Avid Bioservices Inc (CDMO)

[exwannabe]

33% first look-in, 50% second look-in and about 67% (guess based on how most trials are designed) for unblinding.

The company sets the total number of events for final unblinding trigger however they wish (subject to established trial design guidelines).

But PPHM has clearly stated that the two early looks are at 33% and 50% of that number (expected number of events in final analysis), whatever it might be. So if final at 450, then IA2 at 225. Get it?

If the first 225 events occur over an average of say 12 months (we do not know the enrollment curve shape), the next 225 would take well over another year from then. And that is without a "long tail".

On historical comparisons, do not forget that many patients are likely now on Opdivo that showed 17 months OS. One can not simply take this number (as the setting was different), but it likely does bump the totals when the data is finally in.

P.S.: One can hope that it is true that Bavi does increase PDL-1 expression, in which case Opdivo could add more to the Bavi arm.