Replies to post #20148 on RespireRx Pharmaceuticals Inc (RSPI)

[gfp927z]

Thanks Neuro. Any thoughts on whether an interim analysis was necessarily done in RD-1? We know the ability to do one was authorized in the RD-2 protocol, so one would assume the same provision was in RD-1. However, the decision to actually do an interim analysis may have been optional.

Being a dose escalation trial, one might expect an interim analysis in RD-2 to be especially desirable, to see where they stood prior to going to 2100 mg (which is above the unofficial MTD). But RD-1 dosed all subjects at 1500 mg, so there could be less rationale to justify an interim analysis.

If we knew RD-1 had gotten through an interim analysis successfully, I'd feel pretty confident of getting sufficient RD efficacy in enough RD-1 subjects to yield useful analgesia data.