Biotech Values

[poorgradstudent]

Re: FGEN/AKBA

That said, to be testing 2 different dosing regimens in phase 3 is odd and potentially problematic - e.g. how can you aggregate safety data across trials that way?

One can argue this may be what tripped up LLY/INCY's baricitinib.

I see both sides of the argument though. In a sense, by running a trial with a single dose, you're limiting information on the risk-reward profile of the drug. I would think the FDA would rather see more data than less. But if running trials with 2 doses is deemed a risk by companies, then you have a problematic situation.