As a general rule I enjoy ambiguity. In this case I find it annoying because because I have seven figures riding on it.
But I digress.
At the risk of murdering a fine point, something generally best left to others...the primary endpoint definition is ambiguous at best.
If it means that EVERY PATIENT must show 20%+ lesion reduction in under 3 days, then I am surprised any drug would ever meet that tough of a standard. Yet this is the literal interpretation of the protocol.
If it means that THE AVERAGE lesion reduction must be 20%+, then it leaves way too much room for wiggling. For example, one way to achieve average lesion reduction of 20% is for 20% of the patients to show 100% reduction and 80% to show nothing at all.
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One other point...No patients required "rescue" treatment. That in itself in a very significant outcome.