is...Long
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I personally believe they will be forced to act eventually, the trouble is that the corruption runs so deep. Griffiths practically bragged that he should be allowed to continue his fraud with impunity as it would be detrimental to the market working efficiently. The trouble is having the necessary will and leadership to clean up the mess, I am not sure if it currently exists in the US, far too many are making fortunes as a result of the status quo and unlimited funds to lobby ensuring laws and Regulations are held at bay. Look at what happened with the recent propesed SEC changes to regulate shorts, they were instantly challenged in court. The crooks will not give up their fortunes easily.
Bio99's twitter post makes an interesting point.
"If you wanted to create massive synergy with $NWBO DCVax, what would you want to do? Answer: you’d want to give a drug that strengthens the interaction between T-cells and the tumor antigens presented by dendritic cells. That’s what Harpoon Therapeutics makes, which is being bought by Merck, probably tomorrow, according to Reuters… makes you think, no?" https://reuters.com/business/healthcare-pharmaceuticals/merck-talks-buy-harpoon-therapeutics-around-700-mln-bloomberg-news-2024-01-08/
Some notes on Harpoon therapeutic's technology:-
T CELL ENGAGERS INDUCE TUMOR KILLING INDEPENDENT OF MHC-PEPTIDE RECOGNITION
T cell engagers, or T cell-engaging bispecific antibodies, is a new therapeutic modality in the fight against cancer. T cell engagers are engineered proteins that redirect T cells to attack targeted tumor cells. They work as adaptors that transiently connect T cells with their target cells for redirected tumor cell lysis.
Unlike most other immunotherapies, T cell engagers allow binding of T cells to tumor-associated antigens. This way, redirected lysis by T cells becomes independent of T cell receptor (TCR) specificity and recognition of major histocompatibility complex, or MHC, expression. Loss of MHC expression is a frequent mechanism by which cancer cells escape T cell recognition.
https://www.harpoontx.com/science/
https://twitter.com/BIO99_BIO99/status/1744246095142957543
Probably because the 'Most Liked Posts (Last 30 Days)' section is incorrect and not recording the data correctly.
It is worth noting that within the criteria for Recognition route B there does appear to be some leeway for Regulator discretion and "exceptional circumstances" that may or may not apply including:-
The fact that GBM is designated an orphan disease
GBM is a cancer rated as 'unmet need'
DCVax®-L being designated PIM by MHRA
And let us not forget, The PIP was fast tracked by MHRA using the same trial design as the P3 trial. 🤔
'Food for thought'.....
Key features of Recognition B:
To be eligible for Recognition B, the RR approval should have been granted within the previous 10 years. A CHMP positive opinion or an MRDC positive end of procedure outcome is an RR approval for the purposes of IRP
IRP applications will follow Recognition B if any one of the following criteria applies:
RR has granted a conditional or exceptional circumstances MA (or international equivalent).
A conditional or exceptional circumstances MA is sought in UK/GB.
Additional manufacturing sites are cited that have not been assessed by the RR (except for secondary packaging, labelling and QP release sites).
There are substantial changes in the manufacturing process or analytical methods compared to what was assessed by the RR.
At least one manufacturing site is not yet GMP certified.
The Environmental Risk Assessment (ERA) has not been assessed by the RR.
The Risk Management Plan (RMP) has not been assessed by the RR.
There are UK-specific risk management activities (e.g., which may be reflected as additional pharmacovigilance or additional risk minimisation activities).
The RR has mandated one or more post-authorisation safety studies (PASS).
The product contains a first-in-class new active substance.
The product incorporates novel or cutting-edge technologies.
Clinical efficacy or safety data are available for a later cutoff than those assessed by the RR.
The pivotal clinical data are from single arm studies.
The pivotal clinical data include real world data.
Advanced therapy medicinal product (ATMP) as classified by the HMRs 2012.
Fractionated plasma product.
Application for orphan drug designation.
Comparator product used in bioequivalence or therapeutic equivalence study was sourced outside the UK/EU/EEA (generic/hybrid applications).
Product is not subject to medical prescription.
Co-packaged medical device components are not CE or UKCA marked.
Where an IVD is required for correct use, the IVD is not CE or UKCA marked.
An approved body or notified body report is not available for integral medical device components.
The RR assessment cites guideline(s) that are not adopted by the MHRA.
Proposed container closure system, shelf-life or storage conditions differ compared to those accepted by the RR and/or additional stability studies have been provided to MHRA.
Recognition B procedures will run to a 110-day timetable from validation to allow for consultation with the Commission on Human Medicines (CHM). Submission dates for Recognition B to align with CHM dates for New Active Substances (NAS) are below:
https://www.gov.uk/government/publications/international-recognition-procedure/international-recognition-procedure
Let us take a closer look at Ex's B/S
"ECDRP and MRDCRP submissions received before 1 January 2024 will be processed under the existing practices. For ECDRP applications, the Committee for Medicinal Products for Human Use (CHMP) positive opinion (but not necessarily the European Commission Decision) should be received before 31 December 2023"
Nobody has said anything about NWBO accessing these procedures so B/S and irrelevant, again just trying to spread FUD with nonsense as usual.
https://www.gov.uk/guidance/european-commission-ec-decision-reliance-procedure
https://www.gov.uk/guidance/decentralised-and-mutual-recognition-reliance-procedure-for-marketing-authorisations
"IRP will be open to applicants that have already received an authorisation for the same product from one of MHRA’s specified Reference Regulators (RRs). A CHMP positive opinion or an MRDC positive end of procedure outcome is an RR authorisation for the purposes of IRP"
Again totally irrelevant, after MHRA approval when we will meet the criteria of being approved by one of the partner agencies (MHRA) we will be using the procedure to (IRP) to apply to all the other partnering agencies, as Julian Beach, MHRA Interim Executive Director of Healthcare Quality and Access, said
"In return, our partners can consider applications based on MHRA authorisations, creating a ‘win-win’ for regulators, developers of innovative treatments, and patients".
https://www.gov.uk/government/news/mhras-new-international-recognition-procedure-irp-goes-live-from-1-january-2024
Totally agree and would also meet LP's comment about being "strategic" with approval applications.
WOW your pathetic attempts at FUD are worsening. This is totally irrelevant to the fact that WHEN we receive MHRA approval we can then apply to use the IRP procedure
"Regardless of the submission date, this does not change the process in the UK as -L is not approved by any of the other RAs"
IRP is not a temporary procedure, NWBO will not be attempting to access the program until MHRA approves DCVax, your B/S comment is exactly that.
"For other countries that follow later we will have to see what they do"
Can you read the guidance and procedures, or are you just ignoring it to suit your agenda (as usual)? "For other countries that follow" yeah right
The guidance lists the specific countries signed up to this program as I have posted and as you are well aware, your B/S again is ignorant of the facts
Honestly, I personally believe your posts were never credible but please get with the program and improve your game, your responses have become a joke. get a grip!
https://www.gov.uk/government/publications/international-recognition-procedure/international-recognition-procedure
"At launch, the MHRA will partner with regulators in Australia, Canada, Japan, Singapore, Switzerland and the USA, as well as the European Medicines Agency, individual EU member states and those in the EEA (European Economic Area)".
There are some truly interesting prospects here, not just that Australia, Japan, Singapore and Switzerland are additional to the initial four RA's we were expected them to sumbit to but it would include the whole of the European Medicines Agency, individual EU member states and those in the EEA (European Economic Area)". and all potentially on an accelerated basis as part of this program. WOW
Potentially huge as the MHRA approval could 'open the floodgates' for accelerated approvals to all of these other Regulators.
I cannot see any problem following the guidance once we have MHRA approval leaving us free to start the process. The following is also a requirement:-
"The Applicant/MAH must be established in the UK (Great Britain or Northern Ireland) or in the EU/EEA"
which of course we are as a company registered in the UK:-
https://find-and-update.company-information.service.gov.uk/company/09103355
Guidance
International Recognition Procedure
Updated 5 January 2024
https://www.gov.uk/government/publications/international-recognition-procedure/international-recognition-procedure
Read the followiing extract:-
"IRP allows us to access the expertise of trusted regulatory partners, who have already authorised products. In return, our partners can consider applications based on MHRA authorisations, creating a ‘win-win’ for regulators, developers of innovative treatments, and patients"
So, when we receive MHRA approval, we can apply under the IRP for submission to IRP partners
"At launch, the MHRA will partner with regulators in Australia, Canada, Japan, Singapore, Switzerland and the USA, as well as the European Medicines Agency, individual EU member states and those in the EEA (European Economic Area)".
https://www.gov.uk/government/news/mhras-new-international-recognition-procedure-irp-goes-live-from-1-january-2024
Exactly my take as well as I posted on twitter below
"Common sense should prevail! The company has to tell us if the application is unsuccessful, by law. 'No news is good news'
#dcvax #allsolidtumors $nwbo #gbm
— Peter Davis (@peter_brit) January 4, 2024
Common sense should prevail! The company has to tell us if the application is unsuccessful, by law. 'No news is good news'
Thanks for all your work in highlighting these patient's stories. I sincerely hope that anybody who wins the Tesla will give it straight back to them to raise more funds.
So sad.
— Peter Davis (@peter_brit) December 30, 2023
Sam's story and crowdfunder page..
"DCVax-L which is available in the UK through Northwest Biotherapeutics"https://t.co/v80feC4Rsthttps://t.co/s9e9AVx5Va
#dcvax #allsolidtumors $nwbo #gbm
— Peter Davis (@peter_brit) December 30, 2023
Some interesting presentations by Steven Brem:-
Friday, January 26, 2024
CME/CNE-accredited
patient & caregiver program
7:30 am - 4:00 pm EST
In person or virtually
Progress in “The War on Cancer” Innovation and Scientific Breakthroughs… pic.twitter.com/1XHUtdvmXW
#dcvax #allsolidtumors $nwbo #gbm
— Peter Davis (@peter_brit) December 29, 2023
Excellent post by @d_stock07734
I believe the inclusion of Murcidencel (AKA - DCVax) to the high cost drugs list proposed for 2024/2025 to be significant as it shows consideration for pricing for DCVax is at an advanced stage.
I have… pic.twitter.com/xMGhlIRx0e
"taking some additional time to help ensure that the full MAA package is as strong as it can be is especially important since the Company plans to submit applications to multiple regulators"
The company thought it prudent to mention the submission to "multiple regulators" in a pr about delays to MHRA submission, it appears the other submissions were foremost in their plans after MHRA submission.
"Sure, there is. It would be a waste of time to begin work on other submittals until NWBO gets an indication from MHRA that the submittal to them is good"
I do not agree at all, in fact it would definitely be a "waste of time" if they did not.
In the company statement
"taking some additional time to help ensure that the full MAA package is as strong as it can be is especially important since the Company plans to submit applications to multiple regulators" There was no IF the MHRA submittal is good. In fact, as the company has stated they are to be "strategic" it would make more sense to have multiple applications in so as not to have 'all eggs in one basket"
https://nwbio.com/northwest-biotherapeutics-provides-update-on-near-term-plans-for-submission-of-marketing-authorization-application/
Based on many factors (frequently discussed) the chances of MHRA approval are extremely high however, IF the MHRA application failed and we did NOT have other approvals pending, I believe the chances of us surviving would diminish massively. I personally cannot see the company sat waiting for potentially anything up to 150 days for approval of MHRA BEFORE they submit to other RA's and then what ? wait the same or even longer before the next submission etc etc ? I simply cannot see it happening, just IMO
That would be "strategic"
Yes I do firmly believe this. There is absolutely no reason for them to not work towards submitting the three other applications. Nothing to lose and everything to gain. To be fair to them it has only been 4 days since first submission and there has been holidays in between however, The extensive work that was done to finish the MAA application is finished. The completion of the necessary supporting documents also serves to make up the majority of documentation required for the other RA's submission requirements IMO. I believe just some minor 'tweaks' will be necessary and therefore not take much time to achieve.
LP stated the following:-
"taking some additional time to help ensure that the full MAA package is as strong as it can be is especially important since the Company plans to submit applications to multiple regulators"
https://nwbio.com/northwest-biotherapeutics-provides-update-on-near-term-plans-for-submission-of-marketing-authorization-application/
I believe this is testimony to the fact that the MAA package will indeed make up most of the submission for the remaining regulators. Again there is IMO no reason to delay these submissions. Another consideration is that LP stated the company would be "strategic" with the approval applications and there are a number of ways still possible to expediate these submissions.
Doc, it's simply the case that "by fall 2024" it is more than likely NWBO will be approved by all four initial RA's (or very close to it), Ex is setting himself up with a timeline to exit as he knows damn well he will be laughed off the board spouting his nonsense as multiple approvals come in.
Merry Christmas $NWBO supporters, if you celebrate! Repeat, but a must. Looking forward to what @NorthwestBio brings in 2024 for patients and supporters! pic.twitter.com/kiZjLkmV5V
— Henry (@HenryMuney) December 24, 2023
Agreed. All longs should always reply with something like the following
"Usual B/S and lies posted repetitively by by paid posters trying to spread fear, uncertainty and doubt. All posting lies that have been well refuted and backed by evidence'
IMO the PIP was fast tracked for a reason I personally expect them to expedite the approval ASAP. There are 3 holiday days to take into consideration but other than that I truly expect good things from MHRA
Professor Ashkan is far better placed than any NWBO employee as he has frequent dealings with and insight of MHRA
All anybody can do is speculate however, worth noting that Professor Ashkan recently stated "we should know in a couple of months' (paraphrasing)
Agreed, they lie for a living
"The enigmatic financier, known for his vast wealth and astute investments as founder and CEO of the once Chicago-based Citadel"
Soon to be known for his criminality when NWBO takes this to 'Discovery' after MTD denial and with him already facing the illegal 'spoofing' charges.
Griffin has a lot to thank the US Government and it's regulatory bodies for his continued wealth generation. His complacency in having plans to spend such huge sums of money on himself is testimony to his greed. I just hope the same media outlets all report on his criminality when everything is revealed. Very obvious that we cannot rely on Regulators to take sufficient action so it is left to NWBO - "the little engine that could"
As ever completely pointless discussion to have unless further qualified and nothing more than speculative guesses. A random figure means nothing for example, I personally believe by the end of 2024 we will be approved in UK, USA, Germany and Canada, partnership (s) will be announced perhaps with upfront payments and milestone payments arranged and I expect we will have started on further trials including paediatric and Direct p2 trials. This is just IMO but shows IF these all happen then the pps will likely IMO be higher than $7.50, and this doesn't even address such possibilities as naked shorts or potential court settlements. Also, bear in mind we are most likely to be approved not just for nGBM but rGBM and potentially other types of brain cancers
Wow... you cannot escape the Israel connection.
"Ms Wolfe was on the board of the Israeli company that Roger Smith (who had a Cognate company laptop, not a notebook) was now working for"
and:-
Phase 5 author Julia Skripa-Serry, wrote the report whilst working for an Israeli hedge fund located less than 1 hours drive away from where the founder of Nococure lives (in Israel)
Lol.. I took early retirement when I turned 55 so everyday is like Xmas for me 🤣
I can assure you next week is just a normal working week in the UK. If it worked out that Xmas eve had fallen on the Friday some companies would have perhaps closed at lunch but as it does not, most will be working. Similarly, the week after, Wed, Thur and Fri will be normal working days for most.
I think it is hilarious that not being able to refute my statement the best NotSure2 can do is use the 💩emoji but that is about all they have nowadays, the 'writing is on the wall' as they well know 🤣
I see it as complacency. They are used to being allowed to 'get away with it' with Regulators just 'turning a blind eye' I think it suited the Regulators
when there was the debate on the existence of 'naked short shares' but as their own recent statements prove, they knew this was a fact all along.
Thanks for sharing your excellent post.
I also believe it is important to note the fact that the plan for two paediatric trials as part of pre-requisite for PIP approval was 'fast tracked' with the same trial design as the P3 trial.
"but is it not possible that the MHRA's decision on the Vertex treatment for Sickle Cell Disease preceding the FDA's positive decision by such a short time could be due to the 2 Regulatory Authorities having recently come to some some form of information sharing?"
Of course, MHRA and FDA collaborate all the time, here are just a few examples:-
https://www.fda.gov/news-events/press-announcements/fda-brief-fda-collaborates-health-canada-and-uks-mhra-foster-good-machine-learning-practice
https://www.gov.uk/government/news/mhra-and-international-partners-publish-five-guiding-principles-for-machine-learning-enabled-medical-devices
https://mhrainspectorate.blog.gov.uk/2020/06/30/mhra-and-fda-joint-paper-data-integrity-in-global-clinical-trials/
https://www.fda.gov/drugs/news-events-human-drugs/joint-us-fda-mhra-uk-health-canada-good-clinical-practice-pharmacovigilance-compliance-workshop
https://www.bmj.com/content/380/bmj.p633
#dcvax #allsolidtumors $nwbo #gbm
— Peter Davis (@peter_brit) December 9, 2023
Updated: Will the UK’s triple-pronged approach ease pricing, regulatory and financial bottlenecks?https://t.co/RfCrOX11pb