Ann: SPL receives positive FDA feedback on DEP SN38 for PROC, page-6

It is great news that they have met with FDA but there are many hurdles but at least the opportunity is open should data support progression.
Keep it in perspective as we don't know just what studies they will not have to do but understand that it will still require the right trial design.
The next question is funding and how far SPL walk with this . They indicate licensing so shareholders can only hope SPL have learnt from all their history and can come up with a deal that is suitable

It isn't worth a KPI IMO


"The FDA indicated that DEP® SN38 may qualify for accelerated approval based on an interimanalysis of early surrogate endpoints from the proposed Phase 2/3 clinical trial program. Finaloutcomes will depend on the results of these studies and the overall data package; however, thisaccelerated approval could provide early access to DEP® SN38 for patients with platinum-resistant ovarian cancer."