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I cannot imagine a reputable PR firm suggesting this venue
You go on and on, sell your shares (if you have any?) if you are not happy and move on, thanks.
In my view, in a year we will most likely see RA approval in the UK at a minimum, resulting at a conservative estimate, in a fair value share price of $2 or better
There is absolutely nothing of any good news of clown Les G performing in the big booze show from his pig stale apartment. Why is Les agreeing to perform in a bar surrounded by alcohol and quack like an idiot duck making a complete fool of himself? Its because he wants to sell his securities and for no other reason. If any material news would come any time soon Les would not perform in this idiot scenery, because that would mean that there would be no need to sell NWBO securities at this low-level SP.
The average drug costs 2 billion in R&D. We're going to market less than the average.
The analysis, published in the current issue of JAMA Internal Medicine, concludes that it costs, on average, $650 million to develop a new cancer drug.
If you're correct, so be it. We've waited this long. We can wait a bit more.
Let hope so
FDA will likely be the last in the world to approve.
and its only the last one that counts smartypants. As a short, you dont get to choose which trial protocol counts
https://www.statnews.com/2023/06/06/novocure-optune-electric-fields-device-lung-cancer/
your buddy Adam disagrees with you lol
if it wasnt clear you are a Novocure inside men its clear now. What I do puzzle with is why dont you come forward and just say that you are.
Good quote
Mark Twain realized that some need to be informed of the immense lies that a few are trying to mislead others with. So therefore I exchange with some fools to correct them and put the truth out. Mark Twain would have appreciated those that protect others who are easily misled by lies. That's the kinda guy Mark was.
Then let me quote Mark Twain for you
“It's easier to fool people than to convince them that they have been fooled.”
sorry to hear you can't handle FACTs from FICTION. Are those 1.2 billion naked shorts here with you now in the room?
This is what is happening to many biotechs over the last few years its a common trap, and NWBO was not the only one. As a matter of fact, I wrote about this phenomenon 14 months ago and was of course shut down here.
Longs load up on anticipation of TLD, then an attack on the SP after positive TLD, Longs then panic and start selling to pocket their gains from the last weeks in anticipation of TLD. Short sellers who started the panic cover their short position. I read an extensive article about it in Yahoo Finance two years ago. It works really well because many longs think they can have a nice gain after TLD and there are no longs who want to buy after the fact of TLD.
First, did you see cancer in plural form?
Second, what's your point? Are you trying to say DCVax-L is not working on other solid tumors?
Im fairly confident they are in a rolling review, at least that is what I have heard. Therefore the moment they added, changed the last info or scanned the last page or whatever they are doing to the million/million and a half pages of the MAA application they can submit it which at the same time is then accepted by the MHRA since its a rolling review.
So application submittal of the application IS the same as acceptance by the MHRA.
Thanks to Senti who duck up the old PR
1. DCVAXL has in ancient history treated patients with DCVAXL for other indications than GBM
https://www.biospace.com/article/releases/northwest-biotherapeutics-conducting-ovarian-cancer-clinical-trial-with-dcvax-r-l-at-university-of-pennsylvania-first-patients-enrolled-and-being-tre/
Northwest Biotherapeutics Conducting Ovarian Cancer Clinical Trial With DCVax(R)-L at University of Pennsylvania First Patients Enrolled and Being Treated
dropdown menu from 23 Jul 2011 - 30 Dec 2019
and with that undeniable fact provided by way back machine, this myth has been busted.
"DCVax-L can potentially apply to any type of solid tumor (multiple other cancers treated in compassionate use cases and a prior small pilot trial."
Dude,
NWBO many years ago already treated different patients in a DCVAXL Phase 1 and 2 for different cancer indications. That's what Dr Bosch here is referring to. NWBO does NOT have the right to sell DCVAXL outside GBM for other cancer indications.
Know your NWBO history.
dude thats from the P2 trial from literally 10 years ago
Thermo's brother has been treated for prostate many years ago
https://nwbio.com/dcvax-prostate/
Now I literally have to quote Page 4 to dismiss this ongoing BS. I have better things todo
• DCVax®-L is comprised of autologous dendritic cells (DCs) loaded with
autologous tumor cell lysate
– Uses dendritic cells, which are the master cells of the immune system
• DCs instill both targeting and direction of the response
– Uses tumor cell lysate to ensure a broad-spectrum immune response against
multiple antigens
– Uses lysate from patient’s own tumor to ensure correct antigens targeted
• DCVax®-L treatment is intended as adjuvant treatment following surgery
• DCVax ®-L has been used to treat ~600 patients with GBM, and tens of patients
with other cancers
• Phase III trial showed association between DCVax-L treatment and extended
survival (L. Liau et al., JAMA Oncology, January 2023)
• Manufacturing takes 8 days, and produces several years of doses, which are
cryopreserved. The personalized doses are then “off the shelf” throughout the
treatment regimen.
Someone keeps citing the 21st Century Cares Act as evidence that this can be approved in all solid cancers incorrectly. You need trials period. That all solid cancers talk without trials is just absurd. You can go apply for the RMAT or Break Thru and run some biomarker driven trials or single arm cohorts or even basket trials, but again you must run trials to get approved in other indications. That dude's credibility just goes out the window each time he repeats this nonsense.
I provided you with a reliable source that disputes your claim and this is your best response?
No source no quoting of a RA regulation Just your "trust me I know better". Well, news for you no one relies on the "trust me bro" source. Provide a reliable source where it can derived from NWBO has been granted the right to sell DCVAXL for other cancers for compassionate use than GBM. I'm waiting.
but this slide deck presented yesterday by Marnix Bosch at ASCO (as interesting and thorough as it is) is going to do very little to convince the average, rank-and-file ASCO member to prescribe DCVax-L to patients with glioblastoma after DCVax-L has been approved.
I replied incorrectly my apologies. What I am saying is that just because they added this form https://nwbio.com/patient-inquiry/ without any PR doesn't mean that somehow they now have permission to, without any new trial, offer compassionate use for all solid tumors. They just dont have that permission
https://www.ema.europa.eu/en/human-regulatory/research-development/compassionate-use
The medicine must be undergoing clinical trials or have entered the marketing-authorisation application process and while early studies will generally have been completed, its safety profile and dosage guidelines may not be fully established.
But then it disappeared again from the NWBO website. Look it would be awesome but when it comes to NWBO I am on a first believe then see basis
No the evil shorts are somehow withholding Linda to file a request for approval. No idea how but Damm you shorts grrr
Holy moly. Did the fulltime NWBO CTO attempt to change something about MWBOs website??
That is huge. It failed but still huge, ;)
The post you're commenting on said end of 24, not 23, that's 19 months
Far too conservative - I believe $NWBO market cap will be stable above $30B by end of 2024.
there is no long that appreciates dilution, fall of stock price, and slow as mud deliveries.
And if a long appreciates dilution, low SP, and slow delivery by management he/she should check in with a self-mutilation clinic
To be fair the market in general for non revenue biotechs for years now has shifted from awarding the binary topline data event to show me the money events such as approvals or licensing or rumors of buy out. That’s not just NWBO.
The only problem with this is you are relying on this mgmt team to be able to actually submit and reply successfully to the RFI requests from two agencies. And not even knowing that the application needed re-work becuase they were scared to submit PR about BLA/MAA rejection. This may take a few years.
Please provide an alternative pharmaceutical compound or biologic that shares the identical mechanism of action as Trodelvy (Immunomedics ) in triple-negative breast cancer and exhibits a similar therapeutic response. Can you?
And while you add it, please provide a quote in any of my posts where I claimed DCVAXL is not effective and unique in the treatment of GBM, which I never claimed. Can you?
I just wish I could still accumulate on Monday.
It's not a claim. It is a fact as reflected by the data.
all nonrevenue cancer drug biotechs and their shareholders claim their platform is the best of the best unique and groundbreaking, one-of-a-kind, never seen before bla bla bla. Immunomedics claimed they were incredible and unique and their shareholders said it
NWBO shareholders saying it is no different.
I will say it too if that will x10 the SP :)