Digging around regarding Promising Innovative Medicine (PIM) designation vis-a-vis interim Phase 3 DSMB analysis

Athenex's Oraxol (Cancer Drug) did exactly this...

https://www.globenewswire.com/news-release/20...taxel.html

Quote:

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The PIM designation follows the independent Data Safety Monitoring Board’s first interim analysis of the Oraxol 001 Phase III Clinical Trial, where they unanimously recommended continuation of the study and encouraged rapid recruitment toward the scheduled second interim analysis, which Athenex previously announced on October 5, 2017. The recommendation was based on a positive overall response rate and particularly the relatively limited number of occurrences of the adverse event of painful neuropathy with Oraxol, which is currently a severe dose-limiting side-effect of IV paclitaxel.

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So we aren't blazing a new path. That's good IMO!