Replies to post #37174 on Biotech Values

[gofishmarko]

>> the best outcome in phase-3 would be superiority of NM283+pegifn vs SoC and non-inferiority of NM283+pegifn vs NM283+riba+pegifn. <<

The problem I see with that scenario is the requirement for large , and maybe slow-enrolling , trials for the tx-naive gen-1 cohort. If SOC ( pegifn/riba ) gets 50% SVR and NM283/pegifn gets , say 55% , how big of a trial would they need for good power ? I don't think the FDA will allow a pegifn-only control arm nowadays , except maybe in specific groups of nonresponders.

I'd rather see riba boost the NM283 SVR rates into the 70-80 % range and then they go for approval in naives first , like VRTX.