Monday, June 20, 2016 3:19:08 PM
You ask how could this trial still be blinded with all that has happened to other companies with regard to illegal access to data. The answer might be as simple as no one knows how to interpret the data yet, blinded or otherwise. We know that Dr. Linda Liau indicated that all patients appeared to be living longer than expected and that eventing was slower than expected for their high end (she mentioned 24 months) and much slower than the original expectations from the protocol. When the resizing was done an astute commentor, I don't remember who, said that one of the main reasons a trial might be resized is for unexpectedly slow eventing. The interpretation of this slow eventing, ascribing benefit from treatment vs additional options with regard to OS and perhaps different PFS between "early" and "late" treatment (in the trial before and after automation), not the raw data itself, is what I believe may be keeping this trial blinded and the company needing more money to finish the trial than originally and subsequently planned for. The extended need for money has been the pile driver on the price. This is a known factor in a place where enigma abounds. Best wishes.
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