10BagR,

Thank you for this. Excellent summary. Just a couple of clarifications to add:

"Now, I am not sure what the difference is between a Phase III completion, and a Market Approval status, but if we assume they are the same........"

Phase III completion means just that the Phase 3 trial has run its course, finished, and presumably met its pre-specified primary/secondary outcomes. Once Phase III trial is completed, then NDA and MMA applications may be filed with the US FDA and European EMA to seek approval for commercialization/marketing. So they are two distinct steps: first Phase 3 completion, then market approval. Just to add a clarification here.....now that the FDA is on board with US study sites for BETonMACE, the timing for European and US Phase 3 BETonMACE completion, and the timing of NDA/EMA filing/approval, are likely in sync with each other and not really separate steps as the NPV projection table is laid out.

"I may need Bear or someone to clarify whether or not ACS, Diabetes, and CKD are still all in play to the level that was planned 3 years ago or not......"

Yes, they are still in play. BETonMACE is in high-risk ACS patients with diabetes. The renal program is focusing on high-risk ACS patients with CKD. However, the Phase 2 renal trial has yet to begin and thus completion of a renal Phase 3 is a ways off. Hopefully the future Phase 3 renal trial in ACS/CKD patients includes both European and US study sites so that EMA/FDA approval can come from the same trial as described above for ACS/diabetes in BETonMACE.

BearDownAZ