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reg2015,
The suggestions I saw made by others in response to this post are probably the best places to start I have seen to date. Our prayers are with you. Best wishes and may God bless.
ELecsol28,
Once approved, L will be used off label on a very regular basis due to safety profile and genetic changes at progression that leave almost all true solid tumors vulnerable to DC treatment at progression. This will be quickly factored in to valuation. The other issue is that since failure has been nearly fully factored in, the manufacturing capacity has been completely discounted along with it. Validation of the platform brings added value to this capacity and for estimated future earnings from Direct as well especially if something more specific about current Direct survivor treatments is revealed to be a significant factor and that endpoints with extremely short time frames will be encorporated in the Phase 2 portion. Best wishes.
BuyWhenISell,
I think XenaLives suggested that some shares sold short may have been called. Best wishes.
chinatown1980,
What is going on is a reversal of fortune. Chearleading welcomed. Best wishes.
flipper44,
Ondra was his choice, his hire. Best wishes.
hankmanhub,
Some of the doctors you are referring to might also have access to non public information with regard to this trial. Trading on that information would be a big problem. Those who do not have any more information than we do are in the same boat as all the rest of us. Best wishes.
sentiment stocks,
I was going to respond in more general terms along the same lines then saw your much more precise post. Moonshot always looked like a big pharma catch up attempt to me. Too late to help NWBO much but sure to help big pharma try to get next generation combos and products out faster. Best wishes.
flipper44,
A bidding war would free up a lot of currently under water retail and even institutional sales and bring in traders with the volatility as valuation increases get projected in from additional information about Direct Phase 1 should they have it (I believe they do) and choose to share it. At a minimum, this would provide a solid price base even if they decided to go it alone. Mr. Woodford appears to be covering the bases as best he can while benched with regard to NWBO. Best wishes.
biosectinvestor,
Your explanation of the cause of this lawsuit is sound. The only legitimate cause for concern by shareholders is the fact that NWBO/Cognate did not act quickly enough to rectify the situation. Best wishes.
flipper44,
"....creating systematic change in the field's ability to fast-track clinical development of the most promising emerging brain cancer therapeutics."
You mean like one where all patients are apparently living longer and there are regular submissions being made to regulators and where manufacturing has been established in multiple countries? Isn't the company that makes that about to get delisted, go bankrupt, restart with their private company making grapefruit juice and making sure their current retail investors lose all of their money? LOL. Best wishes.
exwannabe,
There is also the possibility that the company and regulators are waiting on a median point even if the trial could otherwise be unblinded correct? This would require close monitoring especially when closing in on that point. Best wishes.
john1045,
Sure looks like a rolling submission to me as well and has for a while as flipper44 pointed out. The company has informed us multiple times that they are in dialogue with and supplying updated information to regulators on a regular basis. Best wishes.
exwannabe,
So far, I see the unlawful enrichment claim as potentially going either way until we hear more but since most of that enrichment has been in the form of stock, one might argue that this was being done to counter illegal stock price manipulation. The MFN clause could be seen as potentially having been done for the same reason. Now that an independent investigation is ongoing, perhaps this need is mitigated by what has been found but resolution can not occur until the share price is restored to non manipulated market valuation if that argument is accepted. This is of course all part of the discovery process as you say so, as you also pointed out, I jumped the gun by suggesting certain outcomes and I thank you for pointing that out. Best wishes.
I wonder if anything shared today in court by NWBO in their defense will be shared openly or will be shared only with the judge and essentially sequestered. I would suspect that much would not be made public if indeed there is an ongoing investigation and otherwise non public information might be included in the defense argument. The defense argument probably centers around stock price manipulation in an orchestrated attempt to rest control of the company out of majority owner control by way of dilution caused by ensuing poor financing or partnering options. If NWBO has a substantial undisclosed and unfinished case, I don't think we will get any new information and the judge will be forced to continue the case or find in favor of the defendent without prejudice. Best wishes.
CaptainOblivious,
I wonder if Mary Jo White may have a lovely parting legacy gift of cooperation with another agency to share with the public on or before her departure. Best wishes.
Doktornolittle,
Rkmatters is right and I might add that NWBO knows quite a bit about all types and sources of DCs and has learned some additional critical information over the course of the Direct trial. Best wishes.
flipper44,
If there has also been an ongoing investigation into stock manipulation by the FBI and perhaps other agencies, and Mr. Trump announces some type of proposed regulatory reform desired prior to any published reports, he will look like a genious. Low hanging fruit for him to pick especially if Les gives him any clues as to what might be happening or what they expect to happen based on their own initial investigation efforts before the independent one was started. Best wishes.
flipper44,
Now tie this idea of direct negotiations for drug pricing by Medicare in to Obama care reform and you see where Mr. Trump can garner a great deal of bipartisan grass roots support which he needs to leverage congress. Best wishes.
XenaLives,
Very good point. Scrap it, write a new one or.. head fake? Best wishes.
flipper44,
I remember about 3 years ago I played around with the numbers being used for the safety analysis and assumed a 2 month benefit from crossover. At that point in time I was just starting to get a feel for what types of synergy between DC treatment and other therapies might provide. These opportunities are much better understood now and I believe the learning process with regard to this came into play big time at NWBO around that time or maybe suspected a year or so earlier. I think the opportunity for synergies and mostly expected and historically safe use of DCs helped give rise to the broad nature of the Direct trial. Best wishes.
doingmybest,
They seem to have understood the need to speed up event rate when the December 2013 safety analysis occurred. Lowering the inclusion number in Germany and Dr. Linda Liau's comment that the necessary events had not occurred yet and the later statement that lack of events was not helping the trial all point to this possibility. Best wishes.
flipper44,
Thanks for taking hopefulsurgonc's question. I just now saw it myself and was getting ready to reply when I saw you had replied and others chimed in as well.
The whole thought process being discussed here by you, Rkmatters, exwannabe and brought up by hopefulsurgonc is consistent with how trials that are eventing slowly are usually handled. First the DMC notices the slow eventing and suggests increasing the numbers to speed up results. Then someone, probably the Germans in this case, suggested lowering the lymphocyte count requirements to help speed up SOC event rate to get them to crossover sooner. This required an end of trial assessment to take this into account. At some point NWBO may have also decided to abandon the interim in favor of OS powering as you and Rkmatters are suggesting. I believe this type of scenario and resulting silence may have caused the board to consider OS as a possible coprimary change being made prior to Rkmatter's disclosure that the protocol already allowed for separate assessment.
As noted by Dr. Linda Liau in her video and posters here, the number of events (referring to PFS) was taking longer than expected which is a neutral statement as no absolute reason why is indicated. Obviously her saying this might be construed by some as a finding consistent with previous trials while others would argue that slower eventing indicates SOC is doing better than expected due to inclusion requirements and improved surgical procedures. This board did a good job of discussing these topics and accounting for such improvements in the bull and bear theses. Dr. Linda Liau also stated that all patients apparently are living longer which could be neutral except that the context she was speaking in put possible OS at about 24 months, with protocol assumptions just below this and a 36 month OS from their earlier trial. To put this in further context, she mentioned adjuvant therapies that could be used at crossover that would potentially help some patients receive benefit that had not benefitted from SOC or initial treatment as much as other genotypes or methylated MGMT would have. Synergy is a beautiful thing and I am sure Dr. Liau made sure every DCVax-L treatment center was made aware of her findings and recommendations. While improved OS for all patients might be confounding in some situations, an overwhelming benefit seen by all at some point does become self evident especially in relationship to ancillary evidence which regulators will be very aware of.
Now when you consider what you stated to hopefulsurgonc about regulatory agencies potentially having early access to blinded or unblinded data and why we are still waiting on the financing deal to go through, we would expect to see a few folks start to give pause to rethink what might be going on behind the scenes. If the stock price should be dropping because NWBO is out of money, has bills to pay and has a financing project in limbo maybe a few folks are starting to scratch their heads about where the need is being filled from. Best wishes.
exwannabe,
Thanks for the honest answer. I think Wall Street thinks like you do to a significant extent. I lean towards the current FDA understanding the GBM situation well enough and the source of benefit from synergy being well enough established that in this case they would lean towards approval. I am not invested here because of counting on this outcome, however. Best wishes.
exwannabe,
That was a very good explanation and I appreciated having the opportunity to see this as well. Much appreciated. If you don't mind commenting a little further about your last point I would appreciate that as well. I am not asking this to be sly or make a point. Rather I am asking for your commentary based on your experience and point of view. You stated "One argument that does not go far is 'OS failed due to crossover'. There is simply no way to prove this. Comparing data within the trial is flawed due to selection bias on the crossover. And the FDA basically hates to compare OS with historical norms." Is it not also true that FDA has in fact approved some treatments based on comparison to historical norms on very rare occasion? Best wishes.
HappyLibrarian,
You seem to be missing the point. Mr. Woodford paid considerably more than $.40 a share for NWBO and he still plans to win big with his investment in it. I believe that Mr. Woodford is essentially legally pinned down by what both he and NWBO know that he knows about the company that has not been made public yet. I believe that Linda's strategy to maximize long term shareholder value by maintaining a controlling interest of the company so the company can not be bought out or controlled at minimum value is the right strategy. Mr. Woodford's actions have caused the shareholders that agree with this strategy to lose the typical interim value of a company with multiple product lines and a Phase 3 trial coming to an end and put greater pressure on them and those with shorter term investment horizons to sell at a loss during this time frame. In no way can his actions be construed as a defensive action by him on behalf of his investors as the consequences of any rift between him and NWBO could easily be extrapolated with simple logic. His public attempt to suggest that this was indeed his motive provides a facade for those less well versed in the complex nature of what survival of the fittest means to large scale investors and their friends.
I believe that some specific news that NWBO has is being held up for the sake of playing off of other news they have been waiting on. You can wait out the maneuvering, take advantage of a potentially huge discount created by it, create a straddled position based on potential news or sell and move on. The news you want now is better off left unshared until it can be combined with news that is much more meaningful especially if damages will be sought for shareholders from those who sought to do them harm. NWBO certainly has had reasons to doubt Mr. Woodford's intentions. If there is any evidence of wrongdoing on his part perhaps they are trying to get him to play nice or maybe it goes deeper than that. Capicce? Best wishes.
HappyLibrarian,
Mr. Woodford's actions have put his motives into question. While his motives remain in question his skill and experience in moving funds under his management towards positive outcomes for his investors likewise can be called into question which they have been. When Mr. Woodford first invested he had several possible ways to win. He may have overplayed his hand in one direction in favor of certain connections and priorities he has and is now playing with a different direction in mind. He still plans on winning big longer term, though, as that is a given with his investment strategies. Best wishes.
flipper44,
I think you were reading negativity into a post I was trying to be deliberately vague about. Sorry for the confusion I created as I was not trying to imply that you were mixing truth with fiction or that you didn't understand the consequences of what you were saying. The pay dirt comment was a reference to DC preparation evidence you shared. The warning with regard to the claim jumpers reference was in relationship to those who might try to duplicate or closely mimic NWBO tech at some point whose possible efforts I was laughing at. Best wishes.
hopefulsurgonc,
Congratulations on the birth of your baby girl! May she be the first of many blessings to come yet this year for you and your family. With regard to your January options, the Cubs were down 3-1 earlier this week but today they were flying the W at Wrigley field after the last game of the year. Based on the precipitous fall in ticket prices for game 5, many people obviously felt the Cubs would lose the Series quickly but of course now we know that never happened. If NWBO catches a break on timing of news, it would be to their advantage to have the shares behind the January options get into strong long positions because MFN is no longer helping Linda. Best wishes.
md1225,
I agree that the Germans do not want to be left behind. The British understand the absolute necessity of nimbleness right now, though, so these moves flipper44 is highlighting speak volumes. I believe that the British see an opening that could quickly close if they don't take advantage. Sawston represents their future. Get it done or get left behind. Best wishes.
XenaLives,
TC_Trader post 78849 references Bloomberg finding that NWBO is part of the pilot program. I do not have access to that point of referrence. TC_Trader originally posted that NWBO was NOT part of this program(78016) then posted 78849 afterwards. Best wishes.
chinatown1980,
The Supreme Court sided with those who want state courts to make final decisions with regard to cases of potential stock price manipulation. That is a fact that many manipulators are going to be dealing with for years to come. This pilot program with regard to the uptick seems to be aimed at helping motivate market makers create more liquidity in issues where liquidity problems could be favoring manipulators. Who are the complainers? I'll let the chips fall where they may but you are certainly right about one thing and that is that this problem extends well beyond the scope of just NWBO. Best wishes.
XenaLives,
I finally got around to finding the info you wanted. Take a look at posts 78013 and 78879 for comments about the pilot program with regard to the uptick rule. NWBO appears to be involved in this program. Some folks appear to think that they have something to lose. Best wishes.
XenaLives,
I'll get back to you by tomorrow. Just catching up. Best wishes.
maverick_1,
I went on hiatus this weekend and have just been doing some catching up. I'll check back in by tomorrow. Thanks and best wishes.
Rkmatters,
Nice post. The beautiful consequence of AVII's false positive concerns is that if there is any validity, it leads to crossover and a return to a better dosing regimen for these responders which should lead to better OS results. If early Phase OS results could not be faked, as he said, then improved dosing schedule might or even should make those results even better. I think AVII77 understands this because he has said that OS is NWBO's best hope but is still hesitant to get excited about the possibility because of other reservations. Best wishes.
Rkmatters,
The opportunity to return to $1 almost always is extended to 1 year on appeal as long as any other issues are not being neglected. By the way, Dr. Linda Liau is making plans to move up the ladder not sideways or down. Making public statements now about glass ceilings would be counter productive with regard to contingencies for DCVax-L failure. Best wishes.
chinatown1980,
That $3,000,000 payment out of cash if L were to fail would make more sense if NWBO didn't already owe Cognate more than that. Hmmm. I would like to know what you think the share price would be if institutional investsors thought the raise was for payment to Cognate for a failed L trial. Weren't you predicting dire straits from this sort of scenario a while back and where is all the talk about the mortgage payment due in November? Best wishes.
iclight,
And I am saying they both have something to gain from moving the technology forward as partners and have found a way to work out the rent. Some people are actually able to work things out like that unlike Cain who let his jealousy turn his heart to strife and murder. Best wishes.
chinatown1980,
I would suggest you go back to look through all the posts surrounding the speculation about the Bank of New York connection to NWBO recently. There was a quote brought up that pertained to concerns about proprietary trading secrets being exposed from compliance with new rules and perhaps a need to move to alternative methods. If you look hard enough you will find it. The board I referred to was ihub not NWBO. I would venture to say, though, that the NWBO ihub board is read once in a while by some who are close to NWBO. Best wishes.
joeycav11,
I am a daydreamer at heart. I try to think of as many possibilities that I can imagine and then see which ones can be weeded out. I believe that these types of comparisons are yet a very strong possibility and perhaps a source of validation for improvements. Best wishes.