In THIS video SI says re the first interim analysis:
@10:46
"......looking at surrogates of the primary event. Surrogates being systolic and diastolic volume and as I said we saw very dramatic effects in the phase 2 trial so if we see similar directionality in the first interim then we'll be very pleased in terms of the administrative look."
Could it be that one of the parties in the 'we' was not very pleased? Note SI is not talking about the IMDC looking at these results in secret, he is saying we.
In the audio podcast SI said that we are not allowed to release this data not that he didn't know it. This is completely consistent with the above transcript.
But more revealing is the transcript below from THIS video interview with Michael Schuster; one of the founders of MSB:
@4:35
The first interim analysis is looking at surrogates. This is a carryover from one of the prior TEVA leadership changes. And this is really (an) administrative look to make sure we're going in the right direction. There is no chance of the trial stopping.
When I first saw this interview I did not know what Schuster meant by "administrative look". Now I believe it refers to:
"For the avoidance of doubt, Cephalon shall have a right to withdraw from the P3CHF Trial only if (1) the Statistician determines that the surrogate endpoints set forth in paragraph 3 above have not been achieved;" (my emphasis).
Do your own research. I just thought I would share mine.
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