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NWBO has failed repeatedly on this issue, so no real reason to expect otherwise.
The last meeting was about 18 months after the previous. A few years ago they missed a financial year. They skipped calendar 2023. They are very close to skipping an ASM for a financial year.
Holding ASMs is basic corporate governance. It is not tied to when they have news to hype.
At least for legit companies.
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.
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
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
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.
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
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?
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.
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.
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.
From the MHRA Guidance
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.
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.
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.