TRUTH). Experience tells me that Feb 6 was conservative when setting expectations at a few months after lock, but here we are now at a few months after lock. Those that say otherwise are wrong (SHAME, SHAME!), multiple runs of experience tell me so.
One thing I know is that negative knowledge must be shared, but where I come from positive people can wait. It can wait until the 6th or the 17th, doesn't matter much to me.
It is difficult to market an oncology drug without a median PFS gain to report. In the context of a potential competitor who would have both PFS and OS numbers, this is even harder. Only handset can tell us that IMUC would ultimately fail.
The fact that patients are living longer, and IMHO those randomized to treatment had taken much longer to even event than estimated, means the study went on, and on, and on. As Lind L, stated that's not necessarily a good thing. Funds dried up and manufacturing capacity sat relatively idle, except for Expanded Access Program use.
BTW - expanded access programs are regulatory approved and intended to be used to speed access to promising drugs.... would that be considered good news if say 100+ patients were allowed access outside the p3 study while we waited for people to event?
Suppose 110 PFS events triggered in June-July 2015 and the blinded DSM review saw approximately 55 cases in arm A and 55 cases in arm B. With 2:1 randomization, the randimization code could remain blind and yet DSM could make a determination of effect.
What might the DSM have done at that point? How would Linda react to a DSM recommendation? How would FDA respond?
Perhaps the last 2+ years provides an answer.
Suppose that the data lock that began on 2/6 produced the "Interim Double-blind" PFS results in time to submit with the regular SNO abstract deadline in June. Having informed us on 6/6 that OS was pending, the timing may have been perfect. The "pending" acceptance leading to ultimate "release" in November would have come in Sept but after SMI, causing an 8k explanation. This would mean a SNO abstract embargo is lifted on 11/6 in time for a PR before SITC, thus making the booth there very, very relevant. Late breaker embargo lifts just over a week later, negating the value of an SITC booth.