Biotech Values

[iwfal]

FGEN

It doesn't mention statistical significance. So possibly Roxadustat could have shown a statistically significant higher rate of MACE than placebo, but which does not matter in the real world ("no clinically-meaningful difference") and/or might be attributed to the 'too high number of enrolled patients'.

The number of events in the NDD trial is such that it is unlikely that they could be stat sig less than the inferiority margin and also stat sig worse than placebo. However I am on the record that I expect the eGFR patients worse than 15 will have meaningfully worse results than patients better than 15 (this was a largely post hoc division BY FGEN).

Thus the big questions are:

1) whether they release data on this NDD subgrouping WHICH THEY CHOSE TO START TALKING ABOUT.

2) what is the nominal MACE HR in NDD (how far above 1.0? Above 1.10?)?

3) what is the MACE HR in the DD population that is not new new to dialysis.