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🔑So, even though I did not ask for identity of any possible companies when I asked MHRA the status of their “swift approval process” and whether they were running pilot companies through it, MHRA converted my question into a FOIA.
I imagine I’ll get a blank stare response in “twenty days.”
Twenty days. 🤔
I guess you repeated yourself to have the last word, because I already countered that point.
I disagree. Instead the past did not have the
International Review Program which was instituted, in part, to unclog the MHRA’s other pathways.
Now they have IRP. Their other pathways will be freed up.
Regardless, even the accelerated 150 (maximum) day programs should start living up to their titles, because the international review program should have unclogged the queue they were in. I also surmise this will reduce the number of RFIs required.
(NWBO would not say, oh by the way, even though we are applying for 150 day (80 + (if necessary 60 clock off) + 70 if necessary), we are hoping to be selected for the incoming “swift approval process” pilot program (if it exists))
So here is my layman’s understanding. I could be wrong.
UK will dramatically unclog their independent review queue if companies approved in other jurisdictions shift their 2022/2023 maa applications over to MHRA’s International Recognition Program. This started January 1, 2024.
My hypothesis is that the independent “swift approval process” might be getting introduced as of January 1, 2024 as an as yet unrevealed hyper accelerated program, and is running pilot cases through its process at this time.
My hypothesis is that NWBO lined their application up to be in pole position (perhaps then getting chosen for swift approval process). My hypothesis is NWBO intentionally concurrently applied at the exact time Advent’s HTA license was granted/renewed after manufacturing inspection, and Advent’s commercial license was freshly granted just nine months earlier when the funding came in. See below.
The “swift approval process” along with the IRP included 10,000,000 pounds of funding, and I surmise most went to IRP (international review program) for more staff, but that by unclogging the independent review tract, this also benefitted the “swift approval process” where expert veteran teams can see through a high impact therapy application from start to finish.
In other words, IRP has freed up the U.K. independent accelerated processes.
Stonkmaster, much appreciated:
We are at the early stage of introducing a new process which has the potential to reduce timelines substantially. We will work with industry stakeholders to develop this process further. — MHRA January 2024
I guess I see the FDA doesn’t mind being second to U.K. for covid vaccine, CRSPR and probably Cancer Vaccine approvals. We might be seeing more cooperation between regulators as opposed to heated competition. UK looks like it is the one who takes high impact off beat innovations. That’s not a bad place to be for a very intelligent but smaller regulator.
I listened to some recorded public MHRA meetings recently, and they anticipate doing their own assessments about 60% of the time and IRP 40% of the time. My guess is that number will flip, but no matter, the UK is creating a fantastic niche.
I do think a swift process is possible.
1. Commercial manufacturing facility inspection/approval/granted fresh from March 2023.
2. HTA inspection/approval/renewal/granted concurrent with submission/validation of maa.
3. All electronic databases double checked prior to submission.
4. Final section of MAA edited by two different editors.
5. MHRA “swift approval process” announced by Jeremy Hunt in March 2023 for “high impact” therapies like ”cancer vaccines”, was located just two business days ahead of Advent’s (most advanced UK cell manufacturing facility) announcement of commercial license for its facility. It doesn’t take a genius to surmise the actual pass may have been concurrent
Anyway, my gut tells me the double editing, concurrent HTA/MAA actions, concurrent MHRA announcement/actions are somehow more than just a coincidence.
So, it could be, just guessing what happened, is that potential financiers did not want to make a deal unless they knew maa was accepted. However, upon finding it probably was, via court inferences of time, a deal went through. Now those shares being sold to others in market. I guess not who, but ihub board vacancies should allow some to guess.
Personally, I hear some longs praising buying opportunities, but from my perspective, it’s just getting harder to get up to the deal making PPS levels the same longs want.
Can’t wait to see some form of resolution. I hope this was the bottom.
So, neurolink just successfully implanted a telepathic chip that will allow humans to play video games, etc, with their mind.
If you think it was hard to have a conversation with someone buried in their iPhone, you ain’t seen nothing yet.
Thanks, although the incremental increases are starting to feel like:
Dripping water
Main article: Chinese water torture
What is called the "Chinese water torture" was a torture described by Hippolytus de Marsiliis in the 16th century that was supposed to drive its victim insane with the stress of water dripping on a part of the forehead for a very long time. It may also be characterised by the inconsistent pattern of water drips. There are no expert opinions on the true cause of torture in this method. — Wikipedia
Musk, musk….? He’s the cologne guy, right?
Don’t think it hasn’t crossed my mind.
According to:
January 2, 2024 email written by the attorney for Black, Boynton, Jasinowski, Malik, Powers and Goldman:
Over the next three months, the Company will be preparing for and undergoing detailed inspections of the contract research organizations (CROs) that managed the trial, the Sponsor, the Trial Master File, a number of individual trial sites selected by the regulator from among the 94 sites that participated in the trial, the GMP facility and manufacturing information. Our clients are heavily involved with that process every step of the way. I will be happy to provide more detail on what that process will entail during today’s call.”
January 4, 2024 email written by the attorney for Black, Boynton, Jasinowski, Malik, Powers and Goldman:
“I have also received confirmation that all of the Company’s senior management, including Ms. Powers and Mr. Goldman, will be devoting substantially all of their time to the inspection process over the next three months.”
Well of course not, as a robot droid, you’re lucky that way. Good luck on X! You’ll possibly be missed here by someone.
There is a reasonable alternative. Instead of off-label use, there could be many ECA trials in multiple indications with randomization but no placebos. If BP sponsors those trials, they could become very large and make L more accessible than difficult off label use permissions, which would require two levels of permission.
I can’t stress this enough, DCVax-l has been tested in one of the two or three most deadly and difficult to treat cancers.
There are historical reasons why they chose such a difficult cancer, wherein early thought but ultimately unfounded fears made them choose a location where medicine at the time thought L would be safer to test in what was considered to be an immune privileged (devoid) region — the brain.
Enough history. That choice to carefully prove impeccable safety, mechanism of action and improved efficacy, allows DCVax-l (and Direct) the near term opportunity to employ ECA and/or RWD to speed more therapy to more patients in many more cancer indications. Imo.
Anyway, that’s a partial/possible alternative to off label use.
Weeee, the preprint and likely forthcoming final on that combo trial interim analysis is/will likely be part of submission package’s additional supportive materials, but surprise surprise, your ihub unlearned comments won’t.
You are just confirming your willful ignorance.
QALY calculations are not being valued on the confounded number, they are being calculated on the ECA numbers. Which are the two current main endpoints.
Great, I’ll check on X to see where you went to. Thanks for posting here. Good luck out there.
Or better still, perhaps the same inspectors that signed in March 2023 (commercial) and December 2023 (HTA), in order to avoid redundancy. 🤞
They have explained it, you are just too willfully ignorant to understand.
You would be a terrible CEO. You know very well you don’t know what the 232 v. 99 is, but you do know, due to therapeutic efficacy and crossover, it is confounded (perhaps less than you think); and, for QALY therapeutic valuation and primary efficacy, the current main endpoints are necessary for obtaining two, as opposed to one approval with sufficient valuation. You don’t understand what returned censors may contribute to the original endpoint, and you are quite lucky you won’t have to post after (probable) approval to start the excuse train.
Moreover, the method of action correlates with survival, DCVal-l directed t-cells not only cross the blood brain barrier, they cross the tumor microenvironment to kill tumor cells, and they do so in large and broad spectrum numbers due to DCVax-l directed t-cell clonal expansion.
Yes, when you look at a few key events from last year, it seems like NWBO has timed, progressed and accomplished matters in order avoid RFIs on manufacturing and PIP.
Good news that people forgot about, because NWBO announced (very exciting news) maa submittal the following day. Advent HTA license renewal was confirmed granted on December 20, 2023 after September 8, 2023 inspection and Advent corrections. (Note: Prior grant was in October 2021 after an August 2021 inspection).
Manufacturer’s HTA license renewal is a good thing to have in one’s back pocket the same day you file your maa.
LAST UPDATED ON 20 DEC 2023
Advent Bioservices Ltd
LICENCE NUMBER
22694
LICENSED PREMISES
Advent Bioservices Ltd
DESIGNATED INDIVIDUAL
Cristina Trento
LICENCE STATUS
Licence Granted
SECTOR
Human Application
In the UK, an HTA license is required for the collection, processing and storage of human tissues and cells for medical purposes. This includes the tumor tissues used to prepare the lysate for DCVax-L products, and the immune cells that comprise the active ingredient of DCVax-L. Obtaining such a license required an application, inspection and certification process.
Which is worse?
An adulterated idiot, or an unadulterated idiot?
After the MHRA asked me for more specificity and links regarding their (March 2023 announced) proposed swift approval process for 2024 regarding high impact therapies (supposed to be faster than 150 day process), they have not gotten back to me again yet.
Just a little logic. I don’t doubt that management will be doing the following:
January 2, 2024 email written by the attorney for Black, Boynton, Jasinowski, Malik, Powers and Goldman:
Over the next three months, the Company will be preparing for and undergoing detailed inspections of the contract research organizations (CROs) that managed the trial, the Sponsor, the Trial Master File, a number of individual trial sites selected by the regulator from among the 94 sites that participated in the trial, the GMP facility and manufacturing information. Our clients are heavily involved with that process every step of the way. I will be happy to provide more detail on what that process will entail during today’s call.”
January 4, 2024 email written by the attorney for Black, Boynton, Jasinowski, Malik, Powers and Goldman:
“I have also received confirmation that all of the Company’s senior management, including Ms. Powers and Mr. Goldman, will be devoting substantially all of their time to the inspection process over the next three months.”
Found this DD regarding cement.
Well, I'm a cement mixer
A churning urn of burning funk
Yes, I'm a cement mixer for you, baby
A churning urn of burning funk
— James Taylor
Just keeping updates going.
And now….
$NWBO
(In my opinion, for now. These are just the expected 150 day process times for therapies. It could be on a faster or slower track)
DCVAX-L MHRA MAA TRACKER
40 days since submission.
40 days until Phase 1 of the assessment is complete.
52 days until the CHM meeting takes place.
110 (170*) days until Phase 2 of the assessment is complete and DCVAX-L is (probably) approved (with/if 60 day clock-off RFI*).
Fair enough. Part of Merck’s vaccine manufacturing capacity expansion may be for their incoming pneumococcal vaccine.
I see you’re calling yourself a shill now. Admitting you have a problem is the first step to recovery.
Some perhaps working together, whilst others swooping in to acquire before competition, like BMY just did on two therapies.
Again, that “personalized cancer vaccine” by Merck/moderna for melanoma, which I’ve already critiqued, is going to be manufactured by Moderna.
This then doesn’t explain Merck’s major foray into expanding vaccine manufacturing capacity. (DD on expansion courtesy of Dstock)
How it’s done. Examples very recent acquisitions in other types of platforms.
Interesting article.
https://www.fiercebiotech.com/biotech/bms-won-out-against-other-pharmas-bid-rayzebio-just-days-after-competing-karuna
Aasaeeeehoooooliiiiixuuuuu.
So now you’re betting on 2024? It’s not like shorting and going long ex. You can’t cover one bet not to post with a bet on the opposite prospect so that you can post.
Aaaasoooooeereediiiiiuuuuuuu.
Pardon, I’m working on my whale call.
Aasasooooojeereeegiiiiuuuuuuuu.
🐳 🐋