Biotech Values

[dewophile]

I am probably less concerned about safety then you.

don't get me wrong i am not losing sleep over a safety issue here at all. my point was simply that it's not too early to assess efficacy as monotherapy and if strong i think that bodes very well even though the SOC has shifted now to esbriet and ofev

I think its looking more and more likely a combo study which means a pretty big trial and perhaps longer than the ~1 year ones used for approval.

I'm not sure why the length of the trial would have to be longer since the regulatory endpoint should be the same. what might happen though is you need a larger trial since the treatment effect may not be as large comparing a combo to a positive control SOC vs in the past to placebo. as you say if the results are stellar they could think about head to head vs SOC but it would have to be a really impressive tx effect. so i think combo vs soc is far more likely if the ph 2 is positive

i agree re partners but it's a lucrative market so there could certainly be other suitors as well. FGEN has stated they want a partner that would be interested in the developing the drug for multiple indications so someone with some oncology focus as well - but still plenty that fill that role in addition to the 2 you mention - BMY for example could be another suitor
FGEN is in a pretty strong financial position - i am not partnering is a must, but the IPF indication alone is probably at least two 600 pt trials and 150+ million so yeah a partner would be nice! (although if they get some significant roxadustat milestones along the way they really can go it alone IMO)