Isofol Medical AB (publ) Data Analysis of Phase III Agent Study Transcript
Thank you and good afternoon, everybody that's on the line. I've probably sent out the press release that we are now starting the analysis process that will lead to the unblinding and data out of that study.
But let's go to slide four and a little bit about the background to our announcement. So, last year in December, we identified that we had more patients than anticipated that were censored without having a documented tumor progression. And the reason for the censoring was that many of them had started a new therapy without having a progression, which was again violation of the protocol.
The consequence is that we did not reach the prespecified number of progression for the event that was needed as a milestone for us to start the unblinding process. As the company is unblinded to the study, this is a blinded study where we don't know what's going on in this study. So, this concept is completely blinded. The physicians know what patients we are receiving. And so, there is no safety issue for patients.
And we've had seven independent
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