Ann: Investor Webinar, page-18

I suppose that there’s distinction between improving kidney function and slowing the kidney failure down? This is noted:

”The common clinical marker for progression of kidney disease is an increase in protein in the urine (known as proteinuria), and a significant reduction in proteinuria demonstrates the progression of kidney failure as been slowed.”

for the P3 trial design to be agreed the end points would have to be quite robust, so regarding the protein markers I think if we can repeat P2 it should be positioned well for approval.

in the trial details it notes that the egfr slope at week 104 compared to baseline is the primary ‘approval’ endpoint.

now with it already being approved by tga for compassionate use (or similar, forget actual term) and there being odd break through approval potential at first read outs in Q1 - the egfr may, in my eyes, be less impactful. But, the fda may think otherwise and I could be wrong so happy to hear other thoughts