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threefoot,
L is the closest to "being ready" for commercialization as far as we know. Big pharma wants quick turn around if possible and if UCLA's biomarker analysis can be approved for patient selection and a trial endpoint can be reduced to just immune response then you have a very quick turnaround with L. Much more is unproven and relatively unknown about Direct which is why the SAB is going to be helpful at putting the best minds together to work on proper anticipation of MO and, therefore, trial design. Best wishes.
Doktornolittle,
That assumption of no enrollment after initial screening has already been debunked so good question. What I believe flipper44 might have alluded to is the possible petition for the addition of the pseudos into the trial results assuming an internal blinded review for the main arm was showing a strong trend toward outstanding efficacy. I am no expert on the review process going on but is it possible that if this is the case then either this would result in some sort of review towards approval, a denial of the request and eventual continuation of the trial to finish enrollment or a complete response letter depending on how regulators respond to the request and or data provided?
Doktornolittle,
That is a fair summary. I think dade has a fair point to make too but fails to illucidate the risk/reward points of intereest. For example, what would the low be after any given unfavorable event and what would the high be for positive events. The need for financing is obvious. The timing of other news is not. Best wishes.
flipper44,
I hope the "Ashcroft" folks are still busy working with the feds. These attacks are sure to have links that form the obvious pattern. I expect cyber DNA will link the wolfpacks.
antihama,
Thanks for sharing. I did not see that one yet.
exwannabe,
Mr. Woodford causing a short squeeze? Do you mean like when the April 15 2015 calls went wild? Mr. Woodford would if he could but he (probably) can't so he won't. Insider/NDA. Now if NWBO releases news that frees up Mr. Woodford to get back in then I expect he is more than ready.
antihama,
They could mention they are looking to get an SPA if they actually were but.. what would the media response be? I think we know the answer to that. I am sticking to the theory that about 7 arrows are aimed at the same target and are scheduled to hit at about the same time. Have you noticed the lack of articles and other buzz lately? There is obviously a backlog building. Best wishes.
flipper44,
Locusts can also become canibalistic so I guess the stress some have come under with NWBO still isn't too bad comparatively speaking. LOL.
Gramatical or punctuation differences ie ., ;, or :!.. ? LOL.
flipper44,
Drought conditions are a source of stress on plants and animals. In plants it can trigger a massive relocation of energy resources to reproductive activity hence high fruit yields after drought stress. This is used in apple production. In animals, grasshoppers under extreme stress undergo metamorphosis into locusts ie Dr. Jekyll and Mr. Hyde.
With the announcement yesterday of the new scientific advisory board for NWBO and the suggestion that one or more on that board will be involved with future trials, is it possible that NWBO is seeking an SPA for Direct Phase 2 as well perhaps for combo trials with L? Perhaps this is why they have been quiet about everything?
flipper44,
The CXCR4/CXCL12 relationship is used for motility in both cancer cells and dendritic cells.
flipper44,
None that I am aware of. Does Duke have anything going on close to the finish line? That was the only thing that came to mind.
Evaluate,
Having lower expectations and being pleasantly surprised is always better than having higher expectations and being disappointed, especially considering where NWBO is at right now.
sentiment stocks,
I believe a while ago Dr. Linda Liau mentioned that all tumors were classified according to subtype in post hoc data from the earlier trials. I believe the protocols mention data is collected from the tumor sample before treatment with regard to methylation as a distinguishing factor and then somewhere mentions other measures. By the time the trial was resized they would have wanted to make sure all had tumor subcategories accounted for even if they did not spend alpha on mesenchymal at that time.
sentiment stocks,
They have been testing for tumor subtypes for a while now though that has not precluded enrollment into the trial. If someone asked for a review of data based on subtypes to be sure that there is proper representation so data is not skewed, that might be part of the review process.
spartex,
The only news that can drive the price of the stock right now is what is known to be expected. The need for a cash raise is the only near term news that is a known given and an announcement is expected soon by many. Any other price moving news has a more speculative time table and as such is discounted off the current valuation. Some here are hoping for good news by the end of this month. That would be nice but should not be counted on. The big pharma collaborations have no announced benefit as of yet which leads me to believe that NWBO is being toyed with while needing financing. Investors should view this as such until a formal announcement is made. Manufacturing inspections can take time if regulators do not make them a top priority. News like today's has often been followed by a financing. Be prepared.
flipper44,
That would be awsome! I would also like to hear from a few of the doctors that were involved in that roundtable discussion a while back. The discussion about products that might be beneficial but offer no financial reward ought to be picked up on by those who want to help find answers. I think they mentioned $10,000,000 would be enough to get a good look at potential benefit of one of those product types.
beartrap12,
Several comments by the company a while back indicated that L would not have full automation at the expected trial endpoint. With the trial endpoint moved back, automation available and problems with contamination at NIH, perhaps the Germans became more dogmatic about it and wanted the patent thoroughly vetted before any widespread use of the process. Just a guess but worth considering. Best wishes.
exwannabe,
All evidence points to synergy between checkpoint inhibitors and DC vaccines. That said, those tax writeoffs might be looking good to several companies don't you think? If bankruptcy became a legitimate topic of discussion might someone break ranks and bid before any bankruptcy proceedings could be approved? Based on Wall Street MO, I am guessing that someone would do exactly this. Hence, the tax write offs have more value than those of DNDN.
afford567,
Linda has made several statements that can and would be used against her and any assets linked to her if the company were to fail. One of those statements was when a "shareholder's bill of rights" was mentioned in an SEC document. Turning "good news into bad" was another one. Time is not always our enemy even when it appears to be. Best wishes.
exwannabe,
Thanks for helping to connect the dots. The big picture is always very important which is why the external NWBO investigation is probably still on the tip of a very big iceberg. Best wishes.
Doktornolittle,
I know you are not arguing with sentiment stocks and I agree with you about the rediculousness of being able to sell this priveledge to others. I was just trying to explain how our shadow government works.
Doktornolittle,
Our government likes to fund some projects off the books and things like this FDA provision would allow them this opportunity through the appearance of unrelated legitimate business transactions. In such cases where legitimate businesses might be tempted to misuse the program there might be some unexpected scrutiny in some cases.
Poor Man,
Focus on the manufacturing readiness and equivalency. Sentiment stocks demonstrated how this may be the cause of delays with regard to FDA decisions. This is also true in Germany and Great Britain. The delays in eventing and various new tests that can be used to correlate benefit to treatment are probably all being looked at as well in the mean time. Best wishes.
flipper44,
The 66 events that triggered the first scheduled interim analysis, that ended up being for safety only, may have been eventing at only a slight PFS advantage based on modeling discussed on SA and elsewhere back in 2013/2014. The way trials are set up, though, modeling is difficult to get right because there is generally no strict linear enrollment of SOC to treatment patients. In this case a 2 to 1 ratio is not 2 treatment patients followed by 1 SOC patient as each new patient is enrolled. That said, the idea that all patients appear to be living longer with a referrence to 24 months MOS as the baseline and other statements that point to early treatment vs later treatment comparison, may indeed point to early (vanguard) patient benefit compared to later enrolled patients for PFS but much better than expected MOS for all patients and perhaps later treated patients having better PFS as well. The context of these statements seems to be with regard to treatment arm vs crossover arm but vanguard to non vanguard is also possible. If this is the case then later enrolled patients benefitted from TFF manufacturing without initially realizing this would happen. By the time Germany was ready to come on board this benefit may have begun to be recognized and they wanted to know why. Getting this resolved would take some time and since it affects both L and Direct, news and trials appear to have been deliberately held up while the issue is being resolved. NWBO and or Germany probably felt they were seeing some unexplained benefit which led to NWBO voluntarily suspending new screening and giving their data and understanding of its interpretation to regulators. In the mean time, the Germans seem to have wanted more details about the patent which may have led to HE being held up on their end as well as planned trial enrollment there which led to everyone being held up and this long delay while issues on both sides of the pond are being worked out. Perhaps a German company was interested in a combo trial as well so everything went quiet with all the discussions, reviews and investigations going on. One thing is for certain and that is there is a great deal of activity going on behind the scenes and resolution seems poised for later this year.
TiltMyBrain,
Hoping for the best for ARGS but limited sample size to extract antigens perhaps means hit or miss on aquiring the best antigen targets. Best wishes.
spartex,
Lower price does not mean institutions are not accumulating. Traders are getting out and or potential financiers are shorting ahead of an expected financing. Retail buyers are not large enough players to impact the direction that others want to take this stock over the next couple of months. Based on the playbook there are some hoping to bring one last massive attrition between now and September. Best wishes.
sentiment stocks,
Awesome job putting it all together as a distinct possibility. Very well reasoned. Best wishes.
flipper44,
About 7 arrows all pointed at one target and released to hit it at about the same time. July, August and boom! HE (typically Feb or Sept announcements), PIM part 2 (waiting on manufacturing readiness including patent approvals?), Direct Phase 2 (waiting on possible final combo agreement) , combo trials (DCVax-L and or Direct), worldwide manufacturing expansion inspection and equivalency approvals, internal investigation report, external investigation report.
Lack of accrual at this point essentially equals validation that the company and FDA and other regulators must figure out.
sentiment stocks,
Wasn't the actual manufacturing of L supposed to be able to be done in Great Britain but ended up coming from Germany? If this was the case and Germany had a beef about automation and Great Britain did not then this would explain why NWBO was slow to enroll there and then went to contract manufacturing.
flipper44,
Great find. The words "positive or negative selection" sums it up for me. Now from this you can determine the approximate time for final manufacturing approvals to be granted based on time needed for final acceptance of the translated patent documents (if the Germans require this), the commercial manufacturing site inspections being passed (where any new sites or expansion has occurred) and verification that final staffing needed has been put in place. Contract manufacturing appears to be in place for early initial demand. Sawston is prepped for rapid buildup of additional multi product capacity and just needs to pass inspections to have manufacturing approvals granted which would also correlate to the second part of the PIM application.
The trial is still scheduled to end in September/October even if many lives that otherwise would have done likewise, according to Dr. Linda Liau, do not. Best wishes.
Regina,
It's good to take a breather. When I am with family my posts stop. Once in a while I will stay up late to put my thoughts together when everyone else is sleeping. That said, I sure appreciate your thoughts and sharing of due diligence.
This last week several friends shared that they had just been diagnosed with primary or secondary cancer. One apparently developed leukemia from chemo treatments for another cancer type. That person had not been advanced enough to qualify for the Direct Phase 1 trial so I shared some info for them to consider that I would not otherwise openly share while Direct is in clinical trials. That might help them if their doctor will act upon it. To date he has not. Fortunately the primary cancer has been mostly controlled with the chemo though biomarker count is rising again. Leukemias have become more treatable in recent years so I was able to reassure them about that. The good thing about all of this is that these folks are talking and know that there are those who care, are praying and actively looking for answers.
I have a story about someone I know personally that had a liver damaged by hepatitis, a broken marriage and a condo underwater. He joined a prayer group about one year ago when he was bottoming out. He just moved after selling his condo for a profit after receiving 2 bids in about 6 days when the realtor said maybe it would sell in 6 months at around breakeven at best. His marriage has been restored as have the attitudes that were wreaking havoc on it. Last but not least, his liver returned to completely normal function. He asked his nurse if she had ever seen this happen before. She said that this was a first time experience in her entire career. Wait until she sees seemingly hopeless cancer patients going home to live! Enjoy your time off. Best wishes.
Rkmatters,
The trading price ranges and patterns have indicated what I said happens in this stage of the game. TC has kept a close eye on this. The price gets pushed low for accumulation by institutions or covering by institutional shorts. The accumulation period generally begins in earnest about 3 months before news. Institutional ownership has been on the rise gradually and what you allude to is the "in earnest" part beginning to show up. Best wishes.
Rkmatters,
Just figure out how you get about 7 arrows to all hit the same target at the same time and then you can determine your risk over time. Best wishes.
sturmndrang555,
That promo was not targeted at company educated investors. It's a scam designed to get those who don't do their own due diligence to pay a subscription fee and or help promote a stock price that someone decides to target. The way the ARGS price has bounced around without news is another "interesting story" that should be looked into. Best wishes.
flipper44,
Absolutely. This is why those warrants Cognate has, MFN clause, holding off Mr. Woodford's accumulation and long term shareholder shares are so important. Best wishes.
Reefrad,
Agreed!
sentiment stocks,
How about a combo using L and D with UCLA and MD Anderson aka Alan Butler first in man? Fun to guess.
exwannabe,
Let's hope they get enough money to get through the end of the year. They need to stop hoping for the best even if Germany would be remiss without some information in September. Direct won't start until L news or Direct news can support a raise, or spending on L is mostly done, or a partner pays for it, or Direct gets funded directly by Moonshot or similar. Lots of ifs in there so let me add one more.
In the final analysis, I believe we have reached the point where if the internal review is clean or fairly clean and there is any "good news" (per Linda) to be had from DCVax-L or Direct then she can crush the shorts with one simple unexpected preemptive announcement that she can control.. the merger of Cognate with NWBO. That would be a devastating blow to the antagonists. What we are experiencing now is the perfect set up for this move and it might get those potential big pharma partners to think twice about any low balling or stalling tactics. Granted, this would only be possible if the NWBO/Cognate relationship is clean enough and maybe being separate is actually more practical in some ways but the possibility is intriguing with what is on the line. Best wishes.