Replies to post #75410 on Innovation Pharmaceuticals Inc (IPIX)

[muelch]

Either you answered incorrectly or misinterpreted NR's question.

No, it is absolutely not the case that every lesion must show >=20% reduction for the trial to be considered a success.

That criteria applies to each indivdual patient in the itt population to rate each as a clinical success or not. A statistcal comparison is then made between the percentage of patients rated as clinical success within each treatment arm.

The positive top line data announced by Cellceutix means that these percentages for the B arms were all within the statistcal uncertainty for the D arm, or something like that. They were "comparable". I don't know if this was an equivalence or non-inferiority trial.

So there are numbers we don't have here yet. Say D had a clincal success rate of 90% at 48 to 72 hours, if the B arms were all at 85% they'd probably still be within statistcal uncertainty and make the trial a success.

The numbers are important for projecting the chances of success in the phase 3. I believe it has to be a non-inferiority trial and some margin must be agreed on with the fda that we must reach.

Edit: It sounds like it's a non-inferiority trial with a margin of 10%, so if D was say 90% B would need to be at least 81%

[TheDane]

Your explanations paired with Kahuna's and a few others have been helpful to understanding this 48-72 hour business. I'm thinking you must have taught at some time?

Thanks!