Avid Bioservices Inc (CDMO)

[exwannabe]

There is no SPA for SUNRISE.

The SAP (Stat Analysis Plan) will define the target P, but the FDA will either agree or not at decision time.

The P value target will NOT be <.05 for the final look, it will be a bit (not much) lower. The reason is that the the early looks spend alpha (certainly the second, first is unclear).

The second line P2 was such a screw-up (for whatever reason) it is really not meaningful to discuss is being stat sig. You can not compare post hock 3 mg vs combined arms and claim stat sig (and they were not anyway). You can not compare 3MG + (placebo with some bavi) to (1mg bavi with some placbo) and claim this means anything at all.