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So much noise over the past few days. I remain extremely relaxed, after all we are one day closer to the big reveal, the closer we get the louder the pack will howl. In the meantime I will sit back and somehow turn those howls into a symphony, a painful one I know, but one that will never be applauded but instantly forgotten when the curtain falls.
Mar 1st, Mar 10th and Mar 20th are JCO's dates for March.
No need for follow up, your reference must be to this "We're just as anxious as you are for the damn thing to get out, but we have to be patient".
The way she portrayed damn is to point out shared frustration as I believe they were hoping that the piblication of this article would have been before the ASM.
Flipper, I must have missed the reference to the phrase "That Damn Article". Was this something LP said at the conference because if so then this in itself would generate cause for concern. No CEO should be referencing such an article in such a manner considering the importance this article has to the future valuation and potential value of this science.
Yep, with you on this, waiting patiently for an uptick in volume as this will be a signal for imminent publication.
There current holdings.
https://fintel.io/i/intracoastal-capital-llc
Look at NWBO:
https://fintel.io/so/us/nwbo
Fun to watch the desperation. Chart looking good for imminent breakout, hoping this signals publication is around the corner. Next JOC publication is tomorrow followed by the 10th and 20th.
We may have seen this before but nevertheless here we have a publication just out that will cost you $3500 to peruse future market share of a number of BP's in glioma treatment. Is it not strange to see NWBO included in this article. Wonder what the projections are.
https://www.themarketreports.com/report/global-oligodendroglioma-treatment-market-professional-survey-report-2018
And as we have mentioned before the publish date for JOC was for Saturday 20th Jan. Volume slowed on the Wednesday because it is my guess the buyers got wind that the publication was delayed. Speculation I know. Next 3 publication dates for JOC 1st,10th and 20th Feb. Let's look for an increase in volume as this may indicate imminent publication.
Looks like they release on the 1st, 10th and 20th of each month. Enjoy the weekend all and fingers crossed for publication soon.
The next actual official release of printed JOC will be Feb 1st. It will be interesting to watch buying activity between Mon and Thur leading into this date. They then do a further 2 publications in Feb. Following link shows a history of releases so will give us a good idea of future dates.
http://ascopubs.org/loi/jco
On a timing basis it may just be the JCO as the ASM was held the day after publication. If it is the JCO then they must have been waiting on some final feedback and delayed. Looks like Feb 3rd may be the magic number. Expect PPS to continue to climb as it has been ever since the other magic day of November 15th when the tide turned. That must have been when the article was submitted. The statement of waiting for interim blinded data was in all probability NWBO waiting for final completion of analysis before submission to the selected journal. Exciting times ahead for us as whatever was submitted obviously caused enough of a stir to reverse the trend and give confidence to the latest financing i.e Bigger.
The delay in the publication is the issue. Why would she present as that would conflict directly with the 8K sent out last year and reasons they gave for not presenting at past conferences.
While we wait for the publication there should be few sellers. If there are buyers out there then I would assume a rise in PPS.
What we have seen recently is the buyout of JUNO for almost $10B and they had huge issues with killing patients. JUNO is still 18 months to 2 years away from possible approval for a treatment for blood cancer only. This type of buyout as well as that of KITE demonstrates the eagerness and desperation BP are displaying just to get into the immunotherapy space. When we look at the science on display with NWBO's pipeline and the impending publication, I cannot imagine the ripples it will create through the industry if the data points towards a successful trial.
Because of this I cannot see why the PPS will not continue to rise over the coming weeks.
My bad Turtle, thought you may be someone else, deleted previous post and yes it can be frustrating waiting for news that can really have an impact. Maybe the Journal will be the start of the liftoff.
My thoughts on the number of questions per attendee make sense considering the number in attendance. Because 10 were answered and not every person made an effort to ask a question probably reflects that many of the questions asked covered the collectives main issues. If however people on this board feel that more questions need to be answered then someone would need to review the answered questions vs the ones submitted by the board prior to the ASM. If there are gaps then those unanswered questions should be submitted to LP and LG from a respected member of this board such as Flipper/Senti and shared with fellow longs once replies are received. I am sure LP/LG would be more than happy to answer legitimate questions that would not give further ammunition to the Fudsters if interpretation would be conceived as an issue. I expect Lawyer talk for some replies where appropriate.
The past few weeks have indeed been interesting and all the speculation as ever entertaining. What I have found most interesting is the approach made by NWBO regarding this years ASM and the insistence of having OKAPI a part of the process. This highlights how much importance is being placed on gathering the exact amount of shares in play. Are we seeing a possible merger in play. This would make most sense as I do not believe there is a BP out there that actually has the money available to buyout the tech on offer by NWBO. If KITE was valued at 11B well NWBO's future valuation is easily 10X this. I think as investors we are all looking forward to positive results, but a merger would be the icing on the cake and would be the wisest move by NWBO to get their critical vaccines out to market as quickly as possible something LP alluded to late in 17. The next couple of weeks will be interesting times indeed.
As expected a rally into close. What we have been witnessing the last couple of weeks is real and I expect more of the same until solid news. This stock will be manipulated to spread fear and try force weak hands to sell. Supreme confidence at this juncture is what is required by all longs. I watch the waves with amusement. Looking forward to the coming weeks. Enjoy the weekend all.
The sales volume is pathetically small and does not justify the drop at all. Typical MM manipulation to push people to sell. These bear raid tactics are seen all the time and should be ignored by any smart investor. We will climb back up.
Agree with you on this as the low volume dictates no news and the MM's are taking advantage by driving the price down to scare people to sell. However let's see how this plays out for the rest of the day as it is common that prices are driven down early to invoke the jitters and hopefully some sales ahead of a climb into close. There may be some players wanting lower entry points or just a scare tactic to allow covering.
We bought our shares through Fidelity and when I spoke to Okapi they had my name and street address and confirmed the number of shares across all my trading accounts. 100% accurate. Looking forward to some positive vibes next week.
Hi Senti, your calculations are way off and total share count is now at 1 billion. It looks like management considers asking long term holders to further dilute their holdings is positive news. There continued silence apart from dilution after dilution these last couple of months is not something to be cheering on or spinning as a positive. Why they continually refuse to notify their investors of anything concrete and instead ask them to dip into hard earned money to further dilute cannot be spun as a positive. It looks like all long term investors are going to be strung along into the New Year and beyond as any hope of news between now and the New Year is obviously truly wishful thinking. They have sent each and everyone on this board a bag of coal for Xmas and burdened them with additional stress through the New Year. They are obviously happy as they scamper off with loaded pockets.
Walked down on low volume. No real selloff so a MM manipulation down. Expect this to turnaround as this financing will be seen as a positive from a long term holding point of view as it gives true longs who believe in the science the opportunity to open a potentially expansive lucrative position. Just a 10K preferred position with 10X conversion to commons and warrants is a good deal if you believe. However is this truly related to long term holders pressuring LL and LP to get on the deal or another money grab right before Xmas to slap everyone in the face because they could not close on the original deal.
Looks like Jim Cramer will be the chief architect in all this. He has publicly admitted to shorting companies and it looks like he continued this profitable enterprise through The Street. So easy to manipulate the herd and easy money at the expense of small struggling companies. Maybe Karma will catch up too Jim and all his cronies.
I am sure it will not be a shock to anyone if AF comes under the microscope in the near future regarding his many disparaging critiques of small biotech's struggling to bring new advanced medical techniques to the market. Why anyone would take an obvious narcissist theories seriously is what has always surprised me. This man writes as if he has insider knowledge and his recent hit pieces of biotechs such as PLX bring into question his motives and the powers behind such pieces. Any person who makes continuous assaults on the integrity of small biotech's need to be looked at closely as these type of attacks are obviously for the purpose of destroying promising technologies for the benefit of competitors afraid of losing market share.
All I can say is that there are no new toxic shares for the shorts to cover with. I cannot see longs selling at this point because of this exact point. Day traders have already had there play last week. Positive news with FDA and now friendly financiers with preferred shares points to a bullish opinion amongst true investors. I believe we continue to see more buying than selling and the shorts will now start to really sweat. I am expecting news regarding interim blinded data shortly to really kickstart the climb.
So Tilt, are you saying this reverses back to .17c as we have seen before.
HL, I have not really given much credence to your constant negativity but all I can say is you and a few others are quite obviously blind to the potential of what this science has to offer the world. That potential in itself to move the cancer space towards a possible cure is ground breaking. You keep harping on about the financial position this company is in and again I will call you a blind bat because no matter what financial position this company is in the turnaround from financial obscurity to financial freedom will be faster than that achieved by Dendreon as an example. What NWBO has to offer oncology makes that of KITE and JUNO insignificant. If you think there are not a line of suitors knocking at LP's door then you are delusional. This board has revealed so many breadcrumbs pointing to the obvious that only a fool or a desperate short supporting the dark pools would argue against the eventual success of this company.
I for one believe that a company like Roche would dive headfirst into a partnership and this would include both NWBO and Cognate in the deal. We are close to the big reveal and my bet has always been on success. I sleep really well at night, how about you.
For those interested in reading the full terms of the ROCHE / FMI deal here is the link.
https://www.roche.com/media/store/releases/med-cor-2015-01-12.htm
This in my mind looks like the best type of deal for NWBO and us as shareholders as it suddenly propels NWBO into a whole new world and will allow them to ample financial muscle to treat patients all over the world. With FMI's unique methods of blood screening cancers we would be onto a winner.
It has been an interesting week that is for sure and a ton of speculation. Let me add to that speculation by building on a partnership of sort with Roche. I believe the Roche / NWBO parthenship will be structured to match the partnership they undertook with FMI back in 2015 as follow.
Basel, 12 January 2015
Roche enters a broad strategic collaboration with Foundation Medicine in the field of molecular information in oncology
Collaboration leverages both companies’ strengths to advance the progress of personalized treatments for patients with cancer
Roche to acquire a majority interest in Foundation Medicine (FMI) of up to 56.3% on a fully diluted basis through a tender and acquisition of newly issued shares. Roche will tender for approximately 15.6 million Foundation Medicine shares at USD 50 per share with an aggregate tender value of approximately USD 780 million. Roche will also invest USD 250 million in Foundation Medicine by acquiring 5 million newly issued shares at USD 50 per share.
Partnership includes both a broad R&D collaboration with the potential for more than USD 150 million funding by Roche to accelerate FMI’s new product development initiatives, optimize treatments for oncology patients, and better design and understand the results of clinical trials based on molecular information, as well as commercial collaboration agreements aimed at expanding the global sales efforts for FMI’s current and future products.
Michael J. Pellini, MD, FMI’s president and CEO, and FMI’s management team, will continue to lead FMI post-closing; Company will maintain operational independence; Roche to obtain minority representation on the expanded FMI Board of Directors; Roche and FMI Boards of Directors have unanimously approved the transaction.
Novel approaches to R&D, Product Development and Commercialization
Under the terms of the R&D collaboration agreement, Roche is committing to R&D funding of potentially more than USD 150 million for a minimum of five years and will contribute its expertise and breadth in oncology. FMI will continue to operate independently and will contribute its experience in the development of comprehensive genomic profiling tests for oncology. The initial focus of the R&D collaboration will be on developing genomic profile tests for cancer immunotherapies and for continuous blood-based monitoring.
Roche will be able to utilize FMI’s proprietary molecular information platform to standardize clinical trial testing. This aspect of the relationship is designed to enable comparability of clinical trial results for R&D purposes, and ultimately in the clinic. FMI’s pharmaceutical business will not be impacted and could be enhanced as FMI capabilities increase with the investments and experience in working with Roche as a customer.
I believe this type of collaboration would suit LP and allow NWBO to build up their pipeline and bring DCVAX to the world. Who knows within a couple of years the share price could be 50 to 100 in this type of a setup.
Something to ponder but I believe this may be exactly what LP would agree to and with the obvious synergy with FMI as well we are onto a winner.
Thoughts.
All the very best to you in your everyday battle and as you do, we all hope that NWBO comes out flying to help all those in need.
Words of encouragement from Jim Ness.
Encouragement like flowers
Can brighten a way,
Turn storms into rain
Paint colors from grey.
Find good in the bad
Bring laughter from pain,
Lift up a spirit
Even loosen a chain.
Rainbows from darkness
Or a peek at the sun,
Blessings enjoyed
Or a moment of fun.
Sharing is easy
With a little each day,
Blossoms of joy
To brighten the day.
Basic explanation is that it took 100's of millions of shorts to lower the price to the level of 16c and at one point 14c. A majority of these short positions were not linked directly to actual borrowed share positions as a standard short position needs to be but a naked short position which the MM needed to cover at a later point once real shares came available. The talk on these boards is that there are still millions of naked shorts out there waiting to be covered and the MM's holding these positions were hoping for continued toxic financing in order to obtain real shares to cover. However now that toxic financing has dried up there is an expectation that once the SP continues to push north the need to cover becomes more and more urgent hence the expected spike driven by Naked Short covering or indeed real short covering as per Milner's recent example of closing out his short position.
Fair points. What are your thoughts on the wording from the 10Q regarding the 15%.
""he Company’s Board approved a new plan for equity awards of fifteen percent of the authorized shares at present""
This reads to me that they will not add additional shares for this but use current authorized shares.
Thoughts.
What still intrigues me is the exact match of share distribution between Cognate (for debt payment) and NWBO (employee compensation) with regards the number of employees in both.To me this looks like the investor is interested in both Cognate and NWBO (Advent as well). It could be possible that we are seeing a merger of all three into a single entity that may in itself evolve into it's own BP. Maybe wishful thinking but not impossible if there is an investor willing to bankroll such a merger with a mindset of generating a company that could become the new SOC for all tumor related cancers. Think about the potential valuation of such a company. Dilution at this time would become insignificant.
I am with you on smelling a deal. Something Tilt has been alluding to all day.
Some interesting math regarding the payoff of shares to Cognate = 163,171,355.
15% compensation of current float to NWBO employees = 67,500,500.
Number of employees at Cognate around 30.
Number of employees at NWBO around 12.
So lets look at equal distribution just for fun.
Each Cognate employee would receive 163,171,355 / 30 = 5,439,045
Each NWBO employee would receive 67,500,00 / 12 = 5,625,000
Now I might be a little off with actual number of employees and the numbers may be slightly off but we are looking at almost equal distribution regarding employee numbers between NWBO and Cognate.
For me what we are seeing is a work in progress to a major deal soon to be announced.
It can be fun to speculate.
I am beginning to see the light with regard to the crumbs Tilt has pointed to.
From the 10Q.
Recent Issued Accounting Pronouncements
Compensation-Stock Compensation
In May 2017, the FASB issued ASU 2017-09, Compensation-Stock Compensation (Topic 718): Scope of Modification Accounting , which clarifies when to account for a change to the terms or conditions of a share-based payment award as a modification. Under the new guidance, modification accounting is required only if the fair value, the vesting conditions, or the classification of the award (as equity or liability) changes as a result of the change in terms or conditions. It is effective prospectively for the annual period ending December 31, 2018 and interim periods within that annual period. Early adoption is permitted. The Company is currently evaluating the impact of adopting this standard on the condensed consolidated financial statements and disclosures, but does not expect it to have a significant impact.
For all here is a breakdown of what this really means in a nutshell.
http://www.ey.com/publication/vwluassetsdld/tothepoint_03149-171us_modificationsbp_11may2017/$file/tothepoint_03149-171us_modificationsbp_11may2017.pdf?OpenElement
A merger with Cognate and new stock symbol would be something to behold at this point.
So the point you are trying to point people towards is the following wording relating to the shares.
""The unvested portions of the Options are subject to accelerated vesting upon (i) a change of effective control of the Company, (ii) the filing of the first Biologics License Application or other application for product approval in any jurisdiction, (iii) completion of any randomized clinical trial that meets its endpoint(s) (Phase II or Phase III), (iv) decision by the Board, in its discretion or (v) the death of the recipient.""
Correct?
So RK please explain your earlier post to your latest analysis of 3 years past last enrollment. I think you need to re-assess as you are dead wrong if you think that this company can limp on for another year without proving anything to it's investors. They may continue to collect data but after all that has been said and posted by the company this year I cannot believe they will not unblind until Nov 2018.
Your previous post as follows.
The Company does not have the money to continue the trial another year for those last in after locking and censoring the trial data. The Company has the right to end the trial any time they want to, for any reason. And so, it is quite possible that they are tying data lock with the conclusion of study end and that is why we are not being told what is going on.
If they learned in August that the trial reached the 233 in July, as they anticipated, then I would imagine that that is the point the trial clinical site investigators would be told, by their CROs, to get the last MRI on each remaining patient in the study, and conduct an end of treatment visit. The trial is meant to be 3 years from enrollment for patients who are alive that have not crossed over. The Phase III consent forms makes it clear that each patient must go through an EOT visit at the end of the 3 years (36 months in).
http://neurosurgery.ucla.edu/Workfiles/Site-Neurosurgery/Brain_Tumor_Program/DCVax%20Consent.pdf
"18. STOPPING THE STUDY
The sponsor may decide to stop the study at any point, for any reason." -- protocol
I truly think it is not reasonable to expect a virtually bankrupt company to continue to fund a trial that is about to be censored upon data lock for another year plus. Long tail follow-up is still on-going and can still be done on their study if it is ended early. But if they do decide to end early, further injection treatment schedule would not be followed. And so it's quite reasonable to believe they may be extending their right to end the study a year early for last in patients upon considering both the primary and second Endpoints are crossed.
If NW Bio decided in August to data lock survival, it still may mean the trial can run into November as they attempt to line up data lock with the study ending after 2 years after the last enrolled patients. End of study (EOT) visits require that each patient undergoes an MRI, which are conducted every 2 months, plus or minus 14 days at this point. Ensuring each patient undergoes their final MRI is a process is a multi-month. And then remember, some of those visits will coincide with scheduled injection treatments. The last DCVax-L injections may still take place. And so then one more additional month of 30 days follow-up would be needed to record tracking information on AE.
From the protocol:
"8.5. END OF TREATMENT (EOT) VISIT SCHEDULE AND PROCEDURES (ALL PATIENTS – RANDOMIZED AND CROSSOVER):
• EOT Visits for all patients who discontinue from the study should occur at least 7 days, but ≤ 30 days, after the last immunization and prior to beginning other treatment. Procedures to be performed during the EOT Visit include:
• Physical Exam
• Neurological Exam
• Vital Signs
• KPS
• MRI of brain
• CBC and Differential
• Blood Chemistry - Comprehensive metabolic panel, including electrolyte balance, and hepatic and renal functions
• Serum markers of Autoimmune disease (anti-DNA)
• Urinalysis
• AE Assessment
• Concomitant Medication" -- protocol
Also note this from the protocol, 30 days after the patient exits from participation in the trial or last study treatment, (whichever comes later) tracking information on AE is still necessary:
"Study-Specific Adverse Event Recording
• The time period for AE assessment starts at pre-leukapheresis through 30 days after the patient exits from participation in the trial (off study date) or last study treatment, (whichever comes later). It is recognized that the date the patient is determined to be “off-study” may not coincide with a visit date. " -- protocol
And:
"13.3. RECORDING AND FOLLOW-UP OF ADVERSE AND SERIOUS ADVERSE EVENTS
All AEs that occur (or that worsen from pre-leukapheresis status) from preleukapheresis through 30 days after the patient exits from participation in the trial or last study treatment, (whichever comes later), will be recorded. Adverse events that occur after enrollment but before the first immunization will be considered not related to study drug. Duration, severity, and outcome for each AE will be recorded on the CRF Adverse Event Form, and treatment administered for the event will be recorded on the Concomitant Medications pages; this information must also be recorded in the source documentation. Adverse events will be followed until resolution, until no further improvement is expected, or until the patient is lost to follow-up, whichever comes first." -- protocol
If they were to decide to treat overall survival secondary endpoint crossing as news that would start the process for conclusion of the study (verses going the full 3 years - November 2018), that would mean treatments would stop upon final statistical analysis. In short that would leave Sept and October timeframe to conduct all final visits and then November to undergo the 30 day AE follow-up. Again, considering they have the option to end the study at any time over any reason, it may be necessary that they do so because of funds; and therefore, they are tying up all loose ends, and plan to conduct the final analysis once all patients undergo an end of treatment visit (albeit earlier than the 3 years for the last enrolled patients) and all necessary follow up is complete. And we won't hear about it until it is done.
You may ask why I believe this might be the action they are taking? Well, because the clinical sites are in the process of gathering information for a review paper that can only be released once the study concludes. And it is also quite possibly that the Company gave the okay to begin the process of ending the study, with a specific trial end date in mind, a couple of months ago.
From the protocol on publications:
"The Study is designed as a multicenter study and not powered for analysis and presentation of Study results by individual Study sites. It is anticipated that the final results of this study will be submitted to a peer-reviewed scientific journal. Authorship on such a paper will be acknowledged with customary scientific practice. As such, without the expressed permission of the Sponsor, only clinical Study data relating the Study as a whole will be published. If permission is granted by Sponsor for publication of ancillary data from individual sites, prior to submission for publication of any manuscript or presentation of any poster, presentation, abstract or other written or oral material that describes the results of Study, Institution and/or PI shall provide Sponsor at least 60 days (or as otherwise specified in the sites executed Clinical Trial Agreement) to review any such materials. Such materials shall not divulge any of Sponsor’s Confidential Information, and Institution and/or PI shall promptly remove any Confidential Information as requested by Sponsor. If requested by Sponsor, the PI and Institution shall delay the submission of any publication or presentation up to 60 days from the date of Sponsor’s request for such a delay. In addition, Sponsor has the right to require that any publication or presentation concerning the Study will acknowledge Sponsor’s support." -- protocol
Time will tell if they continue the study after overall survival data lock. But my bet is that they will end the overall Phase III study at the time they conduct the final analysis. And I sincerely doubt we will be waiting until November 2018 (the full 3 years after the last enrolled patient) for them to do so. I think they are in the final stretch, now.
Now that profit taking is over we should trend higher. Nothing has changed regarding all the positive news from the FDA and news relating to LL's recognition at SNO. RK has been suggesting this goes for another 6 months to a year without news but I do not buy that at all considering the 8K produced regarding missing a conference due to waiting on interim data. The 10Q clearly represents confidence by Cognate to choose shares over cash and these shares will be clearly handed over to friendlies rather than toxic financiers. All in all the shorts may kick and scream but nothing changes the scientific facts presented to date. I see some old crows are back patting themselves on their backs but this self congratulating splurge will be short lived. Today's trend will reverse of that there is no doubt.
Let's get real here, 5,000,000 worth of shares at .17 = 29,411,764 + equal amount of warrants 29,411,764 = a total of 58,823,529 shares. Some of the numbers being thrown around here regarding impending massive dilution is laughable. What is obvious here is that Cognate will be richly rewarded on approval and those proceeds can be used to expand manufacturing services to aid NWBO's expansion into the markets. Looks like a clever play to me.