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Tuesday, October 29, 2019 6:58:11 AM
They can't unblind before their SAP is accepted because then it is improper. It needs to effectively be prospective. A few months ago we all debated this ad infinitum. Now it's as if it never occurred.
The notion that "they need to just end the trial now, it's been too long..." is really not connected to regulatory reality. It's bulletin board wishful thinking.
It will end when the SAP is accepted. No "regulator is telling them to not end it", and I haven't seen anyone argue that point. That is simply the result of redoing their SAP's.
With 4 of them to get through, even if 1 regulator agrees, it still can't be unblinded until 4 are in agreement.
People can wind themselves up all they want to. But that's the situation. Period.
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