NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

Wow. Listen to this on radiomics at 1 hour 6 minutes and 17 seconds through 1 hour seven mutes and 31 seconds.

Thanks to RK for posting the link.

Listen to the end of that 1 minute plus segment very carefully. Now, reconsider this draft guidance.

Draft Guidance FDA March 2015.

Quote:
Clinical Trial Imaging
Endpoint Process
Standards Guidance for Industry

fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm268555.pdf

Quote:
To determine whether image readers should be blinded to clinical information, sponsors should
251 have knowledge of the underlying clinical condition, an understanding of the precedent for the
252 use of imaging as a trial’s primary endpoint, and detailed insight into the trial’s unique image
253 interpretation procedures (such as a plan for sequential locked-read image interpretation where
254 an assessment can't be altered versus an option for modification of prior image interpretations).

255 In certain disease conditions, readers should be blinded to the image acquisition date and/or
256 knowledge of prior imaging observations. Again, we note that even if the image reader is aware of individual-level clinical information, blinding to treatment assignment is almost always
258 critical.