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Exactly! That’s what I was trying to say, but not as succinctly as you just did.
Scotty you’re back in spirited form! I’ll give you that the trust will have to be earned and LP gave us the targets to measure and we all know the targets could move and if so we’ll have to assess the validity of the corresponding reasons, like we do with any project. I’m very happy to have the timeline this specific for the first time.
In addition to the inherent value of having the additional data available, would it be a big stretch to think that lack of this data item could later be used to bring into question whether or to what degree this variable drives outcomes versus treatment?
How unrealistic or disingenuous can the points be? Would anyone truly expect any company to make statements of the type that give dates certain when any business person, manager, or spokesperson knows full well it is neither possible nor wise nor believable to anyone working in the real corporate world.
Similarly pointing to boilerplate clauses/caveats that are now standard practice everywhere including at the beginning of all investor conference calls, presentations, and documents, is also disingenuous or uninformed.
Sorry for being a bit harsh, however pulling such AF-like moves is joining a sorry club. Up your game again, don’t play in the gutter.
Requires HIPAA sign off though, doesn’t it? Also could it be that the workarounds LP referred to are utilizing remote approaches and that weren’t in place when covid impacts came in to impact the tasks and thus took some time to establish workarounds at multiple hospitals?
Really, other trials with over 80 sites in multiple countries with records going back 10+ years? I’m far from an expert in trial execution requirements however isn’t part of the validation of the data to try to rectify any and all apparent information issues in order to result in as accurate a dataset to lock and turn over to the statisticians? And isn’t that why visiting the trial sites is called for?
Yo Scotty, you’re dragging a little tonight and who can blame you given the long difficult day it must have been in the face of the interesting disclosures of the asm.
Get a good nights sleep, recharge your batteries, and tomorrow’s another day to resume the campaign against NWBO management.
I’m just playing a little, no hard feelings, although I’m a long I almost enjoy reading your posts for the endless energy and no missed angles of attack. So hopefully you can take a little good natured ribbing. After all long time longs have been waiting something like 8 years for this moment:)
All the best.... really!
One might logically think that since the asm changed to a remote teleconference the need for a retraction was greatly diminished and at least for me the providing of a timeline with some color was very interesting.
The raise was a downer I have to admit however once I calmed down I came to the conclusion that the cash needed to be raised as counting on public success to raise cash at better terms would be risky, and now we know management was aware of new delay. What I especially didn’t like about the raise was that we all weren’t privy to get in on the deal for cheap shares and options.
As for the dilution impacts what is 20 million shares and a bunch of options on top of a base of over 600 million to a billion, around 7% or so? Not insignificant but also not devastating. I was happy we weren’t voting on a new increase in allowable share creation ceiling.
The puzzle pieces are fitting together.
First the SAP completion has been confirmed.
LP’s 2 month planning notice and statement that the asm should be interesting enough to attend in person lines up at the time before covid impacts, and would be consistent with management believing data lock and possibly unblinding would have occurred.
The resulting 2 month delay impact appears believable and even better than I was expecting LP to put out there and the work arounds to achieve this limited impact indicates serious effort to move things along.
As the naysayers are quick to point out the timeline can be missed however we finally got a pretty specific timeline and an assertion that we will be informed of significant changes.
Of course none of this guarantees success of the trial, however the end is within sight.
Ex
In the strict sense of things your points are correct and I took some expedient/lazy liberties in attribution to Merck of the phase 2 combo trial, and DCVax/NWBO, however I believe Merck and NWBO nonetheless have vested interests in the phase 2 and beyond. Approval of DCVax-L would enhance
As previously established, Merck is doing a combination trial of Keytruda and DCVax-L. Wouldn’t it be desirable for DCVax to be an approved treatment in order to make the combination treatment available?
Scotty, so the distortions of the articles by AF and the attempts at frivolous law suits, and the anonymous “group 5” piece that had lots of bs accusations, were all happenstance?
Re Duffy’s coming and going, one could conjecture that trials and sales of a combination of Merck and NWBO treatments may be positioned better if both treatments are approved in their own right. Merck is there already and DCVax-L obviously isn’t quite there. Could Duffy have been made available to NWBO at a key time to help with the SAP and other approval late steps? Duffy was also privy to an up close and personal look at NWBO that might better inform Merck for M&A or other business reasons.
An optimist may imagine a scenario where Duffy successfully contributed to the cause of helping achieve approval of DCVax.
A pessimist may imagine negative scenarios, as a number of posters have offered.
We shall hopefully soon find out!
Full disclosure - I’m a long time NWBO long.
I’m being repetitive however Blacks value includes who he knows, which often trumps other advantages.
Re Cofer
I wouldn’t underestimate the value of “who you know “ especially in government/political circles.
Connections can be priceless!
And that type of behind the scenes benefits are usually not advertised.
Yes, the turboprop puddle jumpers to/from DC, home of the Nwbo ASM. LP must have something interesting to share with us to even suggest we plan to attend.
Dr Bala, I worked in Owego in the late 70’s. Broome county airport was interesting to fly in/out of in those days as you had service for smaller short distance planes, no direct flights to the west coast. I worked for the largest employer at the time, a technology company. But I digress :)
As an North East Coaster who hasn’t been out to SoCal that much lately, In and Out burgers are not available to me but their reputation puts them in a special category of fine dining. I’m suddenly feeling very hungry :)
This location sounds close to Las Brisas restaurant right on the coast, if it’s still around. Might be a good venue option for board members to meet for a fine dining meal.
Very interesting and hoping my bias as a long time long isn’t deluding me, I am thinking (IMHO) the following:
1) would BP do a trial with Dcvax-L if dcvax was likely not to be approved? IMHO no
2) if the trial branches are Dcvax and Dcvax + Keytruda, doesn’t that position Dcvax like a SOC to compare the efficacy of Keytruda+Dcvax against? IMHO yes however my bias may particularly be affecting my judgement.
Your thoughts please?
It’s been a year and a half since I posted the “screen play” about our hero and her little company’s epic quest to improve the survival, with vastly better QOL, of GBM patients and ultimately for all solid tumor instances.
Although I thought the P3 trial results would have been known by now, the plot has continued and thickened. The recent positive plot elements include the sharing of encouraging blinded data, the hiring of IR and CFO, and most importantly that people (trial participants) apparently are living several years and more beyond their enrollment in the trial.
Among the negatives are that the Sawston funds appear to have been consumed, additional dilutions/fund raises, continued sparse communication from the company, and that data lock, TLD release, and success/failure of the trial are still not achieved. The share price remaining in the 21-25 cent range for a late P3 trial biotech with encouraging results shakes the logic around success while some other biotechs that are not this far along have their share price and market cap grow.
Is this a compelling suspenseful plot or what?
Even staunch Longs such as myself are repeatedly tested by weighing the positives and negatives and running through the logic trail over and over.
I guess I’m an optimist, continuing to come out net positive that the plot will prove to be an inspiring set of outcomes and a major advance medically, for patients, investors, and our hero’s,
Regarding Les statement, FDA involvement from the FDA’s perspective can not directly prevent Nwbo from providing commentary HOWEVER I think Les points to the inherent risks of the FDA interpreting any part of a statement as negative to the FDA.
Since the FDA is the approver of the treatment it seems like common sense to avoid even the chance to piss off the approver or run afoul of politics, etc.
I’ve found myself in situations where a statement was taken completely or partially not as intended innocently, and imagine what those wanting to hurt Nwbo would say to distort in a negative damaging manner, like had been done previously many times as blatantly obvious merit less attacks.
Unfortunately I’m seeing and experiencing more miscarriages of justice and systems rigged with bias such as to perpetuate existing ecosystems of jobs even at the expense of what is logical and right.
So Les’s statement of cautiously avoiding running afoul of the FDA when approaching approval sounds prudent to me, fwiw and imho.
BSB,
Thanks for your reply. It’s encouraging that your observations regarding efficacy are positive and our diverse views of management are what they are and contribute to the large pool of views and information this board provides its readership.
Since finding this board, it’s become the only board I read daily.
Thanks to all for sharing!
BSB
Do you and your friends who invested big bucks in NWBO believe the odds are good that DCVax-L will be approved and our investment will be successful?
While I didn’t invest millions I did put a lot of money for my circumstances, initially buying around $3/share and buying more on the way up to $12+ figuring if NW bought in big to the tune of over $100M, there was smart money betting big.
Digesting all the info on this board and all the pro/con points and factoids, and the various presentations, I keep concluding the risk/reward is worth it, and after paper losses of more than 90% I decided I’d hold to the end.
IMHO management is driven to bring a more effective treatment to those with cancer, and not necessarily to optimize shareholder returns and not driven by riding a gravy train of sorts as some believe. These are successful already wealthy people that I believe can get a higher financial return for their efforts elsewhere.
Senti thank you for your input and your choice to use T :)
WW55 we are each entitled to our views and can learn more by sharing and integrating all the diverse viewpoints than not. So I value your perspective and I’ve lost the most investment value when I ignored input I didn’t agree with.
Ike, if I were LP I wouldn’t touch that question if for no other reason than it is controversial in nature and a no win position. Not that we shareholders should be kept in the dark, however discretion is the better part of valor, so to speak.
WW55, maybe having worked for large corporations I have a perspective that C-suite management salaries and perks for LP and LG are not grossly out of line. Consider that most senior executive managers make more than $500k and $375k while typically having large organizations to carry out their directives and do the drudge work. NWBO is relatively much leaner with a small number of employees, so I’m guessing LP and LG wind up doing relatively more actual work for relatively less compensation while fighting off the attacks of those wanting NWBO to fail in disruptive treatments for cancer, all IMHO.
Marzan, interesting find! Looks like this technology can also be used to identify multiple paths that can also be preemptively patented to prevent competitors from selling such an equivalent. However given what’s been in the news lately, one might worry about whether the technology could possibly be abused.
I don’t understand how LP would not keep her bod position with all her own votes and friendly insiders?
Also,although I’m down more than 90% on my investment I have long believed that for LP reaching success of the Dcvax treatment as a new and quite tolerable treatment for cancer is the goal, with or without shareholder investment success.
And I believe genius towards this goal demonstrates LP’s smarts, dare I say genius again.
Consider the following elements and structure:
+ trial includes multiple countries which provides diversity and some checks and balances vs BP/FDA attacks
+ manufacturing and patents were private in Cognate and friendly hands to negate hostile takeovers of Nwbo
+ shut down of attacks and frivolous lawsuits that were distracting and costly to defend (Black and diligence)
+ Sawston deals and repositioning of manufacturing for less conflict of interests and multiple sourcing
+ and much more
Looking at the event schedule all the speakers have 15 minute time slots.
It may be a real estate deal but even so it appears to have been a good deal that brings a big chunk of funds to Nwbo that are needed to get to approval hopefully without vulture and dilutive funding.
Thanks Sentiment! The excerpt you provided is what I was thinking as unambiguous. I do acknowledge that ambiguity in this matter is in the eye of the beholder and everyone is entitled to their view.
I’m not very knowledgeable about detailed trial process so I don’t know about things like SAP timing opportunities and possible prerequisites. However one significant difference between 2017 and 2018 is the exposition of the tail, which very recently appeared to be deemed established enough for the nwbo’s advisory group to support concluding the trial. So perhaps 2017 was deemed to early and risky towards achieving FDA approval?
Whether LP was using another carrot to lead everyone on to keep the company and trial going, maybe.
At this point with the recent moves with Bigger and Sawston, and Cognate, and the statements of moving to conclusion, it feels like end game. I’ve been wrong before and could be wrong again with this investment, however when I try to analyze the logic and what info is publicly available, I keep coming up long.
Scotty, Linda didn’t impress you when she realized and stood up to what appeared to be a move against Nwbo and current management to effect a wolf in sheep’s clothing takeover of the company and/or its manufacturing secret sauce?
My belief is that LP has been committed to getting Dcvax over the goal line for reasons that might be more important than stock gains. Of course stock gains are a very good thing for Nwbo and Longs including LP however I feel that extending lives of loved ones has been the top goal to achieve whether with or without stock profits. I also believe both goals may be achieved.
Hasn’t LP very recently stated quite clearly that the phase 3 trial will now move to data block and unblinding in deliberate order. This statement wasn’t ambiguous sounding to me unlike most previous statements.. the timing may be open to speculation however the decision to proceed to closure appears to be clear.
Turns out that ENMD wound up making a deal that provided Celgene with the basis to create and market Revlimid, a blockbuster cancer drug that propelled celgenes stock price and opportunities. ENMD went on trying to bring a particular kinase inhibiter drug through the clinical trial process, and still is. Over the years ENMD stock price was mostly around $1 and less, even less than Nwbo current SP.
A change of management and strategy to address China and American drug opportunities, along with new investors and insider ownership, recently moved CASI (new symbol) from sub dollar to a high in the $8+ area and now back down to around $4+.
This saga took place over more than a decade, and no, I still didn’t sell shares. So it seems I’m drawn to long and painful investments. Like many of the longs in Nwbo I keep holding and adding, to way more than I should have, on the basis of the science, the respected doctors and trial sites, and a belief that LP is in this effort for more than financial gain.
I could be very wrong on all the above however I keep going through the logic and keep betting long. It’s also not all about money since like many others here I have family fighting a cancer and the thought of a well tolerated treatment that might extend lives is such a dream possibility.
For full disclosure I am long Nwbo casi and celgene, but at levels that wouldn’t put my family finances at terrible risk. After all, one shouldn’t risk more than tolerable, imho.
First and likely only reply to your posts, however how do you explain the patients discussed at Chicago ASCO ? Cherry picking? Unrelated spontaneous remissions? And the lead doctor from the UK clinical trial giving his emotional appeal to make Dcvax available? All regarding an ineffectual vaccine for which LL is receiving building recognition? That’s all.
Ex thanks for the info