Biotech Values

[ghmm]

AZN / FGEN:

I posted this on SI. I only skimmed through the call for pertinent discussion on Roxadustat so can't comment on anything else (its 1:50 in total length).

Event URL: http://engage.vevent.com/rt/azemea/index.jsp?seid=1549

The presentation was straight forward not too much depth (starts around 32 min mark +/-)

There were a couple questions in the Q&A
1. (Around 1:20 mark +/-) About the CV safety. For dialysis they are looking at superiority over EPO (meta analysis of all the studies), powered for 20% safety improvement but that is not required for approval. For the non-dialysis saying they should be equal safe as placebo.
2. (Around 1:28 mark +/-) Shortening time to US filing (from 2018)? Said very unlikely only said event driven trial & need sufficient number to do CV analysis (no talk of interim).
3. (Around 1:30 mark +/-) Given less aggressive hemoglobin targets today how it effects potential to show CV risk reduction. Think doesn't matter much if anything works to advantage.