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OUCH! THAT'S GONNA LEAVE A MARK. FBI GUY?
Poor Man,
The same thing happened with VICL. The courts have decided it is buyer beware. If you take anything away from this it should be that you must always, always, always balance out your risk and hang out with people honestly looking for the truth to get good imput from both sides of any position for or against. Best wishes
Ready4bluesky,
I understand your concern and a case would need to be built that there was intrinsic value that was being deliberately devalued by those seeking to obtain it for themselves at a below market value. Based on my research, I actually think I have enough scientific evidence to support the idea of high intrinsic value if such a case were to be made in court. I also think that Mr. Woodford and others might be able to do the same only much better so there are checks and balances here. Based on my understanding of who Linda Powers and Les Goldman are though, that scenario would never see the light of day. UCLA and Dr. Linda Liau could also make things difficult as could the other research hospitals that currently support her. There really is no incentive for privatization unless all these institutions would give Linda support to do this as a last resort to get beneficial treatments to patients.
There are those who have been hardened by the cold reality that experience in this world system has provided them to the point where there no longer seems to be any good left for them to believe in. Linda Powers will do what she needs to do to get this to the finish line. If she can't get the help she needs from those who will support her effort publicly, she will take it home herself but that is not how she or cancer patients can benefit the most.
Pyrrhonian,
You know I am in to the end even if there is a reverse split again but will consider any hypothesis you have as to why I consider CXCR4 to be so important to my investment thesis. Best wishes.
Rkmatters,
I have found that good investing or good science always benefits those who can find the best premise to begin with. I searched for years looking for a company or companies that were focused on multiple targets and working to reverse immune system failures after originally investing in CELG back in the late 90s. I found IMUC and NWBO and considered CLDX and STML. As I continued my research I chose the company with the better science with regard to my premise. I parted with IMUC with a profit and began to invest more near the lows with NWBO. My initial research gave me some really good notes which Steven actually triggered me to go back to and research more with regard to CXCR4. He was not even discussing NWBO with that trigger post for me but rather ischemia in damaged heart tissue and a product that helped repair it.
By the way, AVII77 is right to bring up the possibility of a reverse split as Linda has obviously planned for it if necessary. I will repeat again for all to hear that as long as the NWBO house is divided with regard to Linda and Mr. Woodford we must be ready for scorched earth tactics and that might mean a reverse split. Be prepared. Best wishes.
exwannabe,
QUOTE:
"BUT changing the endpoints always add to the negative list wrt the trial being run well." exwannabe
That is one way to look at the process but the reality is that science is about learning and a good trial design allows you to learn and adjust. When you can no longer adjust you either have something or you need to start over. One look at all that has been learned over the course of this trial and how NWBO has left options on the table to be able to navigate through it all and you can see why so many believe this company is either the best sham ever or a model for future clinical trials to follow if successful. Best wishes.
DoGood DoWell,
Now you know why I suggested to be ready for a scorched earth policy and why Linda sought more financing before this next move. Whether it comes from Mr.Woodford or not the appearance of division is being used to force a reply of support for NWBO or help assist in support of any upcoming negative action taken. He can try to use his reputation against hers to gain leverage. Linda would use his demand of using Ondra against him in that case and expose his past "active investor" activities to any uneducated investors to balance the scales. Like I said before, I hope everyone is ready for a scorched earth strategy. Having some dry powder is a good thing right now.
Koman,
NWBO does indeed have a patent and a couple of the posts Evaluate put up on the board will give you clues as to understanding it's importance. It takes some digging and a little bit of fitting pieces of the puzzle together but it goes a long way in explaining what we have seen from Direct so far and why I expect Phase 2 to do exceptionally well. They want automated manufacturing ASAP because if what I think is happening really is what is going on, it is the single biggest limiting factor for this company right now.
AVII77,
I understand your concern about the psPD patients getting into the info arm and the info arm data being potentially reflective of this, however, this should be balanced out by trial design in the Phase 3. For every SOC psPD patient that potentially could be mislabeled a progressor and then get treatment, there should be 2 of the same from the treatment arm that received the more timely treatments and would be expected to event later, especially if this trend is seen more in mesenchymal GBM as per Dr. Linda Liau's comments. If the ratio of events correlates well to higher numbers of mesenchymal biomarkers and methylation as Dr. Linda Liau has alluded to then PFS benefit has a very good chance to be well established. In this scenario the only confounding data would be coming from .33 of the psPD crossover population. If Reefrad and you can agree on the scan interpretations, I believe other expert radiologists will, upon review of all the data, be able to agree as to what was actually happening and when. I also believe that the benefit will be ascribed to treatment and not separated from it. Then, when they look specifically at the mesenchymal GBM patients, the data should really stand out both with PFS and OS. Either this is true or Dr. Linda Liau is misinformed. My money is on Dr. Linda Liau being right.
austimediainc,
Just pointing out that you said you sold your shares a while ago which preserved some liquid equity and have stated that you are willing to go the distance with your warrants. You have a thought out plan. Everyone should have a thought out plan and not just be hoping for the best or expecting the worst without one. Best wishes.
AVII77,
Ok, I understand post trial data analysis gets the boot. That is what happened to Stimuvax. I am talking about a prespecified and accounted for subset in this trial for which you yourself said there was a .03 spend left out to work with. You have guessed at how it is being used with regard to an endpoint change. Is there an alternative here with regard to mesenchymal patients that you haven't shared yet?
Poor Man,
That is correct and Mr. Woodford might also be classified as an insider as an owner of more than 10% of the company. Kind of makes you wonder why the "left out" information is being used to try and steer the thinking away from the truth here. This argument was brought up on SA in detail before. No ifs ands or buts were left to discuss.
koman,
I see you have scratched the surface with regard to CXCR4 and its role but I strongly suggest you keep digging. I believe Mr. Woodford and his team understand quite well what I mean.
AVII77,
Very good observations about clinicaltrials.gov web site and ONTY. I followed ONTY as well and used their history as part of the basis for allowing 20 years for an immunotherapy from the 1990's to get to a regulatory decision or similar validation. I like your observations with regard to OS endpoint change and when that may have occurred. I also like the fact that you mentioned the protocol changes in trials as being a normal practice. Some posters like to use these changes as negative talking points but then again traders would view most delays as strong negatives with regard to their cash out points instead of a normal part of the scientific validation process. We have some good traders on this board and I wish them well even when the price is down as it is now. Best wishes.
AVII77,
You stated "The primary ethical reason would be that the consent form is no longer valid." This may be true but why would you not mention that, if accounted for separately, mesenchymal GBM consideration might be causing some consternation with regulators ethically speaking. I know this discussion has come up before but I can not see regulators finding an easy way around this issue. Their PRIMARY purpose is to work for the best interests of the patients and is the reason for their existence in the first place. I believe they would have trouble ethically if they didn't do something positive for patients if, after a look at data that shows a clear benefit for a pre-planned treatment subgroup, crossover does not help this group as well. I believe this screening hold was initiated by NWBO and may be designed to offer them the option you and others have discussed but also create the opportunity for an ethical dilema. I have stated there might be an ethical dilema challenge before on SA. Linda does like "multiple shots on goal". Your thoughts?
exwannabe,
It's not a "fairly serious allegation", it's a fairy serious strategy for those who might feel threatened. You want me to feel mad and greedy about being diluted and I want to feel like I am supporting a breakthrough technology that will help cancer patients and pay big dividends in the longer term. Please feel free to explain the biological importance of CXCR4 if you would like. I am very happy with my understanding of it how about you?
koman,
Very good post with regard to conservative analysis and especially good take on biotechs. Better to be surprised to the upside than the downside. Modeling without actual numbers just has too many limitations to be really consistently accurate but strong trends have a chance to give clues.
Rkmatters,
As someone who looks mainly for realistic and probable explanations for what is not being explained for us here, I am happy to see you have looked at AVII's theory realistically. This is a plausible explanation for putting Les's reported comments with Dr. Linda Liau's comments and creating a realistic interpretation. Good job. The one other thought I had about this is whether or not NWBO views this process as a way to give FDA reason to take an unscheduled look at data. The company of course would remain blinded during this process so they don't "know" what FDA or others will do but as flipper44 has stated, FDA may be interested enough with the data itself or with regard to CLDX to take a peak. This would also help explain the second hand comments by Les through Drum and add a necessary reason to consider the recent financing. If there were any doubt at all that the data might stay blinded to FDA, thus preventing at least an ethical quandary for FDA with regard to methylated mesenchymal GBM patients, the money would be needed for continuing the trial to regular completion or for completion with a new primary or coprimary endpoint.
koman,
Thanks for the reply. I do appreciate your point of view and have considered the evidence you and others have pointed to and the obvious lack of clarity given by the company. I do also know about the grant income which was set aside for trial participants. The HE reimbursement issue is separate from that based on the conditions given for its use. You should be aware of that if you are not.
I have yet to hear an explanation from any negative poster for the importance of CXCR4. Would you care to take a stab at it? Best wishes.
koman,
Linda stuck her neck out when saying "..good news into bad". She said this during a time of general discontent expressed by some shareholders regarding fudiciary responsibility concerning the response to the German site wording of the screening suspension. I think Reefrad's comment with regard to something bad not having happened in this context makes perfect sense.
antihama,
For the time being I will defer my explanation to those who have a very good handle on regulatory matters. I hope AVII, Steven or flipper44 might chime in here. Anyone else that feels qualified is welcome to respond as well. Best wishes.
koman,
Notice I did not say all revenue is booked when received. The clarification was made by flipper44 with regard to some revenue types, such as might be received from HE reimbursement, that NWBO might receive.
I had a small business myself at one time and had the choice to use cash or accrual methods. I used cash. By the way, your responses to flipper seem to be more antagonistic than necessary. I understand you want to make a point but why not simply clarify without the one upmanship? Best wishes.
flipper44,
It takes 6 months to get 5 vaccinations so that they can have results included in the trial analysis. The 12 weeks is to separate out the early progressers and early pseudo progressors. Later pseudo progressors are being kept in the trial as responders which is one of the beefs AVII and Steven have with this trial. I don't have as much of a problem with late pseudo progressors being in the trial as there is not yet enough evidence to support discounting their response is due to DCVax. This is why Steven suggests his model indicates only about 100 deaths have occurred so far. His model could be close to being correct but DCVAX will get the credit unless FDA has absolute proof of selection bias. That may be be very difficult or even impossible to prove based on fairly speculative evidence at this point and other strong evidence that synergy does indeed exist.
flipper44,
This most recent NWBO financing came after Mr. Woodford announced he had sold some of his holdings to purchase more shares of companies with game changing potential. If Mr. Woodford signed an NDA then he may expect previously undisclosed news soon and is preparing to buy. In line with her goals, Linda may have needed to create the dilution necessary for him to do so without allowing him to gain a controlling interest. This is a chess match as "Situm"/chessnotcheckers would be fond of saying. We may not like what is happening to our shares at the moment but I can wait out 10-12 more months if necessary like Linda has now planned for. Remember, label extensions are all that are needed once approved. Approval of L also helps derisk Direct. Direct full automation is expected by next year. My guess is that a good chunk of change has gone in that direction.
flipper44,
NWBO revenue is booked when received. This was previously stated by them. When negotiations are complete then revenue will begin to be booked. There are certain ways that Cognate gets paid from making vaccines that is different from how they are paid for manufacturing expansion. These agreements for payment must be analyzed carefully in order to understand how NWBO expenses and payments to Cognate might be breaking down with regard to actual vaccine production. At one point there was a potential cost for payments to Cognate for about 100 non trial patients included in their quarterly payments based on my rough estimates. This cost could have been for something else but I don't know what that would be for based on the then current agreements.
Evaluate,
I apologize for even bringing up Medical Center Cologne without keeping track of what was happening there. The site I went to as a follow up to your questions is not the same as the one I used before. I could not find any reference to DCVax-L at all. All I saw was their product called DCVax and nothing very specific about it. I don't know if they were making claims that were unsubstantiated and this led to changes in their format but there are some unfavorable testamonies that can be found near where there Web address can be located. Medical Center Cologne appears to be known best as an alternative treatment facility. With what I have recently found about their new Web site, I would put no weight behind any of the previous claims I read on their old site. I referenced this old site information from memory but much of this information seems to have been eliminated from the current one.
As to the time frame for full automation of Direct, this was mentioned in one of the Web casts and DCVax-L was mentioned as well but not with regard to full automation as tumor processing was explained as a separate step from DC maturation before exposure to lysate. The time frame given in that presentation was "about 2 years" for full automation of Direct.
austinmediainc,
How many understand the importance of CXCR4? I guarantee you that Mr. Woodford does. He is primarily invested because of the science. Wall Street experts are watching the business end. Their science "experts" dismissed DC technology as untenable and that put them in a position of having many big bad bets if they are wrong. Three lead investigators of DCVax-L at various well respected sites have now weighed in with positive comments. Why do you think that the IBB has corrected so much? Do you really think that Hillary or general market unrest caused this much of a drop? The investment reset button has not been pushed yet because the future of disease treatment is at stake and the next 5 years will see a great deal of change. Official validation takes risk off the table so we wait.
austinmediainc,
The company will not get into open declarations of ramp up for commercial production. They already said they would do this once and do not want any heat from any source for over emphasizing this point. Low key is the MO during regulatory review and internal investigations.
A quick aside for those who have forgotten, Medical Center Cologne provided a great deal of supporting evidence for effectiveness of DC therapy and they adopted DCVax as their therapy of choice vs their own in house version.
The limiting factor for DCVax treatments if approved, more than anything else, is commercial production capacity sufficient to match projected demand. Full automation is anticipated in about 1 year for Direct so part of the foot dragging for Phase 2 must be related to this. The timing with automation and therapy approvals is critical for expeditious commercialization. All the regulatory approvals for production must receive top priority for this to happen. Hopefully, Mr. Woodford's investment has speeded up automation development and approvals can be announced sooner. Regulators do not want to look like the bad guys if results are exceptional and may be pushing a pathway that buys them and NWBO time to accomplish expedited commercialization at the current expense of stock price. There are greater concerns involved here than what investors present. Production capacity of a "breakthrough" technology MUST be able to realistically deal with expected demand. Regulators do not want to face the heat of desperate patients and their families if grest results ate announced publicly. HE reimbursement will help with ramp up costs but early release of excellent results could result in troubling demand issues so better to stay quiet as long as possible.
AVII77,
That was an honest assessment of the trial results based only on trial evidence known to us. Based on predictive analysis of known biological processes and known potential influencing factors controlled by NWBO, there is strong evidence that there will be more data analysis shared that predicts a positive pathway forward for Direct.
flipper44,
That axis appears to show different patient activated vs replacement DCs. Certain DCs may be able to not only deliver higher cytokine levels but may be able to remain longer in the tumor microenvironment before being genetically modified by it to become circulatory. This would be a key factor to maintaining an increasingly effective immune response to the point of tumor defense degradation. The point of no return so to speak where the tumor defenses become overwhelmed.
flipper44,
Very good observations but there is also the point that Pyrrhonian brought up which is valid. That point is that patient characteristics changed part way through so patients would live long enough to see immune response be helpful. I don't know if all early patients were indeed method A or not, because good science rarely is dictated by convenience, but this also should be considered as a possibility. I still believe that there is evidence that method B is better or Dr. Bosch would have waited longer to be sure his statement was correct.
flipper44,
"More protecting patents.... fairly early on I might add."
Yes. I discovered this year's ago. Evaluate will eventually reach the point where 2 particular antibodies were selected from many more discovered. Want to guess about method A vs method B? I could just about guarantee you that big pharma does.
iclight,
I for one appreciate your patient advocacy. I also appreciate your doubts. I have dropped hints to others and will reiterate to you that you should learn as much as you can about CXCR4. I will not connect the dots out of respect for those who have spent lifetimes doing this kind of research. Best wishes.
austinmediainc,
What you wrote is absolutely correct but judicial interpretation allows so much slack as to make the definition virtually useless unless being used selectively to make an example of someone. I believe the recent court decision in favor of VICL and it's management vs shareholders made this perfectly clear. The laws as they exist now are essentially "buyer beware".
I followed a court case fairly closely a while back that had to do with eminent domain. A beachfront property that had been passed down within one family for many generations was basically handed over to local authorities for development just to increase the tax base. That is the way the courts work sometimes. Linda knows the laws and if NWBO finds success, most lawsuits against NWBO, if not all, will most likely fail. All these arguments about what Linda has or has not done reminds me of the movie "The Producers". The movie was supposed to fail so the money raised for the production would never need to be paid back. The only problem was that it was so rediculous that it became a huge success and created a whole new set of problems. Any naked shorts and or scheming CEO would have similar problems right now. The CEO here has had multiple chances to be vetted and still has the same accountants. Naked shorters, on the other hand, have had their wrists slapped recently. Best wishes.
iclight,
The strategy here appears to be to benefit the private investors first as they laid out the cash in the first place in a very risky investment. They almost were roasted themselves as Linda took loans from friends to keep things going at one point. The risk they took was real and it has paid off but not nearly as much as it could from success with DCVax. Their derisking diluted retail stock holders, and perhaps still does, but also held together the supporting network of companies. This network was designed to get DCVax to the finish line without the absolute need for outside help. In the mean time, the science became more compelling which brought in Mr. Woodford. This allowed NWBO to take the brakes off of ramp up. Prior to his interest Linda got NWBO listed on the NASDAQ and then on to index funds. These are accomplishments that many penny stocks never achieve. Now we wait patiently or choose to bring up every little thing that the company has done to stay in business over the years. These are things you look at before you invest and Phase 5 showed us many of the pertinent filings. For those who were inclined to make the proper due diligence effort, most of what they wrote was not new.
As to my best wishes adendum, this was not directed specifically at anyone, especially not you, even though the post was to you. This was just my poor attempt, from a quick thought that crossed my mind, to remind all of us to stay patient focused. If patients are doing well with any treatment then those invested in companies that make those treatments will have a chance to do well with their investments. Best wishes (no adendum and sincerely meant).
Rkmatters,
You are correct. Bases are covered but FDA has made no formal decision. This means that discussion of this matter may come up during FDA consideration of DCVax under certain circumstances. Under other circumstances the discussion would be a mute point if you catch my drift. I expect this issue to be a mute point.
iclight,
Good post! This clearly demonstrates the financial hardship that NWBO was in before Linda took the helm. This arrangement is kind of like getting free warrants on top of lower priced shares for financing right? Great cash flow strategy to minimize risk for financiers and spread out risk to other interested investors while the company gets back on its feet. Thank you for showing us all how creative Linda and Toucan have been to keep this company alive. Very resourceful people at NWBO. Those who don't think so should just wait and complain all the way to the bank or their favorite lawyer, whichever comes first. Best wishes, betting against cancer patients excluded ie. no safety issue here.
autologousvax95,
Awesome news! This is what many longs here have been hoping our investment would lead to on a wide scale. If patients do well our investment has a chance to do the same. Best wishes to you and your friend.
flipper44,
Freudian slip?=LOL=SYNERGY=GO NORTHWEST BIO=Turtle dance=Smiles for the board
foxhound02,
I warned on my Seeking Alpha posts more than 2 years ago to watch for DNDN type of manipulation. When Larry Smith was attacked I warned that character assassination was another ploy used and to expect lawsuits, hostile takeover attempts through potential board of director additions and or outright all out scorched earth attack on share price to wrest control out of Linda's hands. Sound familiar. Linda already had the patents protected, the antidilution clauses came in after I was already invested. I had hoped that Linda and Mr. Woodford were on the same page but it appears that was not the case. Mr. Woodford, whether "duped" or not, must take full responsibility for actions he took that caused damage to his shareholders investment. That is what good investment managers do.
The Direct Phase 1 trial did not reveal a complete MO so that the trial could morph quickly into Phase 2. This was most likely due to inadequate spacing of treatments more than anything, in my opinion, though number of tumors injected also plays a critical part in systemic immune response build up based on prior mouse model evidence.
Much has happened in the last 2 years with regard to DCVax-L and Dr. Linda Liau has allowed us to see a glimpse of that which puts the focus on OS and finishing the trial. Any action taken earlier than that would probably require an unscheduled look by regulators or petition for early regular approval which would be risky based on what NWBO has said they were planning to do. They have said they will let the data mature and finish the trial as scheduled. The potential then for an unscheduled look or data request by any of the regulators and or potential looks at other trial evidence from a parallel trial and more mature open label data could explain what is happening.