Innovation Pharmaceuticals Inc (IPIX)

[BonelessCat]

The comparison is in the trial design, but it is not included in the end points as outcomes. No where in the protocol does it say that B must compare to Dapto, only that B must hit efficacy benchmarks. The comparison is part of the final report, part of the final analysis. Loanranger's question asked about the 2-3 day endpoint and using that benchmark when one has completed dosing and the other is only 2/7 or 3/7 complete. The answer is they both must be > or = 20% lesion reduction at that time window for primary outcome success.

I realize this is a fine point, but the trial design includes a comparison arm only as a control where a drug with known outcomes should perform in an expected way. If the control does not perform as expected, then the trial design and its procedures are questioned. How the resulting data is used in final analysis is for reports and not successfully meeting endpoints.