what could go wrong?, page-101

"Although I am confident HA-I can prolong lives, the question I do have, what if say 10% only reacted positive to HA-I, is this a good result? Will FDA be happy with it? What is a good percentage result then?"

What specifically do you mean by react positively? React positively in terms of what? This could be measured in many ways, however in this study we're focused on PFS. However you can't just ask "what is a good percentage result" You need to define that question more.

If you're speaking in very "general" terms, then in this study if only 10% were to react positively to HA( eg demonstrate an improvement in PFS over control) then no it's not a good result.

For example, in the Phase 2 study:

"The proportion of Patients exhibiting disease control( complete response, partial response, or stable disease) was 30% higher in the Hycamp arm (HA), than the Camptosar arm( (Irinotecan)"

"After the initial two cycles, patients in the Control group (51%) were more likely to have progressive disease in the first 2 cycles compared to patients in the HA-Irinotecan group (20%)"

"34% of HA-Irinotecan patients compared to 14% of irinotecan patients completed the full 8 cycles of therapy"

If you want to look at "results" then you need to look at the difference between two survival curves over the course of the study, So the difference between FOLF(HA)Iri vs FOLFIRI at different intervals along the treatment cycle( Hazard ratio)

Perhaps refer to this presentation from side 18-

http://www.mcccresearchsymposium.org/assets/MCCC/MCCC_Speaker_Presentations/MrStevenClavant.pdf