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Austin,
I do find your repetitive cynicism a little bit wearing.
You said it yourself. Her plans have been derailed by external factors.
No wonder she now elects to keep silent. There is a whole array of forces waiting to shoot her down. And not a few of them are on this board!
Aren't you more frustrated with these external forces that knock things back constantly?
Your consistent cynical interpretation, when added to that of others, will only hurt your own investment.
Please have a little bit of faith!
Behind the scenes, she is advancing things as best she can. I think it is absolutely heroic the way way she is forging ahead with manufacturing capacity, which is a necessity before PIMS/EAMS becomes a reality.
Of course the German insurers don't want to start paying for this treatment, and will wrap NWBO in as much red tape as possible!
Would you rather that NWBO had not been granted these unprecedented European provisional approvals?
My apologies if it was in fact 'crook' rather than 'liar'
My point remains, however. The term 'crook' is certainly derogatory if not defamatory. And surely constitutes a personal attack.
If you are allowing yourself that amount of leeway, then you must surely do the same to other posters.
Nice to see us us outperform the sector.
Go NWBO!!!
I'm not advocating for the right to be able to call someone a liar.
I'm just pointing out the irony that it is apparently OK for Outside Lane to call LP a liar, yet he/she, in moderator role, would appear to be deleting other posts left right and centre...
Can anybody clarify 'personal attack'?
Is it OK to call someone a liar, in this case CEO Linda Powers, or does that privilege only come with moderator status..!!?
So, Direct data remains extremely promising.
Given its breadth of applications for all inoperable solid body cancers, the potential to revolutionise cancer treatment is as compelling now as it ever was.
Of course it is frustrating that we have not yet moved to Phase 2/3, but the blame for that should be laid at the door of the industry of short traders and their 'associates', who use every trick in the book to repeatedly depress the PPS.
Woodford, I'm sure, had the intention to continue investing and provide the funding 'runway' through L approval and on to Direct.
I hope and expect that he will resume stock accumulation, when the investigation reports. I hope and expect that the investigation will throw up nothing worse than indiscretions on the part of NWBO i.e. more sinned against than sinned!
The fact that Mr. Feurstein is here on this board, and not on any other, just reinforces my view regarding the above hypothesis.
Highly unlikely. The author was familiar with this message board, to the extent of maligning regular posters. Acting in cahoots with short traders.
Previously did a hatchet job on VTL's Elad, which was then subject to a concerted short attack, which Shkreli openly bragged about, back in August, and took PPS from $17 down to $3 in a day or two.
Perhaps someone with SA account might care to screeenshot Phase Five Report?
Let's try again. Previous attempt deleted within minutes for being 'off topic'
Phase Five Research, who made serious allegations against NWBO, leading to a significant drop in PPS, appear to have closed their website, though I believe Seeking Alpha report still up at time of writing.
L'affaire se corse!
NB. My original post has now been restored after I questioned deletion.
Phase Five Research website is down or closed......
Tracks being covered?
L'affaire se corse!
No bad thing for AF to be under rigorous scrutiny both here, and no doubt elsewhere. It has been well documented, notably by Larry Smith, how NWBO's PPS has been adversely affected through shorting activity, on many occasions, shortly after an AF communication.
He doesn't need biotech experience.
He needs forensic investigation skills.
His raison d'etre is to investigate stock manipulation and Phase Five Research.
Eminently qualified I would suggest....
The difference this time round is that naked short sellers will be exposed and Charles Price is on the case:-
'Mr. Charles Price has been engaged to be available as a resource for the independent investigation, and to help seek action by the authorities in regard to manipulation of the Company’s stock. Mr. Price is a highly decorated, nationally recognized former FBI Special Agent and certified public accountant (CPA) who retired from the FBI approximately a year ago after a 28-year career with the Bureau, and is now a Managing Director with MorganFranklin Consulting, LLC where he is a leader in their Corporate Investigations and Dispute Solutions practice. Mr. Price received the FBI Director’s Award for Excellence in HUMINT (human intelligence), the Bureau’s highest award, in 2011, and received more than a dozen Outstanding Public Service Awards from US Attorney’s offices, as well as numerous commendations and awards from the FBI for excellence in investigation. Prior to joining the FBI, Mr. Price worked as a CPA at Arthur Andersen & Co. performing financial statement audits in the financial services industry.'
And if he does have a 'mole' within a CRO for example, who divulges prior information re trial results then he is on very thin ice...
Usual thoughtful, cogent analysis from Larry Smith.
Pretty well says it how it is. He reiterates that P3 trial outcome is the pivotal event, and everything else, is of secondary or peripheral importance.
One trusts that adequate funding is in place to see us to that point.
With this investment, when traditional DD doesn't give you all the answers, you have to have a lot of faith in LP.
She cannot afford any breach in trial protocol, and if she has to maintain silence at this point, then so be it.
I've been invested for 18 months. She has given this decades of determination, and I'm not about to criticise her.
Wish I could say the same for the repetitive posters, who seem determined to talk this down at every opportunity.
Hmm. Gone Green.
Must have been my top -up purchase that went through at 1.15pm.
Current PPS:- 2.16
Target price:- 100.00 (best be modest)
Recommendation:- Buy.
I didn't say it was identical. Just pointing out that some of the terminology and phraseology is similar. It raised my curiosity. Seems not to have raised yours.
The use of 'as is'
'warranty, express or implied'
and:-
'sources it believes to be accurate and reliable'
compared to:-
'sources...believes to be reliable and accurate'
Like I say, probably just coincidence, and similar terminology is probably used in thousands of these statements.
Still made me curious though!!
Too technically inept. Somebody else might like to oblige perhaps, just for the record..
Just taught myself how to do it!
Investment Site T&C's
Interesting how a lot of such sites use similar terminology in their Terms of Use or Terms and Conditions. Take Ondra compared to Phase Five Research, for example.
Purely coincidental, I guess...
I think frankly the short selling and general PPS manipulation came as a bit of a shock to NW, who, despite his vast experience, is relatively new to US Biotechs.
He gauges value in terms of fundamentals, and the only thing that has slightly shaken his belief in NWBO is the allegations of impropriety.
Personally, I think he was shocked when the Ondra conflict of interests came to light.
I don't think anything has really affected the mutual respect between NW and LP. Their interests are largely aligned, so I don't think either will allow enmity to get in the way.
The investigation, I trust, will clear the air for both of them. I don't think NW can divest any of his holdings until it has reported. No other large investor will come on board until this happens.
As we know, LP and NW are both resourceful, determined individuals. I guess that his current stratagem is devised to nullify his paper losses, and he has calculated what proportion of his holding he needs to sell and at what price. No way he can do this on the open market.
Both LP and NW have shown that they play the long game. NW will make his investment work eventually, and ultimately enhance his reputation in the eyes of his investors. This is just 'a bump along the way'
Stilwell. Agree with all this. LP would have been aware of all LL's research findings back in the summer. I'm sure that some sort of trial extension was designed at this time to build in use of demethylation and expression of NY-ESO-1.
LP has stated how closely and cooperatively they are working with FDA. Hence the screening hold, while new protocol is designed.
Just my 5p's worth.
What if he is just manoeuvering into position to sell a portion of his holding to a fellow large investor with more than adequate funds in a private deal. Such a deal could have already been informally arranged. Then it would just be a matter of timing.
At a wild guess, because NWBO have made a case for the later enrollees to be subtyped at screening.
Slight paraphrase:-
-We chose Decitabane as the demethylating agent because it already has FDA approval and we can get it to clinical trials quickly if necessary...
Are you classifying Decitabine as purely a chemotherapy drug?
I have seen it described as a hypomethylation agent, which sounds a bit more specific, and clearly not just an alternative to temodar.
Then perhaps the screening hold was initiated at NWBO's request, who wanted the trial to begin to include consideration of GBM subgroups, and that NWBO undertook to provide details of LL's up to date research.
Question:- Does initial trial candidate screening include identifying GBM subgroup?
I just have a hunch that the screening hold is not unrelated to this.
Cherry Tree.Totally agree.
Your post mirrors my sentiments.
Sorry to labour the point, but perhaps Decitabine constitutes the combination therapy that LP alluded to last year, not checkpoint inhibitors or anything like that.
I'd say it is essential that NWBO receives approval in the next six months for at least a subgroup of the GBM population, in order to receive some belief and approval from the financial world, and to enable further financing needs to be met on equitable terms, and of course to start generating meaningful income.
I am trying to gauge the likelihood of this happening, when a paucity of hard information is available.
Your info on VAL-083 is very interesting, but I don't readily see how it will affect DCVax L or Decitabine.
How do you conclude that two thirds of folks fail TMZ?
I thought that it was effective for most of the patients in slowing down the cancer progression, but ultimately cannot prevent tumour regrowth.
Are you asserting that two thirds of folks derive no benefit from it at all?
So when (I'll say when!) DCVaxL becomes SOC, the manufacturers of Decitabene can sponsor a trial to test its efficacy as an adjunct added to SOC?
Does that sound about right?
I'm afraid I don't understand your statement about disease progression being determined before enrollment. How does that fit with determining PFS?
Sorry if I'm being dense...
Decitabene clearly is important in relation to GBM.
It can also potentiate the efficacy of Temozolomide apparently.
Can't do links, but lots of info by googling Decitabene/Glioblastoma.
Any thoughts on the use of Decitabene?
It appears that, in relation to Glioblastoma it has only been researched with animal subjects by LL et al, though it is approved already for Acute Myeloid Leukemia. Could it be conceivably be employed in the existing DCVax phase 3 trial? Unlikely I suppose.
I'm a little concerned about the reported tumour 'swelling' that can apparently occur prior to tumour necrosis after L administration.
Wouldn't want this phenomenon to be mistaken for disease progression...
Re. the subgroupings, LL initially mentions four subgroupings, and that they subsequently adopted more meaningful titles used by other researchers, though only mentions three by name.
My interpretation of her presentation was that apart from the mesenchymal subgroup, the other subgroups (in mouse studies) benefited reliably and consistently from the use of Decitabene in addition to 'L' in animal studies, and the written report states systemic transfer (tail vein?) was superior to intra-cranial administration.
Decitabene apparently 'induces the expression of an immunogenic tumour rejection antigen NY-ESO-1.'
Would have been great if the video had included the subsequent Q and A session!
Fast track approval for mesenchymal subgroup?
I am beginning to think that the screening hold is somehow related to Glioblastoma subgroupings, and involves the submission of further research data from NWBO.
I don't believe that LP knows any more than she should know, regarding a blinded trial.
However, she is convinced enough about outcome, to go full steam ahead with ramping up manufacturing and commercialisation.
That is good enough for me.
Mesenchymal subgroup actually did best.
On watching this a second time, it is apparent that, in fact, the mesenchymal subgroup responded best (not worst) to L vaccine.
In her comparison of the two male subjects in their thirties, it was the mesenchymal patient, who was (and remains) a long tail survivor.
She went on to talk about further research to enhance survival prospects of the other subgroups, which has involved the use of a demethylating agent, and specifically mentions the pro neural subgroup. She mentions Decitabene, which is the demethylating agent employed.
Decitabene appears to radically improve things in animal studies allowing the T cells to migrate and act systemically, including when administered via the tail vein (in a mouse)!
Could it be that the screening hold has something to do with the introduction of Decitabene to subjects that are not mesenchymal?
Highly unlikely, I suppose, given that the demethylating process has only been tried on animal subjects.
I am enormously encourage by the video. It would appear that the mesenchymal subgroup can effectively be 'cured' by DCVax L, and an effective additional therapy (Decitabene) can be employed to significantly enhance L effectiveness in the other subgroups.
And, perhaps most significantly, the latest research clearly demonstrates a systemic response, and possibly systemic memory.
Thankyou Senti.
Very encouraging information.
It's just a matter of time...
Yes, keep posting Mr. Feuerstein. It livens up the Board and enables your posts to be examined, discussed, and countered. That's the beauty of a public forum.
No we don't have a full on short squeeze, but signs of nervous covering...
So that would be an admission that you mislead investors then?
Intentionally?
Well here's one or two questions for you:-
Can you shed any light on Phase Five Research authorship?
Had you come across them at all prior to their NWBO report?
If you consider NWBO to have similarities to many other hyped up trial stage biotechs, why have you alighted on this particular board, and spending so much time on it?
Seasonal wishes to one and all!
Mr. Feuerstein gives NWBO a massive vote of confidence.
That is my interpretation of his presence on this board.
Despite repeated requests from myself and others, he has declined to state his motive for posting on this Board.
I therefore have to hypothesise why he is here as part of my DD.
To my knowledge, this is the only Biotech board that he has taken to openly posting on in this manner.
The fact is; NWBO remains a huge potential 'gamechanger' in the field of oncology treatment. This is a massive challenge to established vested interests, most obviously Big Pharma.
It is not surprising in the least therefore, that NWBO will experience all sorts of attacks and attempts at undermining its huge promise.
Phase Five Research is a prime example. While some of their report does raise some cogent issues, much of it descends in to clearly fantastical assertions. Basically, whichever particular interest group commissioned the report is prepared to throw any amount of resources at the problem. Much of the report is clearly open to legal challenge. No wonder, therefore, that the authors have gone to such extraordinary lengths to hide their identity. And added some rather strange and almost certainly invalid 'terms of use' in an attempt to deflect potential future legal challenge.
One unintended outcome of the report is that NWBO will now go to every necessary length to ensure that all its transactions will stand up to every scrutiny.
It is precisely because of NWBO's massive potential, it will meet an unprecedented array of challenges from many directions. To my mind, many of these actually reinforce my view regarding its fundamental value.
Hence, I am quite happy with my relatively modest investment, in order to be a part of this intriguing drama.
Not easy to distinguish between Pyrr's arrogant tone and AF's arrogant tone...