Replies to post #104795 on NorthWest Biotherapeutics Inc (NWBO)

[sentiment_stocks]

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? - anti

Regarding that, I brought that up in a later post to RK. If one waited to confirm progression for 2 more months after the Month 2 MRI, the patient would be into 7 months since diagnosis.

3 months screening
randomized, begins treatment

2 month MRI
see possible progression

wait and see until next one...

4 month MRI (2 months after 2 month MRI)

= 7 months

According to the protocol, they were anticipating a median of 7 month PFS for the control patients. I don't think they have the time to wait and see here. Especially considering no one knows if that patient is control or treatment. Of course, if one knows a patient is on the treatment, one would continue on it and before removing the patient from it. But that doesn't happen in this case.

As to your comment about the Info Arm

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?

The trial was also enrolling during the same time as the info arm. So if it was starting to become common knowledge in 2012 and 2013 figured it out later, would they/could they change the assessment criteria mid stream to now allow a wait and see approach? That would be nice. But I'm not sure they could do that in 2013, if they didn't do it for patients in 2008, 2011-2012.

And I don't know when (and if, though I suspect it did at some point - like maybe 4th Q 2015) it started becoming apparent for this trial. There really hadn't been any mention of it before other than people asking if PFS was a good indicator for OS. It seemed for quite some time that people were suggesting/arguing that some of the psPD patients had not evented in the first 3 months, and then were subsequently eventing in the 4th and 5th months - all as a result of the RT/CT treatment. Then Avii pointed out to me that he was not suggesting that... but that it was the treatment itself that he thought might cause psPD. And all of a sudden, several patient blogs were reflecting that pseudo progression on this treatment was rather common place.

Yes, very patiently waiting too. :)