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Nice bump in property value, provided it covers the additional plant investment. Does anyone know how much NWBO spent on the fit out?
Not sure if this article has been posted, but this quote is good:
"The surprising part was that the 100 ‘extended survivors’ don’t appear to have the usual characteristics associated with a good prognosis. We are continuing to study these patients to understand why they have done so well.”
- Jian L. Campian, MD, PhD. Siteman Cancer Center
https://neurosciencenews.com/brain-cancer-vaccine-9199/
Sorry, was being tongue-in-cheek.
Though I expect, if the sky does fall, NWBO's apparent endorsement of Bohsie's (et al) analysis would be fodder for a litigious mind.
And that's worth arguing in the class action case, should things not go well...
Depending on market share and revenue multiple, my figures don’t rule out trillion dollar valuations.
Take my initial 720B potential revenue figure and use a larger market share (50%) and even a multiple of 3 gets you to a trillion.
Feel free to share your working though, there’s more than one way to skin a cat.
If it works, I’d expect it to quickly gain market share. The dearth of options and public interest in ‘miracle’ cancer treatments will mean wide PR appeal and quick raise in awareness among treatment centers.
Sure, but the L figures are compelling on their own.
But as proof of concept, L's success bodes well for Direct so that valuation would have to be taking into account before Direct goes into P2.
I was being conservatively erroneous in retrospect. ;)
Valuing this is difficult.
It could be zero, but if L is a blockbuster, and Direct also works as well as we hope, the global market is immense.
Every solid cancer. $120k per 3-year treatment. (~12 million patients, but lets say 6m for major markets who can pay)
That's $720B potential revenue. $7.2B for just 10% market share.
Pick your valuation multiple.
DCVax-L alone: in the US, 23,000 glioma/gbm cases projected for 2018. $2.7B possible revenue.
Triple for global major market figures: $8B x Revenue multiple.
EBITDA is an unknown, but cost of goods could be quite reasonable for L, (tumour resection is done as part of biopsy/SOC so that cost shouldn't be borne by NWBO). Direct has lower manufacturing costs but higher administering costs (image guidance) but not exorbitant. Let's say COGS an average of 20-30% across both. Pretty great margins.
Where NWBO sits on that zero-hero continuum is what everyone is betting on.
If it provides patients a better alternative to SOC, and they're willing to pay for it, then it's a boatload more than $5.
If it's marginal and uptake is slow, it's might go the way of Provenge.
Yep:
Keith? @KeithT5678 7h7 hours ago
Looks like Adam Feuerstein finally got fired from @thestreet $CYTR $NWBO $CRBP $MNKD. Carnell is cleaning the house
Looks like he's going to some place called ... ah, who cares...
But Celldex's enrolment criteria is different. It's apples and oranges.
(No PsPD in DCVax, which are long tail survivors - they could have contributed to a longer control in Celldex)
Not a lot of rooftop shouting going on, then...
Second half was only going to be formulation B wasn't it? Still unblinded?
At least in this article there were no mistruths. Yes, it's obviously biased, but there's not much in there that you can refute.
In the meantime, what's going on with Direct?
"Substantial number of patients on a compassionate basis under an Expanded Access Protocol."
Anyone else discussed this?
Can NWBO release anecdotal non-trial results before p3 data lock? It's unblinded, right?
Well, you can't criticise this stock for being boring.
I was almost going to hit the sell button this morning, too. Only to buy in again lower. That would have been a real kick in the teeth, buying back less shares.
And lots of new posters being very excited on our behalf.
So I can help but feel sceptical about these moves.
Hopefully I'm proven wrong
How are we looking technically, down here?
(Let's keep fundamentals out of this for a second.)
Some commenters elsewhere are suggesting a bullish move.
A little bit of light laundry going on in the spare space for Toucan...
And who's opinion is this?
This is not entirely true. Quality of life is a huge benefit for terminally ill patients.
Hindering tumor growth is especially beneficial in GBM patients, where progression causes pressure on the the healthy brain tissue and creates all kinds of neurological and psychological issues.
So, in that case, would you rather have 12 great months and then drop dead, or drag your life out an additional few months, losing your personality, memory, motor skills and becoming a heart-breaking burden for your loved ones as they watch you struggle through palliative care?
No question which option I would take.
So, you're now focusing your bear thesis on PFS as the primary endpoint?
How do you suggest that the trial be designed around OS if the FDA required all patients who progress to cross over into an open label treatment arm?
Ultimately, the FDA (and no one else) will have to make the call on this - and they will certainly have to take into account their insistence on the crossover arm.
Puzdar had made it clear he is more flexible with these envelope-pushing trials.
The total amount will surely depend on how much tumor they had access to for manufacturing the vaccine.
i.e.
Placebo arm patient-X may only have had the minimum amount of tumor for the trial (presumably around double the amount required for the treatment protocol in case of early crossover?)
and treatment arm patient-Y may have enough tumor to create more than needed. So I don't think clinics should be able to tell who is in what arm by how much vaccine is left. Each will have different amounts (but still enough to get them through the crossover treatment, if needed)
So nice of this "Phase 5" outfit to freely publish their obviously significant research.
They've looked things up on the internet and everything.
I wonder what they hope to gain from offering all their time and effort for free?
Hmm. Something smells here and it ain't DCvax.
Well, that was an exciting day.
Missed most of it only to find a stop I'd set a while ago triggered (only a portion of my holdings).
I set it thinking this would be where the price would be if there was a major trial issue or failure. Ridiculous that this perfect storm can force the price down so far.
If the assumptions on the board about Woodford's NDA are correct, I bet he's wishing he didn't sign it now so he could buy.
Now the big question is what price to get back in?
Take the market on open, set a limit or stop to try lower or get in on the way up.
Maybe a mix...
However, in the case of NWBO, enrollment hasn't stopped. Just the screening aspect.
Which is unusual.
Not so secret signals?
I think perhaps he meant that 16 of 19 had stable disease past 8 months. Those 16 have so far survived.
Anyone heard of HITV vaccine? Sounds pretty similar to Direct (including immature DCs)...
http://www.hitvlab.com
Nice sleuthing.
Excuse me?
"The recent rGBM arm data doesn't look as promising as I had hoped. 15.1 months is not good enough. "
The median overall survival for this indication is between 8 and 10 months.
A greater than 50% improvement is better than good enough.
Pretty solid thoughts, mewards.
You can only apply for SPA after completion of phase 2 but pre-phase 3
Because we upgraded the PII trial to PIII, we couldn't apply for SPA based on the fact that there was no completion and, therefore, no unblinded data to discuss.
Sorry, my post was more tongue in check than serious. But yes, you're right. F-stain is a distraction, probably moreso to us than the company.
The Street has better lawyers than NWBO then.
Why aren't we making the Street clarify that their misinformation and innuendos are just that.
"Col. Jessup of biotech"
I just assumed my military trivia was lacking when I had no idea who F-stain refers to himself as in Twitter.
I googled him the other day, this famous Colonel.
For those of you who don't know, he's the character played by Jack Nicholson in 'A Few Good Men'.
You know, the guy who's famous for saying, "You can't handle the truth".
Pretty apt, F-stain, I'll give you that.
Look who precedes NWBO in the agenda:
10.05 Key opinion leader view
Dr Laurence J. N. Cooper, Director, Immunology Laboratory of Physician Scientists, Department of Immunology, The University of Texas MD Anderson Cancer Center
10.25 Questions & discussion
10.30 Personalized approaches to immune therapy
Linda F. Powers, CEO, Chairman of the Board, Northwest Biotherapeutics, Inc
Thanks, Evaluate.
RE: PIM next steps.
Opinions on the bolded points?
Step 2
EAMS scientific opinion
? Must have PIM designation to apply
? Phase III data required (Phase II in exceptional circumstances)
? Scientific review by MHRA (assessment of benefit–risk)
? EAMS pre-submission meeting
? Assessment fee up to £29,000
Step 3
National Health Service (NHS) commissioning
? Approval by NHS commissioning board
? Clinical advice from clinical reference groups (CRGs)
? Treatment restricted to specialised centres
? Medicine provided free of charge.
quote:"... I might be mistaken but I thought progression allowed crossover and I'd be inclined to think, at some point, he got the vaccine...."
It's impossible to say. There are certain reasons why this may not be the case.
One being the speed of progression in combination with location of the mass(es).
A drawback of immunotherapy is an inflammatory response.
This is not so much of an issue elsewhere in the body, but in the brain, there is limited space in the cranial cavity for expansion (soft grey matter is no match for dense bone, and something has to give).
As a tumor grows, it puts pressure on the rest of the brain and spinal cord. Often, the loss of brain function that patients experience is not from the areas near the tumor itself, but from the areas where the pressure is greatest.
If Robert was indeed in the control arm, and his rGBM was aggressive, it's possible that it was not caught in time.
Administering an immunotherapy (with a known inflammatory response) to a patient with increased intracranial pressure is quite possibly an earlier death sentence - The additional pressure from the vaccine could cause seizures, hemiplegia or fatal damage to the spinal cord.
Normally, debulking surgery would have to take place in order to relieve pressure on the brain, but this isn't always possible.
Of course, he could just have been on the treatment arm and not responded both times.
But, given the weight of growing evidence, one might favor the assumption that he was on control.
RIP
F-stain couldn't have said it better himself.
Or perhaps he just did...