RespireRx Pharmaceuticals Inc (fka RSPI)

[gfp927z]

Neuro, With that much time gap between results (3-4 weeks), this becomes a double binary event in some ways. The only maintenance of analgesia data will come from RD-1, so we'll remain in the dark on that parameter until perhaps late August/early Sept.

Having the same DSMB involved in data analysis of both trials is a plus. As you said, the University researchers have more RD related experience than the CRO, but having the DSMB closely involved with both provides some continuity/overlap.

One scenario that would create some angst would be if in RD-2, 2100 mg works but 1500 mg doesn't. On the positive side we'd have our POC in RD (a big positive), but there would be the potential for no useful maintenance of analgesia from RD-1, which only doses at 1500 mg. However, if 1500 mg was to show some limited RD activity, there could still be some subtle trends seen in the analgesia parameter. I'd settle for that - POC in RD at 2100 mg (RD-2), and a trend in maintenance of analgesia at 1500 mg (RD-1). I still think RD-2 should have been designed to include maintenance of analgesia measurements, at least in the 2100 mg cohort.