Saturday, December 31, 2016 11:00:21 AM
FGEN 3019:
Appreciate your thoughts as always!
Yes for substudy I was referring to 3019+SOC arm. I am probably less concerned about safety then you
. So far there really hasn't been anything to be concerned and the patient population could probably accept some level of AE (i.e. Esbriet and Ofev have their own issues).
If the results are extremely superior (monotherapy) then I am less concerned obviously how they take it forward (It would be great if they think they could beat SOC head to head).
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. If so doesn't it make sense to partner? My guesses would be Roche which has poor Pirfenidone IP and already is interested in other IPF agents (Last I was aware they had a couple early programs maybe more if they kept Intermune's alive) and they have the resources to pursue other 3019 indications which FGEN is probably seeking in a partner. The other name would be GILD which has said they like derisked P2 assets so they can do their own P3's. Again with the resources to move forward.
Appreciate your thoughts as always!
Yes for substudy I was referring to 3019+SOC arm. I am probably less concerned about safety then you
. So far there really hasn't been anything to be concerned and the patient population could probably accept some level of AE (i.e. Esbriet and Ofev have their own issues). If the results are extremely superior (monotherapy) then I am less concerned obviously how they take it forward (It would be great if they think they could beat SOC head to head).
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. If so doesn't it make sense to partner? My guesses would be Roche which has poor Pirfenidone IP and already is interested in other IPF agents (Last I was aware they had a couple early programs maybe more if they kept Intermune's alive) and they have the resources to pursue other 3019 indications which FGEN is probably seeking in a partner. The other name would be GILD which has said they like derisked P2 assets so they can do their own P3's. Again with the resources to move forward.
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