Thursday, December 14, 2017 4:51:02 AM
At this point, if there will be an early data readout(early compared to 2016 enrollment), all is possible,
I'd repeat my opinion: something in between pass and not pass. In this case very important are the talks with FDA.
My warning was that they said in August 2016, when they wanted to lower the OS percentage to 6.5% from 10% and to raise the enrollment to 1,200 patients, already in accordance with non-USA regulatory agencies.
The FDA took it pretty hard and on September 26 2016 placed the trial on clinical hold.......
Just IMO.
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