Biotech Values

[DewDiligence]

> POTP – You are saying that if SPA is not involved, they don't need written agreement with FDA to conduct an unscheduled interim analysis.<

That’s correct, although most companies would seek advance FDA approval anyhow just to be on the safe side.

>What will it take for the clinical data related to the 150 events (mentioned in the PR) to be released to the company?<

If interim data is released from the DSMB to the sponsoring company, then the trial is no longer considered fully blinded. In that case, the FDA statisticians may penalize the company for the early unblinding when they review the NDA. It is for this reason that few companies conduct such unscheduled interim looks.