research reports and media, page-4391

Agreed, it's hard to gauge. Looking at the criteria for Provisional Approval, we don't need to be lifesaving anyway, we just need to show it's a major therapeutic advance (and compares favorably to existing therapies). Blind Freddie can see we satisfy that criterion.

If I were a decision maker at the TGA I would be saying to PAR that they do not have an actionable plan - until the FDA allows us to proceed with P3 and a deal is done to fund it, we cannot demonstrate that we are able to action any plan to provide further comprehensive clinical data.
I suspect they won't let us pursue the PA without those two milestones met. And perhaps they would like to see what data we will be collecting (based on FDA feedback) before they can say our plan is a sound one.