Ann: Investor Presentation, page-21

That's TIS and the study refers to the various (uncontrolled) UK clinical tests in 2010/2011 with limited patient numbers.
This stuff is regurgitated over and over but nobody cares to look at the actual underlying facts and/or deliberately obfuscates them.
I seriously doubt that this was presented to the FDA for the current Phase II study. One thing is sure: It was not good enough to pass the EMA.

See Post 30854809 - and for further details look at the TIS threads for 2009-2011.

But on a more upbeat note: I shall gather a few dollars more and fully participate in the CR - not because I am a believer but I might just get my investment back in a year or so.