THIS. I have been amused at the charlatans who attempt to denigrate the MHRA as if submitting to them was seeking approval from a second rate health authority. No one should buy the lie that they are held in anything but the highest esteem.

Strange how the cultish here ignore the fact that 'fast track' was a lie.

There is no direct correlation between the time it takes for the MHRA to approve an application and the likelihood of it being approved

I talked to this man on the phone. He should be the first one ousted after MHRA approval. Replaced with someone younger and more experienced.

Quit playing. If/When approved, DCVax-l would be protected under exclusive use/marketing for an orphan indication (GBM) for eight (to ten) years following approval. In UK/Europe, I think it’s ten or twelve years.

They lied about fda,

Potential patent infringements with NWBO's existing patents.

Reading comprehension is a good thing. The 13% IDH-mutant population is only part of the problem. The SurVax trial also had a significant overweight of better-performing, longer-living methylated patients. Our trial had about 60-40 unmethylated/methylated patients. Since you are so on the ball, why don't you do the math?

How do you reverse split a bucket of liquid gold?

... then the FDA will have to explain NWBO how to force patients kicking and screaming into the control arm of the new (P3) (confirmation) trial because of bureaucracy. Its absurd and you know it

i]Gee EX could you provide a quote? I was not discussing SurVaxM.

Yes, we looked at that [external controls] briefly. The FDA would not accept any external control plan that we presented to them. What they had offered was that we had to look at patient level external controls, and what that means is that every patient in the study would have to matched with a patient from a database and as we pursued the databases that were out there, which was kind of surprising to us, there not enough data to match these individual patients.

The Journal Article endorsed by 73 coauthors indicates statistical significance. Your opinion is just that. Your opinion. The 73 other qualified opinions are qualified opinions. No further trials will be necessary or are needed.

Was it not the FDA that mandated that placebo patients who
progressed have the option of receiving DCVax-L after progression?

But on this planet this is only one unique technology that can make dendritic cells digest tumor lysate and then present hundreds of tumor-associated antigens to immune system. ...

One has Tim Cloughesy from ucla talking on the gbm AGILE program ongoing.

'Fast track' is the myth LP pushed, of course it was not fast tracked....

Checkpoint inhibitor combination patent grant published on Oct 31 2024. Take that for seeing the forest.

Something else to think about is if the original control arm no long matters does that lighten the need for investigation and inspections??

If a new trial was needed, it would have been pointed out in the Journal, no doubt.

The FDA approved the endpoint change, that's all that matters.

As far as your claim about presenting topline data before a journal is released, I suggest you brush up on the preferred way of a Company to present top-line data

Blame Phase V as they brought NWBO onto OTC not management.

These guys make money in other ways. I'm sure they get the real details on the internal plans before putting down their money. It doesn't hurt them to pump some optimism on this board

If you were the judge would you stick your neck out only to have your judgement tore apart?

I’m not double checking an earlier in time conclusion I made but historically LP uses shares for operations and banks for hard assets like expansions and edens

Considering NWBio will need to start servicing its debt from Streeterville Capital, LLC loan in Nov 2024, and the amount NWBio needs each month, the amount of this deal (5 million) is merely more than a month for NWBio to operate. So a logic conclusion is UK MHRA approval may be expected by NWBio to happen within a month or so, which the lender must have the privilege to peek into the existing information and signed a NDA; otherwise no one would sign such an obvious-favorable deal to the borrower.

Thanks for the reply, I was thinking the same. If that was part of the plan LP could make that contract say what ever she wanted and just make it part of the Cognate deal.

ORR to get AA; OS for traditional approval. You get accelerated approval via shorter term endpoints to start getting sales followed by OS data from the same trial to get traditional long-term approval.

As a reminder, from the August 10-Q and will likely be repeated on the 3Q 10-Q:

It’s a COMPETITOR.

NovoCure Ltd (NVCR) Q3 2024 Earnings Call Highlights: Strong Revenue Growth Amid Strategic ....
And :Net Loss: $31 million, or $0.28 per share !!

Over one third of our planet intends to grant and/or already granted this DCVax Direct patent technology. Expiration 2035/2036.