The mhra is swell with nwbo to continue its use of dcvax within its specials program but is unwilling to approve it.
Makes perfect sense to me.

Based on https://www.biorxiv.org/content/10.64898/2026.02.21.707071v1.full.pdf, what would be a good treatment for GBM?

Are you still thinking of retiring to Pattaya with your gains?

It makes no sense that the regulatory agency that has known the trial data for more than two years and got it through their CHM in June of 2024, if they had questions about the data would not have issued a rejection or, more likely, the application would have been withdrawn by now.

And most importantly, it showed that it was safe and a viable treatment for further study in ALL solid tumor cancers!

Well this is amazing. I don't how many pancreatic cancer patients used DCVax-D in their treatment. I hope it was more than one.

The ovarian cancer trial demonstrated some positive treatment

I can't believe pseudoprogression is still being discussed.

If NWBO is doomed for failure, why has the company been hiring more employees?

Good points on both fronts Gary. The German enrollment situation is genuinely under appreciated. Ethics committees there don't intervene lightly, and if they blocked placebo enrollment while allowing the treatment arm to continue, that's a meaningful signal about how the data was reading at the time.

CPXX got BO after TLD. (Just 90 days from $1.6 to $30 ).

its spoofing. they need to cover their shorts before the AH PR

Your "common effing sense!" is based on thin air and nothing else. As you pointed out there is no evidence that NWBO ever discussed filing with the FDA.

83% of (no longer) contested (2020 alloted) shares go to management. 2.25 million dollars to NWBO from insurer. Clear security count makes non-dilutive debt solutions cleaner to enter.

Unlike Cognate, Sawston’s infrastructure supports autologous cell therapy at a commercial level, including storage, cryopreservation, and logistics which would all likely be needed for gaining approval.

Cognate BioServices’ manufacturing facility for clinical-grade cell products is located in Memphis, Tennessee. Cognate BioServices' facility is approximately 80,000 square feet and contains substantial buildout expansion space in addition to the portions currently built out and in use. The current manufacturing facilities are sufficient to produce DCVax for at least several thousand patients per year. The expansion space will allow us to procure significantly increasing capacity when needed for commercial readiness. We are also developing a facility for manufacturing in the U.K. for the European market. It is necessary for us to have manufacturing operations in Europe to meet the logistical requirements for European patients relating to the collection, delivery and processing of the patient’s blood draw containing the immune cells (for which the time window is too limited to reach the US manufacturing facility).

I already bought 2 first class tickets to Europe. Told the wife to stop complaining since we're already rich. Told her to just call me at 1:30pm

Yes. Due to DCVax-L being a very personalized cell therapy with manufacturing and handling in Sawston UK, location would play a huge role in seeking first approval. Why not the FDA first? well that's the reason.

While it's true that unexercised options aren't "shares," Market Makers (MMs) under Regulation SHO use the existence of these management options as "Locates." They point to the 2020 grant pool and tell the SEC: "There is potential supply here, so we have a 'reasonable belief' we can settle our short sales."

Fact: As I've established, these 2020 grants have served as "Locates" for synthetic short positions. When 17% of that pool is deleted by the Delaware Court of Chancery, the MMs lose their legal cover

The 10K, due by 3/30, will be as of 12/31.

The company has already run a P1 for Direct. Why on earth would they have to run another one?

Any one have any comments about the FDA ruling,

Doubt they’re capable at this point of a big dilution event given the level of distrust and lack of trading. Was thinking more like jettisoning L to pursue other endeavors announcement?

There's a lot we don't know but too bad he only got three vaccine doses.

My opinion is pneumonia brought on sepsis which over ran

Which dendritic vaccine did he take and when did he take it?
Also, was he still on chemo, and if so why?
Thanks

Darn. DCVax-L failed to prevent pneumonia. Who knew? The failure is your arguments against DCVax-L.

I also think that another likely factor in the delay is the nefarious actors spammed the proverbial crap out of the MHRA in response to the request for public comment on the use of ECTs. This mountain of - no-doubt well-crafted - spam will have taken the MHRA considerably longer to sift through than what they are accustomed to in this regard. Besides this public request for comment I have heard that they have been absolutely inundated with FOIA requests and ICOs almost certainly from shorts trying to derail/ slow things down

Comments on Potential New MHRA Policies.

In the UK, the MHRA issued a draft Guideline of important potential new policies under which clinical trials would be allowed to use external controls instead of within-study placebo arms, especially for severe or rare diseases, and the MHRA called for public comments during the second quarter. The Company worked together with physician collaborators, patient groups, statisticians, academics and political representatives to help mobilize public comments.

Settlement Rules.
4. Do I need to do anything?
In 99% of cases: Nothing. Your broker handles the back-end routing. You just wake up on Monday morning (Jan 19) and notice that the "Bid/Ask" is being driven by the London Main Market instead of the OTC market makers.

I respect what you write but this may not be true though. I remember seeing a few companies, who had overseas manufacturing units. FDA inspect them as a part of the application process.

In other words, he may not be crazy