Replies to post #195571 on Innovation Pharmaceuticals Inc (IPIX)

[frrol]

There are usually dropouts, and bigger sample is better than smaller. In larger advanced trials (2B and 3) biotechs will establish a floor (ie minimum) sample target that meets what they and the FDA (and possible BP partners) would deem "adequate", with room for additional patients as contingency.

[TheDane]

Were they recruited or did they request to sign up?

[BonelessCat]

Why would they recruit 10 addtl patients?
Anybody?

A couple of reasons: 1) possibly replace dropouts and maintain a number considered reliable to BP and others(as already mentioned); 2) increase the sample size for either arm, 300mg or 400mg; 3) however, most likely but needs confirmation, add reliability to the 400mg arm if it showed greater efficacy than 300mg. I say it's more likely because there were 27 in the 400mg group and increasing the N to 35 or more would further confirm anything they saw against the placebo. IMO, there would be no reason to add more test subjects to the 300mg arm since the N=81 would already be sufficiently powered ahead of a pivotal trial. Also, 10 more strengthens the safety data and better insures approval of a Phase 3 at the higher dose.

Recall that the previous trial results showed dose dependence. 10 more would further confirm any perceived increased efficacy.