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I had chemo for metastatic colorectal cancer and didn’t lose my hair. Not all chemo has that side effect. Where I had radiation, that was a different story. Fortunately, it did the job, but it’s not fun.
Yes, once again Ex states things as fact, like he’s some sort of expert. Following his line of logic, every GBM tumor is different, so each batch is unique and would require separate approval. Nice try Ex, but your bullshit doesn’t fly.
The only time I remember them PR'ing a patent was when they got a patent for using TFF (Tangential Flow Filtration) as part of their manufacturing process:
https://nwbio.com/nw-bios-patent-portfolio-further-expanded-with-manufacturing-automation-patent/
I for one didn’t miss you coming here with your stupid comments. What are you, 5 years old? Crawl back into the hole you came out of.
I believe this is one of the key patents that has been licensed, and provides an interesting read for those wanting to do a deeper dive into the workings and potential synergies this may bring to what NWBO already has,
https://patentscope.wipo.int/search/en/detail.jsf?docId=WO2018160666
I believe the EXCLUSIVE licensing deal makes revelation of the terms less sensitive, but do agree it is curious that they put that level of detail into the PR. I think it is a very good deal that could increase the market potential/efficacy by many times that investment and didn't break the bank. Glad to see yet another piece of the puzzle un-fold. Linda is playing chess and everyone else is playing checkers.
Kinda like some were poo-pooing the Flaskworks deal as nothing and it has turned out to be a pretty good one. Maybe NWBO knows what they need to complete the picture and is going after it with patience and perseverance. Time will tell.
Yes, I think that was a major selling point to inking this deal with really minimal outlay on the company’s part. Both parties have lots to bring to the party, but only NWBO/Flaskworks bring the technology to mass produce DC’s for commercial expansion at an affordable and maintainable rate.
“The Company believes that the infrastructure and systems it has developed, and experience it has gained, in producing and delivering personalized living-cell DC based therapies for large numbers of patients make it uniquely positioned to help accelerate the late-stage development of the licensed DC technologies.”
It’s about strengthening both. Paragraph 3 of the release states:
“The DC based therapies include versions with tumor antigens loaded into the DCs and versions for intra-tumoral administration without pre-loading of antigens.”
Why would the 10Q have stated two dates if there wasn’t some significance to each? I tend to believe the confirmation is what starts the clock. As many have said here, it doesn’t matter if the MHRA is not meeting their goal anyway. It will be approved when it gets approved. I’m tired of guessing games at this point.
In the guidelines in the link you provided, they state the following;
“The assessment timetable for new active substances and biosimilar products or existing active substances will begin after the validation of the application.”
In NWBO’s 10Q, they stated:
“On January 24, 2024 the Company received notification from the MHRA that the MAA had passed validation.”
In the Email response from MHRA today, they stated:
“The 150-day assessment timeframe begins from when the applicant receives CONFIRMATION that the MAA has passed validation.”
Furthermore, in the 10Q they stated:
“On March 7, 2024, the Company received notification from the MHRA that the validation was CONFIRMED.”
So, the clock starts on March 7.
Fidelity and Schwab both emailed me this past Friday with the proxy/voting link.
They have held it on Saturdays in the past. It allows some that still work to attend on Saturday.
Again, these are likely warrant exercises not private placements or other “sales” by the company into the market. Many of those warrants may be close to expiration as well.
My understanding was that Orphan drug status means no application fees. At least with the FDA.
While waiting for news, it's always reassuring to know that we have such talented team members driving this technology and continuing to enhance our understanding of the DCVax technology. This is a little dated, but it's interesting to note that Linda Liau considers DCVax to be her crowning glory of her very impressive career:
"What achievement are you most proud of in your professional career? Developing the first cellular vaccine (DCVax) for brain cancer."
https://poetsandquantsforexecs.com/students/2016-best-embas-linda-m-liau-ucla-anderson/
Let’s not forget, in addition to PIM designation, they also were able to undertake the treatment of a large number of patients under the Specials program in the UK which gives them additional data and experience in treating patients outside of the trial environment.
Think what you want. Might as well spread some more FUD while you’re at it.
I have tried to manage Asian workforces in a prior life. It is cheaper in direct costs, but it is a logistical nightmare to manage; especially in something as sensitive as living cell therapies. Also, I would not trust our IP anywhere in Asia at this stage.
EDEN is the way to go. Linda took the long-term view and I think it’s worth waiting for. Unlike some here, when Linda talks about franchising, I do believe that includes EDEN. We could very well distribute and control EDENs at Point-of-treatment or at other BP facilities to take control of MFG for specific indications/combinations. Most have some level of cryo storage they could take advantage of. All under the DCVax process patents and Flaskworks patents to prevent IP theft and ensure the proper royalties are collected.
I'm of the opinion that they have known for quite some time that the only way to meet the demand, be profitable, and make it affordable to patients and RA's was to have a highly automated way of making the vaccine. Without that, it would be a bespoke treatment that only the wealthy could afford. By meeting that challenge, I believe they are putting themselves at a very competitive advantage. I think they are going to give the CAR-T and mRNA vaccines a run for their money in terms of pricing, efficacy and safety once the EDEN units are in place.
As I mentioned the other day, most, if not all of these shares are probably warrant purchases. If someone has warrants that are due to expire, likely they are exercising. Or it could be friendlies who are just providing cash to the company by exercising their warrants. Some may be selling, but most are probably holding the shares waiting for a good squeeze.
It may also be exercise of warrants, not outright sales by the company. I’m sure warrant expirations are a factor.
UCLA is a research center and NWBO is a commercialization organization. They don’t have the funding as a small company to fund early stage research like UCLA can with grants, etc.
When the time comes to commercialize the combination, NWBO will be involved. Especially since Linda is now on their scientific advisory board.
I posted a page from UCLA’s website the other day that clearly stated in black and white that ATL-DC is DCVax-L. That is proof enough for me. I don’t need to waste time asking the company to provide same it writing. You’ll continue to ignore it anyhow and claim it is not. It doesn’t fit your narrative.
You missed the most important one:
Pembrolizumab and a Vaccine (ATL-DC) for the Treatment of Surgically Accessible Recurrent Glioblastoma
This phase I trial studies the side effects and how well of pembrolizumab and a vaccine therapy (ATL-DC vaccine) work in treating patients with glioblastoma that has come back (recurrent) and can be removed by surgery (surgically accessible). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Vaccines, such as ATL-DC vaccine, may help the body build an effective immune response to kill tumor cells. Giving pembrolizumab and ATL-DC vaccine may work better in treating patients with glioblastoma compared to ATL-DC alone.
Location: UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California
https://www.cancer.gov/clinicaltrials/NCI-2019-07994
It seems to me they booked the Industry Expert Theater closer to the actual event in the past. Maybe waiting to see if they have something they can share.
I agree, this should not be a controversial decision for them to make. It is the perfect candidate for their 150 day approval goal. A safe, effective treatment for an orphan designated candidate for a disease that has seen no improvement to SOC for almost 20 years.
NICE approval might be a little longer given the cost and potential improvements EDEN would bring.
Wrong again. inquiring, who I have on ignore responded directly to my message. So, take your insults elsewhere.
No, Inquirin shows as responding to my message directly. Wrong again.
Correct Gary. Poly-ICLC is approved by FDA for Squamous Cell Carcinoma. EX once again states something as fact that is not so. It would be off-label use, but assuming DCVax-L is approved, then it’s a matter of whether the doctor wants to risk prescribing off-label use of Poly-ICLC. Given the apparent safety profile of both in the sample thus far, that would appear to be a minimal risk to take.
You didn’t answer the question, but that’s OK. you’re on ignore anyway. Too bad ignores don’t work with replies.
Your opinions are not valued here, in case you haven’t gotten that message by now.
If DCVax-L is an approved biologic, and Poly-ICLC is an approved immune modulator, what’s to prevent a doctor to prescribe both treatments? Especially if there is strong evidence of safety in the combination of the two.
The only place I’ve seen that is on Twitter/x posted by Maverick. You’d have to ask him where he got that information. I find his shorthand posts very hard to understand and I’m not sure who he’s talking to sometimes. Maybe it’s me.
UCLA has done a lot of work around DCVax ( e.g. poly-ICLC, Keytruda). The FUDsters say, “ yeah, but it’s not DCVax”. We know that is not the case and it has been proven in black and white and also verbally by Linda Liau.
They then say, but Northwest isn’t the sponsor of these combo trials, so they can’t use the findings. So, I suppose the DCVax/CI combo patent is worthless then, right? Yeah, go with that.
They are running out of storylines and they are starting to panic. They have their FUDsters working 24/7 and have brought more resources on recently to try and drown out the positives that are becoming more obvious by the day. Tick-tick-tick…
Yes, and this is the only stock he chooses to spend all of his time on, even though he “doesn’t care whether we buy one stock or another”
What a bunch of horse manure.
The primary endpoint was PFS, and the secondary was OS. The hope was PFS would lead to an earlier approval possibility, with confirmation coming afterward on OS. However, given the issues discovered with PFS determination, they made the primary endpoint OS. And, given the issues with the control arm crossovers, they then moved to contemporaneous external controls. All of this was done before unblinding, and with the apparent agreement of the RA’s.
So, there’s that.
How do you square that with the finding that many of the long-term survivors had prognosticators that would have been expected to yield poor OS, including incomplete resections?
Oh, I see. So the play of the day now is that even if they get approval, NICE won’t reimburse for it. Ok, you go with that one. You guys are really funny! You apparently are the self anointed NICE specialist. You’ve been singing that tune since you showed up here.
Sounds like you had the same experience Senti. So it’s just transfers in then. Thanks for clarifying.
Sorry for the misinformation on this board regarding this. It was a bit of a cluster between Schwab and Fidelity at the time. Seems kind of a random rule for them to not allow transfers in, but allow buys.
Sorry, my mistake. Thanks for the info.