Replies to post #208528 on NorthWest Biotherapeutics Inc (NWBO)

[longfellow95]

It's strange how a trial with exactly 23 patients keeps popping up everywhere. And I wonder if they are all one and the same trial.
Results from such a study (or studies) have been used to assert that mes do particularly well, and that use of poly-ICLC improves outcomes.

I'm pretty sure this is the one you are referring to:-
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3071163/

But then there is this one:-
https://academic.oup.com/neuro-oncology/article-abstract/20/suppl_6/vi10/5153800?redirectedFrom=fulltext

And this one:-
https://clinicaltrials.gov/ct2/show/NCT01204684

I have to say I can't see that the FDA would grant anything on the basis of blinded data from a randomized trial, whereas they can and do grant approvals based on open label single arm P2's (or even P1's..)

I think we may be forgetting RMAT, which can lead to AA, and which can be confirmed through following patient registries rather than through a P4 confirmation trial. Though that is looking like a longshot now.


In any event LP being LP, will follow a road less travelled!

[AVII77]

Below is the list of patients. The first number is the patient number (e.g. 10-5) and the next number is the number of days until they PFS evented. These numbers are from my old notes from a post I did on i-village quite some time back.

10-5: 173
5-5: 229
1-5: 237
5-1: 275
10-2: 391
1-1 394:
10-3: 416
1-9: 639 (639/30.42 = 21.01 median PFS
10-6: 791
10-4: 1483
1-6: 1496
1-2: 1781
5-3: 2104
5-4: 2138
1-3: 3107

Now according to my notes, Dr. Prins noted back in 2011 that patients 1-2, 5-4, and 1-3 all exhibited inflammation that could have been due to the vaccine. So that's about 20%.

And to be clear about the Bear argument: it could have been due to the chemorad treatment they received and have nothing to do with the vaccine.

[CogDiss 1188X]

Senti, thanks for sharing your thoughts - it will help me begin to understand where some of you are coming from so I can at least follow the conversation and start to form a better picture of these issues.