NorthWest Biotherapeutics Inc (NWBO)

[antihama]

Hi Senti, the last couple of days took me away from this board and I just got back on and I know I got a lot of catching up to do but before I catch up, I wanted to respond to your post w/o being influenced by the, I’m sure, lot more discussion on this topic. Here’s my reason why I think that psPDs may not have been removed from the trial. Regarding

And if they put that passage in to determine psPD before randomization, why didn't they put it in for those patients who might falsely progress after randomization? Well I think it's because they didn't realize that psPD could happen from DCVax... just TMZ and RT

It could very well be what you say is so but I believe if they did know in 2013 that psPDs could happen w immunotherapy then I would think they would follow standard practice at the time. Say you are a radiologist in 2013 and everybody knows that you need multiple scans to determine psPDs why on earth would you declare a pt has progressed on 1 scan? Because the protocol didn’t go into detail on what to do? I don’t think so. I have to tell you in a previous life I used to audit pre-clinical protocols (the caveat here is that clinical protocols may be different but not by much). The pre-clinical protocol spells out in general detail what you are supposed to do e.g. draw blood at x,y, and z timepoints and analyze for drug abc. The protocol doesn’t tell you any more detail than that but somewhere you know what you need to do. You are going to have a method on how to analyze those bioanalytical samples and the method is going to tell you exactly what you need to do to. There is going to be a Std Operating Procedure on how you validate a bioanalytical method, on computer system validation, on pipette, and weighing scale calibration etc so there is a lot of stuff that you don’t see in the protocol. I’m sure a radiologist will have SOPs that guide them on what to do when encountering a psPD patient. I see from the consent form that was recently referenced that MRIs are given every 2 months (month 2, 4, 6, 8 etc). Why wouldn’t you wait for the next scan or 2 to make that determination? I just don’t see it. Regarding

Information Arm, that enrolled in 2008, 2011 and 2012, had 25 patients that the very professional radiologists (the same ones used in the trial) couldn't determine what they were.

Hard to argue against your point. Just wondering if for the most part those pts were recruited early on when radiologists still weren’t sure about what was happening. So, the Q that comes to mind is when did it become common wisdom that psPDs could be a good thing? Regarding

And if 3 out of 15 patients in the P1 trial (20%) - the best performing patients I believe - all showed false progression that would have deemed their response a progression event in this trial, well then, I'd suggest to Houston that we have a problem.

Ditto on wondering if for the most part those pts were recruited early on when radiologists still weren’t sure about what was going on.

As we patiently wait.