Biotech Values

[DewDiligence]

>I offered a hypothetical 55% vs. 50% for NM283/pegifn (NOT NM283/SOC) vs. pegifn/riba (SOC). An SVR in the 55% range for a treatment with no riba would be quite respectable.<

For NM283+pegifn vs NM283+SoC, the goal will presumably be non-inferiority rather than superiority.

The point I think you’re missing is that a non-inferiority analysis contains a delta—the agreed amount by which the tested treatment can be worse than the comparator and still be deemed non-inferior.

In the phase-3 NM283 trial, the FDA might set the delta as high as 10 percentage points. E.g. if NM283+pegifn (without riba) showed an SVR of 55% and the delta were 10 percentage points, then NM283+pegifn would be considered non-inferior to NM283+SoC unless the latter showed an SVR>65%.

In short, to employ the trial design I proposed in message #37174, a mammoth-sized trial would probably not be needed.