Biotech Values

[jb_118]

FGEN

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

Remind me if you think the worse results in the population is because

A) FGEN created this subgroup post-hoc and therefore selected a line that made the >15 look better

B) This sicker group had differential and higher dropouts in the placebo arm, specifically bc they weren't on treatment (ie if you analyzed the endpoint as a combination of (MACE or dropout) the worse results would disappear

C) Some underlying real biological effect

D) Other


Agree re: The Big Three questions. Whenever they talk about the "totality of data", I worry they won't answer those questions with direct answers until the FDA formally weighs in. Feels like they trust the FDA to accurately/fairly incorporate the totality of data, but not the street, so the B) scenario above.