Replies to post #301984 on NorthWest Biotherapeutics Inc (NWBO)

[eagle8]

Hi CherryTree1,

I thought I understood that each leg was going to be compared to historical soc results regarding approval.
Comparing other legs with each other may be necessary for further analysis.
Or am I wrong?

GLTU

[flipper44]

Why are you asking this now? Do you honestly believe that more than five control patients are Progression free at this time? It’s probably less, way less, like 0. Moreover, Dr. Liau stated most long time survivors were progression free. Controls don’t get DCVax-l if they don’t PFS event, and again, the likelihood is that all controls already PFS evented. Yet if they evented (even if controls later received DCVax-l), they are not likely long term survivors. That’s just the way GBM works with SOC. You instead need to get DCVax-l early. Imo. Controls don’t get DCVax-l early.

[sharpie510]

I think late vaccination in the phase 3 trial is effectively treating a recurrent GBM patient. Not only that, the vaccine is made with the original lysate, not the recurrent tumor.

If you look at the video for Kristyn Power's father and Kat Charles, you might not have noticed but their DCVax-L was created with the last tumor resected, not the original. I believe in both cases, the vaccine was made with the 3rd resected tumor, and both Power's and Charles' resections were not complete resections (only 70% in Power's case). I think early vaccination (in relation to the lysate used) matters a great deal as tumors mutate and if you don't start the treatment before that happens, the tumor probably has a better chance to win that battle. Because of this, the recurrent GBM crossover group in the phase 3 may benefit with late vaccination with the original lysate, but probably not as much as the newly diagnosed GBM treatment arm that received early vaccination soon after resection.

Perhaps once the data is unblinded and DCVax-L is (hopefully) approved, rGBM patients and other solid tumor cancer patients will be able to access DCVax-L and have it covered off-label under their health insurance.

In cancer treatment, these issues have been largely addressed through 1993 federal legislation that requires insurance to cover medically appropriate cancer therapies. This law includes off-label uses if the treatment has been tested in careful research studies and written up in well-respected drug reference books or medical journals. In 2008, Medicare rules were changed to cover more off-label uses of cancer treatment drugs.

https://www.cancer.org/treatment/treatments-and-side-effects/treatment-types/off-label-drug-use.html

[TopelRoad]

By traditional standards, this would have trouble passing regulatory scrutiny. It's a phase II trial design filing as pivotal. There are prospective study breakthrough designations for pivotal phase II's; they are awarded rarely.

However, I would guess NWBO feels they have statistical significance between the arms. I would guess they feel there is a path to regulatory approval. They certainly have had plenty of time to arrive at a strategy.

If NWBO did not feel the trial could pass, they could simply withdraw the trial and not report results.