Replies to post #764064 on NorthWest Biotherapeutics Inc (NWBO)

[learningcurve2020]

Folks here were saying this back in 2015.

>>Seems to me, with all the data and the safety profile of DCVax-L doing a confirmatory is a death sentence to those it may benefit.

NICE won’t want to pay for nebulous results.

[skitahoe]

I'd like to know why people are making a big thing about confirmatory trials. Many of the biggest products have been approve with confirmatory trial required, but regardless, the company already has said it plans additional trial that should be initiated after UK approval. What's important is that they'll be paid for product sold to those not in a trial, which will be by far the majority. I also believe that some of the trials that occur will be co-sponsored, or even sponsored by other companies who want to prove their therapeutics are effective with our vaccine.

I think what's far more important is what the trial is being aimed at. If they're asked to confirm a tumor agnostic label, I'd be absolutely thrilled. Let's relax and see what the UK does, once we know that, we may know a great deal more about what's happening the rest of the way.

Gary

[Chiugray]

Attila, Agree. It is clear that the DCVax-L Phase 3 results are strong and points toward full approval for GBM, as the MAA application was submitted for.

If there is going to be any conditional approval, my guess is it would be an expanded label to treat Grade 3 brain tumors. Not saying there will be because it was likely not part of the MAA submitted, but if it were to happen this would be some support:

- UCLA phase 2 brain tumor trials had some grade 3 patients who showed very positive responses after using DCVax
- Since DCVax-L uses the patient's own tumor cells to create a personalized vaccine, the antigens are the same, and DCVax works the same, across all the different grades of brain tumors. It is the same biology.