is Retired - a status to which everybody should aspire
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Gentlemen do not discuss a lady's age - certainly not in public.
.... and I'll expect to hear no more from you due to your extreme embarrassment.
Hygro - Like a worm wriggling at the end of a fishing line, trying to get off the hook (of his own making)..
Maverick, may I bring to your attention the excerpts below from a guidance document produced by the FDA in October 2022:
Maverick, I don't think that I've misunderstood the gist of what you are saying - viz GBM is only a very uncommon form of malignant disease (1% of the total) so that in absolute economic terms it is a very small fish in a very large pond. If that is not what your post is all about then what follows is irrelevant (for which I apologise).
One of the great features of NWBO's method of producing DCVax is that it is targetting all the epitopes being displayed by each patient's particular malignancy. (Epitopes are abnormal proteins etc, that are present on the surface of the malignant cell as a consequence of the mutations in the nuclear DNA that have caused the cell to become malignant.) It is not targetting a specific type of cell (eg a kidney cell, a liver cell etc) nor will it have any effect on cells which don't display any malignant epitopes (ie "normal" cells) but will target any and all malignant cells irrespective of their originating tissue. DCVax-l is, as the FDA have described it, "agnostic" in its action within the human body.
The consequence of this is that when a Regulatory Authority gives it the go-ahead, it will be authorised for treating not only "small fish" GBM but any and all malignancies including the "big fish".
From my understanding (admittedly superficial at the present) mRNA vaccines are constructed from separate epitopes as decided by their designers so a vaccine will only be effective if the malignant cell is presenting the chosen epitopes. If the chosen epitopes are not present the vaccine is just so much grapefruit juice (I think that was the term used by an earlier commentator).
That is why Big Pharma is worried as they can see their business models collapsing under the onslaught of dendritic cell vaccines.
ILT, Sorry to hear about your terminally ill patient but it would appear that there is no prospect of DCVax-D being produced.
Just 6 weeks ago I enquired of NWBO about the possibility of a friend (who has since died) being treated with DCVax-Direct and Sue Goldman advised inter alia that "Unfortunately, we are not manufacturing DCVax-Direct at this time, we are only manufacturing the ADCV under the Specials Program in the UK".
Sorry.
This has just come through on Seeking Alpha:
Thanks, Bio. An email to Dave Innes is under way. I shall just enjoy the weekend as if no Sword of Damocles might be hanging over me!
Best wishes,
DocLee
PGSD, I hope that MIA (UK) is not announced on April 1st - "All Fools Day".
Now you worry me about counterfeit shares.
I reside in Europe and have bought shares in NWBO for 9 years in 2 separate periods. For the first 3 years I bought via an on-line UK broker (which I sold after 3 years when the SP started its near-terminal plummet) and 3 years later I re-entered the market. Initially this was via a Dutch on-line broker but after 1 year via an off-line European broker. Through that last broker I have accummulated my current holding.
I have, therefore, held shares in NWBO for at least 8 full years, bought them via 3 different European/UK brokers but at no time have I received any notification about the ASM either directly or via my broker.
Might this suggest that my shares are counterfeit? It seems to me to be unlikely but, just to give me absolute peace of mind, is there any on-line site where I can check that I am a shareholder in NWBO? (I cannot contact my broker until after the weekend.)
With the SNO meeting being held on 14th February,(the feast day of St. Valentine) perhaps we all should send Prof Liau a Valentines Day card.
I hope that he's also on Pembrolizumab.
Thanks, Hygro, for clarifying that point for me.
However, I think that arguments over the design of the study will soon be redundant in the light of the number of long term survivors (ie cures) that have been produced by the addition of DCVax to the S.O.C. This number could very well be dwarfed by the percentage of survivors in Prof Liau's current study (DCVax + Pemrolizumab + poly-ICLC) in which median survival has not not yet been reached with over 50% surviving longer than 2 years.
Now if you tell me that this trial will not play a part in the Regulators decision on the DCVax-L trial I will disagree with you. Regulators are not fools (some may be venal and veer towards Big Pharma) but they are highly unlikely to turn down a treatment which most people accept as having been shown to work (not you, quite clearly) for a condition which otherwise is a death sentence.
If a Regulator truly is undecided I am sure that it would easily find a way to give provisional acceptance now and then review it after several years of observation in clinical pratice.
D'accord!
After hip replacements they get you mobilised as quickly as they can. I'm d*mned sure that if I'd been fully awake after mine they'd have made me walk back to the ward from the operating theatre.
Like Angelofoca I don't really have too much time left to wait to see NWBO take off. Perhaps this is a good thing because I sometimes feel that wanting to see NWBO soar to the stratosphere is giving me something to hang on for.
PS I like the slant that Angelo gave to Peyronie's Disease. It always gives rise to hilarity when our group of retired doctors meet for its regular lunch and the pub/restaurant serves "Peroni" Italian beer.
Live long and prosper!
First you take the healthiest patients that have the greatest likelihood of surviving
I bet they'll take this very seriously and scrutinise every bit of apparatus with which their employees can contact the outside world without the firm knowing - not looking for unauthorised dealing but for evidence of who might be preparing to blow the whistle to the SEC.
How do you explain the improvement in 5-yr survival that DCVax-L has shown??
Mediaeval Bishops arguing how many angels can stand on the head of a pin. Futile and inconsequential arguments about trivia whilst ignoring the elephant in the room.
DCVax is saving lives and has the prospect of saving innumerably more lives and all you can do is to argue about minutiae of the successful trial.
Waste of time and effort (which gives rise to doubts about your motive.)
Yes, Really. Optune hasn't had long term survivors in excess of current SOC - DCVax-L has many, plus a step change increase in numbers (>50% survivors at 2 years) when Checkpoint Inhibitors (as in Prof. Liau's current study) are added.
You demonstrate the fallacy of your case when you have to use Weasel Words to try and prove it.
It is post hoc when the protocol, endpoints, comparators and SAP are completely changed AFTER the trial is virtually complete.
Bitter-sweet news today which both pleases me [SWEET] and annoys me [BITTER].
I've been invested in NWBO for just on 10 years. About 10 months after taking my position in NWBO I opened a position in Geron with it's candidate drug for haematological pre-malignancies, Imetelstat. I stuck with both companies as they both sank towards oblivion before both levelling out. I always had greater confidence in DCVax-L than in imetelstat but believed that both would ultimately succeed. So I hatched Plan B; that if either of them should show really positive signs that success was just around the corner, I would sell my holding in the dormant one and buy as many shares of the blossoming one with the proceeds. When a good profit had been achieved, those shares would be sold to buy an increased number of shares in the dormant stock to await its blossoming.
I started to build up my stock in NWBO when it was down in the 20c range. Whilst NWBO climbed on tidbits of encouraging news, Geron stayed firmly down down in the dumps. So, when a presentation by NWBO was announced for the New York Academy of Sciences soon after TLD had been confirmed, Plan B was put into action. I sold my holding in Geron and bought as many NWBO shares as possible with the proceeds.
Unfortunately as we all know, nefarious forces are at work and the expected rise on excellent news from the trial became a disastrous slump which still, persists. Consequently, I have not yet been able to renew my holding in Geron.
Today, Geron unexpectedly announced the successful results of its Imetelstat study with a 60+% rise in SP. SWEET that my assessment had been correct and that another successful treatment has been added to the anticancer armamentarium; BITTER that those malign forces that are still undermining the market in NWBO have prevented me from sharing in the success of a company in which I have faith and had backed for close on 10 years.
Thanks, Happy. It just seems to me that they are so focused on what they are doing (and presumably what they are doing is important) that they have disregarded their "loyal" non-corporate supporters (who are not actually necessary in the big scheme of things).
I would have hoped that Dave Innes might have thought issuing an official transcript, what with him being Head of Investor Relations, and all.
Thanks, VM. Greatly appreciated.
Can you produce a transcript of the transcript that is behind the money wall so that al of us can see what was said?
In respect of the Phase 3 DCVax-L trial, I suggest that everybody (and I don't mean just those on this board) should look at the totality of knowledge about how many people have ever been cured of GBM (not just the percentage figures of comparison groups in other trials) with and without the current Standard of Care (SOC). The answer is ZERO (or as near as zero as you can get). Then they should look at how DCVax-L has altered the Overall Survival (OS) in both new GBM and in recurrent GBM. The result jumps off the page and hits you square between the eyes that DCVax-L has a significant positive effect on both being cured and, if not cured, surviving longer.
Add into this, the early survival results from Prof. Liau's current ongoing study of survival with DCvax-L + checkpoint inhibitors in GBM. This shows that after 2 years the median overall survival point hasn't been reached (ie more than 50% patients are still alive 2 years after they started the combined treatment). The benefit of DCVax-L treatment is undeniably, slam, bang, dunk obvious for all to see.
Of course, there are people biased against DCVax for whatever reason - financial (probably Big Pharma together with its paid minions of FUDsters), personal pride (eg Stupp, van den Bent and Preusser) and those whose god is filthy lucre and care nought for the sufferers who have died and will die because DCVax is not yet licenced. They are going to delay the inevitable for as long as they can by arguing the toss over the minutiae of the Phase 3 trial; was the comparison group truly representative?, was the recruitment really unbiased or was it skewed to produce a better result?. The list could be endless.
They have to argue the toss about whether the Phase 3 trial did actually show that DCVax works in the hope of delaying the licencing of DCVax until such time as NWBO is bakrupted and the residua of the Company can be bought at rock bottom prices by those very same people who bankrupted the company.
Just listen to the trivial arguments that they are dredging up to make a case against the validity of the trial. It is reminiscent of the now unbelievable arguments among some Bishops of the early Christian church as to how many angels could stand on the head of a pin!! It is arguing over inconsequential points - in the current instance, to muddy the waters for as long as possible.
You can see this, I can see this, and I have no doubt whatsoever that the membership of the MHRA and NICE (and even the FDA) can see this. I have no doubt that they can recognise spoiling tactics when they see them. I also have no doubt whatsoever that the MHRA will licence DCVax, based on the totality of current knowledge. That will be big news and the efficacy of DCVax in the teatment of GBM will soon become common knowledge among the medical population of the UK. Eventually it will make the general Press in the UK (especially if NWBO step up to the plate and push its product into the limelight) because the UK is smaller and more compact than the USA with fewer inimical organisations based here to mount a campaign against it). Once licenced over here, the FDA will not dare delay much longer because of the pressure that US popular opinion will place on them.
I wish all (even FUDsters) the compliments of the Season / Happy Christmas / Happy Hannukah / Chag Urim Sameach (plus greetings in any other religious language about which I have no knowledge).
van den Bent's article described by Feuerstein as "peer reviewed" is to be found in "Neuro-Oncology" here. Its journal citation is an "editorial", specifically the Editor's Choice; ie not a peer-reviewed article.
It was in 2014 at 1m40secs of this YouTube video.
Best wishes
Oh, now I remember!
It was in 2014 at 1m.40s on this website, noted for its well-researched and reliable factual content, delivered by an impartial commentator.
"She was voted one of the worst biotech CEO's,"
Hank, So do I. I appreciate your interest.
Doclee
Hoffmann6383 - many thanks for your advice - doclee
Thanks, Biosect.
Because of the distance from a regional Oncology Centre, the initial investigation was carried out locally (the Channel Islands). The local Pathologist was unable to effect the histological diagnosis so the specimen was referred to the regional centre (Southampton) where it was characterised as metastatic Merkel's. I am presuming that the pathological specimen was taken by an ultrasound-guided needle biopsy rather than an open excision-biopsy.
I suppose that an open resection could be carried out but my mind turned to DCVax-Direct. However, I'm sure that this will be discussed by my friend with his Oncologist.
Many thanks for your help.
A friend and colleague, a retired Anaesthetist, has just been diagnosed with metastatic Merkel Cell carcinoma in his lumbar spine and is imminently starting pembrolizumab. The primary had been removed from his neck some months ago and was followed by radiotherapy but not by anything else.
I recall a presentation by NWBO at an ASCO meeting some years back when NWBO presented several patients who had received DCVax therapy for a variety of malignancies and had not only survived but without recurrence - presumed cured. One was a patient who had had metastatic Merkel's Cell carcinoma but I have not been able to find any reports on NWBO's website relating to the use of DCVax in Merkel Cell carcinoma nor have I found any scientific papers on dendritic cell therapy in the treatment of Merkel's cell carcinoma.
The only relevant item that I have found is a video on YouTube! It is a rather poor copy of the ASCO meeting (found here) which features the woman with Merkel Cell carcinoma.
Can anybody tell me where I can find any scientific papers documenting the treatment of Merkel's with DCVax for my colleague and, just as importantly, for his Oncologist whom (I suspect) has never heard - yet - of DCVax.
My thanks for any help which I can pass on to my friend and his Oncologist.
Best wishes and a Happy Christmas to all.
Legend, You may be right, but in the long run, when (not if) NWBO gets DCVax onto the market in the very near future, will this persisting low SP have resulted in any long term damage to the company and the shareholders (apart from frazzled nerves and torn out hair)?
Regards
those Moderna mRNA platform produced Covid vaccines are causing heart problems and inflammation in some patients
Thanks, Flipper - confusion virtually lifted in its entirety.
Thanks, Flipper.
I'm still somewhat confused about the trial with its result reported in graph form because it doesn't seem to conform to the trial protocol as described in clinicaltrial.gov. It was either changed considerably (see my reply to Lefty) or else the link that was given by skylimit was wrong
Thanks, Lefty, but in the trial design shown at clinicaltrial.gov the comparator group (which I presume is the blue line in the graph showing a median OS of 275 days) is given no pembrolizumab at all. The pre-surgical treatment in the comparator group is a saline infusion (in the experimental arm it is pembrolizumab) which is repeated every 3 weeks post-operatively (pembrolizumab in the experimental arm). It also shows that both arms of the trial also received Poly ICLC, but that seems not to have been mentioned on the graph
I have to presume that either the trial design was changed to compare pre-operative (ie adjuvant) therapy with postoperative adjuvant but I cannot see that there is any mention of that in clinicaltrial.gov, or else the link to clinicaltrial.gov has linked to the wrong trial.
Still confused, partly because I cannot understand why the ATL DC is described as an adjuvant when it is clearly the main component of the therapy.
Best wishes.