Biotech Values

[DewDiligence]

Other than standard issues with open-label trials, why do you think the use of ORR as the primary in combination with open label is especially terrible?

It’s not ORR per se that’s a problem, but rather the use of a subjective primary endpoint in an open-label trial, which creates a large window of opportunity for fudging. PFS in an open-label trial has the same problem to a slightly lesser degree.

The above problem is typically addressed by having progression events adjucated by blinded evaluators, but that wasn’t done in the PPHM trial.