Replies to post #521818 on NorthWest Biotherapeutics Inc (NWBO)

[Bob_LobLaw]

For the sake of cancer patients, let’s hope BP has outright bought or partnered with NWBO. Otherwise you are right, it will be another decade before -L and -Direct see the light of day in other solid tumor cancers.

[CrashOverride]

Researchers are now aware of pseudoprogression so should be able to control for that false positive. I believe with secondary endpoints which validate the tumors are dead we will see surrogates like PFS used in future trials so they won't take as long as they would with overall survival as the primary endpoint. BP can't fix this problem nor could they run the trial any better than NWBO's world-class management. In fact all of the GBM trials which BP ran were complete failures.

[Doc logic]

dennisdave,

Retail investors don’t typically look at what is going on behind the scenes but I do. I like the big picture and NWBO and UCLA amongst others have been working hard to change the big picture. The talk about biomarkers is important for all future trials but seldom gets a mention here. Those that know about this biomarker evidence being included in submissions know the importance of it’s affect on future trials using them. Those that don’t or know that most others don’t can state that future trials will take an inordinate amount of time when the reality is they will be shortened dramatically not only by the use of biomarker evidence but also because of treatment effect and “sameness” of very specific DC characteristics created by very specific activation/maturation. The time to patient use will also be shortened due to newer legislation that gets patients to approved treatments sooner in other indications. Once the broader market figures this out they will all want cheap $5-$10 shares that no longer exist. Right now the market sees nothing to be excited about because they are not generally aware of the significance of manufacturing preparedness. The bigs do but they have been kept on the sidelines by their investing guidelines and the price Linda requires for doing business or because they have been potentially shelved as partners due to any past history of being involved working against NWBO. Much to be revealed and a great many good surprises await for patients and longs. Best wishes.

[biosectinvestor]

The new paradigm is much abbreviated post approval. These guys are, I am pretty sure, trying to not just demonstrate efficacy for gbm, but with biomarkers, for tumors generally.

We’ll see, but with Real World Data and data summaries, as a means for extension to other indications, I actually expect that immunotherapies will be much more quickly and broadly available than some expect.

And it is already happening in some quarters. This is not a prediction of the future, this is what the law already says.

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=169981653

[hankmanhub]

You are way way out. Max 2years per other solid cancers hopefully running concurrently, They will start right into PIII and these will not take as long now that they have a beaten track and experience in running the trial and its design. They may even have additional results from off label use in that period to help guide them further. Hopefully they will be all done between 2024 and 2026 at latest.

[dstock07734]

You obviously don't keep update with the latest technology development. Advanced imaging combined with deep learning or AI can differentiate pseudoprogression from true progression. Also fluorescence technology can tell if T-cell infiltration is happening, namely if the cold tumor turns into hot.

[biosectinvestor]

As for measurements of efficacy, it will differ for other tumor types not encased in a skull, but also even for the combination trial, they have a whole slew of different additional measures and new tactics also for measuring PFS that were not the standard when the Phase 3 trial started, and you cannot change such a measure mid-trial, so they had what they had because pseudoprogression was not understood when that trial was started and the encasement in a skull made it particularly difficult at that time, relying just on scans at certain particular and early dates with no further protocol. Now they have a bit longer protocol for validation of PFS. Doesn’t take as long as OS, but it’s also not the only measure, nor the primary one.