Pardon my ignorance in this area @ttppxx, you refer to "how the...

Pardon my ignorance in this area @ttppxx, you refer to "how the COBRA Reference Standard was constructed" in reation to "A positive 64Cu-SAR-bisPSMA scan shall be considered a False Positive if the Reference standard is Negative".

Which party constructs the Reference Standard for a trial? I assumed it was Clarity itself.

If so, wouldn't the decision to allocate a scan as False Positive if the Reference standard is Negative just be a matter of taking a conservative approach?

Doesn't this effectively render the trial almost useless. I suppose it tests whether the trialled product is as good, just not whether it's better?

Thanks, appreciate your contribution here