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iclight,
Just to be clear, the expected SOC PFS by Rkmatters is higher than that of the trial protocols and that is part of the reason why the trial design left too few SOC patient events in the trial to end it sooner. The other more important part is that treatment benefit appears to have exceeded expectations and events have tailed off prior to expectations. This would be the major reason for adjusting the primary completion date twice within one year. Best wishes.
iclight,
Living longer does not help a trial end when the end depends on events. Lowering the entrance requirements to speed up PFS eventing results, as the Germans did, does help speed up event rates but can only help to a small degree as the treatment arm must supply the majority of events. There are 2 theorhetical primary completion medians for PFS. One is for SOC theorhetical cohort (N=83) PFS and the other for treatment arm theorhetical cohort (N=165) PFS. This is theorhetical based on no treatment difference. The trial expects, of course, that actual eventing will be coming much more quickly from the SOC cohort which is why 348 patients were expected to enroll. The problem is that if everyone is living longer, even if 116 SOC PFS events happen, the trial still needs 132 treatment PFS events to occur to reach primary completion. The reality is that SOC could be approaching 100 events and event rate tailing off and treatment should be tailing compared to SOC from the beginning of enrollment. This puts the trial in the dilema of tailing from both cohorts and obviously needs more events from the treatment arm which in immunotherapy treatments has a tendency to drop off very quickly once moving past a critical inflection point. We are at 13+ months past last patient treated and we still don't have a declared primary completion which we were told was expected sometime in November. Might 13 months also correlate to a critical inflection point on the Kaplan Meijer curve for the entire group of patients in this trial where the majority of patients that progress after this point begin to stretch out the entire patient population eventing tail? Look at Rkmatters' recent post about SOC PFS and you see her expected range of 11-13 months SOC PFS which reflects inclusion criteria and improved methods and treatments for SOC. If we accept her rational as reasonable, this means we should have a clear SOC PFS in the books. The problem with great treatment success and SOC expectations that are too low is that it puts too much pressure on the treatment arm events to end the trial. Expectations for treatment benefit that are insufficient to end the trial timely and SOC tailing due to any pseudos who made it in and longer lived subsets means that treatment events need to make up the difference but are only able to do so very slowly. This would result in the expected primary completion date to be pushed back multiple times perhaps. Now where have I seen that happen. Hmmm, I guess you could say that this dilema is not really helping the trial.. finish. Best wishes.
learningcurve2020,
Sure Dr. Linda Liau is doing "interesting research" just like her mom passed from an "interesting" disease. Highly dedicated, motivated focused and purpose filled research is what I see. Best wishes.
iclight,
The science of this trial says that all patients are living longer because of treatment dosing, schedule, crossover and manufacturing changes encorporated into this trial. Crossover and treatment restart causes the cancer to be hit when it is most vulnerable to DC treatment. I don't think you will find that NWBO used an active comparator like CLDX and IMUC did either so no help for your position there. Best wishes.
flipper44,
The Cures Act is correct. Best wishes.
iclight,
Correct, no mention of NWBO in recent reports and no explanation either.. and yet all patients are living longer. Best wishes.
marzan,
The 2016 Evaluate Pharma report predicts Merck will rise 8 spots in oncology worldwide sales and not because of prescription or over the counter drugs. See pages 33,34. The rise is in line with projected zKeytruda sales. Opdivo sales from BMY also expected to rise very rapidly. Best wishes.
beachlifeisfun,
The potential for this scenario certainly is currently still in play but don't count on it happening because it only works if buyers are lined up, timing of the news can be well controlled, the media is ready to respond and retail holders of other biotechs, large and small, are previously made keenly aware of how positive news from NWBO about L and more specific news about Direct could affect their current positions. One thing is sure, the January options represent an even bigger opportunity than the April 2015 options for someone to pounce on with good news. Best wishes.
iclight,
The key word in their report is "consensus". There is no consensus right now about NWBO because of all the controversy and analysts that try to help tell the truth about DCVax potential will be attacked like Larry Smith has been if they have influence. The science has already been essentially confirmed by big pharma, much to their chagrin, and it is not in their best interest to shoot themselves in the foot by helping NWBO dictate terms or move in on their market share. Analysts that don't want to be dinged by the powers that be or high risk calls are not going to lend support to this company right now. Despite this, creating a new "truth" here has been a little more challenging than hoped for because the science and those patients who are all living longer just do not want to cooperate. The price is down but control of the company has not been lost. NWBO is still a big threat and the big longs are not budging. Best wishes.
sentiment_stocks,
Thanks for the 2014 report. The one iclight refers to is the 2016 report that does not mention NWBO. Best wishes.
iclight,
Kind of impossible to put a company at currently microcap level for whatever reason in with the big boys and be taken seriously now right? Too much controversy to deal with now and yet no reason given for removing it from the lists. Their report is based on a consensus of analysts and I don't see microcaps covered here. In 2014 Mr. Woodford's investment added validation after their report came out. Mr. Woodford appears to be sidelined now and potential dilution pending. Not great incentives to get support for no matter what an analyst might think could happen. Best wishes.
learningcurve2020,
At one point several years ago it seemed as though that is exactly what Linda was thinking with regard to the mention of a shareholders bill of rights and the options mentioned along with it. The number of retail customers was still pretty small, though, and probably would not have been able to put up the kind of funding that was projected to be needed. The Most Favored Nation clause and Mr. Woodford came onboard within about a year or so of this mention. With Mr. Woodford's now questionable moves and motivations, that option is completely off the table. Nice try though. Best wishes.
Looks like today is the day for the algorithm war. Look at the bunching. Best wishes.
Turtle65,
It's all about primary completion. If it takes more time it creates more doubt and erodes sentiment of traders which provides opportunity for shorts. A little push from shorts creates the assumption of a low rate financing agreement whether there is one or not. A low rate financing, if it does occur, then creates the opportunity for the typical double bottom market makers like to work from and shorts will try to take it a little below the true double bottom just to squeeze out the programmed trades. Best wishes.
vator,
Thank you and best wishes.
biosectinvestor,
Evaluate Pharma put out the report and it was stickied but the link has been lost or removed as I just tried it to validate my recollection. The report was from 2014 and maybe Rkmatters or sentiment_stocks has a link or a saved screen shot that will work. Best wishes.
Jack2479,
There was a report on NWBO a while back that suggested 2017/2018 for approval and major ramp up I believe. NWBO was projected to have a very rapid growth pace as well. Near the top of all biotechs if I remember right. This report was stickied but has since been removed. It was from Evaluate Pharma in 2014. Best wishes.
Rkmatters,
The patent is where I think I saw it first as well and the connection to the busiest situation was immediately understood. Thanks for this reminder. Best wishes.
Jack2479,
Thank you for the update. Best wishes.
Stillwell888,
Sure looks like that to me and the imprecise language after thorough consideration of the questions does nothing to diminish my concerns. As even the bears on this board have asked, why is he waiting for NWBO's investigation to finish when he should have been able to satisfy the concerns of his own investors relatively quickly? That represents a very defensive posture. Best wishes.
DoGood_DoWell,
"Coincidence??", I think not nor do I think that the Phase Five article gained traction until Mr. Woodford gave it legs. Best wishes.
Jack2479,
I know you are getting frustrated with the lack of movement with Phase 3 results but we are all waiting on an event based update. In the mean time, have you seen or heard anything further going on at Sawston? You are our eyes and ears there so anything you have as an update would be helpful. Any new permits, job openings or construction going on? Thanks and best wishes.
Smokey21,
I also agree that those who have tried to hurt NWBO should not be a top priority for investors. I do believe that those saboteurs have been handsomely rewarded for the risks they have taken but might lose it all and then some once NWBO is successful. I think many have taken the precautions they thought necessary to mitigate their own risk,though, so finding the weak links to actually cause change is the difficult part. Best wishes.
biosectinvestor,
There is at least one person who lives in China who has written negatively about NWBO before. I am sure Phase Five has insulated themselves fairly well. Best wishes.
tencoin,
Read the last paragraph carefully. This legislation helps non transformative drugs get approval faster in new indications. That's a big pharma win. This may help NWBO somehow but this is definately designed to get cheap combos in use more rapidly especially, I would think, those that are approved that have tolerable levels of adverse events but are not nearly as safe as DCVax. Big pharma has been playing interference and catch up for 4 years with NWBO as well as with others and the general public and even Doctors and patient advocates for the most part have absolutely no clue. Best wishes.
learningcurve2020,
You are right and he found reason enough in the science to invest even after the stock price began to collpse. Good money after bad right.. unless he is waiting out the confirmation of the science like I am. November is over and no news so the primary completion is perhaps again moving past expectations as the longer tail of eventing stretches everything out. Pyrrhonian now is past being able to find even an outlier study that can explain these results. This means that somebody will likely surprise the market with a big buy soon even without Phase 3 results. This does not need to come from institutions either. The bear defense lines will soon be completely destroyed. Best wishes.
exwannabe,
Linda knows the laws and regulations well and there has been public acknowledgement of access to non public information by Mr. Woodford's team but no specific source is mentioned. Something more than that confession may be needed for Linda to reasonably "know" and then disclose this by formal filing. Kind of like the police needing a signed confession.
There is more to this story than meets the eye as many sleuths here have uncovered. The changing legal and regulatory environments as well as the dialogue moves and counter moves around all parties involved here have created the kind of drama worthy of a generational story. NWBO is the most visible and front running target in this story right now but that could very well change. Best wishes.
flipper44,
Gee whiz, why did you have to go and lob one on the ammo dump. I love the fireworks but I have enjoyed watching which targets the bears have been trying to hit. Now they are at the end of November and hardly have any ammo left thanks to you and a few others here recently. Nice post and best wishes.
exwannabe,
Can you please explain how Mr. Woodford having insider information, while considered an exempted insider, would cause NWBO to be in violation of FD regulations if he does not trade on that information. Also, what if NWBO suspects but needs to prove that a third party may have tipped off Mr. Woodford with non public information. Would that create a stalemate so to speak that requires an independent investigation to sort it out before a violation by anyone can be determined. Just trying to get this straightened out. Thanks.
exwannabe,
What about the possibility that a third party acted on its own accord to pass on non public information indirectly to Mr. Woodford, how would that put a damper on things? That also might be considered a type of "interaction" right? Best wishes.
Savage39,
I certainly understand the frustration most all shareholders feel with financing strategy and I wish a blue collar or teachers pension fund or two would kick in but they generally go with low risk picks. If you have strong connections to several such groups that might be interested I suggest you let NWBO management know. They can use all the help they can get even if Linda knows how and who to approach for funding leading up to results. I would love to see continued alternative financing, if needed, as compared to what we have had for almost one year up until this last loan. This last loan does seem to indicate a possible turn away from poor financing options. Best wishes
power11,
I am just guessing here because of the limited basis you gave us for initial look into NWBO but a bio analyst is probably looking at the science and not overly concerned with the financial situation because primary completion of the Phase 3 is expected soon. The 6 months he suggested is probably expected news plus data lock until readout and a 3 to 4 month cushion for any delays due to considerations with regard to multiple regulatory agencies that may be trying to coordinate their efforts or other factors. A six month wait for price moving news would certainly lead to depressed price financing before then as a recent loan received will not get them there. On the other hand this loan of over $2,000,000 is seen by several here as a clue that news is expected much sooner. So take that for what it is worth.
There is definately risk here but I think your friend is looking at the risk/reward ratio and suggesting you consider getting in on that basis alone at a level that takes the risks into very careful consideration and are not just pushed aside for the hope of some enormous reward. Best wishes.
flipper44,
I have come to believe that 2 really important factors are involved in all patients apparently living longer. First the dosing regimen is improved and I believe that this is a key that can be improved upon further. Secondly, earlier research showed that genetic changes which can move many non mesenchymal tumors towards a more mesenchymal marker like assay after initial remediation treatment can begin to occur quickly. In some cases this begins to happen within hours, but that may be dependent on the amount of residual tumor and tumor type. Researchers do know this change, if it happens at all, does occur by the time of measurable recurrence and most escape pathways also become active and vulnerable to DC treatment during the early stage of recurrence. You have discussed the vulnerabilities of the escape mechanism and the importance of the relationship of overall survival to being able to prevent new metastases in prior posts and you may want to bring that up again at some point as a reminder to the board.
The bottom line is that early treatent deals with low tumor burden which helps DCVax therapies work better but the crossover dosing regimen essentially attacks the cancer when it is in a very vulnerable state and synergies with other treatments can go on to help even more. Best wishes.
HappyLibrarian,
I think you misread something into what I said. The investigation is independent of trial results and those results are not waiting on them. The investigation is putting together information that must be untangled first and then presented in a manner concise enough to make sense to those not familiar with the methods being used by manipulators. Remember that the Deep Capture claim was that regulators did not understand how their oversight was being undermined. One year may not be enough time to put together a case that can adequately explain this or provide sufficient evidence to support criminal charges or monetary benefit to NWBO shareholders even if they could have enough proof to exonerate NWBO personally. You seem to want the quick exoneration. I am willing to wait for more impact than that. Best wishes.
HappyLibrarian,
I am not worried about an investigation masterpiece that comes "too late" as you say. I consider the investigation as potential icing on the cake whenever it finishes. The cake is still baking, just about to be removed from the oven and there are plenty of bakers watching over it. By the way, all patients are living longer which means the science is being validated by patient benefit. That is the true masterpiece. Best wishes.
learningcurve2020,
Leaving before finishing what he set out to do is not Mr. Black's modus operandi. I doubt very much that the masterpiece he is working on will remain unfinished or miss the mark. This seems to be not to the liking of some who would try to finger paint over the character of his true colors. Best wishes.
iclight,
Mr. Woodford also made it clear that in the course of discovery, you may want to think Ondra and a certain Ms. Wolf or separate investigation team, that he came into posession of certain undisclosed information that could put him at jeopardy of trading on non public information. Many people have found ways to trade on non public information either legally, like congress, or illegally because they are confident they won't be caught. Mr. Woodford must believe that he would be caught and be found liable if he traded on the information he has. He chose to explain his absence as self imposed. NWBO may have an alternative explanation as hinted at by their sudden change in source of financing once Mr. Woodford made public comments calling NWBO actions into question. Perhaps he did not realize NWBO had figured out how to neutralize his attempted involvement in company affairs and cause him some grief along the way while still moving the trial towards completion. Best wishes.
iclight,
Your statement that a majority of patients have OS evented demonstrates your total lack of understanding of the effect of starting or restarting treatments at crossover. This point in time is is when the mesenchymal phenotype shows up in 85% of all patients which is where DCVax-L has it's best effect. This is also when Dr. Linda Liau suggested that other treatments could be used in some non-mesenchymal phenotypes to synergistically enhance benefit in those who otherwise might see little to no additional benefit. This trial is not about validating management style it is about validating the science which many to most people still have very little grasp of which is why investment here has so much upsi de potential. Those who do understand do not want to help this company succeed due to the longer term implications for their own therapies. Best wishes
hankmanhub,
I am not saying that there is only one patient that has been enrolled in the Hospital Exemption program at each site, only that each site must have one go through in order to be fully qualified. As to the rest of your questions, I would suspect that because this is a non advertised program there might be a request made to patients not to disclose too much as results from trials have not yet led to approval and has only been an enrolled trial treatment for 2 years in Germany. Best wishes.
flyfishingcherokee,
Excellent post and welcome to the board. Now perhaps others will begin to understand the subterfuge ramifications of what is at stake here and why the attacks have been unrelenting. Cognate did not just take out a $24,000,000 mortgage to play tiddly winks with and Sawston preparation is ongoing. I believe that Mr. Woodford gained access not only to DCVax-L progress but also DCVax-Direct progress and expectations by way of Ms. Wolf. If so, this may explain his apparent lack of options until specific information is made public. Big pharma is in no mood to hurt themselves by helping the NWBO cash situation either. In the mean time we watch, wait and see if the big bad wolves can blow down this brick house disguised as straw. I think I hear some of them up on the roof and is that a big pot of boiling water Coffer Black is stirring in the fire place. Best wishes and thanks again.