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Agreed.
Though I was also thrown off by the fact that I think I replied in a previous sarcastic post (not yours) and that kind of started a snowball.
Yes.
It could have been even faster though. Per leaked documents disclosed by Secret Squirrel, the MHRA intentionally delayed it a couple months because the sponsor PR'd that the MAA had been validated.
Yes, perhaps before he learned the MHRA discourages PR's on validations.
It is YOU that NWBO (DI) is very angered with not me for your BS.
Perhaps the reason is that patients are now using Trodelv for the indication (approved a few years ago), and not Dasatinib as the trial was using?
I have no opinion either way on that, but it would be a very reasonable why MD Anderson could not recruit.
But why did nobody want to partner DC Prostate and run the trial with their cash? NWBO has made clear they were willing to partner it for the last 15 years or so.
Does BP have no money? Did NWBO prefer the asset just go to waste than take something like $20M up front $100M milestones and royalties? Certainly if it was anywhere near what longs assert BP would gladly pay that to push the P3 ready trial.
And now the asset is worth nothing having long since been off patent.
And Direct is starting down the same path. Already 10 years since the last patient was enrolled in a Direct trial. Hope they have a good cleaning crew so the cob webs are not getting to bad.
BTW, for anybody who cares, DC prostate results as reported. 1999
Who is producing the vaccine???
They must be anticipating some income in the near future.
For all those who keep asserting that anything DC related is NWBO.
Start by reading this article on the first 1000 DC vaccine trials
Not everything in the space is NWBO
Roswell and NWBO are both on the organizing committee at this event:
There have been many trials injecting DCs that are not yet activated "directly" into tumors over the last 3 decades. The process of growing the DCs from monocytes is similar, though of course minor variations.
So far, none have advanced to P2s.
I think you miss the point. For something like 5M patients, a doctor trying to prescribe generic V will see it not approved as only V is.
The insurance front has always been the battle that AMRN needs to win for US sales. And now a skirmish is won. Hopefully more to follow.
You can deny reality all you want, but it is a fact that MHRA approves few new drugs on their own.
Per this MHRA document correctly cited by Hoffman, the MHRA has approved 7 initial drugs in 2023 (through Nov) that did not rely on other RAs. THE FDA has approved 55 novel drugs and all based on their own analysis.
The vast majority of MHRA approvals are via reliance on EMA approvals. That is just a fact.
Longs can hype all they want the nonsense that the new program by MHRA to accelerate approvals for drugs others have already approved helps the -L cause, but anybody who does not need Chat GPT to function knows it is BS.
If that is true, then why bother to ask for an extension?
Charles Schwab is once again trying to secure shares to lend for short sales.
Re: Hoffmans chart showing the average MHRA approval time for new national initials is over a year.
Hoff notes the MHRA performance report for 2023. He correctly notes the chart on page 11 as being what counts.
The solid red bars show time to approvals for that month. The solid blue line is number of approvals that month (scale on right)
As can easily be seen there were 7 approvals.
1 approval in March, about 360 days.
1 approval in May, about 420 days.
1 approval in Aug, about 400 days.
2 approvals in Oct, median about 360 days.
2 approval in Nov, about 350 days.
➡️MHRA Validation & Approval Timelines⬅️$NWBO
— hoffmann6383 (@hoffmann6383) December 26, 2023
Validation Timeline:
See Prior Post. 4 days (mean) to 7 days (90%).
Approval Timeline:
2020 Time to Complete Assessment, New Marketing Authorisations - UK Only [1 & See Image 1]
2021 Time to Complete Assessment, New… https://t.co/KczzKK09i9 pic.twitter.com/x2QnYhnWlw
Does anyone know what happened to Dr. Bala? He seems to have disappeared and is not listed as a moderator as well.
Great. Now if they can file amended complaint be next week
Huh? This just means the MTD being granted comes quicker.
Once that happens team NWBO will be on the clock again to resubmit a new complaint. 2 months?
I would be interested to learn in case someone knows, if any of the 30 asterisked transactions occured on May 10th?
Not true...The MHRA is okay with a company PR'ing the submission and NOT okay with a PR on validation...
Per your quote, FINRA did not remove the FTD data. They took MMTLP off the SHO lost because the rules are different for reporting companies.
You yourself published the MMTLP FTD numbers a few weeks ago., They were almost nothing.
The MMTLP story was foolish retail investors being played by scammer asserting there would be some sort of squeeze when in reality there was always to be a single dividend payment of all assets and the stock would be cancelled.
...because SOC no longer was fit for purpose or because of Fraunhofer’s claim that enrollment only occurred to the point statistically necessary.
That (pathway B) is still a plan whereby the MHRA will approve faster for drugs already approved ex-UK.
In one post you assert nobody is pushing that nonsense of it applying to -L, and in the next you yourself push it.
There is no leeway in plan B for the "approved by others" point.
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.
So you really think the FDA now has a secret pathway that approves drugs faster because the MHRA announced they will approve faster based on other countriies' approvals?
I think I will wait for the FDA to announce it first.
The MHRA does mot assert others are doing such. They say others could do it.
Just the expected response from NWBO sayin g no extension is needed.. Along with a fairly reasonable note that if there is an extension, it applies to NWBO also.
Re: Northwest Biotherapeutics Inc. v. Canaccord Genuity LLC, et al.,
No. 1:22-cv-10185
Dear Judge Woods:
We represent Plaintiff Northwest Biotherapeutics, Inc. in the above-captioned action and
write in response to Defendant Citadel Securities LLC’s letter (ECF 138) requesting a 30-day
extension of the deadline for Defendants to object to the Report & Recommendation (“R&R”)
issued by Magistrate Judge Stein (ECF 137).
Plaintiff does not believe an extension is necessary or warranted, as Defendants have long
been on notice of the exact issues covered by the R&R. The Amended Complaint, to which
Defendants’ motion to dismiss and the R&R is directed, was filed nearly nine months ago on April
10, 2023 (ECF 95). Defendants filed their motion to dismiss three months later on July 12, 2023
(ECF 114, 115), Plaintiff’s opposition was filed on August 25, 2023 (ECF 123), and Defendants
replied on September 27, 2023 (ECF 124). An extensive oral argument was held before Magistrate
Judge Stein on November 14, 2023.
Defendants claim that an extension is needed for them to coordinate among themselves,
but Defendants’ army of lawyers – seven firms and twenty-nine counsel of record – are more than
sufficiently equipped to timely respond to the same issues in the R&R that they briefed and argued
months ago.
While Plaintiff opposes an extension of the current briefing schedule, to the extent the
Court grants such an extension, Plaintiff respectfully requests that any extension of time to file
objections to the R&R apply to all parties, not just Defendants. The alignment of all parties’
deadlines to file objections will ensure that those objections, and any oppositions thereto, are
coordinated on a single schedule.
From the MHRA Guidance
From 1 January 2024, the EC Decision Reliance Procedure (ECDRP) will be replaced by the new International Recognition procedure (IRP). The Mutual Recognition/Decentralised Reliance Procedure (MRDCRP) will be incorporated under the umbrella of IRP.
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.
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.
Team NWBO is free to file an amended complaint whenever they want. I doubt they would do so before the court grants the MTD though.
Today's request would delay the MTD decision by a month.
The clock starts when the complaint is filed. Given the R&R, NWBO will be submitting a new complaint. So any time delay prior to that is on NWBO.
As for an injunction, that is a joke.
I think it means that after submission (X days) it's assessed and if it's found to be valid, the assessment clock starts from the day of original submission.
The assessment timetable for new active substances and biosimilar products or existing active substances will begin after the validation of the application.
And just like that, the lawsuit discussion has vanished...
It will give assurance that application is complete and valid as I don’t have much faith in company doing so . So external validation will help to boost confidence in new investors
That [when 85M shares existed] must've been back in the phase 1 days.
You linked to the rules authorization to run trials, not approvals.
Other than that, I do agree the point of your post. Whatever one calls validation, it is clearly different than an ack that the submission was received. And is about 2 weeks. But not as hard date as the link for trials.
I believe that the company takes the position that the regulators do not look favorably on any type of public announcements regarding the status of the MAA with the MHRA until such time as something material happens (and that wouldn’t be that the MHRA is in receipt of the MAA).
Very likely that pattern from the AI is common.
In that case it did find a company that announced a MHRA MAA being accepted. But it matched it up with a more recent case of the same company getting a recent MHRA approval and presented that as the "answer."
In general anybody in this space knows that acceptance of an application (along with timeline update based on priority review) being PR'd is common. There are not as many examples in the UK for the obvious reason most companies do not bother to hype the UK market.
Well trial has ended and data locked years ago, so why can’t they elucidate the reason of hold or whatever name that was given for it, after being asked multiple times . What is the good argument . Please help us
With the MAA acceptance -validation cacophony now put to bed , let's move into the nwbo stock price.
Today , one of our md-phd friends reportded in. He's chomping at the bit to have his prostate cancer clinic get on with a DCV VAX L-prostate trial .They are studying () to pick the best combo.
DCVax®-Prostate is designed specifically for late stage, hormone independent prostate cancer. Such cancer involves the spread of micro-metastases beyond the prostate tissue. In most patients, there is no focal tumor which can be surgically removed and used to make lysate, or into which dendritic cells can be directly injected.
What is ironic is that many longs were arguing that submission would not be PR'd as they would wait for acceptance (validation).
Me thinks many "longs" just prefer that NWBO say nothing so they can pump fairy tale stories.
Not quite sure why people who want to pump the PPS in order to sell are actually "longs", but whatever.
She's the one that has gotten us this far and from the start I would add.... .
we are on the cusp of product approval thanks to her....
Biologic protection from biosimilars is 10 to 12 years.