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Were you randomized into the trial. In other words, were you assigned to start vaccine treatment before you left the “study.”
Yes or no?
Ours, earlier:
https://patentscope.wipo.int/search/en/detail.jsf?docId=WO2021071977
Theirs, later:
https://patentscope.wipo.int/search/en/detail.jsf?docId=WO2021102057
My guess is we in-licensed theirs as a precaution.
I think we filed in July 2020 and Children’s Medical Center Cororation filed in November 2020. We also had priority data ahead of them in 2019.
My guess is we in-licensed their IP in 2023.
(Again, referencing Hyperactive Dendritic Cells) Next Generation.
If granted, patent might go out to 2040.
Hyperactive Dendritic Cells. IMO.
In-licensed, imo. We had/have a parallel patent application for this with a separate institution. I wondered what was going on with that, and now it makes sense.
He found it on page 5 of the 10k. Middle of page.
Remembering Temodar can suppress the immune response, and in particular, incapacitate the t-cell response, I am not surprised that we will soon read the compelling case study below showing DCVax-l impact with immune enhancing diet.
Red_Right_Hand
Re: None
Tuesday, 03/05/2024 6:09:27 PM
New peer-reviewed publication already accepted:
"a patient with an enormous (14 cm.) GBM tumor of which only half could be removed by surgery and the remaining half regressed with treatment by DCVax-L and nutritional support for the immune system (case study accepted for peer reviewed publication)."
https://www.otcmarkets.com/filing/html?id=17343766&guid=58d-knzRuvJzB3h
They are talking about 2023 as conditions were then.
Continued.
You’re welcome.
Now ask yourself, why did they say they will continue to monitor timelines.
05 March 2024 A meeting was held between NICE and the company in early-February regarding next steps for the appraisal of DCVax-L for treating glioblastoma, and more information WILL BE AVAILABLE in due course. NICE will continue liaising with the company and “monitoring timelines”. — NICE
We aim to publish final guidance (regarding appraisal timeline) for all new technologies within 90 days of receiving marketing authorisation (regarding MAA timeline) — NICE
You are trying to correct something that was correct in the first place. It said “appraisal.”
Continued: Got it? Now read this with a more discerning eye.
Status In progress — NICE
05 March 2024 A meeting was held between NICE and the company in early-February regarding next steps for the appraisal of DCVax-L for treating glioblastoma, and more information WILL BE AVAILABLE in due course. NICE will continue liaising with the company and monitoring timelines. — NICE
3.1.5 If possible, NICE informs consultees and commentators about timeline changes during an appraisal and the reasons for these changes. Sometimes, however, if the reasons are COMMERCIALLY SENSITIVE, NICE cannot disclose the details. Nice works with the company to release as much information as possible to consultees and commentators, and on the NICE website. — https://www.nice.org.uk/process/pmg19/chapter/the-appraisal-process
National approvals were difficult for MHRA for a couple years after Brexit.
New target dates helped quantify this struggle, and allowed them to start tweaking guidelines to increase efficiency.
Now, because the IRP program is dividing international marketing application reviews away from the national reviews, national reviews are more focused with veteran teams.
Additionally, while funding has increased for the new IRP program and its staff, this effectively allows the national program to remain robust with smaller case review demand, thus speeding reviews, which is why we are suddenly seeing a dramatic shift. Imho.
3.1.5 If possible, NICE informs consultees and commentators about timeline changes during an appraisal and the reasons for these changes. Sometimes, however, if the reasons are commercially sensitive, NICE cannot disclose the details. NICE works with the company to release as much information as possible to consultees and commentators, and on the NICE website. — https://www.nice.org.uk/process/pmg19/chapter/the-appraisal-process
The NICE title changed from:
(Before) “DCVax-L for treating newly diagnosed glioblastoma”
(Now) “DCVax-L for treating glioblastoma”
to
It is also now designated as a single technology appraisal “STA”
Smart
Senti, you need to clarify your response was not talking about captain obvious.
No, hospital exemption and other compassionate use goes back further than a decade. To get the PIMS in September 2014, they had to provide months/years of data prior. We are well over a decade of established use of this medicine.
“Who cares what you say”? You are an ignorant poster not providing links to your own assertions giving an alternative definition of established medicine in your last sentence.
George Bailey said:
”The definition of established medicine includes medicine in use for 10 years with safety and efficacy making it established. I conclude since DCVax was not previously approved then the National established medicines rules regime do not apply.” — GeorgeBaily
BETHESDA, MD, September 16, 2014 – Northwest Biotherapeutics (NASDAQ: NWBO) (“NW Bio”), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, announced today that its DCVax-L is the first product to receive formal designation as a “Promising Innovative Medicine” (PIM) under the new “Early Access to Medicines Scheme” (EAMS) launched in the UK in April 2014. A PIM is the first step in a 2-step process for early access approval under the EAMS.
The PIM designation for DCVax-L covers all malignant gliomas, which would include both Glioblastoma multiforme (the most severe grade) as well as less malignant grades, and would include both newly diagnosed and recurrent gliomas.
The EAMS is an important new initiative in the UK, launched by the Medicines and Healthcare Products Regulatory Agency (MHRA, the FDA of the UK), to lead the way in accelerating patients’ access to innovative new medicines for serious diseases. Information about the EAMS program can be found on the MHRA website at: http://www.mhra.gov.uk/Howweregulate/Innovation/EarlyaccesstomedicinesschemeEAMS/index.htm
The first step under the EAMS is MHRA’s scientific evaluation of whether a product candidate meets three criteria for a PIM designation: (i) the product is for a serious disease or condition with high unmet medical need; (ii) the product is likely to offer a major advantage over treatments available today; and (iii) the potential adverse effects of the product are outweighed by the potential benefits.
“Extremely rare” is my point.
Not my point.
Sounds like you have not read the latest on National established medicines. MHRA wants to get to determination after initial assessment. If your argument were true, they could not do that because initial assessment would not cover everything. Moreover, if there is a “complete” response to the rfi (if one is issued after initial assessment), it goes to determination, not further assessment.
I just sorta scanned the nt-10ks. This is the first one Les signed. I don’t recall him signing any other 10q or 10k either. I could be mistaken.
I could be wrong, but I think this was the first
Nt-10k Les signed instead of LP.
DD was speaking about the phase I study, I believe. You are discussing the phase II study.
“…. will be filed on or before the fifteenth calendar day following the prescribed due date;” — 10k
Hmm? Wasn’t thinking of you at all.
But if your quote today below is you “defending” NWBO, I’m glad they have Cofer and Posner as backups.
FEMike said:
NWBO is OTC is honestly doesn't care about regulatory requirements. They pretty much just do whatever they feel.
The material weakness is a nothing burger.
What’s funny is that they needed to go with the “Monte Carlo” valuation method.
Only on Wall Street.
So, correct me if I’m wrong, but it appears, and I don’t mean to speculate too much here, that the nt10k was filed on Friday, March 1, 2024.
This also means, and you can drop me in a vat of two buck chuck if I’m wrong, that NWBO filed as a large accelerated filer.
Oh, it also means they did care about following SEC rules.
It’s still Friday there as well.
It’s still Friday where I live.
Says the basher who thought nothing was going on between NICE and NWBO. SMH.
NWBO was a listed sponsor in the Phase I DCVax-l + poly-iclc study.
You overstated/mistated most of what I said.
Because linking the relevant entire tweet was considered off-topic by admin.
Recent movement. (Update)
1. Combination patent application in Europe to be granted, includes both DCVax-l (lysate pulsed) and/or DCVax-Direct (partial maturation) with checkpoint inhibitors.
2. 72 days since MAA was filed.
3. MHRA and FDA looking at further cooperation.
4. Nature Journal article on DC/poly-iclc combination study nearing publication. Primary completion date for study occurred nearly thirty days ago.
5. Active negotiations with other parties for combination trials going on for over a year, awaiting MAA to be “cemented.”
6. Large pharma struggling to adapt to upcoming patent cliffs.
7. Cohen/Milstein/Posner about to file second amended complaint, and with it, formulaic method to arrive at loss causation.
8. Flaskworks (aka: NWBO) continues IP momentum.
9. Advent hiring head of production to hire team to facilitate biotherapeutic production for clinical use. (Direct?)
10. FDA pursuing Promising Pathways.
11. Apparently NICE has been working with NWBO recently, and it anticipates an update on the topic website in the next week or so.
12. The End Brain Cancer Initiative (EBCI) Advocates for DCVax®-L to Gain FDA Approval
13. 10 Minute Rule Bill passed in UK for the 3,200 people who are diagnosed with a glioblastoma brain tumour every single year