My personal view is this, the agencies will understand the cohort includes the toughest of toughest cases, chronic OA in grade 3-4 range with confirmed diagnosis well beyond 5 years.
The biomarker performance, objective outcomes measure performance and the radiographic outcomes now confirm this drug is worthy of a commercial license as it will enhance most patients in the grade 3-4 range AND the earlier the drug is administered the less work the molecule has to do to perform at its absolute peak.
So we come back to its safety profile and we know it’s safe. So let’s get it out there to assist those in need.
What are we waiting on? The world has a very very sound option available.
Ann: iPPS Demonstrates Multiple DMOAD Signals in Phase 2 Study, page-65
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