Replies to post #75419 on Innovation Pharmaceuticals Inc (IPIX)

[biodoc]

If I understand correctly NR asked

if EVERY PATIENT must show 20%+ lesion reduction in under 3 days

OR if

THE AVERAGE lesion reduction must be 20%+

.

I was addressing EVERY vs. AVERAGE. It is NOT the average lesion size reduction. Again, did the patient show >20% reduction in lesion size at 48-72 hours? If yes, then the patient achieved a successful clinical response for the primary efficacy endpoint and will be counted as such in the trial statistics. EVERY patient is evaluated in this way but not EVERY patient has to have a successful clinical response for the trial to be successful.


From the FDA guidance document:

The primary efficacy analysis is based on the difference in the proportions of patients achieving a successful clinical response (e.g., at least a 20 percent reduction in the lesion size at 48 to 72 hours when compared to baseline).

Sorry if I am misinterpreting the question. Nowhere did I suggest that every patient had to have a >20% reduction for the trial to be considered a success. This is getting a bit frustrating.

[noretreat]

I completely agree with your explanation. I have run many analyses like this over the years, and your description of the procedure is accurate for every one of them.

But...I really hope the Apparition is right....it would be great if every lesion responded with at least a 20% reduction in under 3 days!!!

Everyone's viewpoint on this is welcome, as nothing said here changes anything.

Fun on a Sunday afternoon in between yard work and redesigning my home.