Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Funny, but I think the target audience missed the point.
So ARPA gives their fast grant to a consortium using mRNA technology to differentiate monocytes into DCs (as opposed to the old tech used by NWBO and hundreds others), and somehow this is good for NWBO?
Yes, AZ (a UK company) went first to FDA and EMA for approval. UK came with IRP where the MHRA rubber stamps other RAs.
For NICE, they are slow playing it as many do. Nobody wants to be forced to discount pricing (as all do for UK) before establishing the high margin markets.
Even a UK company basically does not care about the UK market.
In the Citron case, it looks like SEC had help from 1. Financial Industry Regulatory Authority.
Flipper, agree that this seems simpler bc — on its face — it’s a single issue to address vs all others already covered in the prior R&R, ...
u must be one of those short mfrs; otherwise you would understand what I am trying to do here;
Meirluc, Next month we'll be a lot closer to Flaskworks being "ready or almost ready", which is what I wrote, than we are today.
I like the hypocrisy.
Some non NWBO related company posts a trial that uses DCs targeting specific antigens and the board screams it cannot work.
Now that NWBO owns a DC targeting specific antigens it is the best thing since sliced bread.
FWIW, reality is nobody knows. Either way.
Well you are bringing FDA arguments, to a MHRA MAA decision.
Feel free to ignore me,.
The only thing your posts are good for is for my crickets to use them in training classes.
How could MAA be rejected? This is no such possibility.
Yes, it was a request but you’d have a difficult time explaining why this wouldn’t be considered an unmet medical need, which would fall under the 150 day process.
I have been saying this for long time . When I suggested she should have given 50% stake 10 years ago for 1-2B , everyone called me fudster . The remaining 50% would have been worth a lot more by now
They will need more true ups now
The recruitment status is a mandatory 30(?) day update. The estimated completion is not.
Regardless, this is not really anything that matters. The trial is clearly on schedule and the results (and BLA amendment submission) will be about as what they have guided.
Dress warm.
Somebody may have already brought this up , but submittimg 1.5 Million pages plus or however many pages is ridiculous
LP walks on Water!
I read up on all that guidance years ago, have seen multiple examples of companies not ready with manufacturing getting CRLs and you are more than welcome to look up the guidance and post to the contrary.
Therefore short's claim that the FDA will always demand individual patient-level data for ECA comparison is idiotic dumb and stupid
Sponsors must include in their marketing applications relevant patient-level data (i.e., data on each participant and patient in the externally controlled trial), as required under FDA regulations,
Interim looks into trials allow regulators to stop futile treatments from advancing further at the expense of patients who deserve to receive the best options.
There is no other company that has as much data in its possession, and over as many years as NWBO has.
There is nothing in any FDA regulation, guidance or past history that says a sponsor needs sufficient capacity to meet demand in order to be approved.
One does need to have a facility in place that can be inspected and verified to produce the product as per the CMC section of the NDA/BLA. But nothing about meeting some level of demand.
We know as a fact that drugs have been approved w/o sufficient capacity in place. DNDN's Provenge for example.
This entire "capacity is needed for approval" concept is a concoction of this message board to justify LP spending NWBO cash to scale up her CDMOs.
Sorry no specific link to this, as it is hard to link to pink ponies. I can suggest CFR 21 if you want to read through it.
Then make a bet with me. 💪
Also important to keep in mind, how long new regulatory guidance took to establish RWE as viable, and or even preferable, from an ethical perspective for severe disease trials, which helps the recruiting efforts to enroll trial participants.
Sponsors must include in their marketing applications relevant patient-level data (i.e., data on each participant and patient in the externally controlled trial), as required under FDA regulations,
Sponsors should finalize a study protocol before initiating the externally controlled trial, including selection of the external control arm and analytic approach, rather than selecting an external control arm after the completion of a single-arm trial
Also keep in mind, that it was the regulators who required the crossover.
When the Trial began in 2007, per the demand of investigators and patients it was necessary to include a crossover option in the Protocol in order to recruit and retain patients.
We're going into the eighth month of what was supposed to be a five month approval process in the UK
RD, I'm still hoping for 2025 and believe that the EDEN can be approved by the end of the first half of that year.
Then tell me a specific patent it would infringe. You will not, because you cannot.
Alas I can not prove the pink pony in the closet does not exist. Up to you to show it does.,
The FDA PDUFA date would have been one month ago. The FDA is supposed to make that exact date, though sometimes fails.
The FDA has overall been fastest to approve amongst the RAs. One can find a few exceptions, but they are not the norm.
Reminds me of the AMRN longs crying about the FDA when they (a UK company) were not approved in the EU/UK till much later.
Not sure what your point is.
Corning's FBR closed, automated system for adherent cell processing is clearly not Flaskworks based. They decided to go forward with that the FBR tech and canceled Flaskworks.
As we know, there are others in this space with tech actually commercially available. OTOH, NWBO is still in development stage.
Think about the poor dogs.
That they exert a "trading tax" is true. At the same time, this is why trade commissions go down.
There is a lot of money to be made on the fractions of a penny per trade. The MMs vs the brokers are fighting for who gets what,
That does not really matter a lot to retail investors though.
I'm sure replies pay them 1 or 2 cents a post. I've now ignored both to keep from wasting my reading time.
Yes, MHRA and NICE getting it done.
The drug was approved by the FDA under project Orbis last Dec. So MHRA had a fully completed technical review of the submission to work on for 9 months and still just approved it last week. NICE is expected to publish an opinion in March 2025. The CDF should provide funds (if NICE agrees) for a month or so before that until the formal approval by NHS to pay.
And this is for a UK based BP.
Not that AZ cares, they know where the margin markets are.
Weeee, DCvax-L has orphan designation in the EU/US.
What that means is GBM is considered a small indication, so as an encouragement to get sponsors to run trials in such the first to do so (and get approved) gets exclusivity in that indication for that agent.
As fat as the this thread, orphan would certainly not block the DC vaccine by Diakonos in any indication. It would not block anything outside of the GBM indication.
If BP knows how huge this is. why have they not launched their own trials in various indications?
Also the 2 new trials licensed from Roswell Park Comprehensive Cancer Center that are already fully paid for…
Does this encroach on DCVax patents?
Senti, my views on this align with yours fairly well.
I am perfectly willing to assume NWBO can spin stories and act in dubious ways as a company. I do not see even a remote chance this was this case to the aspects of the trial under control of the investigators.
As far as exactly what happened to nem wrt the trial, I doubt anybody (even nem) will ever know. About the worst I could see is that some doc/nurse thought the trial was a good choice for nem and over sold the opportunity.
BTW, Mulholland did take a trip to a conference on NWBO sometime, but assume several years prior. Not a big deal though. In reality any researcher in the field will have various connections all over the place. That is why the dot connecting based on that is pointless.
You do know all the exact same appliers to pumpers?
Obviously we are waiting for notification of MAA Approval however, important to note we are also closing in on some important dates in both combo trials:
Dr. Ashkan is a rockstar in the neurosurgical community!
This theory does not account for the naked shorting. Larry Smith believes that there has been a significant naked shorting campaign with respect to NWBO. A positive PR will still cause a squeeze due to the naked shorts. If I'm missing something please let me know.
Yes, you missed that longs have been pumping this lame nonsense for over a decade and the market just does not care.
Since that post, over 1B real shares have been sold into the market., And short shares are still in the 10s of millions and naked shorts in the thousands.
Tool on.